An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease
- Conditions
- Granulomatous ColitisCrohn's EnteritisCrohn's DiseaseGranulomatous Enteritis
- Interventions
- Drug: BMS-986165Other: Placebo
- Registration Number
- NCT03599622
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 239
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986165 Dose 1 BMS-986165 - Placebo Placebo - BMS-986165 Dose 2 BMS-986165 -
- Primary Outcome Measures
Name Time Method Percent of Participants Achieving Clinical Remission at Week 12 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.Percent of Participants Achieving Endoscopic Response at Week 12 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.
- Secondary Outcome Measures
Name Time Method Percent of Participants Achieving Clinical Response at Week 12 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.Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12 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.Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12 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.
Trial Locations
- Locations (257)
Local Institution - 0319
🇺🇸Chicago, Illinois, United States
Local Institution - 0232
🇺🇸Miami, Florida, United States
Local Institution - 0011
🇺🇸Las Vegas, Nevada, United States
Local Institution - 0301
🇺🇸Indianapolis, Indiana, United States
Local Institution - 0029
🇲🇽Queretaro, Mexico
Local Institution - 0278
🇵🇱Nowy Targ, Poland
Local Institution - 0026
🇵🇱Warszawa, Poland
Local Institution - 0279
🇵🇱Warszawa, Poland
Local Institution - 0180
🇨🇭Bern, Switzerland
Local Institution - 0216
🇵🇹Santa Maria da Feira, Portugal
Local Institution - 0044
🇷🇴Bucuresti, Romania
Local Institution - 0060
🇷🇴Timisoara, Romania
Local Institution - 0160
🇵🇱Wroclaw, Poland
Local Institution - 0267
🇨🇳Taipei, Taiwan
Local Institution - 0256
🇧🇷Salvador, Bahia, Brazil
Local Institution - 0348
🇮🇪Tallaght, Dublin, Ireland
Local Institution - 0275
🇦🇺Murdoch, Western Australia, Australia
Local Institution - 0192
🇩🇰Aalborg, Denmark
Local Institution - 0300
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0236
🇨🇦Toronto, Ontario, Canada
Local Institution - 0317
🇨🇦Montreal, Quebec, Canada
Local Institution - 0187
🇯🇵Kurume-shi, Fukuoka, Japan
Local Institution - 0318
🇯🇵Urasoe-Shi, Okinawa, Japan
Local Institution - 0189
🇯🇵Hamamatsu, Shizuoka, Japan
Local Institution - 0207
🇯🇵Sagamihara-shi, Kanagawa, Japan
Local Institution - 0179
🇯🇵Suita-shi, Osaka, Japan
Local Institution - 0217
🇯🇵Sapporo, Hokkaido, Japan
Local Institution - 0188
🇯🇵Hiroshima, Japan
Local Institution - 0206
🇯🇵Kyoto, Japan
Local Institution - 0203
🇯🇵Sapporo, Japan
Local Institution - 0276
🇺🇸Largo, Florida, United States
Local Institution - 0259
🇺🇸Jacksonville, Florida, United States
Local Institution - 0261
🇺🇸Jacksonville, Florida, United States
Local Institution - 0223
🇺🇸Ypsilanti, Michigan, United States
Local Institution - 0003
🇺🇸Chesterfield, Michigan, United States
Local Institution - 0253
🇺🇸Iowa City, Iowa, United States
Local Institution - 0308
🇺🇸New York, New York, United States
Local Institution - 0043
🇺🇸Lake Success, New York, United States
Local Institution - 0231
🇺🇸Jackson, Mississippi, United States
Local Institution - 0218
🇺🇸Chesterfield, Michigan, United States
Local Institution - 0349
🇺🇸Oklahoma City, Oklahoma, United States
Local Institution - 0305
🇧🇪Edegem, Belgium
Local Institution - 0085
🇧🇷Sao Jose do Rio Preto, SAO Paulo, Brazil
Local Institution - 0343
🇫🇷Montpellier cedex 5, France
Local Institution - 0069
🇧🇷Juiz de Fora, Minas Gerais, Brazil
Local Institution - 0086
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution - 0090
🇩🇪Berlin, Germany
Local Institution - 0082
🇵🇱Sopot, Poland
Local Institution - 0185
🇯🇵Otsu, Shiga, Japan
Local Institution - 0322
🇧🇪Gent, Belgium
Local Institution - 0314
🇧🇪Yvoir, Belgium
Local Institution - 0084
🇫🇷Saint-Etienne, France
Local Institution - 0127
🇫🇷Toulouse Cedex 9, France
Local Institution - 0110
🇫🇷Clichy Cedex, France
Local Institution - 0017
🇧🇷Rio de Janeiro, Brazil
Local Institution - 0294
🇩🇪Hannover, Germany
Local Institution - 0089
🇩🇪Jena, Germany
Local Institution - 0140
🇩🇪Munster, Germany
Local Institution - 0104
🇭🇺Bekescsaba, Hungary
Local Institution - 0083
🇭🇺Gyongyos, Hungary
Local Institution - 0171
🇮🇹Catanzaro, Italy
Local Institution - 0056
🇮🇹Messina, Italy
Local Institution - 0211
🇭🇺Budapest, Hungary
Local Institution - 0064
🇰🇷Daegu, Korea, Republic of
Local Institution - 0274
🇪🇸Barcelona, Spain
Local Institution - 0158
🇰🇷Ansan-si, Korea, Republic of
Local Institution - 0213
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0106
🇲🇽Guadalajara, Jalisco, Mexico
Local Institution - 0177
🇵🇱Bydgoszcz, Poland
Local Institution - 0194
🇯🇵Omura-shi, Nagasaki, Japan
Local Institution - 0149
🇰🇷Busan, Korea, Republic of
Local Institution - 0311
🇮🇹Milano, Italy
Local Institution - 0167
🇫🇷Toulouse, France
Local Institution - 0263
🇭🇺Budapest, Hungary
Local Institution - 0186
🇮🇱Nahariya, Israel
Local Institution - 0074
🇷🇴Bucharest, Romania
Local Institution - 0262
🇧🇷Salvador, Bahia, Brazil
Local Institution - 0330
🇮🇪Dublin, Ireland
Local Institution - 0332
🇮🇪Galway, Ireland
Local Institution - 0152
🇨🇳Taoyuan, Taiwan
Local Institution - 0198
🇮🇱Rehovot, Israel
Local Institution - 0021
🇪🇸Las Palmas de Gran Canaria, Spain
Local Institution - 0341
🇬🇧Birmingham, United Kingdom
Local Institution - 0157
🇬🇧Glasgow, United Kingdom
Local Institution - 0170
🇮🇹Pavia, Italy
Local Institution - 0054
🇭🇺Debrecen, Hungary
Local Institution - 0061
🇰🇷Daegu, Korea, Republic of
Local Institution - 0235
🇬🇧Cambridge, United Kingdom
Local Institution - 0353
🇬🇧Manchester, United Kingdom
Local Institution - 0004
🇪🇸Valencia, Spain
Local Institution - 0284
🇵🇱Lodz, Poland
Local Institution - 0288
🇵🇱Warszawa, Poland
Local Institution - 0303
🇳🇱Amsterdam, Netherlands
Local Institution - 0034
🇵🇱Wroclaw, Poland
Local Institution - 0163
🇷🇴Bucuresti, Romania
Local Institution - 0032
🇰🇷Yangsan-si, Korea, Republic of
Bioterm
🇷🇺Barnaul, Russian Federation
Local Institution - 0335
🇮🇪Ballinasloe, Galway, Ireland
Local Institution - 0336
🇮🇪Drogheda, Louth, Ireland
Local Institution - 0320
🇩🇰Odense, Denmark
Local Institution - 0168
🇫🇷Colombes, France
Local Institution - 0176
🇵🇱Olsztyn, Poland
Local Institution - 0195
🇯🇵Minato-ku, Tokyo, Japan
Local Institution - 0007
🇲🇽Mexico, Distrito Federal, Mexico
Local Institution - 0015
🇰🇷Seoul, Korea, Republic of
Local Institution - 0150
🇰🇷Incheon, Korea, Republic of
Local Institution - 0080
🇪🇸Girona, Spain
Local Institution - 0309
🇪🇸Santiago De Compostelle, Spain
Tomsk Regional Clinical Hospital
🇷🇺Tomsk, Russian Federation
Novosibirsk Gastrocenter
🇷🇺Novosibirsk, Russian Federation
Local Institution - 0325
🇪🇸Sabadell, Spain
Local Institution - 0107
🇪🇸Sevilla, Spain
Novgorod Regional Clinical Hospital
🇷🇺Velikij Novgorod, Russian Federation
City Clinical Hospital Number 24
🇷🇺Moscow, Russian Federation
Novosibirsk State Regional Clinical Hospital
🇷🇺Novosibirsk, Russian Federation
Medical Center Healthy Family
🇷🇺Novosibirsk, Russian Federation
Clinic Ultrasound 4D
🇷🇺Pyatigorsk, Russian Federation
Local Institution - 0339
🇩🇪Brandenburg An Der Havel, Germany
Local Institution - 0178
🇩🇪Halle, Germany
Local Institution - 0340
🇩🇪Tubingen, Germany
Local Institution - 0356
🇺🇸Milwaukee, Wisconsin, United States
Local Institution - 0113
🇪🇸Santander, Spain
Local Institution - 0012
🇰🇷Wonju-si, Korea, Republic of
Local Institution - 0197
🇮🇱Beer Sheva, Israel
Local Institution - 0184
🇮🇱Petah Tikva, Israel
Local Institution - 0248
🇺🇸Zephyrhills, Florida, United States
Local Institution - 0292
🇭🇺Budapest, Hungary
Local Institution - 0001
🇺🇸Hamden, Connecticut, United States
Local Institution - 0258
🇺🇸Los Angeles, California, United States
Local Institution - 0255
🇺🇸Clearwater, Florida, United States
Local Institution - 0162
🇺🇸New Port Richey, Florida, United States
Local Institution - 0277
🇺🇸Suwanee, Georgia, United States
Local Institution - 0282
🇺🇸Shreveport, Louisiana, United States
Local Institution - 0359
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0047
🇺🇸Wyoming, Michigan, United States
Local Institution - 0156
🇺🇸Ocean Springs, Mississippi, United States
Local Institution - 0072
🇺🇸Nashville, Tennessee, United States
Local Institution - 0226
🇺🇸Monroe, North Carolina, United States
Local Institution - 0125
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0357
🇺🇸Wyomissing, Pennsylvania, United States
Local Institution - 0252
🇺🇸San Antonio, Texas, United States
Local Institution - 0238
🇺🇸Hershey, Pennsylvania, United States
Local Institution - 0240
🇺🇸Spring, Texas, United States
Local Institution - 0307
🇺🇸San Antonio, Texas, United States
Local Institution - 0302
🇺🇸Tyler, Texas, United States
Local Institution - 0246
🇺🇸Garland, Texas, United States
Local Institution
🇪🇸LHospitalet de Llobregat, Spain
Local Institution - 0266
🇺🇸Seattle, Washington, United States
Local Institution - 0327
🇺🇸Seattle, Washington, United States
Local Institution - 0191
🇺🇸Seattle, Washington, United States
Local Institution - 0254
🇦🇺Woolloongabba, Queensland, Australia
Local Institution - 0268
🇦🇺South Brisbane, Queensland, Australia
Local Institution - 0265
🇦🇺Adelaide, South Australia, Australia
Local Institution - 0042
🇦🇺Ballarat, Victoria, Australia
Local Institution - 0351
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0058
🇧🇷Botucato, Sao Paulo, Brazil
Local Institution - 0059
🇧🇷Santo Andre, Sao Paulo, Brazil
Local Institution - 0045
🇧🇷Sao Bernardo do Campo, SAO Paulo, Brazil
Local Institution - 0048
🇨🇦Calgary, Alberta, Canada
Local Institution - 0324
🇨🇦Edmonton, Alberta, Canada
Local Institution - 0159
🇨🇦Vancouver, British Columbia, Canada
Local Institution - 0283
🇨🇦Etobicoke, Ontario, Canada
Local Institution - 0202
🇩🇰Copenhagen NV, Denmark
Local Institution - 0280
🇨🇳XIamen, Fujian, China
Local Institution - 0312
🇨🇦London, Ontario, Canada
Local Institution - 0225
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0221
🇨🇳Changsha, Hunan, China
Local Institution - 0228
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0220
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0306
🇨🇳Nanjing, Jiangsu, China
Local Institution - 0299
🇨🇳Shenyang, Liaoning, China
Local Institution - 0250
🇨🇳Changchun Shi, Jilin, China
Local Institution - 0219
🇨🇳Shanghai, Shanghai, China
Local Institution - 0234
🇨🇳Shanghai, Shanghai, China
Local Institution - 0360
🇨🇿Brno, Czechia
Local Institution - 0337
🇨🇿Brno, Czechia
Local Institution - 0352
🇨🇿Ostrava, Czechia
Local Institution - 0350
🇨🇿Pardubice, Czechia
Local Institution - 0071
🇨🇿Ostrava, Czechia
Local Institution - 0057
🇨🇿Hradec Kralove, Czechia
Local Institution - 0075
🇨🇿Praha 9, Czechia
Local Institution - 0212
🇩🇪Frankfurt, Germany
Local Institution - 0099
🇩🇪Berlin, Germany
Local Institution - 0257
🇩🇪Regensburg, Germany
Local Institution - 0321
🇩🇪Mannheim, Germany
Local Institution - 0100
🇭🇺Budapest, Hungary
Local Institution - 0210
🇭🇺Mohacs, Hungary
Local Institution - 0243
🇭🇺Szeged, Hungary
Local Institution - 0164
🇭🇺Vac, Hungary
Local Institution - 0290
🇮🇹Bologna, Italy
Local Institution - 0298
🇮🇹Castellana Grotte, Italy
Local Institution - 0304
🇮🇹Milano, Italy
Local Institution - 0182
🇯🇵Toyoake, Aichi, Japan
Local Institution - 0128
🇮🇹Padova, Italy
Local Institution - 0310
🇮🇹Negrar, Italy
Local Institution - 0115
🇮🇹Milano, Italy
Local Institution - 0297
🇮🇹Monserrato, Italy
Local Institution - 0161
🇮🇹Roma, Italy
Local Institution - 0119
🇮🇹Rozzano, Italy
Local Institution - 0285
🇮🇹Torino, Italy
Local Institution - 0328
🇯🇵Toon, Ehime, Japan
Local Institution - 0199
🇯🇵Hirosaki, Aomori, Japan
Local Institution - 0326
🇯🇵Fukui-shi, Fukui, Japan
Local Institution - 0323
🇯🇵Sapporo, Hokkaido, Japan
Local Institution - 0200
🇯🇵Sendai, Miyagi, Japan
Local Institution - 0183
🇯🇵Nishinomiya, Hyogo, Japan
Local Institution - 0196
🇯🇵Saga, Japan
Local Institution - 0046
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Local Institution - 0354
🇬🇧Cannock, United Kingdom
Local Institution - 0291
🇵🇱Lublin, Poland
Local Institution - 0208
🇬🇧Swansea, United Kingdom
Multidisciplinary Consultative and Diagnostic Center
🇷🇺Tyumen, Russian Federation
Saratov Regional Clinical Hospital
🇷🇺Saratov, Russian Federation
Hospital Irkutsk Scientific Center
🇷🇺Irkutsk, Russian Federation
Local Institution - 0329
🇪🇸Alicante, Spain
Local Institution - 0173
🇨🇳Kaohsiung, Taiwan
Local Institution - 0148
🇨🇳Taichung, Taiwan
Local Institution - 0313
🇪🇸Sevilla, Spain
Local Institution - 0144
🇬🇧Blackpool, United Kingdom
Local Institution - 0165
🇬🇧Cheshire, United Kingdom
Local Institution - 0358
🇺🇸Suwanee, Georgia, United States
Local Institution - 0264
🇺🇸Arlington, Texas, United States
Local Institution - 0073
🇺🇸Southlake, Texas, United States
Local Institution - 0204
🇯🇵Chikushino-shi, Fukuoka, Japan
Republican Clinical Hospital Ministry of Health Republic of Tatarstan
🇷🇺Kazan, Russian Federation
Local Institution - 0289
🇦🇺Woodville, South Australia, Australia
Local Institution - 0214
🇯🇵Miyazaki, Japan
Local Institution - 0190
🇩🇪Kiel, Germany
Local Institution - 0205
🇯🇵Sakura-shi, Chiba, Japan
Local Institution - 0102
🇩🇪Ulm, Germany
Medical Center SibNovoMed
🇷🇺Novosibirsk, Russian Federation
Local Institution - 0016
🇰🇷Seoul, Korea, Republic of
Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth
🇷🇺Saint-Petersburg, Russian Federation
Local Institution - 0154
🇪🇸Fuenlabrada, Spain
Local Institution - 0331
🇺🇸Vancouver, Washington, United States
Local Institution - 0122
🇺🇸Sayre, Pennsylvania, United States
Local Institution - 0346
🇺🇸Glenview, Illinois, United States
Local Institution - 0316
🇧🇪Antwerpen, Belgium
Local Institution - 0067
🇷🇴Bucuresti, Romania
Local Institution - 0005
🇷🇴Timisoara, Romania
Local Institution - 0065
🇵🇱Krakow, Poland
Local Institution - 0098
🇵🇱Lodz, Poland
Local Institution - 0174
🇵🇹Guimaraes, Portugal
Local Institution - 0109
🇲🇽Monterrey, Nuevo LEON, Mexico
Local Institution - 0245
🇵🇱Bydgoszcz, Poland
Local Institution - 0063
🇵🇱Tychy, Poland
Local Institution - 0271
🇵🇱Warszawa, Poland
Local Institution - 0009
🇲🇽Cuernavaca, Morelos, Mexico
Local Institution - 0105
🇺🇸Charleston, South Carolina, United States
Local Institution - 0247
🇺🇸Aurora, Colorado, United States
Local Institution - 0201
🇺🇸Orlando, Florida, United States
Local Institution - 0249
🇺🇸Orlando, Florida, United States
Local Institution - 0166
🇺🇸Tampa, Florida, United States
Local Institution - 0224
🇺🇸Richmond, Virginia, United States
Local Institution - 0041
🇦🇺Clayton, Victoria, Australia
Local Institution - 0040
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0242
🇭🇺Budapest, Hungary