Study Stopped
Trial terminated because of lack of efficacy in the short term acute phase
An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease
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
2 other identifiers
interventional
239
26 countries
259
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2018
Longer than P75 for phase_2
259 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2018
CompletedStudy Start
First participant enrolled
July 16, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2023
CompletedResults Posted
Study results publicly available
July 3, 2024
CompletedJuly 3, 2024
June 1, 2024
4.4 years
July 11, 2018
May 30, 2024
June 28, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Percent of Participants Achieving Clinical Remission at Week 12
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
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 Outcomes (3)
Percent of Participants Achieving Clinical Response at Week 12
12 weeks after first dose
Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12
12 weeks after first dose
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
12 weeks after first dose
Study Arms (3)
BMS-986165 Dose 1
EXPERIMENTALBMS-986165 Dose 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (259)
Local Institution - 0258
Los Angeles, California, 90067-2015, United States
Local Institution - 0247
Aurora, Colorado, 80014, United States
Local Institution - 0001
Hamden, Connecticut, 06518, United States
Local Institution - 0255
Clearwater, Florida, 33756-3839, United States
Local Institution - 0259
Jacksonville, Florida, 32207-4958, United States
Local Institution - 0261
Jacksonville, Florida, 32224, United States
Local Institution - 0276
Largo, Florida, 33777, United States
Local Institution - 0232
Miami, Florida, 33136, United States
Local Institution - 0162
New Port Richey, Florida, 34653, United States
Local Institution - 0201
Orlando, Florida, 32808, United States
Local Institution - 0249
Orlando, Florida, 32832, United States
Local Institution - 0166
Tampa, Florida, 33606, United States
Local Institution - 0248
Zephyrhills, Florida, 33542, United States
Local Institution - 0277
Suwanee, Georgia, 30024, United States
Local Institution - 0358
Suwanee, Georgia, 30024, United States
Local Institution - 0319
Chicago, Illinois, 60637, United States
Local Institution - 0346
Glenview, Illinois, 60026, United States
Local Institution - 0301
Indianapolis, Indiana, 46202, United States
Local Institution - 0253
Iowa City, Iowa, 52242, United States
Local Institution - 0282
Shreveport, Louisiana, 71105, United States
Local Institution - 0003
Chesterfield, Michigan, 48047, United States
Local Institution - 0218
Chesterfield, Michigan, 48047, United States
Local Institution - 0047
Wyoming, Michigan, 49519, United States
Local Institution - 0223
Ypsilanti, Michigan, 48197, United States
Local Institution - 0231
Jackson, Mississippi, 39216, United States
Local Institution - 0156
Ocean Springs, Mississippi, 39564, United States
Local Institution - 0359
St Louis, Missouri, 63130, United States
Local Institution - 0011
Las Vegas, Nevada, 89123, United States
Local Institution - 0043
Lake Success, New York, 11042, United States
Local Institution - 0308
New York, New York, 10032, United States
Local Institution - 0226
Monroe, North Carolina, 28112, United States
Local Institution - 0349
Oklahoma City, Oklahoma, 73112, United States
Local Institution - 0238
Hershey, Pennsylvania, 17033, United States
Local Institution - 0125
Pittsburgh, Pennsylvania, 15213, United States
Local Institution - 0122
Sayre, Pennsylvania, 18840, United States
Local Institution - 0357
Wyomissing, Pennsylvania, 19610, United States
Local Institution - 0105
Charleston, South Carolina, 29406, United States
Local Institution - 0072
Nashville, Tennessee, 37204, United States
Local Institution - 0264
Arlington, Texas, 76012, United States
Local Institution - 0246
Garland, Texas, 75044, United States
Local Institution - 0252
San Antonio, Texas, 78229, United States
Local Institution - 0307
San Antonio, Texas, 78229, United States
Local Institution - 0073
Southlake, Texas, 76092, United States
Local Institution - 0240
Spring, Texas, 77379, United States
Local Institution - 0302
Tyler, Texas, 75701, United States
Local Institution
Lynchburg, Virginia, 24502, United States
Local Institution - 0224
Richmond, Virginia, 23249, United States
Local Institution - 0327
Seattle, Washington, 98101, United States
Local Institution - 0266
Seattle, Washington, 98104, United States
Local Institution - 0191
Seattle, Washington, 98195, United States
Local Institution - 0331
Vancouver, Washington, 98664, United States
Local Institution - 0356
Milwaukee, Wisconsin, 53215-5217, United States
Local Institution - 0268
South Brisbane, Queensland, 4101, Australia
Local Institution - 0254
Woolloongabba, Queensland, 4102, Australia
Local Institution - 0265
Adelaide, South Australia, 5000, Australia
Local Institution - 0289
Woodville, South Australia, 5011, Australia
Local Institution - 0042
Ballarat, Victoria, 3350, Australia
Local Institution - 0041
Clayton, Victoria, 3168, Australia
Local Institution - 0040
Melbourne, Victoria, 3065, Australia
Local Institution - 0351
Melbourne, Victoria, 3181, Australia
Local Institution - 0275
Murdoch, Western Australia, 6150, Australia
Local Institution - 0316
Antwerp, 2018, Belgium
Local Institution - 0305
Edegem, 2650, Belgium
Local Institution - 0322
Ghent, 9000, Belgium
Local Institution - 0314
Yvoir, 5530, Belgium
Local Institution - 0256
Salvador, Estado de Bahia, 40110-060, Brazil
Local Institution - 0262
Salvador, Estado de Bahia, 40150-150, Brazil
Local Institution - 0069
Juiz de Fora, Minas Gerais, 26033-318, Brazil
Local Institution - 0086
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Local Institution - 0058
Botucato, São Paulo, 18618-970, Brazil
Local Institution - 0059
Santo André, São Paulo, 09060-650, Brazil
Local Institution - 0045
São Bernardo do Campo, São Paulo, 09715-090, Brazil
Local Institution - 0085
São José do Rio Preto, São Paulo, 15090-000, Brazil
Local Institution - 0017
Rio de Janeiro, 21941-913, Brazil
Local Institution - 0048
Calgary, Alberta, T2N 4Z6, Canada
Local Institution - 0324
Edmonton, Alberta, T5R 1W2, Canada
Local Institution - 0300
Edmonton, Alberta, T6K 4B2, Canada
Local Institution - 0159
Vancouver, British Columbia, V5Z1M9, Canada
Local Institution - 0283
Etobicoke, Ontario, M9V 4B8, Canada
Local Institution - 0312
London, Ontario, N6A 5A5, Canada
Local Institution - 0236
Toronto, Ontario, M4N 3M5, Canada
Local Institution - 0317
Montreal, Quebec, H3G 1A4, Canada
Local Institution - 0280
Xiamen, Fujian, 361004, China
Local Institution - 0225
Guangzhou, Guangdong, 510080, China
Local Institution - 0228
Guangzhou, Guangdong, 510655, China
Local Institution - 0221
Changsha, Hunan, 410011, China
Local Institution - 0220
Nanjing, Jiangsu, 210011, China
Local Institution - 0306
Nanjing, Jiangsu, 210029, China
Local Institution - 0250
Changchun, Jilin, 130033, China
Local Institution - 0299
Shenyang, Liaoning, 110022, China
Local Institution - 0219
Shanghai, Shanghai Municipality, 200025, China
Local Institution - 0234
Shanghai, Shanghai Municipality, 200120, China
Local Institution - 0337
Brno, 602 00, Czechia
Local Institution - 0360
Brno, 602 00, Czechia
Local Institution - 0057
Hradec Králové, 500 12, Czechia
Local Institution - 0352
Ostrava, 702 00, Czechia
Local Institution - 0071
Ostrava, 708 52, Czechia
Local Institution - 0350
Pardubice, 532 03, Czechia
Local Institution - 0075
Prague, 190 00, Czechia
Local Institution - 0192
Aalborg, 9210, Denmark
Local Institution - 0202
Copenhagen NV, 2400, Denmark
Local Institution - 0320
Odense, 5000, Denmark
Local Institution - 0110
Clichy, 92110, France
Local Institution - 0168
Colombes, 92701, France
Local Institution - 0343
Montpellier, 34295, France
Local Institution - 0084
Saint-Etienne, 42055, France
Local Institution - 0127
Toulouse, 31059, France
Local Institution - 0167
Toulouse, 31300, France
Local Institution - 0099
Berlin, 10117, Germany
Local Institution - 0090
Berlin, 13353, Germany
Local Institution - 0339
Brandenburg, 14770, Germany
Local Institution - 0212
Frankfurt, 60590, Germany
Local Institution - 0178
Halle, 06108, Germany
Local Institution
Halle, 06120, Germany
Local Institution - 0294
Hanover, 30625, Germany
Local Institution - 0089
Jena, 07747, Germany
Local Institution - 0190
Kiel, 24105, Germany
Local Institution - 0321
Mannheim, 68167, Germany
Local Institution - 0140
Münster, 48159, Germany
Local Institution - 0257
Regensburg, D-93053, Germany
Local Institution - 0340
Tübingen, 72076, Germany
Local Institution - 0102
Ulm, 89081, Germany
Local Institution - 0104
Békéscsaba, 5600, Hungary
Local Institution - 0242
Budapest, 1062, Hungary
Local Institution - 0263
Budapest, 1083, Hungary
Local Institution - 0211
Budapest, 1088, Hungary
Local Institution - 0100
Budapest, 1097, Hungary
Local Institution - 0292
Budapest, 1136, Hungary
Local Institution - 0054
Debrecen, 4032, Hungary
Local Institution - 0083
Gyöngyös, 3200, Hungary
Local Institution - 0210
Mohács, 7700, Hungary
Local Institution - 0243
Szeged, 6725, Hungary
Local Institution - 0164
Vác, 2600, Hungary
Local Institution - 0348
Tallaght, Dublin, 0, Ireland
Local Institution - 0335
Ballinasloe, Galway, H53 T971, Ireland
Local Institution - 0336
Drogheda, Louth, A92 VW28, Ireland
Local Institution - 0330
Dublin, D15 X40D, Ireland
Local Institution - 0332
Galway, H91 yR71, Ireland
Local Institution - 0197
Beersheba, 8410101, Israel
Local Institution - 0186
Nahariya, 2210001, Israel
Local Institution - 0184
Petah Tikva, 49100, Israel
Local Institution - 0198
Rehovot, 7661041, Israel
Local Institution - 0290
Bologna, 40138, Italy
Local Institution - 0298
Castellana Grotte, 70013, Italy
Local Institution - 0171
Catanzaro, 88100, Italy
Local Institution - 0056
Messina, 98125, Italy
Local Institution - 0304
Milan, 20122, Italy
Local Institution - 0115
Milan, 20142, Italy
Local Institution - 0311
Milan, 20157, Italy
Local Institution - 0297
Monserrato, 09042, Italy
Local Institution - 0310
Negrar, 37024, Italy
Local Institution - 0128
Padua, 35128, Italy
Local Institution - 0170
Pavia, 27100, Italy
Local Institution - 0161
Roma, 00168, Italy
Local Institution - 0119
Rozzano, 20089, Italy
Local Institution - 0285
Torino, 10128, Italy
Local Institution - 0182
Toyoake, Aichi-ken, 470-1192, Japan
Local Institution - 0199
Hirosaki, Aomori, 036-8545, Japan
Local Institution - 0205
Sakura-shi, Chiba, 285-8741, Japan
Local Institution - 0328
Tōon, Ehime, 791-0295, Japan
Local Institution - 0326
Fukui-shi, Fukui, 910-8526, Japan
Local Institution - 0204
Chikushino-shi, Fukuoka, 818-8502, Japan
Local Institution - 0187
Kurume-shi, Fukuoka, 830-0011, Japan
Local Institution - 0323
Sapporo, Hokkaido, 0608543, Japan
Local Institution - 0217
Sapporo, Hokkaido, 065-0033, Japan
Local Institution - 0183
Nishinomiya, Hyōgo, 663-8501, Japan
Local Institution - 0207
Sagamihara-shi, Kanagawa, 2520375, Japan
Local Institution - 0200
Sendai, Miyagi, 983-8520, Japan
Local Institution - 0194
Omura-shi, Nagasaki, 8568562, Japan
Local Institution - 0318
Urasoe-Shi, Okinawa, 901-2132, Japan
Local Institution - 0179
Suita-shi, Osaka, 5650871, Japan
Local Institution - 0185
Ōtsu, Shiga, 520-2192, Japan
Local Institution - 0189
Hamamatsu, Shizuoka, 431-3192, Japan
Local Institution - 0213
Bunkyo-ku, Tokyo, 113-8519, Japan
Local Institution - 0195
Minato-ku, Tokyo, 105-8471, Japan
Local Institution - 0188
Hiroshima, 734-8551, Japan
Local Institution - 0206
Kyoto, 6128555, Japan
Local Institution - 0214
Miyazaki, 8891692, Japan
Local Institution - 0196
Saga, 849-8501, Japan
Local Institution - 0203
Sapporo, 0600033, Japan
Local Institution - 0106
Guadalajara, Jalisco, 44500, Mexico
Local Institution - 0007
Mexico City, Mexico City, 06700, Mexico
Local Institution - 0009
Cuernavaca, Morelos, 62290, Mexico
Local Institution - 0109
Monterrey, Nuevo León, 64060, Mexico
Local Institution - 0029
Querétaro, 76070, Mexico
Local Institution - 0303
Amsterdam, 1105 AZ, Netherlands
Local Institution - 0245
Bydgoszcz, 85-231, Poland
Local Institution - 0177
Bydgoszcz, 85-794, Poland
Local Institution - 0065
Krakow, 31-501, Poland
Local Institution - 0284
Lodz, 90-153, Poland
Local Institution - 0098
Lodz, 90-302, Poland
Local Institution - 0291
Lublin, 20-582, Poland
Local Institution - 0278
Nowy Targ, 34-400, Poland
Local Institution - 0176
Olsztyn, 10-117, Poland
Local Institution - 0082
Sopot, 81-756, Poland
Local Institution - 0063
Tychy, 43-100, Poland
Local Institution - 0271
Warsaw, 00-728, Poland
Local Institution - 0288
Warsaw, 02-507, Poland
Local Institution - 0026
Warsaw, 03-580, Poland
Local Institution - 0279
Warsaw, 04-141, Poland
Local Institution - 0160
Wroclaw, 52-210, Poland
Local Institution - 0034
Wroclaw, 52-416, Poland
Local Institution - 0174
Guimarães, 4835-044, Portugal
Local Institution - 0216
Santa Maria da Feira, 4520-211, Portugal
Local Institution - 0067
Bucharest, 010719, Romania
Local Institution - 0044
Bucharest, 020125, Romania
Local Institution - 0163
Bucharest, 031784, Romania
Local Institution - 0074
Bucharest, 050098, Romania
Local Institution - 0005
Timișoara, 300002, Romania
Local Institution - 0060
Timișoara, 300158, Romania
Bioterm
Barnaul, 656015, Russia
Hospital Irkutsk Scientific Center
Irkutsk, 664033, Russia
Republican Clinical Hospital Ministry of Health Republic of Tatarstan
Kazan', 420064, Russia
City Clinical Hospital Number 24
Moscow, 127015, Russia
Medical Center SibNovoMed
Novosibirsk, 630005, Russia
Novosibirsk Gastrocenter
Novosibirsk, 630007, Russia
Novosibirsk State Regional Clinical Hospital
Novosibirsk, 630087, Russia
Medical Center Healthy Family
Novosibirsk, 630099, Russia
Clinic Ultrasound 4D
Pyatigorsk, 357502, Russia
Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, 195257, Russia
Saratov Regional Clinical Hospital
Saratov, 410038, Russia
Tomsk Regional Clinical Hospital
Tomsk, 634063, Russia
Multidisciplinary Consultative and Diagnostic Center
Tyumen, 625026, Russia
Novgorod Regional Clinical Hospital
Veliky Novgorod, 173008, Russia
Local Institution - 0046
Seongnam-si, Gyeonggi-do, 13496, South Korea
Local Institution - 0158
Ansan-si, 152-703, South Korea
Local Institution - 0149
Busan, 48108, South Korea
Local Institution - 0064
Daegu, 42415, South Korea
Local Institution - 0061
Daegu, 700-721, South Korea
Local Institution - 0150
Incheon, 22332, South Korea
Local Institution - 0015
Seoul, 03181, South Korea
Local Institution - 0016
Seoul, 06591, South Korea
Local Institution - 0012
Wŏnju, 26426, South Korea
Local Institution - 0032
Yangsan, 50612, South Korea
Local Institution - 0329
Alicante, 03011, Spain
Local Institution - 0274
Barcelona, 08036, Spain
Local Institution - 0154
Fuenlabrada, 28942, Spain
Local Institution - 0080
Girona, 17007, Spain
Local Institution - 0021
Las Palmas de Gran Canaria, 35010, Spain
Local Institution
LHospitalet de Llobregat, 08907, Spain
Local Institution - 0325
Sabadell, 08208, Spain
Local Institution - 0113
Santander, 39008, Spain
Local Institution - 0309
Santiago de Compostelle, 15702, Spain
Local Institution - 0313
Seville, 41009, Spain
Local Institution - 0107
Seville, 41013, Spain
Local Institution - 0004
Valencia, 46010, Spain
Local Institution - 0180
Bern, CH-3012, Switzerland
Local Institution - 0173
Kaohsiung City, 83301, Taiwan
Local Institution - 0148
Taichung, 404, Taiwan
Local Institution - 0267
Taipei, 10002, Taiwan
Local Institution - 0152
Taoyuan District, 333, Taiwan
Local Institution - 0341
Birmingham, B9 5SS, United Kingdom
Local Institution - 0144
Blackpool, FY3 8NR, United Kingdom
Local Institution - 0235
Cambridge, CB2 0QQ, United Kingdom
Local Institution - 0354
Cannock, WS11 0BN, United Kingdom
Local Institution - 0165
Cheshire, WA5 1QG, United Kingdom
Local Institution - 0157
Glasgow, G51 4TF, United Kingdom
Local Institution - 0353
Manchester, M13 9NQ, United Kingdom
Local Institution - 0208
Swansea, SA6 6NL, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Trial terminated because of lack of efficacy in the short term acute phase.
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2018
First Posted
July 26, 2018
Study Start
July 16, 2018
Primary Completion
December 12, 2022
Study Completion
October 23, 2023
Last Updated
July 3, 2024
Results First Posted
July 3, 2024
Record last verified: 2024-06