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

January 22, 2024 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Local Institution - 0268
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0265
      • Woodville, South Australia, Australia, 5011
        • Local Institution - 0289
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Local Institution - 0042
      • Clayton, Victoria, Australia, 3168
        • Local Institution - 0041
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Melbourne, Victoria, Australia, 3065
        • Local Institution - 0040
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0275
  • Belgium
      • Antwerpen, Belgium, 2018
        • Local Institution - 0316
      • Edegem, Belgium, 2650
        • Local Institution - 0305
      • Gent, Belgium, 9000
        • Local Institution - 0322
      • Yvoir, Belgium, 5530
        • Local Institution - 0314
  • Brazil
      • Rio de Janeiro, Brazil, 21941-913
        • Local Institution - 0017
    • Bahia
      • Salvador, Bahia, Brazil, 40110-060
        • Local Institution - 0256
      • Salvador, Bahia, Brazil, 40150-150
        • Local Institution - 0262
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 26033-318
        • Local Institution - 0069
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
        • Local Institution - 0086
    • SAO Paulo
      • Botucato, SAO Paulo, Brazil, 18618-970
        • Hospital das Clínicas da Faculdade de Medicina de Botucatu
      • Sao Bernardo do Campo, SAO Paulo, Brazil, 09715-090
        • Local Institution - 0045
      • Sao Jose do Rio Preto, SAO Paulo, Brazil, 15090-000
        • Local Institution - 0085
    • Sao Paulo
      • Santo Andre, Sao Paulo, Brazil, 09060-650
        • Local Institution - 0059
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
      • Edmonton, Alberta, Canada, T5R 1W2
        • Local Institution - 0324
      • Edmonton, Alberta, Canada, T6K 4B2
        • South Edmonton Gastroenterology Research Clinic
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Local Institution - 0159
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Local Institution - 0312
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Local Institution - 0283
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • McGill University Health Centre
  • China
    • Fujian
      • XIamen, Fujian, China, 361004
        • Local Institution - 0280
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Local Institution - 0225
      • Guangzhou, Guangdong, China, 510655
        • Local Institution - 0228
    • Hunan
      • Changsha, Hunan, China, 410011
        • Local Institution - 0221
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Local Institution
      • Nanjing, Jiangsu, China, 210029
        • Local Institution - 0306
    • Jilin
      • Changchun Shi, Jilin, China, 130033
        • Local Institution - 0250
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Local Institution
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Local Institution - 0219
      • Shanghai, Shanghai, China, 200120
        • Local Institution - 0234
  • Czechia
      • Brno, Czechia, 602 00
        • Local Institution - 0360
      • Brno, Czechia, 602 00
        • Local Institution - 0337
      • Hradec Kralove, Czechia, 500 12
        • Local Institution - 0057
      • Ostrava, Czechia, 702 00
        • Local Institution - 0352
      • Ostrava, Czechia, 708 52
        • Local Institution - 0071
      • Pardubice, Czechia, 532 03
        • Local Institution - 0350
      • Praha 9, Czechia, 190 00
        • Klinicke centrum ISCARE IVF a.s.
  • Denmark
      • Aalborg, Denmark, 9210
        • Local Institution - 0192
      • Copenhagen NV, Denmark, 2400
        • Local Institution - 0202
      • Odense, Denmark, 5000
        • Local Institution - 0320
  • France
      • Clichy Cedex, France, 92110
        • Local Institution - 0110
      • Colombes, France, 92701
        • Local Institution - 0168
      • Montpellier cedex 5, France, 34295
        • Local Institution - 0343
      • Saint-Etienne, France, 42055
        • Local Institution - 0084
      • Toulouse, France, 31300
        • Local Institution - 0167
      • Toulouse Cedex 9, France, 31059
        • Local Institution - 0127
  • Germany
      • Berlin, Germany, 13353
        • Charite Universitatsmedizin Berlin
      • Berlin, Germany, 10117
        • Local Institution - 0099
      • Brandenburg An Der Havel, Germany, 14770
        • Städtisches Klinikum Brandenburg
      • Frankfurt, Germany, 60590
        • Local Institution - 0212
      • Halle, Germany, 06120
        • Local Institution
      • Halle, Germany, 06108
        • Studiengesellschaft BSF UG
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Jena, Germany, 07747
        • Local Institution - 0089
      • Kiel, Germany, 24105
        • Local Institution - 0190
      • Mannheim, Germany, 68167
        • Local Institution - 0321
      • Munster, Germany, 48159
        • Local Institution - 0140
      • Regensburg, Germany, D-93053
        • Local Institution - 0257
      • Tubingen, Germany, 72076
        • Universitätsklinikum Tübingen
      • Ulm, Germany, 89081
        • Local Institution - 0102
  • Hungary
      • Bekescsaba, Hungary, 5600
        • Local Institution - 0104
      • Budapest, Hungary, 1083
        • Local Institution - 0263
      • Budapest, Hungary, 1088
        • Local Institution - 0211
      • Budapest, Hungary, 1097
        • Local Institution - 0100
      • Budapest, Hungary, 1062
        • Local Institution - 0242
      • Budapest, Hungary, 1136
        • Local Institution - 0292
      • Debrecen, Hungary, 4032
        • Local Institution - 0054
      • Gyongyos, Hungary, 3200
        • Local Institution - 0083
      • Mohacs, Hungary, 7700
        • Local Institution - 0210
      • Szeged, Hungary, 6725
        • Local Institution - 0243
      • Vac, Hungary, 2600
        • Local Institution - 0164
  • Ireland
      • Dublin, Ireland, D15 X40D
        • Local Institution - 0330
      • Galway, Ireland, H91 YR71
        • Local Institution - 0332
    • Dublin
      • Tallaght, Dublin, Ireland
        • Local Institution - 0348
    • Galway
      • Ballinasloe, Galway, Ireland, H53 T971
        • Local Institution - 0335
    • Louth
      • Drogheda, Louth, Ireland, A92 VW28
        • Local Institution - 0336
  • Israel
      • Beer Sheva, Israel, 8410101
        • Local Institution
      • Nahariya, Israel, 2210001
        • Local Institution - 0186
      • Petah Tikva, Israel, 49100
        • Local Institution - 0184
      • Rehovot, Israel, 7661041
        • Local Institution - 0198
  • Italy
      • Bologna, Italy, 40138
        • Local Institution - 0290
      • Castellana Grotte, Italy, 70013
        • Local Institution - 0298
      • Catanzaro, Italy, 88100
        • Local Institution - 0171
      • Messina, Italy, 98125
        • Clinica Medica Azienda Ospedaliera Universitaria
      • Milano, Italy, 20122
        • Local Institution - 0304
      • Milano, Italy, 20142
        • ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario
      • Milano, Italy, 20157
        • Polo Universitario - LAzienda Ospedaliera Luigi Sacco
      • Monserrato, Italy, 09042
        • Local Institution - 0297
      • Negrar, Italy, 37024
        • Local Institution - 0310
      • Padova, Italy, 35128
        • Local Institution - 0128
      • Pavia, Italy, 27100
        • Local Institution - 0170
      • Roma, Italy, 00168
        • Local Institution - 0161
      • Rozzano, Italy, 20089
        • Local Institution - 0119
      • Torino, Italy, 10128
        • Ospedale Mauriziano Umberto I di Torino
  • Japan
      • Hiroshima, Japan, 734-8551
        • Local Institution - 0188
      • Kyoto, Japan, 6128555
        • Local Institution - 0206
      • Miyazaki, Japan, 8891692
        • University of Miyazaki Hospital
      • Saga, Japan, 849-8501
        • Local Institution - 0196
      • Sapporo, Japan, 0600033
        • Local Institution - 0203
    • Aichi
      • Toyoake, Aichi, Japan, 470-1192
        • Local Institution - 0182
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8545
        • Local Institution - 0199
    • Chiba
      • Sakura-shi, Chiba, Japan, 285-8741
        • Local Institution - 0205
    • Ehime
      • Toon, Ehime, Japan, 791-0295
        • Local Institution - 0328
    • Fukui
      • Fukui-shi, Fukui, Japan, 910-8526
        • Local Institution - 0326
    • Fukuoka
      • Chikushino, Fukuoka, Japan, 818-8502
        • Fukuoka University Chikushi Hospital
      • Chikushino-shi, Fukuoka, Japan, 818-8502
        • Local Institution
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital
      • Sapporo, Hokkaido, Japan, 065-0033
        • Sapporo Higashi Tokushukai Hospital
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • Local Institution - 0183
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan, 2520375
        • Local Institution - 0207
    • Miyagi
      • Sendai, Miyagi, Japan, 983-8520
        • Local Institution - 0200
    • Nagasaki
      • Omura-shi, Nagasaki, Japan, 8568562
        • National Hospital Organization Nagasaki Medical Center
    • Okinawa
      • Urasoe-Shi, Okinawa, Japan, 901-2132
        • Urasoe General Hospital
    • Osaka
      • Suita-shi, Osaka, Japan, 5650871
        • Local Institution - 0179
    • Shiga
      • Otsu, Shiga, Japan, 520-2192
        • Local Institution - 0185
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Local Institution - 0189
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Local Institution - 0213
      • Minato-ku, Tokyo, Japan, 105-8471
        • Local Institution - 0195
  • Korea, Republic of
      • Ansan-si, Korea, Republic of, 152-703
        • Local Institution
      • Busan, Korea, Republic of, 48108
        • Local Institution
      • Daegu, Korea, Republic of, 42415
        • Local Institution - 0064
      • Daegu, Korea, Republic of, 700-721
        • Local Institution - 0061
      • Incheon, Korea, Republic of, 22332
        • Local Institution
      • Seoul, Korea, Republic of, 137-701
        • Local Institution
      • Seoul, Korea, Republic of, 03181
        • Local Institution
      • Wonju-si, Korea, Republic of, 26426
        • Local Institution - 0012
      • Yangsan-si, Korea, Republic of, 50612
        • Local Institution
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
        • Local Institution - 0046
  • Mexico
      • Queretaro, Mexico, 76070
        • Local Institution - 0029
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06700
        • Local Institution - 0007
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44500
        • Local Institution - 0106
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • Local Institution - 0009
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64060
        • Local Institution - 0109
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Local Institution - 0303
  • Poland
      • Bydgoszcz, Poland, 85-794
        • Local Institution - 0177
      • Bydgoszcz, Poland, 85-231
        • Local Institution - 0245
      • Krakow, Poland, 31-501
        • Local Institution - 0065
      • Lodz, Poland, 90-153
        • Local Institution - 0284
      • Lodz, Poland, 90-302
        • Local Institution - 0098
      • Lublin, Poland, 20-582
        • Local Institution - 0291
      • Nowy Targ, Poland, 34-400
        • Local Institution - 0278
      • Olsztyn, Poland, 10-117
        • Etyka Osrodek Badan Klinicznych
      • Sopot, Poland, 81-756
        • Endoskopia
      • Tychy, Poland, 43-100
        • Local Institution - 0063
      • Warszawa, Poland, 03-580
        • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz
      • Warszawa, Poland, 00-728
        • Local Institution - 0271
      • Warszawa, Poland, 02-507
        • Local Institution - 0288
      • Warszawa, Poland, 04-141
        • Local Institution - 0279
      • Wroclaw, Poland, 52-416
        • Centrum Medyczne OPOROW
      • Wroclaw, Poland, 52-210
        • PlanetMed Sp.z o.o.
  • Portugal
      • Guimaraes, Portugal, 4835-044
        • Local Institution - 0174
      • Santa Maria da Feira, Portugal, 4520-211
        • Local Institution - 0216
  • Romania
      • Bucharest, Romania, 050098
        • Spitalul Universitar de Urgenta Bucuresti
      • Bucuresti, Romania, 010719
        • Hyperclinica MedLife Grivita
      • Bucuresti, Romania, 020125
        • Local Institution - 0044
      • Bucuresti, Romania, 031784
        • Centrul Medical Sana
      • Timisoara, Romania, 300158
        • Centrul Medical Tuculanu
      • Timisoara, Romania, 300002
        • Local Institution - 0005
  • Russian Federation
      • Barnaul, Russian Federation, 656015
        • Bioterm
      • Irkutsk, Russian Federation, 664033
        • Hospital Irkutsk Scientific Center
      • Kazan, Russian Federation, 420064
        • Republican Clinical Hospital Ministry of health Republic of Tatarstan
      • Moscow, Russian Federation, 127015
        • City Clinical Hospital Number 24
      • Novosibirsk, Russian Federation, 630087
        • Novosibirsk State Regional Clinical Hospital
      • Novosibirsk, Russian Federation, 630005
        • Medical Center SibNovoMed
      • Novosibirsk, Russian Federation, 630007
        • Novosibirsk GastroCenter
      • Novosibirsk, Russian Federation, 630099
        • Medical Center Healthy Family
      • Pyatigorsk, Russian Federation, 357502
        • Clinic Ultrasound 4D
      • Saint-Petersburg, Russian Federation, 195257
        • Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth
      • Saratov, Russian Federation, 410038
        • Saratov Regional Clinical Hospital
      • Tomsk, Russian Federation, 634063
        • Tomsk Regional Clinical Hospital
      • Tyumen, Russian Federation, 625026
        • Multidisciplinary Consultative and Diagnostic Center
      • Velikij Novgorod, Russian Federation, 173008
        • Novgorod Regional Clinical Hospital
  • Spain
      • Alicante, Spain, 03011
        • Local Institution - 0329
      • Barcelona, Spain, 08036
        • Local Institution - 0274
      • Fuenlabrada, Spain, 28942
        • Local Institution - 0154
      • Girona, Spain, 17007
        • Local Institution - 0080
      • LHospitalet de Llobregat, Spain, 08907
        • Local Institution
      • Las Palmas de Gran Canaria, Spain, 35010
        • Local Institution - 0021
      • Sabadell, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
      • Santander, Spain, 39008
        • Local Institution - 0113
      • Santiago De Compostelle, Spain, 15702
        • Local Institution - 0309
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41013
        • Local Institution - 0107
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
  • Switzerland
      • Bern, Switzerland, CH-3012
        • Local Institution - 0180
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Local Institution
      • Taichung, Taiwan, 404
        • Local Institution
      • Taipei City, Taiwan, 10048
        • Local Institution - 0267
      • Taoyuan, Taiwan, 333
        • Local Institution - 0152
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Local Institution - 0341
      • Blackpool, United Kingdom, FY3 8NR
        • Blackpool Teaching Hospitals NHS Foundation Trust
      • Cambridge, United Kingdom, CB2 0QQ
        • Local Institution - 0235
      • Cannock, United Kingdom, WS11 0BN
        • MAC Clinical Research - Cannock
      • Cheshire, United Kingdom, WA5 1QG
        • Warrington and Halton Hospitals NHS Foundation Trust
      • Glasgow, United Kingdom, G51 4TF
        • Local Institution - 0157
      • Manchester, United Kingdom, M13 9NQ
        • MAC Clinical Research - Manchester
      • Swansea, United Kingdom, SA6 6NL
        • Local Institution - 0208
  • United States
    • California
      • Los Angeles, California, United States, 90067-2015
        • GastroIntestinal BioSciences
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Kaiser Permanente Colorado Institute for Health Research
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • The Medical Research Center of Connecticut
    • Florida
      • Clearwater, Florida, United States, 33756-3839
        • Local Institution - 0255
      • Jacksonville, Florida, United States, 32207-4958
        • University of Florida Health - Jacksonville
      • Jacksonville, Florida, United States, 32224
        • Local Institution - 0261
      • Largo, Florida, United States, 33777
        • Florida Center for Gastroenterology
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute - New Port Richey
      • Orlando, Florida, United States, 32808
        • Omega Research Consultants - Maitland
      • Orlando, Florida, United States, 32832
        • Florida Hospital Orlando
      • Tampa, Florida, United States, 33606
        • Local Institution - 0166
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic - Clinical Research Division
    • Georgia
      • Suwanee, Georgia, United States, 30024
        • Local Institution - 0277
      • Suwanee, Georgia, United States, 30024
        • Local Institution - 0358
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medicine
      • Glenview, Illinois, United States, 60026
        • Illinois Gastroenterology Group
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Local Institution - 0301
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Local Institution - 0282
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan
      • Chesterfield, Michigan, United States, 48047
        • Local Institution - 0003
      • Wyoming, Michigan, United States, 49519
        • Local Institution - 0047
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology Associates
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
      • Ocean Springs, Mississippi, United States, 39564
        • Digestive Health Center - Ocean Springs
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Local Institution - 0359
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Local Institution - 0011
    • New York
      • Lake Success, New York, United States, 11042
        • New York Langone Long Island Clinical Research Associates
      • New York, New York, United States, 10032
        • New York-Presbyterian Columbia University Medical Center
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Atrium Health
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Local Institution - 0349
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health Milton S. Hershey Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
      • Sayre, Pennsylvania, United States, 18840
        • Local Institution - 0122
      • Wyomissing, Pennsylvania, United States, 19610
        • US Digestive Disease Associates - Wyomissing
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Clinical Trials of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt Inflammatory Bowel Disease Clinic
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute
      • Garland, Texas, United States, 75044
        • Digestive Health Associates of Texas - Richardson
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Research of San Antonio
      • San Antonio, Texas, United States, 78229
        • Local Institution - 0307
      • Spring, Texas, United States, 77379
        • Spring Gastroenterology Associates - Houston
      • Tyler, Texas, United States, 75701
        • Local Institution - 0302
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Local Institution
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire Veterans Administration Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
      • Seattle, Washington, United States, 98104
        • Local Institution - 0266
      • Seattle, Washington, United States, 98101
        • Local Institution - 0327
      • Vancouver, Washington, United States, 98664
        • Local Institution - 0331
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215-5217
        • Local Institution - 0356

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Documented diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening, including ileal, colonic, or ileo-colonic disease distribution
  • Must have had an inadequate response, loss of response, or intolerance to 1 or more of the standard treatments
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving clinical remission at Week 12
Time Frame: Week 12
Clinical remission defined by Crohn's Disease Activity Index (CDAI)
Week 12
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)
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants who achieve a clinical response at Week 12
Time Frame: Week 12
Week 12
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
Week 12
Change from baseline in SES-CD (Simple Endoscopic Score for Crohn's Disease) at Week 12
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2018

Primary Completion (Actual)

December 12, 2022

Study Completion (Actual)

October 23, 2023

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-023
  • 2017-001976-48 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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