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An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

  • Clinicaltrials.gov identifier

    NCT03599622

  • Recruitment Status

    Recruiting

  • First Posted

    July 26, 2018

  • Last update posted

    September 29, 2021

Study Description

Brief summary:

The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.

  • Condition or Disease:Granulomatous Enteritis
    Crohn's Enteritis
    Crohn's Disease
    Granulomatous Colitis
  • Intervention/Treatment: Drug: BMS-986165
    Other: Placebo
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 240 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 Crohn's Disease
  • Actual Study Start Date: July 2018
  • Estimated Primary Completion Date: May 2022
  • Estimated Study Completion Date: March 2024

Arms and interventions

Arm Intervention/treatment
Experimental: BMS-986165 Dose 1
Drug: BMS-986165
Specified dose on specified days
Experimental: BMS-986165 Dose 2
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 achieving clinical remission at Week 12 [ Time Frame: Week 12 ]
    Clinical remission defined by Crohn's Disease Activity Index (CDAI)
  • 2. Proportion of participants achieving endoscopic response at Week 12 [ Time Frame: Week 12 ]
    Endoscopic response defined by Simple Endoscopic Score for Crohn's Disease (SES-CD)
  • Secondary Outcome Measures: 1. Proportion of participants who achieve a clinical response at Week 12 [ Time Frame: Week 12 ]
  • 2. Proportion of participants who achieve PRO2 [Participant reported outcome based on the stool frequency and abdominal pain components of the Crohn's Disease Activity Index (CDAI)] remission at Week 12 [ Time Frame: Week 12 ]
  • 3. Change from baseline in SES-CD (Simple Endoscopic Score for Crohn's Disease) at Week 12 [ Time Frame: Week 12 ]
  • 4. Proportion of participants achieving endoscopic normalization at Week 12 [ Time Frame: Week 12 ]
  • 5. Proportion of participants achieving endoscopic remission at Week 12 [ Time Frame: Week 12 ]
  • 6. Proportion of participants achieving deep remission at Week 12 [ Time Frame: Week 12 ]

Eligibility Criteria

  • Ages Eligible for Study: 18 to 75 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: - Documented diagnosis of Crohn's Disease (CD) of at least 3 months' duration, including ileal, colonic, or ileo-colonic disease distribution - Must have active moderate to severe CD - Men and women must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Severe or fulminant colitis that is likely to require surgery or hospitalization - Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than Crohn's Disease - Previous exposure to BMS-986165 in any study - Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric, or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

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Local Institution
Taipei City

Taiwan
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Israel
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Israel
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United States, California
GastroIntestinal Biosciences
Los Angeles

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United States, Colorado
Kaiser Permanente Colorado Institute for Health Research
Aurora

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Hamden

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Clearwater

United States, Florida
University of Florida Health - Jacksonville
Jacksonville

United States, Florida
Mayo Clinic - Jacksonville
Jacksonville

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Lakewood Ranch

United States, Florida
Florida Center for Gastroenterology
Largo

United States, Florida
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Miami

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New Port Richey

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Orlando

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Orlando

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United States, Georgia
Atlanta Gastroenterology Specialists
Suwanee

United States, Illinois
The University of Chicago Medicine
Chicago

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Illinois Gastroenterology Group
Glenview

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Indianapolis

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Shreveport

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Troy

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Wyoming

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Ypsilanti

United States, Mississippi
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Jackson

United States, Mississippi
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Ocean Springs

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Hershey

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Pittsburgh

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Donald Guthrie Foundation for Education and Research
Sayre

United States, South Carolina
Clinical Trials of South Carolina
Charleston

United States, Tennessee
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Jackson

United States, Tennessee
Vanderbilt Inflammatory Bowel Disease Clinic
Nashville

United States, Texas
Texas Clinical Research Institute
Arlington

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

United States, Texas
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Houston

United States, Texas
Gastroenterology Research of San Antonio
San Antonio

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

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Southlake

United States, Texas
Spring Gastroenterology Associates - Houston
Spring

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Tyler

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Hunter Holmes McGuire Veterans Administration Medical Center
Richmond

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Seattle

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Vancouver

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Australia, Queensland
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South Brisbane

Australia, Queensland
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Woolloongabba

Australia, South Australia
Royal Adelaide Hospital
Adelaide

Australia, Victoria
Ballarat Base Hospital
Ballarat

Australia, Victoria
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Camberwell

Australia, Victoria
Monash Medical Centre
Clayton

Australia, Victoria
The Alfred Hospital
Melbourne

Australia, Victoria
St Vincents Hospital Melbourne
Melbourne

Australia, Western Australia
Fiona Stanley Hospital
Murdoch

Belgium
GZA Ziekenhuizen campus Sint-Vincentius
Antwerpen

Belgium
Universitair Ziekenhuis Antwerpen
Edegem

Belgium
Algemeen Ziekenhuis Maria Middelares
Gent

Belgium
Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne
Yvoir

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Salvador

Brazil, Bahia
SER - Servicos Especializados em Reumatologia da Bahia
Salvador

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Juiz de Fora

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Botucato

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Porto Alegre

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Santo Andre

Brazil, SAO Paulo
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Sao Bernardo do Campo

Brazil, SAO Paulo
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Sao Jose do Rio Preto

Brazil
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Rio de Janeiro

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University of Calgary
Calgary

Canada, Alberta
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Canada, Alberta
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Edmonton

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London

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Toronto

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Saint-Etienne

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Toulouse

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Berlin

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Frankfurt am Main

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Halle

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Halle

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Hamburg

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Hannover

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Jena

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Kiel

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Universitatsmedizin Mannheim
Mannheim

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Munchen

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Gastroenterologische Gemeinschaftspraxis am Germania Campus
Munster

Germany
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Regensburg

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Stuttgart

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Tubingen

Germany
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Ulm

Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz
Bekescsaba

Hungary
Szent Margit Korhaz
Budapest

Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest

Hungary
Semmelweis Egyetem I.sz. Belgyogyaszati Klinika
Budapest

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

Hungary
Pannonia Maganorvosi Centrum
Budapest

Hungary
Semmelweis Egyetem
Budapest

Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen

Hungary
Bugat Pal Korhaz
Gyongyos

Hungary
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Gyula

Hungary
Mohacsi Korhaz
Mohacs

Hungary
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Szeged

Hungary
Szegedi Tudomanyegyetem - Altalanos Orvostudomanyi Kar
Szeged

Hungary
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Vac

Hungary
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Veszprem

Ireland, Dublin
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Tallaght

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Ballinasloe

Ireland, Louth
Our Lady of Lourdes Hospital - Drogheda
Drogheda

Ireland
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Dublin

Ireland
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Galway

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

Italy
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Castellana Grotte

Italy
Azienda Ospedaliero-Universitaria Mater Domini
Catanzaro

Italy
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Firenza

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Clinica Medica Azienda Ospedaliera Universitaria
Messina

Italy
ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario
Milano

Italy
Polo Universitario - LAzienda Ospedaliera Luigi Sacco
Milano

Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano

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Monserrato

Italy
Ospedale Sacro Cuore Don Calabria
Negrar

Italy
Azienda Ospedaliera di Padova
Padova

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Pavia

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Roma

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Roma

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Rozzano

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Ospedale Mauriziano Umberto I di Torino
Torino

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Toyoake

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Hirosaki

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Sakura-shi

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Toon

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Fukui-shi

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Japan, Fukuoka
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Chikushino

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Kurume-shi

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Sapporo-Shi

Japan, Hokkaido
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Sapporo

Japan, Hokkaido
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Sapporo

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Nishinomiya

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Sagamihara-shi

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Sendai

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Omura-shi

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Urasoe-Shi

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Suita

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Otsu

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Hamamatsu

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Bunkyo-ku

Japan, Tokyo
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Minato-ku

Japan
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Hiroshima

Japan
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Kyoto

Japan
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Miyazaki

Japan
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Saga

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Mexico, Distrito Federal
Centro de Investigacion en Gastroenterologia
Mexico

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Mexico, Jalisco
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Guadalajara

Mexico, Morelos
JM Research - Cuernavaca
Cuernavaca

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Monterrey

Mexico
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Queretaro

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Utrecht

Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz

Poland
Osrodek Badan Klinicznych Clinsante
Bydgoszcz

Poland
Krakowskie Centrum Medyczne
Krak

Poland
Uniwersytecki Szpital Kliniczny Number 1 im. Norberta Barlickiego
Lodz

Poland
Centrum Medyczne Szpital Swietej Rodziny
Lodz

Poland
Gastromed
Lublin

Poland
Osrodek Badan Klinicznych Allmedica
Nowy Targ

Poland
ETYKA Osrodek Badan Klinicznych
Olsztyn

Poland
Endoskopia
Sopot

Poland
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Szczecin

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

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Warszawa

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WIP Warsaw IBD Point Profesor Kierkus
Warszawa

Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
Warszawa

Poland
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz
Warszawa

Poland
Wojskowy Instytut Medyczny
Warszawa

Poland
PlanetMed sp.z o.o.
Wroclaw

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Centrum Medyczne Oporow
Wroclaw

Poland
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Wroclaw

Portugal
Hospital da Senhora da Oliveira - Guimaraes
Guimaraes

Portugal
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Santa Maria da Feira

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Bucharest

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Bucuresti

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Bucuresti

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Timisoara

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Timisoara

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Barnaul

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Irkutsk

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Kazan

Russian Federation
Republican Clinical Hospital Ministry of Health Republic of Tatarstan
Kazan

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Russian Federation
City Clinical Hospital Number 24
Moscow

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Novosibirsk

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Novosibirsk

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Novosibirsk

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Novosibirsk

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Novosibirsk

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Pyatigorsk

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Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth
Saint-Petersburg

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Saratov

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Tomsk

Russian Federation
Multidisciplinary Consultative and Diagnostic Center
Tyumen

Russian Federation
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Velikij Novgorod

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Nitra

Slovakia
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Sahy

Spain
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Alicante

Spain
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Barcelona

Spain
Hospital Clinic de Barcelona
Barcelona

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Hospital Universitario de Fuenlabrada
Fuenlabrada

Spain
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Girona

Spain
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Las Palmas de Gran Canaria

Spain
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Spain
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Manises

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Sabadell

Spain
Hospital Universitario Marques de Valdecilla
Santander

Spain
Clinica Gaias-Santiago
Santiago De Compostelle

Spain
Hospital Universitario Virgen Macarena
Sevilla

Spain
Hospital Universitario Virgen del Rocio
Sevilla

Spain
Hospital Clinico Universitario de Valencia
Valencia

Sweden
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Lulea

Sweden
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Stockholm

Switzerland
Gastroenterologische Praxis Balsiger, Seibold & Partner Crohn-Colitis-Zentrum
Bern

Switzerland
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Birmingham

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Birmingham

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Bury

United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge

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Cannock

United Kingdom
Warrington and Halton Hospitals NHS Foundation Trust
Cheshire

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Derby

United Kingdom
Queen Elizabeth University Hospital
Glasgow

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London

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Manchester

United Kingdom
Abertawe Bro Morgannwg University Health Board
Swansea

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: NCT03599622 History of Changes
  • Other Study ID Numbers: IM011-023, 2017-001976-48
  • First Posted: July 26, 2018 Key Record Dates
  • Last Update Posted: September 29, 2021
  • Last Verified: September 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Enteritis Crohn Disease