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

June 28, 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)

239

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
        • Local Institution - 0254
    • 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, 3065
        • Local Institution - 0040
      • Melbourne, Victoria, Australia, 3181
        • Local Institution - 0351
    • 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
      • 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
      • Botucato, Sao Paulo, Brazil, 18618-970
        • Local Institution - 0058
      • Santo Andre, Sao Paulo, Brazil, 09060-650
        • Local Institution - 0059
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Local Institution - 0048
      • Edmonton, Alberta, Canada, T5R 1W2
        • Local Institution - 0324
      • Edmonton, Alberta, Canada, T6K 4B2
        • Local Institution - 0300
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Local Institution - 0159
    • Ontario
      • Etobicoke, Ontario, Canada, M9V 4B8
        • Local Institution - 0283
      • London, Ontario, Canada, N6A 5A5
        • Local Institution - 0312
      • Toronto, Ontario, Canada, M4N 3M5
        • Local Institution - 0236
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Local Institution - 0317
  • 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, 210029
        • Local Institution - 0306
      • Nanjing, Jiangsu, China, 210011
        • Local Institution - 0220
    • Jilin
      • Changchun Shi, Jilin, China, 130033
        • Local Institution - 0250
    • Liaoning
      • Shenyang, Liaoning, China, 110022
        • Local Institution - 0299
    • 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
        • Local Institution - 0075
  • 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, 10117
        • Local Institution - 0099
      • Berlin, Germany, 13353
        • Local Institution - 0090
      • Brandenburg An Der Havel, Germany, 14770
        • Local Institution - 0339
      • Frankfurt, Germany, 60590
        • Local Institution - 0212
      • Halle, Germany, 06120
        • Local Institution
      • Halle, Germany, 06108
        • Local Institution - 0178
      • Hannover, Germany, 30625
        • Local Institution - 0294
      • 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
        • Local Institution - 0340
      • 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 - 0197
      • 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
        • Local Institution - 0056
      • Milano, Italy, 20122
        • Local Institution - 0304
      • Milano, Italy, 20142
        • Local Institution - 0115
      • Milano, Italy, 20157
        • Local Institution - 0311
      • 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
        • Local Institution - 0285
  • Japan
      • Hiroshima, Japan, 734-8551
        • Local Institution - 0188
      • Kyoto, Japan, 6128555
        • Local Institution - 0206
      • Miyazaki, Japan, 8891692
        • Local Institution - 0214
      • 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-shi, Fukuoka, Japan, 818-8502
        • Local Institution - 0204
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Local Institution - 0187
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608543
        • Local Institution - 0323
      • Sapporo, Hokkaido, Japan, 065-0033
        • Local Institution - 0217
    • 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
        • Local Institution - 0194
    • Okinawa
      • Urasoe-Shi, Okinawa, Japan, 901-2132
        • Local Institution - 0318
    • 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 - 0158
      • Busan, Korea, Republic of, 48108
        • Local Institution - 0149
      • Daegu, Korea, Republic of, 42415
        • Local Institution - 0064
      • Daegu, Korea, Republic of, 700-721
        • Local Institution - 0061
      • Incheon, Korea, Republic of, 22332
        • Local Institution - 0150
      • Seoul, Korea, Republic of, 03181
        • Local Institution - 0015
      • Seoul, Korea, Republic of, 06591
        • Local Institution - 0016
      • Wonju-si, Korea, Republic of, 26426
        • Local Institution - 0012
      • Yangsan-si, Korea, Republic of, 50612
        • Local Institution - 0032
    • 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
        • Local Institution - 0176
      • Sopot, Poland, 81-756
        • Local Institution - 0082
      • Tychy, Poland, 43-100
        • Local Institution - 0063
      • Warszawa, Poland, 00-728
        • Local Institution - 0271
      • Warszawa, Poland, 02-507
        • Local Institution - 0288
      • Warszawa, Poland, 04-141
        • Local Institution - 0279
      • Warszawa, Poland, 03-580
        • Local Institution - 0026
      • Wroclaw, Poland, 52-210
        • Local Institution - 0160
      • Wroclaw, Poland, 52-416
        • Local Institution - 0034
  • Portugal
      • Guimaraes, Portugal, 4835-044
        • Local Institution - 0174
      • Santa Maria da Feira, Portugal, 4520-211
        • Local Institution - 0216
  • Romania
      • Bucharest, Romania, 050098
        • Local Institution - 0074
      • Bucuresti, Romania, 020125
        • Local Institution - 0044
      • Bucuresti, Romania, 010719
        • Local Institution - 0067
      • Bucuresti, Romania, 031784
        • Local Institution - 0163
      • Timisoara, Romania, 300002
        • Local Institution - 0005
      • Timisoara, Romania, 300158
        • Local Institution - 0060
  • 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
        • Local Institution - 0325
      • Santander, Spain, 39008
        • Local Institution - 0113
      • Santiago De Compostelle, Spain, 15702
        • Local Institution - 0309
      • Sevilla, Spain, 41013
        • Local Institution - 0107
      • Sevilla, Spain, 41009
        • Local Institution - 0313
      • Valencia, Spain, 46010
        • Local Institution - 0004
  • Switzerland
      • Bern, Switzerland, CH-3012
        • Local Institution - 0180
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Local Institution - 0173
      • Taichung, Taiwan, 404
        • Local Institution - 0148
      • Taipei, Taiwan, 10002
        • Local Institution - 0267
      • Taoyuan, Taiwan, 333
        • Local Institution - 0152
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Local Institution - 0341
      • Blackpool, United Kingdom, FY3 8NR
        • Local Institution - 0144
      • Cambridge, United Kingdom, CB2 0QQ
        • Local Institution - 0235
      • Cannock, United Kingdom, WS11 0BN
        • Local Institution - 0354
      • Cheshire, United Kingdom, WA5 1QG
        • Local Institution - 0165
      • Glasgow, United Kingdom, G51 4TF
        • Local Institution - 0157
      • Manchester, United Kingdom, M13 9NQ
        • Local Institution - 0353
      • Swansea, United Kingdom, SA6 6NL
        • Local Institution - 0208
  • United States
    • California
      • Los Angeles, California, United States, 90067-2015
        • Local Institution - 0258
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Local Institution - 0247
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Local Institution - 0001
    • Florida
      • Clearwater, Florida, United States, 33756-3839
        • Local Institution - 0255
      • Jacksonville, Florida, United States, 32224
        • Local Institution - 0261
      • Jacksonville, Florida, United States, 32207-4958
        • Local Institution - 0259
      • Largo, Florida, United States, 33777
        • Local Institution - 0276
      • Miami, Florida, United States, 33136
        • Local Institution - 0232
      • New Port Richey, Florida, United States, 34653
        • Local Institution - 0162
      • Orlando, Florida, United States, 32808
        • Local Institution - 0201
      • Orlando, Florida, United States, 32832
        • Local Institution - 0249
      • Tampa, Florida, United States, 33606
        • Local Institution - 0166
      • Zephyrhills, Florida, United States, 33542
        • Local Institution - 0248
    • Georgia
      • Suwanee, Georgia, United States, 30024
        • Local Institution - 0277
      • Suwanee, Georgia, United States, 30024
        • Local Institution - 0358
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Local Institution - 0319
      • Glenview, Illinois, United States, 60026
        • Local Institution - 0346
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Local Institution - 0301
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Local Institution - 0253
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Local Institution - 0282
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Local Institution - 0003
      • Chesterfield, Michigan, United States, 48047
        • Local Institution - 0218
      • Wyoming, Michigan, United States, 49519
        • Local Institution - 0047
      • Ypsilanti, Michigan, United States, 48197
        • Local Institution - 0223
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Local Institution - 0231
      • Ocean Springs, Mississippi, United States, 39564
        • Local Institution - 0156
    • 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
        • Local Institution - 0043
      • New York, New York, United States, 10032
        • Local Institution - 0308
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Local Institution - 0226
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Local Institution - 0349
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Local Institution - 0238
      • Pittsburgh, Pennsylvania, United States, 15213
        • Local Institution - 0125
      • Sayre, Pennsylvania, United States, 18840
        • Local Institution - 0122
      • Wyomissing, Pennsylvania, United States, 19610
        • Local Institution - 0357
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Local Institution - 0105
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Local Institution - 0072
    • Texas
      • Arlington, Texas, United States, 76012
        • Local Institution - 0264
      • Garland, Texas, United States, 75044
        • Local Institution - 0246
      • San Antonio, Texas, United States, 78229
        • Local Institution - 0307
      • San Antonio, Texas, United States, 78229
        • Local Institution - 0252
      • Southlake, Texas, United States, 76092
        • Local Institution - 0073
      • Spring, Texas, United States, 77379
        • Local Institution - 0240
      • Tyler, Texas, United States, 75701
        • Local Institution - 0302
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Local Institution
      • Richmond, Virginia, United States, 23249
        • Local Institution - 0224
    • Washington
      • Seattle, Washington, United States, 98104
        • Local Institution - 0266
      • Seattle, Washington, United States, 98101
        • Local Institution - 0327
      • Seattle, Washington, United States, 98195
        • Local Institution - 0191
      • 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
Percent of Participants Achieving Clinical Remission at Week 12
Time Frame: 12 weeks after first dose

Percent of participants achieving clinical remission at Week 12. Clinical remission is defined as achieving a Crohn's Disease Activity Index (CDAI) Score below 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms.

Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
12 weeks after first dose
Percent of Participants Achieving Endoscopic Response at Week 12
Time Frame: 12 weeks after first dose

Endoscopic Response is defined as >= 50% decrease from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for things like ulcers and inflammation. Each part is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants before starting study treatment.

Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
12 weeks after first dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants Achieving Clinical Response at Week 12
Time Frame: 12 weeks after first dose

Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of ≥ 100 points or a total CDAI score < 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Baseline refers to the initial set of before data collected from participants before starting study treatment.

Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
12 weeks after first dose
Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12
Time Frame: 12 weeks after first dose

The Patient Reported Outcomes 2 (PRO2) is a way for patients to report how they're feeling. It focuses on two things: how often they have loose or liquid stools, and how much abdominal pain they have. They keep track of these things every day for a week. Stool frequency is rated on a scale from 0 to 3, with 0 being the normal number of stools per day to 3 which is >/=5 stools more than normal per day. The pain is rated on a scale from 0 to 3, with 0 being no pain and 3 being severe pain. The scores for these two things are added up to get a total score ranging from 0-6. If the average daily score for abdominal pain is 1 or less, and the average number of loose or liquid stools is 3 or less, then the disease might be in remission.

Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
12 weeks after first dose
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Time Frame: 12 weeks after first dose
The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for ulcer size, ulcerated surface, inflamed surface, and stenosis. Each is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants starting study treatment.
12 weeks after first dose

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 (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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