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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis

  • Clinicaltrials.gov identifier

    NCT03934216

  • Recruitment Status

    Active, not recruiting

  • First Posted

    May 1, 2019

  • Last update posted

    August 19, 2021

Study Description

Brief summary:

The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

  • Condition or Disease:Ulcerative Colitis
  • Intervention/Treatment: Drug: BMS-986165
    Other: Placebo
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 131 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: June 2021
  • Actual Study Completion Date: April 2023

Arms and interventions

Arm Intervention/treatment
Experimental: BMS-986165
Drug: BMS-986165
Specified Dose on Specified Days
Placebo Comparator: Placebo
Other: Placebo
Specified Dose on Specified Days

Outcome Measures

  • Primary Outcome Measures: 1. Proportion of participants who achieve clinical remission (modified Mayo score) [ Time Frame: At Week 12 ]
  • Secondary Outcome Measures: 1. Proportion of participants who achieve clinical response (modified Mayo score) [ Time Frame: At Week 12 ]
  • 2. Proportion of Participants who achieve endoscopic response [ Time Frame: At Week 12 ]
  • 3. Proportion of Participants who achieve histological improvement [ Time Frame: At Week 12 ]

Eligibility Criteria

  • Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit - Must have documented diagnosis of UC of at least 3 months' duration prior to screening - Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9 points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2 Exclusion Criteria: - Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile]) - Stool positive for C. difficile toxin at screening visit - Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Locations

United States, Connecticut
Connecticut Clinical Research Foundation
Bristol

United States, Florida
University of Florida
Gainesville

United States, Florida
University of Florida
Gainesville

United States, Florida
Advanced Research Institute - New Port Richey
New Port Richey

United States, Florida
Lenus Research
Sweetwater

United States, Georgia
Atlanta Gastroenterology Associates
Suwanee

United States, Illinois
Illinois Gastroenterology Group
Glenview

United States, Louisiana
Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge
Baton Rouge

United States, Louisiana
Louisiana Research Center
Shreveport

United States, Maryland
Chevy Chase Clinical Research
Chevy Chase

United States, Michigan
Infusion Associates
Grand Rapids

United States, Minnesota
Mayo Clinic - Rochester
Rochester

United States, Nevada
Advanced Biomedical Research of America
Las Vegas

United States, New York
New York Langone Long Island Clinical Research Associates
Lake Success

United States, New York
New York University Langone Medical Center
New York

United States, Ohio
Consultants for Clinical Research
Cincinnati

United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center
Hershey

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh

United States, South Carolina
Medical University of South Carolina
Charleston

United States, South Dakota
Rapid City Medical Center
Rapid City

United States, Tennessee
Gastro One
Germantown

United States, Tennessee
Vanderbilt University Medical Center
Nashville

United States, Texas
Digestive Health Associates of Texas - Richardson
Garland

United States, Texas
Spring Gastroenterology Associates - Houston
Houston

United States, Texas
Gastroenterology Research of San Antonio
San Antonio

United States, Texas
Southern Star Research Institute - Medical Center Office
San Antonio

United States, Texas
Texas Digestive Disease Consultants - Southlake
Southlake

United States, Texas
Tyler Research Institute
Tyler

United States, Washington
Virginia Mason Medical Center
Seattle

United States, Washington
Swedish First Hill Campus
Seattle

United States, Washington
The Vancouver Clinic
Vancouver

Australia, Queensland
Princess Alexandra Hospital
Woolloongabba

Australia, South Australia
Flinders Medical Centre
Bedford Park

Australia, Victoria
The Alfred Hospital
Melbourne

Australia
Fiona Stanley Hospital
Murdoch

Belgium
GZA Ziekenhuizen campus Sint-Vincentius
Antwerpen

Belgium
Centre Hospitalier Universitaire Saint-Pierre
Brussels

Belgium
Clinique du MontLegia - CHC
Liege

Czechia
Hepato-Gastroenterology HK
Hradec Kralove

Czechia
Nemocnice Slany
Slany

France
Centre Hospitalier Universitaire de Montpellier
Montpellier cedex 5

France
Centre Hospitalier Lyon Sud
Pierre Benite Cedex

France
Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord
Saint-Etienne

France
Hopital Rangueil
Toulouse cedex 9

Germany
Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum
Berlin

Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden

Germany
Medizinische Hochschule Hannover
Hannover

Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel

Germany
EUGASTRO
Leipzig

Germany
Universitatsklinik Ulm
Ulm

Hungary
Magyar Honvedseg-Egeszsegugyi Kozpont
Budapest

Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest

Hungary
Semmelweis Egyetem
Budapest

Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen

Hungary
Bugat Pal Korhaz
Gyongyos

Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi
Bologna

Italy
Azienda Ospedaliero-Universitaria Mater Domini
Catanzaro

Italy
Clinica Medica Azienda Ospedaliera Universitaria
Messina

Italy
Azienda Ospedaliera di Padova
Padova

Italy
Fondazione IRCCS Policlinico San Matteo
Pavia

Italy
Policlinico Universitario Campus Bio-Medico
Roma

Italy
Fondazione Policlinico Tor Vergata
Roma

Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma

Italy
Istituto Clinico Humanitas
Rozzano

Japan, Aomori
National Hospital Organization Hirosaki National Hospital
Hirosaki

Japan, Fukuoka
Fukuoka University Chikushi Hospital
Chikushino

Japan, Fukuoka
Kurume University Hospital
Kurume-shi

Japan, Gunma
National Hospital Organization Takasaki General Medical Center
Takasaki

Japan, Hyogo
Hyogo College of Medicine Hospital
Nishinomiya

Japan, Kanagawa
Kitasato University Hospital
Sagamihara-shi

Japan, Shiga
Shiga University of Medical Science Hospital
Otsu

Japan, Tokyo
Tokyo Medical and Dental University, Medical Hospital
Bunkyo-ku

Japan, Tokyo
The Jikei University Hospital
Minato-ku

Japan
Saga University Hospital
Saga

Korea, Republic of
Local Institution
Daegu

Korea, Republic of
Local Institution
Daegu

Korea, Republic of
Local Institution
Daegu

Korea, Republic of
Local Institution
Incheon

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz

Poland
Osrodek Badan Klinicznych CLINSANTE Ewa Galczak-Nowak Malgorzata Trzaska
Bydgoszcz

Poland
Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Lodz

Poland
Santa Familia - Centrum Badan Profilaktyki i Leczenia
Lodz

Poland
Osrodek Badan Klinicznych Allmedica
Nowy Targ

Poland
TRIALMED CRS Piotrkow Trybunalski
Piotrkow Trybunalski

Poland
Endoskopia
Sopot

Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne
Szczecin

Poland
H-T. Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia
Tychy

Poland
Centrum Zdrowia Matki Dziecka i Mlodziezy
Warszawa

Poland
WIP Warsaw IBD Point Profesor Kierkus
Warszawa

Poland
Medical Concierge Centrum Medyczne
Warszawa

Poland
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz
Warszawa

Poland
Bodyclinic
Warszawa

Poland
LexMedica
Wroclaw

Poland
Centrum Medyczne Oporow
Wroclaw

Russian Federation
Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko
Nizhniy Novgorod

Russian Federation
Medical Center SibNovoMed
Novosibirsk

Russian Federation
Novosibirsk State Regional Clinical Hospital
Novosibirsk

Russian Federation
Medical Center Healthy Family
Novosibirsk

Russian Federation
Saratov Regional Clinical Hospital
Saratov

Russian Federation
Multidisciplinary Consultative and Diagnostic Center
Tyumen

United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley

United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge

United Kingdom
NHS Greater Glasgow and Clyde
Glasgow

United Kingdom
Imperial College Healthcare NHS Trust
London

United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT03934216 History of Changes
  • Other Study ID Numbers: IM011-024, 2018-004694-27
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: August 19, 2021
  • Last Verified: August 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Ulcer
    Colitis, Ulcerative
    Colitis