An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease
NCT ID: NCT03599622
Last Updated: 2024-07-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
239 participants
INTERVENTIONAL
2018-07-16
2023-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BMS-986165 Dose 1
BMS-986165
Specified dose on specified days
BMS-986165 Dose 2
BMS-986165
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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BMS-986165
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0258
Los Angeles, California, United States
Local Institution - 0247
Aurora, Colorado, United States
Local Institution - 0001
Hamden, Connecticut, United States
Local Institution - 0255
Clearwater, Florida, United States
Local Institution - 0259
Jacksonville, Florida, United States
Local Institution - 0261
Jacksonville, Florida, United States
Local Institution - 0276
Largo, Florida, United States
Local Institution - 0232
Miami, Florida, United States
Local Institution - 0162
New Port Richey, Florida, 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 - 0248
Zephyrhills, Florida, United States
Local Institution - 0277
Suwanee, Georgia, United States
Local Institution - 0358
Suwanee, Georgia, United States
Local Institution - 0319
Chicago, Illinois, United States
Local Institution - 0346
Glenview, Illinois, United States
Local Institution - 0301
Indianapolis, Indiana, United States
Local Institution - 0253
Iowa City, Iowa, United States
Local Institution - 0282
Shreveport, Louisiana, United States
Local Institution - 0003
Chesterfield, Michigan, United States
Local Institution - 0218
Chesterfield, Michigan, United States
Local Institution - 0047
Wyoming, Michigan, United States
Local Institution - 0223
Ypsilanti, Michigan, United States
Local Institution - 0231
Jackson, Mississippi, United States
Local Institution - 0156
Ocean Springs, Mississippi, United States
Local Institution - 0359
St Louis, Missouri, United States
Local Institution - 0011
Las Vegas, Nevada, United States
Local Institution - 0043
Lake Success, New York, United States
Local Institution - 0308
New York, New York, United States
Local Institution - 0226
Monroe, North Carolina, United States
Local Institution - 0349
Oklahoma City, Oklahoma, United States
Local Institution - 0238
Hershey, Pennsylvania, United States
Local Institution - 0125
Pittsburgh, Pennsylvania, United States
Local Institution - 0122
Sayre, Pennsylvania, United States
Local Institution - 0357
Wyomissing, Pennsylvania, United States
Local Institution - 0105
Charleston, South Carolina, United States
Local Institution - 0072
Nashville, Tennessee, United States
Local Institution - 0264
Arlington, Texas, United States
Local Institution - 0246
Garland, Texas, United States
Local Institution - 0252
San Antonio, Texas, United States
Local Institution - 0307
San Antonio, Texas, United States
Local Institution - 0073
Southlake, Texas, United States
Local Institution - 0240
Spring, Texas, United States
Local Institution - 0302
Tyler, Texas, United States
Local Institution
Lynchburg, Virginia, United States
Local Institution - 0224
Richmond, Virginia, United States
Local Institution - 0327
Seattle, Washington, United States
Local Institution - 0266
Seattle, Washington, United States
Local Institution - 0191
Seattle, Washington, United States
Local Institution - 0331
Vancouver, Washington, United States
Local Institution - 0356
Milwaukee, Wisconsin, United States
Local Institution - 0268
South Brisbane, Queensland, Australia
Local Institution - 0254
Woolloongabba, Queensland, Australia
Local Institution - 0265
Adelaide, South Australia, Australia
Local Institution - 0289
Woodville, South Australia, Australia
Local Institution - 0042
Ballarat, Victoria, Australia
Local Institution - 0041
Clayton, Victoria, Australia
Local Institution - 0040
Melbourne, Victoria, Australia
Local Institution - 0351
Melbourne, Victoria, Australia
Local Institution - 0275
Murdoch, Western Australia, Australia
Local Institution - 0316
Antwerp, , Belgium
Local Institution - 0305
Edegem, , Belgium
Local Institution - 0322
Ghent, , Belgium
Local Institution - 0314
Yvoir, , Belgium
Local Institution - 0256
Salvador, Estado de Bahia, Brazil
Local Institution - 0262
Salvador, Estado de Bahia, Brazil
Local Institution - 0069
Juiz de Fora, Minas Gerais, Brazil
Local Institution - 0086
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0058
Botucato, São Paulo, Brazil
Local Institution - 0059
Santo André, São Paulo, Brazil
Local Institution - 0045
São Bernardo do Campo, São Paulo, Brazil
Local Institution - 0085
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0017
Rio de Janeiro, , Brazil
Local Institution - 0048
Calgary, Alberta, Canada
Local Institution - 0324
Edmonton, Alberta, Canada
Local Institution - 0300
Edmonton, Alberta, Canada
Local Institution - 0159
Vancouver, British Columbia, Canada
Local Institution - 0283
Etobicoke, Ontario, Canada
Local Institution - 0312
London, Ontario, Canada
Local Institution - 0236
Toronto, Ontario, Canada
Local Institution - 0317
Montreal, Quebec, Canada
Local Institution - 0280
Xiamen, Fujian, China
Local Institution - 0225
Guangzhou, Guangdong, China
Local Institution - 0228
Guangzhou, Guangdong, China
Local Institution - 0221
Changsha, Hunan, China
Local Institution - 0220
Nanjing, Jiangsu, China
Local Institution - 0306
Nanjing, Jiangsu, China
Local Institution - 0250
Changchun, Jilin, China
Local Institution - 0299
Shenyang, Liaoning, China
Local Institution - 0219
Shanghai, Shanghai Municipality, China
Local Institution - 0234
Shanghai, Shanghai Municipality, China
Local Institution - 0337
Brno, , Czechia
Local Institution - 0360
Brno, , Czechia
Local Institution - 0057
Hradec Králové, , Czechia
Local Institution - 0352
Ostrava, , Czechia
Local Institution - 0071
Ostrava, , Czechia
Local Institution - 0350
Pardubice, , Czechia
Local Institution - 0075
Prague, , Czechia
Local Institution - 0192
Aalborg, , Denmark
Local Institution - 0202
Copenhagen NV, , Denmark
Local Institution - 0320
Odense, , Denmark
Local Institution - 0110
Clichy, , France
Local Institution - 0168
Colombes, , France
Local Institution - 0343
Montpellier, , France
Local Institution - 0084
Saint-Etienne, , France
Local Institution - 0127
Toulouse, , France
Local Institution - 0167
Toulouse, , France
Local Institution - 0099
Berlin, , Germany
Local Institution - 0090
Berlin, , Germany
Local Institution - 0339
Brandenburg, , Germany
Local Institution - 0212
Frankfurt, , Germany
Local Institution - 0178
Halle, , Germany
Local Institution
Halle, , Germany
Local Institution - 0294
Hanover, , Germany
Local Institution - 0089
Jena, , Germany
Local Institution - 0190
Kiel, , Germany
Local Institution - 0321
Mannheim, , Germany
Local Institution - 0140
Münster, , Germany
Local Institution - 0257
Regensburg, , Germany
Local Institution - 0340
Tübingen, , Germany
Local Institution - 0102
Ulm, , Germany
Local Institution - 0104
Békéscsaba, , Hungary
Local Institution - 0242
Budapest, , Hungary
Local Institution - 0263
Budapest, , Hungary
Local Institution - 0211
Budapest, , Hungary
Local Institution - 0100
Budapest, , Hungary
Local Institution - 0292
Budapest, , Hungary
Local Institution - 0054
Debrecen, , Hungary
Local Institution - 0083
Gyöngyös, , Hungary
Local Institution - 0210
Mohács, , Hungary
Local Institution - 0243
Szeged, , Hungary
Local Institution - 0164
Vác, , Hungary
Local Institution - 0348
Tallaght, Dublin, Ireland
Local Institution - 0335
Ballinasloe, Galway, Ireland
Local Institution - 0336
Drogheda, Louth, Ireland
Local Institution - 0330
Dublin, , Ireland
Local Institution - 0332
Galway, , Ireland
Local Institution - 0197
Beersheba, , Israel
Local Institution - 0186
Nahariya, , Israel
Local Institution - 0184
Petah Tikva, , Israel
Local Institution - 0198
Rehovot, , Israel
Local Institution - 0290
Bologna, , Italy
Local Institution - 0298
Castellana Grotte, , Italy
Local Institution - 0171
Catanzaro, , Italy
Local Institution - 0056
Messina, , Italy
Local Institution - 0304
Milan, , Italy
Local Institution - 0115
Milan, , Italy
Local Institution - 0311
Milan, , Italy
Local Institution - 0297
Monserrato, , Italy
Local Institution - 0310
Negrar, , Italy
Local Institution - 0128
Padua, , Italy
Local Institution - 0170
Pavia, , Italy
Local Institution - 0161
Roma, , Italy
Local Institution - 0119
Rozzano, , Italy
Local Institution - 0285
Torino, , Italy
Local Institution - 0182
Toyoake, Aichi-ken, Japan
Local Institution - 0199
Hirosaki, Aomori, Japan
Local Institution - 0205
Sakura-shi, Chiba, Japan
Local Institution - 0328
Tōon, Ehime, Japan
Local Institution - 0326
Fukui-shi, Fukui, Japan
Local Institution - 0204
Chikushino-shi, Fukuoka, Japan
Local Institution - 0187
Kurume-shi, Fukuoka, Japan
Local Institution - 0323
Sapporo, Hokkaido, Japan
Local Institution - 0217
Sapporo, Hokkaido, Japan
Local Institution - 0183
Nishinomiya, Hyōgo, Japan
Local Institution - 0207
Sagamihara-shi, Kanagawa, Japan
Local Institution - 0200
Sendai, Miyagi, Japan
Local Institution - 0194
Omura-shi, Nagasaki, Japan
Local Institution - 0318
Urasoe-Shi, Okinawa, Japan
Local Institution - 0179
Suita-shi, Osaka, Japan
Local Institution - 0185
Ōtsu, Shiga, Japan
Local Institution - 0189
Hamamatsu, Shizuoka, Japan
Local Institution - 0213
Bunkyo-ku, Tokyo, Japan
Local Institution - 0195
Minato-ku, Tokyo, Japan
Local Institution - 0188
Hiroshima, , Japan
Local Institution - 0206
Kyoto, , Japan
Local Institution - 0214
Miyazaki, , Japan
Local Institution - 0196
Saga, , Japan
Local Institution - 0203
Sapporo, , Japan
Local Institution - 0106
Guadalajara, Jalisco, Mexico
Local Institution - 0007
Mexico City, Mexico City, Mexico
Local Institution - 0009
Cuernavaca, Morelos, Mexico
Local Institution - 0109
Monterrey, Nuevo León, Mexico
Local Institution - 0029
Querétaro, , Mexico
Local Institution - 0303
Amsterdam, , Netherlands
Local Institution - 0245
Bydgoszcz, , Poland
Local Institution - 0177
Bydgoszcz, , Poland
Local Institution - 0065
Krakow, , Poland
Local Institution - 0284
Lodz, , Poland
Local Institution - 0098
Lodz, , Poland
Local Institution - 0291
Lublin, , Poland
Local Institution - 0278
Nowy Targ, , Poland
Local Institution - 0176
Olsztyn, , Poland
Local Institution - 0082
Sopot, , Poland
Local Institution - 0063
Tychy, , Poland
Local Institution - 0271
Warsaw, , Poland
Local Institution - 0288
Warsaw, , Poland
Local Institution - 0026
Warsaw, , Poland
Local Institution - 0279
Warsaw, , Poland
Local Institution - 0160
Wroclaw, , Poland
Local Institution - 0034
Wroclaw, , Poland
Local Institution - 0174
Guimarães, , Portugal
Local Institution - 0216
Santa Maria da Feira, , Portugal
Local Institution - 0067
Bucharest, , Romania
Local Institution - 0044
Bucharest, , Romania
Local Institution - 0163
Bucharest, , Romania
Local Institution - 0074
Bucharest, , Romania
Local Institution - 0005
Timișoara, , Romania
Local Institution - 0060
Timișoara, , Romania
Bioterm
Barnaul, , Russia
Hospital Irkutsk Scientific Center
Irkutsk, , Russia
Republican Clinical Hospital Ministry of Health Republic of Tatarstan
Kazan', , Russia
City Clinical Hospital Number 24
Moscow, , Russia
Medical Center SibNovoMed
Novosibirsk, , Russia
Novosibirsk Gastrocenter
Novosibirsk, , Russia
Novosibirsk State Regional Clinical Hospital
Novosibirsk, , Russia
Medical Center Healthy Family
Novosibirsk, , Russia
Clinic Ultrasound 4D
Pyatigorsk, , Russia
Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, , Russia
Saratov Regional Clinical Hospital
Saratov, , Russia
Tomsk Regional Clinical Hospital
Tomsk, , Russia
Multidisciplinary Consultative and Diagnostic Center
Tyumen, , Russia
Novgorod Regional Clinical Hospital
Veliky Novgorod, , Russia
Local Institution - 0046
Seongnam-si, Gyeonggi-do, South Korea
Local Institution - 0158
Ansan-si, , South Korea
Local Institution - 0149
Busan, , South Korea
Local Institution - 0064
Daegu, , South Korea
Local Institution - 0061
Daegu, , South Korea
Local Institution - 0150
Incheon, , South Korea
Local Institution - 0015
Seoul, , South Korea
Local Institution - 0016
Seoul, , South Korea
Local Institution - 0012
Wŏnju, , South Korea
Local Institution - 0032
Yangsan, , South Korea
Local Institution - 0329
Alicante, , Spain
Local Institution - 0274
Barcelona, , Spain
Local Institution - 0154
Fuenlabrada, , Spain
Local Institution - 0080
Girona, , Spain
Local Institution - 0021
Las Palmas de Gran Canaria, , Spain
Local Institution
LHospitalet de Llobregat, , Spain
Local Institution - 0325
Sabadell, , Spain
Local Institution - 0113
Santander, , Spain
Local Institution - 0309
Santiago de Compostelle, , Spain
Local Institution - 0313
Seville, , Spain
Local Institution - 0107
Seville, , Spain
Local Institution - 0004
Valencia, , Spain
Local Institution - 0180
Bern, , Switzerland
Local Institution - 0173
Kaohsiung City, , Taiwan
Local Institution - 0148
Taichung, , Taiwan
Local Institution - 0267
Taipei, , Taiwan
Local Institution - 0152
Taoyuan District, , Taiwan
Local Institution - 0341
Birmingham, , United Kingdom
Local Institution - 0144
Blackpool, , United Kingdom
Local Institution - 0235
Cambridge, , United Kingdom
Local Institution - 0354
Cannock, , United Kingdom
Local Institution - 0165
Cheshire, , United Kingdom
Local Institution - 0157
Glasgow, , United Kingdom
Local Institution - 0353
Manchester, , United Kingdom
Local Institution - 0208
Swansea, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
Other Identifiers
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2017-001976-48
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM011-023
Identifier Type: -
Identifier Source: org_study_id
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