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Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

  • Clinicaltrials.gov identifier

    NCT02435992

  • Recruitment Status

    Completed

  • First Posted

    May 6, 2015

  • Result First Posted

    September 1, 2021

  • Last update posted

    September 1, 2021

Study Description

Brief summary:

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

  • Condition or Disease:Ulcerative Colitis
  • Intervention/Treatment: Drug: RPC1063
    Drug: Placebo
  • Phase: Phase 3

Detailed Description

The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 1012 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
  • Actual Study Start Date: June 2015
  • Actual Primary Completion Date: March 2020
  • Actual Study Completion Date: June 2020

Arms and interventions

Arm Intervention/treatment
Experimental: RPC1063 (Ozanimod)
1mg, daily oral administration during Induction and Maintenance periods.
Drug: RPC1063
Placebo Comparator: Placebo
Daily oral administration during Induction and Maintenance periods.
Drug: Placebo

Outcome Measures

  • Primary Outcome Measures: 1. Percentage of Participants in Clinical Remission at 10 Weeks [ Time Frame: At 10 Weeks ]
    Percentage of participants that are in Clinical remission at 10 weeks
  • 2. Percentage of Participants in Clinical Remission at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants that are in Clinical remission at 52 weeks
  • Secondary Outcome Measures: 1. Percentage of Participants With Clinical Response at 10 Weeks [ Time Frame: At 10 Weeks ]
    Percentage of participants that are in Clinical response at 10 weeks
  • 2. Percentage of Participants With Endoscopic Improvement at 10 Weeks [ Time Frame: At 10 Weeks ]
    Percentage of participants with endoscopic improvement at 10 weeks
  • 3. Percentage of Participants With Mucosal Healing at 10 Weeks [ Time Frame: At 10 Weeks ]
    Percentage of participants with mucosal healing at 10 weeks
  • 4. Percentage of Participants in Clinical Response at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants that are in Clinical response at 52 weeks
  • 5. Percentage of Participants With Endoscopic Improvement at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants with endoscopic improvement at 52 weeks
  • 6. Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10 [ Time Frame: At 52 Weeks ]
    Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10
  • 7. Percentage of Participants With Corticosteroid Free Remission at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants with corticosteroid free remission at 52 weeks
  • 8. Percentage of Participants With Mucosal Healing at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants with Mucosal Healing at 52 weeks
  • 9. Percentage of Participants With Durable Clinical Remission at 52 Weeks [ Time Frame: At 52 Weeks ]
    Percentage of participants with durable clinical remission at 52 weeks

Eligibility Criteria

  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: Aged 18 to 75 years (at screening for Cohort 1 and 2) UC confirmed on endoscopy Moderately to severely active UC (May score 6-12) Currently receiving treatment with aminosalisylate, prednisone, or budesonide Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization Exclusion Criteria: Have severe extensive colitis as evidence by: Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline. Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation. Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk History of uveitis or unknown macular edema Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening

Contacts and Locations

Contacts

Locations

United States, Arizona
Arizona Digestive Health
Sun City

United States, Arizona
Adobe Clinical Research LLC
Tucson

United States, Arkansas
Arkansas Gastroenterology, P.A.
North Little Rock

United States, California
Anaheim Clinical Trials
Anaheim

United States, California
Aurora Care Clinic
Costa Mesa

United States, California
Valley View Internal Medicine
Garden Grove

United States, California
Davita Clinical Trials, LLC
Huntington Beach

United States, California
University of California San Diego Medical Center
La Jolla

United States, California
OM Research
Lancaster

United States, California
University of Southern California - Keck School of Medicine
Los Angeles

United States, California
Southern California Research Institute Medical Group, Inc.
Los Angeles

United States, California
Gastrointestinal Biosciences
Los Angeles

United States, California
UCLA Medical Center
Los Angeles

United States, California
Facey Medical Foundation (Parent)
Mission Hills

United States, California
Alliance Clinical Research, LLC
Oceanside

United States, California
Medical Associates Research Group, Inc.
San Diego

United States, California
University of California at San Francisco (PARENT)
San Francisco

United States, Connecticut
Medical Research Center of Connecticut, LLC
Hamden

United States, Florida
Gastro Florida
Clearwater

United States, Florida
Clinical Research of West Florida Inc - Clearwater
Clearwater

United States, Florida
Advanced Pharma Research, Inc
Delray Beach

United States, Florida
Universal Axon Clinical Research
Doral

United States, Florida
Dolphin Medical Research
Doral

United States, Florida
South Florida Clinical Trials
Hialeah

United States, Florida
Florida Center for Gastroenterology
Largo

United States, Florida
City Medical Group
Miami

United States, Florida
Advanced Clincial Research
Miami

United States, Florida
Advanced Clinical Research of Miami
Miami

United States, Florida
Regenerate Clinical Trials
Miami

United States, Florida
Advanced Research for Health Improvement
Naples

United States, Florida
Advanced Research Institute, Inc.
New Port Richey

United States, Florida
NSB Research
New Smyrna Beach

United States, Florida
Harmony Clinical Research
North Miami Beach

United States, Florida
Med-Care Research
North Miami Beach

United States, Florida
Center For Digestive Health
Orlando

United States, Florida
IMIC, Inc.
Palmetto Bay

United States, Florida
DBC Research, Corp
Pembroke Pines

United States, Florida
Theia Clinical Research, LLC
Pinellas Park

United States, Florida
Florida Medical Clinic, P.A.
Zephyrhills

United States, Georgia
Atlanta Gastroenterology Associates LLC
Atlanta

United States, Georgia
Gastrointestinal Specialists of Georgia, PC
Marietta

United States, Idaho
Grand Teton Research Group, PLLC
Idaho Falls

United States, Illinois
Northwestern University Feinberg Sch of Medicine Division of Gastroenterology
Chicago

United States, Illinois
University of Chicago Medical Center
Chicago

United States, Illinois
DM Clinical Research
Oak Lawn

United States, Illinois
Carle Foundation Hospital
Urbana

United States, Indiana
Indiana University Hospital
Indianapolis

United States, Kansas
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka

United States, Kentucky
University of Kentucky Medical Center
Lexington

United States, Kentucky
University of Louisville
Louisville

United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge

United States, Maryland
University of Maryland Medical Group
Baltimore

United States, Maryland
Woodholme Gastroenterology
Baltimore

United States, Maryland
Johns Hopkins Clinical Research Network
Baltimore

United States, Maryland
Chevy Chase Clinical Research
Chevy Chase

United States, Maryland
Gastro Center of Maryland
Columbia

United States, Maryland
Charm City Research Group
Towson

United States, Massachusetts
Boston Medical Center
Boston

United States, Massachusetts
Commonwealth Clinical Studies, PLLC.
Brockton

United States, Massachusetts
Community Clinical Research Network
Marlborough

United States, Michigan
University of Michigan Health System
Ann Arbor

United States, Michigan
Center For Digestive Health
Troy

United States, Minnesota
Mayo Clinic
Rochester

United States, Missouri
Ehrhardt Clinical Research, LLC
Belton

United States, Missouri
Clinical Research Professionals, LLC - De Paul Medical Dr
Bridgeton

United States, Missouri
Washington University
Saint Louis

United States, Missouri
Clinical Research Professionals LLC - The Pines Court
Saint Louis

United States, Missouri
Clinical Research Professionals, LLC - Olde Cabin Rd
Saint Louis

United States, Missouri
Mercy Research
Springfield

United States, New Hampshire
Mary Hitchcock Memorial Hospital
Lebanon

United States, New York
Montefiore Medical Center
Bronx

United States, New York
NY Scientific
Brooklyn

United States, New York
Long Island Clinical Research Associates
Great Neck

United States, New York
Icahn School of Medicine Mount Sinai Beth Isreal
New York

United States, New York
Concord Medical Group PRIME
New York

United States, New York
New York University School of Medicine
New York

United States, New York
Weill Cornell Medical College
New York

United States, New York
Mount Sinai - PRIME
New York

United States, North Carolina
Asheville Gastroenterology Associates, P.A.
Asheville

United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill

United States, North Carolina
Carolinas HealthCare System Digestive Health
Charlotte

United States, North Carolina
East Carolina Gastroenterology, PA
Jacksonville

United States, North Carolina
Kinston Medical Specialists, PA
Kinston

United States, North Carolina
PMG Research of Rocky Mount, LLC
Rocky Mount

United States, Ohio
UC Health Clinical Trials Office
Cincinnati

United States, Ohio
The Cleveland Clinic Foundation
Cleveland

United States, Ohio
Ohio State University Clinical Trials Management Office
Columbus

United States, Ohio
Clinical Inquest Center Ltd
Springfield

United States, Oklahoma
University of Oklahoma
Oklahoma City

United States, Oklahoma
Digestive Disease Specialists
Oklahoma City

United States, Oregon
Oregon Health & Science University
Portland

United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia

United States, South Carolina
Consultants in Gastroenterology, PA
Columbia

United States, South Carolina
Gastroenterology Associates of Orangeburg
Orangeburg

United States, Tennessee
Gastro One
Germantown

United States, Tennessee
Vanderbilt University Medical Center
Nashville

United States, Texas
Baylor Research Institute
Dallas

United States, Texas
Brooke-Army Medical Center
Fort Sam Houston

United States, Texas
Ventavia Research Group, LLC
Fort Worth

United States, Texas
Gulf Coast Research Group LLC
Houston

United States, Texas
The Methodist Hospital Research Institute
Houston

United States, Texas
Houston Endoscopy and Research Center
Houston

United States, Texas
Gastroenterology Research of San Antonio, LLC
San Antonio

United States, Texas
San Antonio Gastroenterology
San Antonio

United States, Texas
Texas Digestive Disease Consultants - Southlake
Southlake

United States, Texas
Spring Gastroenterology
Spring

United States, Texas
Digestive Health Specialists of Tyler
Tyler

United States, Utah
University of Utah
Salt Lake City

United States, Virginia
University of Virginia
Charlottesville

United States, Virginia
Gastroenterology Associates of Tidewater
Chesapeake

United States, Virginia
Gastroenterology, LTD
Virginia Beach

United States, Washington
Benaroya Research Institute at Virginia Mason
Seattle

United States, Washington
University of Washington Medical Center
Seattle

Argentina
Hospital Italiano
Buenos Aires

Argentina
Instituto DAMIC Fundacion Rusculleda
Cordoba

Argentina
Hospital Italiano de La Plata
La Plata

Argentina
Instituto Medico CER
Quilmes

Argentina
Instituto Medico de la Fundacion Estudios Clinicos
Rosario

Australia, New South Wales
Centre For Digestive Diseases
Five Dock

Australia, New South Wales
Nepean Hospital
Kingswood

Australia, Queensland
Mater Hospital Brisbane
South Brisbane

Australia, Queensland
Princess Alexandra Hospital
Woolloongabba

Australia, South Australia
Royal Adelaide Hospital
Adelaide

Australia, Victoria
Cabrini Hospital Malvern
Malvern

Australia, Victoria
The Alfred Hospital
Melbourne

Australia
Monash Medical Centre Clayton
Bentleigh East

Australia
Royal Prince Alfred Hospital
Camperdown

Austria
Medical University Vienna
Vienna

Belarus
Gomel Regional Clinical Hospital
Gomel

Belarus
City Clinical Hospital No 10
Minsk

Belarus
Vitebsk Regional Clinical Hospital
Vitebsk

Belgium
Imeldaziekenhuis
Bonheiden

Belgium
AZ Maria Middelares
Gent

Belgium
Universitair Ziekenhuis Gent
Gent

Belgium
UZ Leuven
Leuven

Belgium
CHC - Clinique St-Jospeh
Liege

Bulgaria
Medical Centre "Asklepii", OOD
Dupnitsa

Bulgaria
UMHAT 'Dr. Georgi Stranski', EAD
Pleven

Bulgaria
UMHAT "Kaspela", EOOD
Plovdiv

Bulgaria
MC Rusemed ltd.
Ruse

Bulgaria
NMTH "Tsar Boris III"
Sofia

Bulgaria
MHAT "Lyulin", EAD
Sofia

Bulgaria
City Clinic UMHAC EOOD
Sofia

Bulgaria
MHAT 'Tokuda Hospital Sofia', EAD
Sofia

Bulgaria
UMHAT 'Tsaritsa Yoanna - ISUL', EAD
Sofia

Bulgaria
Fourth MHAT - Sofia EAD
Sofia

Bulgaria
UMHAT 'Sveta Anna' AD
Sofia

Bulgaria
UMHAT "SofiaMed", OOD
Sofia

Bulgaria
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora

Bulgaria
MHAT 'Sv. Marina', EAD
Varna

Bulgaria
MC Medica Plus
Veliko Tarnovo

Canada, British Columbia
Vancouver General Hospital
Vancouver

Canada, Manitoba
Brandon Medical Arts Clinic
Brandon

Canada, Ontario
Viable Clinical Research - Lindsay
Lindsay

Canada, Ontario
LHSC - University Hospital
London

Canada, Ontario
LHSC - Victoria Hospital
London

Canada, Ontario
Humber River Hospital
Toronto

Canada, Ontario
Mount Sinai Hospital
Toronto

Canada, Ontario
Toronto Liver Centre
Toronto

Canada, Ontario
Toronto Digestive Disease Associates, Inc.
Vaughan

Canada, Quebec
Centre integre de sante et de services sociaux de la Monteregie-Centre - Hopital Charles-Le Moyne
Greenfield Park

Canada, Quebec
The Ottawa Hospital - General Campus
Ottawa

Canada, Quebec
CHUS - Hôpital Fleurimont
Sherbrooke

Croatia
Clinical Hospital Center Osijek
Osijek

Croatia
Clinical Hospital Centre Rijeka
Rijeka

Croatia
Clinical Hospital "Sveti Duh", Clinic of Internal Diseases
Zagreb

Croatia
Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases
Zagreb

Croatia
Clinical Hospital Dubrava, Clinic of Internal Medicine, Department of Gastroenterology
Zagreb

Czechia
Vojenska nemocnice Brno
Brno

Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove

Czechia
GASTRO JeKa s.r.o.
Klatovy

Czechia
Gregar s.r.o.
Olomouc

Czechia
PreventaMed
Olomouc

Czechia
ISCARE, a.s.
Prague 9

Czechia
Institut klinicke a experimentalni mediciny
Praha 4

Czechia
Thomayerova nemocnice
Praha 4

Czechia
Nemocnice Slany
Slany

Georgia
LTD Research Institute of Clinical Medicine
Tbilisi

Georgia
LLC Vivamedi
Tbilisi

Georgia
LTD Academician N.Kipshidze Central University Clinic
Tbilisi

Georgia
LTD Aversi Clinic
Tbilisi

Georgia
LTD Coloproctological Center
Tbilisi

Germany
Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin
Berlin

Germany
Charite - Campus Virchow-Klinikum
Berlin

Germany
DRK Kliniken Berlin Westend
Berlin

Germany
Medical Care Unit Dachau
Dachau

Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden

Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt

Germany
Crohn Colitis Centrum Rhein Main
Frankfurt

Germany
Universitaetsklinikum Freiburg
Freiburg

Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg

Germany
Asklepios Klinik Hamburg
Hamburg

Germany
Medizinische Hochschule Hannover
Hannover

Germany
Universitaetsklinikum Koeln
Koeln

Germany
EUGASTRO GmbH
Leipzig

Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Luebeck

Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz

Germany
Universitatsklinikum Ulm
Ulm

Greece
Laiko General Hospital of Athens
Athens

Greece
University General Hospital of Heraklion
Heraklion

Greece
University General Hospital of Larissa
Larissa Thessaly

Greece
General Hospital of Thessaloniki Hippokration
Thessaloniki

Greece
424th Army General Hospital
Thessaloniki

Hungary
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfured

Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
Bekescsaba

Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest

Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest

Hungary
Semmelweis Egyetem
Budapest

Hungary
Pannonia Maganorvosi Centrum
Budapest

Hungary
Szent Margit Korhaz
Budapest

Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen

Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Gyula

Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvar

Hungary
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
Letavertes

Hungary
Mohacsi Korhaz
Mohacs

Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza

Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Szekesfehervar

Israel
Wolfson Medical Center
Holon

Israel
Shaare Zedek Medical Center
Jerusalem

Israel
Meir Medical Center
Kfar Saba

Israel
Chaim Sheba Medical Center
Ramat Gan

Israel
Kaplan Medical Center
Rechovot

Israel
Tel Aviv Sourasky Medical Center
Tel Aviv

Italy
Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
Bologna

Italy
Azienda Ospedaliera Universitaria Careggi
Firenze

Italy
Azienda Ospedaliero Universitaria San Martino
Genova

Italy
Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale Sacco
Milano

Italy
A.O.U. Policlinico di Modena
Modena

Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza

Italy
Azienda Ospedaliera Universitaria "Federico II"
Napoli

Italy
Fondazione IRCCS Policlinico San Matteo
Pavia

Italy
Azienda Ospedaliero Universitaria Pisana
Pisa

Italy
Complesso Integrato Columbus
Roma

Italy
Istituto Clinico Humanitas
Rozzano (MI)

Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo FG

Korea, Republic of
Inje University Haeundae Paik Hospital
Busan

Korea, Republic of
Yeungnam University Hospital
Daegu

Korea, Republic of
Konyang University Hospital
Daejeon

Korea, Republic of
Hanyang Univerisy Guri Hospital
Guri-si

Korea, Republic of
CHA Bundang Medical Center CHA University
Seongnam-si,

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam

Korea, Republic of
Kyung Hee University Hospital
Seoul

Korea, Republic of
Seoul National University Hospital
Seoul

Korea, Republic of
Samsung Medical Center
Seoul

Korea, Republic of
Korea University Anam Hospital
Seoul

Korea, Republic of
Asan Medical Center
Seoul

Korea, Republic of
Kangbuk Samsung Hospital
Seoul

Korea, Republic of
Severance Hospital, Yonsei University
Seoul

Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul

Korea, Republic of
The Catholic University of Korea, St.Vicent's Hospital
Suwon

Korea, Republic of
Yonsei University Wonju Severance Christian Hospital
Wonju-Si

Latvia
Pauls Stradins Clinical University Hospital
Riga

Moldova, Republic of
"Sfanta Treime" Clinical Municipal Hospital
Chisinau

Moldova, Republic of
Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery
Chisinau

Moldova, Republic of
"Sf. Arhanghel Mihail" Municipal Clinical Hospital
Chisinau

Moldova, Republic of
Republican Clinical Hospital
Chisinau

Netherlands
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam

Netherlands
Academisch Medisch Centrum
Amsterdam

Netherlands
Universitair Medisch Centrum Groningen (UMCG)
Groningen

Netherlands
Maastricht University Medical Center
Maastrich

Netherlands
Zuyderland Medisch Centrum - Sittard-Geleen
Sittard-Geleen

Netherlands
ETZ Elisabeth
Tilburg

New Zealand
Christchurch Hospital NZ
Christchurch

New Zealand
Dunedin Public Hospital
Dunedin

Poland
Clinsante S.C. Osrodek Badan Klinicznych
Bydgoszcz

Poland
Specjalistyczna Przychodnia Lekarska Medicus
Chorzow

Poland
GLOBE Clinical Research Sp. z o.o. LLC
Klodzko

Poland
PLEJADY Sp. z o.o. (LLC) Medical Centre
Krakow

Poland
Centrum Medyczne A-Z Clinic
Kraków

Poland
Healthcare Center Orkan Med Stec Michalska Spolka Jawna
Ksawerow

Poland
Santa Familia Centrum Badan, Profilaktyki i Leczenia
Lodz

Poland
KO-MED Centra Kliniczne Lublin II
Lublin

Poland
Trialmed Llc
Piotrkow Trybunalski

Poland
SOLUMED Centrum Medyczne
Poznan

Poland
Specjalistyczna Praktyka Lekarska dr med. Marek Horynski
Sopot

Poland
KO-MED Centra Kliniczne Staszow
Staszow

Poland
GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe
Torun

Poland
MDM Healthcare Centre
Warsaw

Poland
Nzoz Vivamed
Warsaw

Poland
Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice
Wierzchoslawice

Poland
LexMedica Osrodek Badan Klinicznych
Wroclaw

Romania
Bacau County Emergency Hospital, Department of Gastroenterology
Bacau

Romania
Hyperclinica MedLife Grivita
Bucharest

Romania
Bucharest University Emergency Hospital, Department of Internal Medicine II
Bucharest

Romania
TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy
Cluj-Napoca

Romania
Sf. Apostol Andrei Constanta Emergency Clinical County Hospital
Constanta

Romania
Craiova County Emergency Clinical Hospital
Craiova

Romania
"Pius Brinzeu" County Emergency Clinical Hospital, Department of Gastroenterology and Hepatology
Timisoara

Russian Federation
Multidisciplinary Medical Clinic "Anthurium"
Barnaul

Russian Federation
Road Clinical Hospital on Station Irkutsk-Passazhirskiy of OJSC Russian Railways
Irkutsk

Russian Federation
SBEI HPE "Kazan State Medical University" of the MoH of the RF
Kazan

Russian Federation
FSBIH "Central Clinical Hospital of Russian Academy of Sciences"
Moscow

Russian Federation
SBIH of Nizhniy Novgorod region " Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"
Nizhniy Novgorod

Russian Federation
SBEIHPE Novosibirsk State Medical University
Novosibirsk

Russian Federation
FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS
Novosibirsk

Russian Federation
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk

Russian Federation
SBEI HPE Rostov State Medical University of the MoH of the RF
Rostov-on-Don

Russian Federation
SBIH City Clinical Hospital #31
Saint Petersburg

Russian Federation
Union Clinic
Saint-Peterburg

Russian Federation
FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Ministry of Defense of Russia
Saint-Petersburg

Russian Federation
SPb SBIH City Hospital # 26
Saint-Petersburg

Russian Federation
Pavlov First Saint Petersburg State Medical University
Saint-Petersburg

Russian Federation
Private Educational Institution of Higher Education "Medical University "REAVIZ"
Samara

Russian Federation
LLC Medical Company Hepatologist
Samara

Russian Federation
FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"
St. Petersburg

Russian Federation
SPb SBIH Alexandrovskaya City Hospital
St.Petersburg

Russian Federation
SBEI HPE "Stavropol State Medical Academy" MoH of RF
Stavropol

Russian Federation
Regional Clinical Hospital
Vladimir

Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine
Belgrade

Serbia
Clinical Center of Serbia, Clinic of Gastroenterology and Hepatology, Department of Gastroenterology
Belgrade

Serbia
Clinical Hospital Center Zvezdara Clinic of Internal Diseases
Belgrade

Serbia
Military Medical Academy, Clinic of Gastroenterology and Hepatology
Belgrade

Serbia
Clinical Hospital Center Zemun Department of Gastroenterology
Belgrade

Serbia
Clinical Center Kragujevac, Clinic of Internal Medicine, Center for Gastroenterohepatology
Kragujevac

Serbia
Clinical Center Nis, Clinic of Gastroenterology and Hepatology
Nis

Serbia
General Hospital Djordje Jovanovic Zrenjanin
Zrenjanin

Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banska Bystrica

Slovakia
Alian s.r.o.
Bardejov

Slovakia
PRO SANUS, a.s., Poliklinika ProCare Central
Bratislava

Slovakia
IBDcentrum s.r.o.
Bratislava

Slovakia
Slovak Research Center-team member, Sukromna gastroenterologicka ambulancia
Ilava

Slovakia
Gastroped s.r.o.
Kosice

Slovakia
Gastroeneterologicka ambulancia MUDr. Peter Hegyi, s.r.o.
Malacky

Slovakia
PIGEAS s.r.o.
Martin

Slovakia
Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
Michalovce

Slovakia
Gastromedic s.r.o.
Nove Zamky

Slovakia
EndoCorp s.r.o.
Trnava

South Africa
Dr MJ Prins Practice
Cape Town

South Africa
Tiervlei Trial Centre
Cape Town

South Africa
Endocare Research
Cape Town

South Africa
Dr JP Wright Practice
Cape Town

South Africa
Dr YS Nanabhay Practice
Johannesburg

South Africa
Emmed Research
Pretoria

Spain
University Hospital Germans Trias i Pujol
Badalona

Spain
University Hospital of the Canary Islands (HUC) La Laguna
La Laguna

Spain
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria

Spain
University Hospital Virgen del Rocio
Sevilla

Ukraine
RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU
Chernivtsi

Ukraine
Dnipropetrovsk I.I. Mechnykov Regional Clinical Hospital
Dnipropetrovsk

Ukraine
Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases
Dnipropetrovsk

Ukraine
Ivano-Frankivsk City Clinical Hospital #1 Dep of Surgery SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk

Ukraine
Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk

Ukraine
CI of PH Kharkiv CCH #2
Kharkiv

Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv

Ukraine
Kyiv City Clinical Hospital #1
Kyiv

Ukraine
SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
Kyiv

Ukraine
CI of Kyiv RC Regional Clinical Hospital #2
Kyiv

Ukraine
Kyiv CCH #8 Dept of Gastroenterology P.L. Shupyk NMA of PGE
Kyiv

Ukraine
Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU
Kyiv

Ukraine
Lviv Regional Clinical Hospital
Lviv

Ukraine
Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU
Lviv

Ukraine
CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU
Sumy

Ukraine
Sumy Regional Clinical Hospital
Sumy

Ukraine
CI of TRC Ternopil University Hospital
Ternopil

Ukraine
A. Novak Transcarpathian Regional Clinical Hospital
Uzhgorod

Ukraine
MCIC MC LLC Health Clinic
Vinnytsia

Ukraine
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War
Vinnytsia

Ukraine
M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
Vinnytsia

Ukraine
Vinnytsia M.I. Pyrohov Regional Clinical Hospital
Vinnytsia

Ukraine
Vinnytsia M.I. Pyrohov National Medical University
Vinnytsia

Ukraine
City Clinical Hospital of Emergency and Urgent Care of Zaporizhzhya
Zaporizhia

Ukraine
Zaporizhia City Multispecialty Clinical Hospital #9, Department of Neurology
Zaporizhia

Ukraine
CI City Hospital #1
Zaporizhia

Ukraine
CI Zapor City Multifunctional CH#9 City Center of Gastroenterology SI Zapor MA of PGE of MOHU
Zaporizhzhia

Ukraine
Zaporizhia Regional Clinical Hospital
Zaporizhzhia

Ukraine
Central District Hospital under Zhytomyr District Council
Zhytomyr

United Kingdom
University Hospital Coventry
Coventry

United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter

United Kingdom
Gloucestershire Royal Hospital
Gloucester

United Kingdom
Whipps Cross University Hospital
London

United Kingdom
St Thomas' Hospital
London

United Kingdom
Royal Shrewsbury Hospital
Shrewsbury

Sponsors and Collaborators

Celgene

Investigators

Study Director: AnnKatrin Petersen, M.D., MSc. Celgene

More Information

  • Study Type: Interventional
  • Study Design: Allocation: Randomized;Intervention Model: Parallel Assignment;Masking: Quadruple;Primary Purpose: Treatment
  • Condition: Ulcerative Colitis
  • Interventions : Drug: RPC1063
    Drug: Placebo
  • Enrollment: 1012

Participant flow

  • Recruitment Details
  • Pre-assignment Details 1012 Participants randomized and treated

  • Arm/Group title RPC1063 Cohort 1 (Induction Period) Placebo Cohort 1 (Induction Period) RPC1063 Cohort 2 (Induction Period) RPC1063 (Maintenance Period) Placebo (Maintenance Period)
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule) -Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner. Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule) - Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule) - Blinded Placebo
    Period Title: Overall Study
  • Started 429 216 367 0 0
  • Completed 401 192 324 0 0
  • Not Completed 28 24 43 0 0
  • Reason Not Completed
  • non compliance with protocol 2 1
  • Adverse Event 11 6 12
  • Lack of Efficacy 4 10 9
  • Withdrawal by Subject 10 8 20
  • Other Reason 1
  • Physician Decision 1

Baseline Characteristics

  • Arm/Group title RPC1063 Cohort 1(Induction Period)Placebo Cohort 1 (Induction Period)RPC1063 Cohort 2 (Induction Period)RPC1063 (Maintenance Period)Placebo (Maintenance Period)Total
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)- Blinded PlaceboTotal of all reporting groups
  • Overall Number of Baseline Participants 4292163672302271469
  • Baseline Analysis Population Description [Not Specified]

Outcome Measures

1. PrimaryOutcome

  • Title Percentage of Participants in Clinical Remission at 10 Weeks
  • Description Percentage of participants that are in Clinical remission at 10 weeks
  • Time Frame At 10 Weeks
Outcome Measure Data
  • Analysis Population Description ITT Population
  •  
  • Arm/Group title RPC1063 Cohort 1(Induction Period)Placebo Cohort 1 (Induction Period)RPC1063 Cohort 2 (Induction Period)RPC1063 (Maintenance Period)Placebo (Maintenance Period)
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)- Blinded Placebo
  • Overall Number of Participants Analyzed 429216367
  • Measure Type: Number
    Unit of Measure: Percentage
  • 18.4
    6.0
    21.0


  • Statistical Analysis Overview
    • Comparison Group Selection Percentage of Participants in Clinical Remission at 10 Weeks
    • Comments
    • Type of Statistical Test Superiority
    • Comments [Not Specified]
  • Statistical Test of Hypothesis
    • P-Value 0.0001
    • Comments
    • Method Cochran-Mantel-Haenszel
    • Comments
  • Method of Estimation
    • Estimation Parameter Odds Ratio (OR)
    • Estimated Value 3.586
    • Confidence Interval (2-Sided ) 95.0%
      1.938 to 6.636
    • Estimation Comments [Not Specified]

2. PrimaryOutcome

  • Title Percentage of Participants in Clinical Remission at 52 Weeks
  • Description Percentage of participants that are in Clinical remission at 52 weeks
  • Time Frame At 52 Weeks
Outcome Measure Data
  • Analysis Population Description ITT Population
  •  
  • Arm/Group title RPC1063 Cohort 1(Induction Period)Placebo Cohort 1 (Induction Period)RPC1063 Cohort 2 (Induction Period)RPC1063 (Maintenance Period)Placebo (Maintenance Period)
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)- Blinded Placebo
  • Overall Number of Participants Analyzed 69230227
  • Measure Type: Number
    Unit of Measure: Percentage

  • 24.6

    37.0
    18.5
  • Statistical Analysis Overview
    • Comparison Group Selection Percentage of Participants in Clinical Remission at 10 Weeks, Percentage of Participants in Clinical Remission at 52 Weeks
    • Comments
    • Type of Statistical Test Superiority
    • Comments [Not Specified]
  • Statistical Test of Hypothesis
    • P-Value 0.0001
    • Comments
    • Method Cochran-Mantel-Haenszel
    • Comments
  • Method of Estimation
    • Estimation Parameter Odds Ratio (OR)
    • Estimated Value 2.755
    • Confidence Interval (2-Sided ) 95.0%
      1.767 to 4.294
    • Estimation Comments [Not Specified]

3. SecondaryOutcome

  • Title Percentage of Participants With Clinical Response at 10 Weeks
  • Description Percentage of participants that are in Clinical response at 10 weeks
  • Time Frame At 10 Weeks
Outcome Measure Data
  • Analysis Population Description ITT Population
  •  
  • Arm/Group title RPC1063 Cohort 1(Induction Period)Placebo Cohort 1 (Induction Period)RPC1063 Cohort 2 (Induction Period)RPC1063 (Maintenance Period)Placebo (Maintenance Period)
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)- Blinded Placebo
  • Overall Number of Participants Analyzed 429216367
  • Measure Type: Number
    Unit of Measure: Percentage
  • 47.8
    25.9
    52.6


4. SecondaryOutcome

  • Title Percentage of Participants With Endoscopic Improvement at 10 Weeks
  • Description Percentage of participants with endoscopic improvement at 10 weeks
  • Time Frame At 10 Weeks
Outcome Measure Data
  • Analysis Population Description ITT Population
  •  
  • Arm/Group title RPC1063 Cohort 1(Induction Period)Placebo Cohort 1 (Induction Period)RPC1063 Cohort 2 (Induction Period)RPC1063 (Maintenance Period)Placebo (Maintenance Period)
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)- Blinded Placebo
  • Overall Number of Participants Analyzed 429216367
  • Measure Type: Number
    Unit of Measure: Percentage
  • 27.3
    11.6
    27.2


5. SecondaryOutcome

  • Title Percentage of Participants With Mucosal Healing at 10 Weeks
  • Description Percentage of participants with mucosal healing at 10 weeks
  • Time Frame At 10 Weeks
Outcome Measure Data
  • Analysis Population Description ITT Population
  •  
  • Arm/Group title RPC1063 Cohort 1(Induction Period)Placebo Cohort 1 (Induction Period)RPC1063 Cohort 2 (Induction Period)RPC1063 (Maintenance Period)Placebo (Maintenance Period)
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)- Blinded Placebo
  • Overall Number of Participants Analyzed 429216367
  • Measure Type: Number
    Unit of Measure: Percentage
  • 12.6
    3.7
    11.4


6. SecondaryOutcome

  • Title Percentage of Participants in Clinical Response at 52 Weeks
  • Description Percentage of participants that are in Clinical response at 52 weeks
  • Time Frame At 52 Weeks
Outcome Measure Data
  • Analysis Population Description ITT Population
  •  
  • Arm/Group title RPC1063 Cohort 1(Induction Period)Placebo Cohort 1 (Induction Period)RPC1063 Cohort 2 (Induction Period)RPC1063 (Maintenance Period)Placebo (Maintenance Period)
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)- Blinded Placebo
  • Overall Number of Participants Analyzed 69230227
  • Measure Type: Number
    Unit of Measure: Percentage

  • 39.1

    60.0
    41.0

7. SecondaryOutcome

  • Title Percentage of Participants With Endoscopic Improvement at 52 Weeks
  • Description Percentage of participants with endoscopic improvement at 52 weeks
  • Time Frame At 52 Weeks
Outcome Measure Data
  • Analysis Population Description ITT Population
  •  
  • Arm/Group title RPC1063 Cohort 1(Induction Period)Placebo Cohort 1 (Induction Period)RPC1063 Cohort 2 (Induction Period)RPC1063 (Maintenance Period)Placebo (Maintenance Period)
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)- Blinded Placebo
  • Overall Number of Participants Analyzed 69230227
  • Measure Type: Number
    Unit of Measure: Percentage

  • 29.0

    45.7
    26.4

8. SecondaryOutcome

  • Title Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10
  • Description Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10
  • Time Frame At 52 Weeks
Outcome Measure Data
  • Analysis Population Description ITT Population who were in remission at week 10
  •  
  • Arm/Group title RPC1063 Cohort 1(Induction Period)Placebo Cohort 1 (Induction Period)RPC1063 Cohort 2 (Induction Period)RPC1063 (Maintenance Period)Placebo (Maintenance Period)
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)- Blinded Placebo
  • Overall Number of Participants Analyzed 127975
  • Measure Type: Number
    Unit of Measure: Percentage

  • 41.7

    51.9
    29.3

9. SecondaryOutcome

  • Title Percentage of Participants With Corticosteroid Free Remission at 52 Weeks
  • Description Percentage of participants with corticosteroid free remission at 52 weeks
  • Time Frame At 52 Weeks
Outcome Measure Data
  • Analysis Population Description ITT Population
  •  
  • Arm/Group title RPC1063 Cohort 1(Induction Period)Placebo Cohort 1 (Induction Period)RPC1063 Cohort 2 (Induction Period)RPC1063 (Maintenance Period)Placebo (Maintenance Period)
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)- Blinded Placebo
  • Overall Number of Participants Analyzed 69230227
  • Measure Type: Number
    Unit of Measure: Percentage

  • 24.6

    31.7
    16.7

10. SecondaryOutcome

  • Title Percentage of Participants With Mucosal Healing at 52 Weeks
  • Description Percentage of participants with Mucosal Healing at 52 weeks
  • Time Frame At 52 Weeks
Outcome Measure Data
  • Analysis Population Description ITT Population
  •  
  • Arm/Group title RPC1063 Cohort 1(Induction Period)Placebo Cohort 1 (Induction Period)RPC1063 Cohort 2 (Induction Period)RPC1063 (Maintenance Period)Placebo (Maintenance Period)
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)- Blinded Placebo
  • Overall Number of Participants Analyzed 69230227
  • Measure Type: Number
    Unit of Measure: Percentage

  • 10.1

    29.6
    14.1

11. SecondaryOutcome

  • Title Percentage of Participants With Durable Clinical Remission at 52 Weeks
  • Description Percentage of participants with durable clinical remission at 52 weeks
  • Time Frame At 52 Weeks
Outcome Measure Data
  • Analysis Population Description ITT Population
  •  
  • Arm/Group title RPC1063 Cohort 1(Induction Period)Placebo Cohort 1 (Induction Period)RPC1063 Cohort 2 (Induction Period)RPC1063 (Maintenance Period)Placebo (Maintenance Period)
  • Arm/Group Description Blinded On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.Open Label On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule) On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules) On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)- Blinded Placebo
  • Overall Number of Participants Analyzed 69230227
  • Measure Type: Number
    Unit of Measure: Percentage

  • 7.2

    17.8
    9.7

Adverse Events

  • Time Frame Approximately up to 52 Weeks
  • Adverse Event Reporting Description Participant overlap due to re randomization occuring before maintenance phase
  •  
  • Arm/Group Title Cohort 2 (Induction Period): RPC1063 1mgIntervention (Maintenance Period): RPC1063 1mgPlacebo (Maintenance Period): PlaceboCohort 1 (Induction Period): RPC1063 1mgCohort 1: Placebo
  • Arm/Group Description Cohort 2 (Induction Period): RPC1063 1mgIntervention (Maintenance Period): RPC1063 1mgPlacebo (Maintenance Period): PlaceboCohort 1 (Induction Period): RPC1063 1mgCohort 1: Placebo

Serious Adverse Events

  • Cohort 1 (Induction Period): RPC1063 1mg Cohort 1: Placebo Cohort 2 (Induction Period): RPC1063 1mg Intervention (Maintenance Period): RPC1063 1mg Placebo (Maintenance Period): Placebo
  • Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
  • Total 0/429 (0.00%) 0/216 (0.00%) 0/367 (0.00%) 1/230 (0.43%) 1/227 (0.44%)
  • Blood and lymphatic system disorders
  • Anaemia 4 /429 (0.93%) 0 /216 (0.00%) 1 /367 (0.27%) 1 /230 (0.43%) 0 /227 (0.00%)
  • Cardiac disorders
  • Angina pectoris 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Coronary artery stenosis 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Pericarditis 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 1 /230 (0.43%) 0 /227 (0.00%)
  • Eye disorders
  • Cataract 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 1 /230 (0.43%) 0 /227 (0.00%)
  • Photophobia 1 /429 (0.23%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Gastrointestinal disorders
  • Enterocolitis 0 /429 (0.00%) 1 /216 (0.46%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Colitis ulcerative 6 /429 (1.40%) 5 /216 (2.31%) 9 /367 (2.45%) 1 /230 (0.43%) 9 /227 (3.96%)
  • Diarrhoea 0 /429 (0.00%) 1 /216 (0.46%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Diarrhoea haemorrhagic 0 /429 (0.00%) 1 /216 (0.46%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Gastritis 1 /429 (0.23%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Haemorrhoids 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Melaena 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Proctitis ulcerative 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 1 /230 (0.43%) 0 /227 (0.00%)
  • Vomiting 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 1 /227 (0.44%)
  • General disorders
  • Pyrexia 0 /429 (0.00%) 1 /216 (0.46%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Hepatobiliary disorders
  • Cholecystitis acute 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 1 /227 (0.44%)
  • Cholelithiasis 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 1 /227 (0.44%)
  • Immune system disorders
  • Food allergy 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 1 /230 (0.43%) 0 /227 (0.00%)
  • Infections and infestations
  • Bronchitis 0 /429 (0.00%) 1 /216 (0.46%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Clostridium difficile infection 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 1 /230 (0.43%) 0 /227 (0.00%)
  • Complicated appendicitis 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 2 /227 (0.88%)
  • Appendicitis 1 /429 (0.23%) 0 /216 (0.00%) 2 /367 (0.54%) 0 /230 (0.00%) 1 /227 (0.44%)
  • Gastroenteritis 0 /429 (0.00%) 0 /216 (0.00%) 2 /367 (0.54%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Gastroenteritis norovirus 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 1 /230 (0.43%) 0 /227 (0.00%)
  • Large intestine infection 0 /429 (0.00%) 1 /216 (0.46%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Measles 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 1 /227 (0.44%)
  • Nasopharyngitis 1 /429 (0.23%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Pneumonia influenzal 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Pyelonephritis 1 /429 (0.23%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Urinary tract infection 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Vestibular neuronitis 1 /429 (0.23%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Yersinia infection 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 1 /227 (0.44%)
  • Injury, poisoning and procedural complications
  • Accidental overdose 1 /429 (0.23%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Concussion 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Contusion 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Neck injury 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Road traffic accident 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Toxicity to various agents 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 1 /230 (0.43%) 0 /227 (0.00%)
  • Investigations
  • Respiratory syncytial virus test positive 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Metabolism and nutrition disorders
  • Dehydration 0 /429 (0.00%) 1 /216 (0.46%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Musculoskeletal and connective tissue disorders
  • Arthralgia 1 /429 (0.23%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Myalgia 1 /429 (0.23%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Neoplasms benign, malignant and unspecified (incl cysts and polyps)
  • Adenocarcinoma of colon 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 1 /227 (0.44%)
  • Breast cancer 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 1 /227 (0.44%)
  • Cervix carcinoma stage 0 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Rectal adenocarcinoma 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 1 /230 (0.43%) 0 /227 (0.00%)
  • Nervous system disorders
  • Headache 1 /429 (0.23%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Ischaemic stroke 1 /429 (0.23%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Syncope 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 1 /230 (0.43%) 0 /227 (0.00%)
  • Renal and urinary disorders
  • Calculus urinary 0 /429 (0.00%) 1 /216 (0.46%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Nephrolithiasis 1 /429 (0.23%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Urethral stenosis 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 0 /230 (0.00%) 1 /227 (0.44%)
  • Respiratory, thoracic and mediastinal disorders
  • Acute respiratory distress syndrome 0 /429 (0.00%) 0 /216 (0.00%) 1 /367 (0.27%) 0 /230 (0.00%) 0 /227 (0.00%)
  • Vascular disorders
  • Hypertensive crisis 0 /429 (0.00%) 0 /216 (0.00%) 0 /367 (0.00%) 1 /230 (0.43%) 1 /227 (0.44%)

Show Other (Not Including Serious) Adverse Events

  • Cohort 1 (Induction Period): RPC1063 1mg Cohort 1: Placebo Cohort 2 (Induction Period): RPC1063 1mg Intervention (Maintenance Period): RPC1063 1mg Placebo (Maintenance Period): Placebo
  • Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
  • Total 15/429 (3.50%) 13/216 (6.02%) 15/367 (4.09%) 2/230 (0.87%) 4/227 (1.76%)
  • Blood and lymphatic system disorders
  • Anaemia 15 /429 (3.50%) 13 /216 (6.02%) 15 /367 (4.09%) 2 /230 (0.87%) 4 /227 (1.76%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

No

Results Point of Contact

  • Name/Title:Bristol-Myers Squibb Study Director
  • Organization:Bristol-Myers Squibb
  • Phone:Please Email
  • EMail:Clinical.Trials@bms.com
  • ClinicalTrials.gov Identifier: NCT02435992 History of Changes
  • Other Study ID Numbers: RPC01-3101
  • First Submitted: April 24, 2015
  • First Posted: May 6, 2015
  • Results First Submitted: June 25, 2021
  • Results First Posted: September 1, 2021
  • Last Update Posted: September 1, 2021