Clinical trial NCT03599622: An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Granulomatous Colitis
Crohn's Disease
Crohn's Enteritis
Granulomatous Enteritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent of Participants Achieving Clinical Remission at Week 12
timeFrame: 12 weeks after first dose
measure: Percent of Participants Achieving Endoscopic Response at Week 12
timeFrame: 12 weeks after first dose
Secondary outcomes:
measure: Percent of Participants Achieving Clinical Response at Week 12
timeFrame: 12 weeks after first dose
measure: Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12
timeFrame: 12 weeks after first dose
measure: Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
timeFrame: 12 weeks after first dose
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution - 0258
state: California
city: Aurora
country: United States
facility: Local Institution - 0247
state: Colorado
city: Hamden
country: United States
facility: Local Institution - 0001
state: Connecticut
city: Clearwater
country: United States
facility: Local Institution - 0255
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 0259
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 0261
state: Florida
city: Largo
country: United States
facility: Local Institution - 0276
state: Florida
city: Miami
country: United States
facility: Local Institution - 0232
state: Florida
city: New Port Richey
country: United States
facility: Local Institution - 0162
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0201
state: Florida
city: Orlando
country: United States
facility: Local Institution - 0249
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0166
state: Florida
city: Zephyrhills
country: United States
facility: Local Institution - 0248
state: Florida
city: Suwanee
country: United States
facility: Local Institution - 0277
state: Georgia
city: Suwanee
country: United States
facility: Local Institution - 0358
state: Georgia
city: Chicago
country: United States
facility: Local Institution - 0319
state: Illinois
city: Glenview
country: United States
facility: Local Institution - 0346
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution - 0301
state: Indiana
city: Iowa City
country: United States
facility: Local Institution - 0253
state: Iowa
city: Shreveport
country: United States
facility: Local Institution - 0282
state: Louisiana
city: Chesterfield
country: United States
facility: Local Institution - 0003
state: Michigan
city: Chesterfield
country: United States
facility: Local Institution - 0218
state: Michigan
city: Wyoming
country: United States
facility: Local Institution - 0047
state: Michigan
city: Ypsilanti
country: United States
facility: Local Institution - 0223
state: Michigan
city: Jackson
country: United States
facility: Local Institution - 0231
state: Mississippi
city: Ocean Springs
country: United States
facility: Local Institution - 0156
state: Mississippi
city: Saint Louis
country: United States
facility: Local Institution - 0359
state: Missouri
city: Las Vegas
country: United States
facility: Local Institution - 0011
state: Nevada
city: Lake Success
country: United States
facility: Local Institution - 0043
state: New York
city: New York
country: United States
facility: Local Institution - 0308
state: New York
city: Monroe
country: United States
facility: Local Institution - 0226
state: North Carolina
city: Oklahoma City
country: United States
facility: Local Institution - 0349
state: Oklahoma
city: Hershey
country: United States
facility: Local Institution - 0238
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Local Institution - 0125
state: Pennsylvania
city: Sayre
country: United States
facility: Local Institution - 0122
state: Pennsylvania
city: Wyomissing
country: United States
facility: Local Institution - 0357
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0105
state: South Carolina
city: Nashville
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facility: Local Institution - 0072
state: Tennessee
city: Arlington
country: United States
facility: Local Institution - 0264
state: Texas
city: Garland
country: United States
facility: Local Institution - 0246
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0252
state: Texas
city: San Antonio
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state: Texas
city: Southlake
country: United States
facility: Local Institution - 0073
state: Texas
city: Spring
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facility: Local Institution - 0240
state: Texas
city: Tyler
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state: Texas
city: Lynchburg
country: United States
facility: Local Institution
state: Virginia
city: Richmond
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state: Virginia
city: Seattle
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state: Washington
city: Seattle
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state: Washington
city: Seattle
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city: South Brisbane
country: Australia
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city: Woolloongabba
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state: South Australia
city: Woodville
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state: Victoria
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city: Antwerpen
country: Belgium
facility: Local Institution - 0316
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country: Belgium
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city: Yvoir
country: Belgium
facility: Local Institution - 0314
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country: Brazil
facility: Local Institution - 0256
state: Bahia
city: Salvador
country: Brazil
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state: Bahia
city: Juiz de Fora
country: Brazil
facility: Local Institution - 0069
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Local Institution - 0086
state: Rio Grande Do Sul
city: Botucato
country: Brazil
facility: Local Institution - 0058
state: Sao Paulo
city: Santo Andre
country: Brazil
facility: Local Institution - 0059
state: Sao Paulo
city: Sao Bernardo do Campo
country: Brazil
facility: Local Institution - 0045
state: SAO Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Local Institution - 0085
state: SAO Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0017
city: Calgary
country: Canada
facility: Local Institution - 0048
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution - 0324
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution - 0300
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution - 0159
state: British Columbia
city: Etobicoke
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state: Ontario
city: London
country: Canada
facility: Local Institution - 0312
state: Ontario
city: Toronto
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state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0317
state: Quebec
city: XIamen
country: China
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state: Fujian
city: Guangzhou
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state: Jiangsu
city: Changchun Shi
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state: Shanghai
city: Shanghai
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state: Shanghai
city: Brno
country: Czechia
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city: Brno
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country: Czechia
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country: Czechia
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city: Ostrava
country: Czechia
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city: Pardubice
country: Czechia
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city: Praha 9
country: Czechia
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country: Denmark
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city: Copenhagen NV
country: Denmark
facility: Local Institution - 0202
city: Odense
country: Denmark
facility: Local Institution - 0320
city: Clichy Cedex
country: France
facility: Local Institution - 0110
city: Colombes
country: France
facility: Local Institution - 0168
city: Montpellier cedex 5
country: France
facility: Local Institution - 0343
city: Saint-Etienne
country: France
facility: Local Institution - 0084
city: Toulouse Cedex 9
country: France
facility: Local Institution - 0127
city: Toulouse
country: France
facility: Local Institution - 0167
city: Berlin
country: Germany
facility: Local Institution - 0099
city: Berlin
country: Germany
facility: Local Institution - 0090
city: Brandenburg An Der Havel
country: Germany
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city: Frankfurt
country: Germany
facility: Local Institution - 0212
city: Halle
country: Germany
facility: Local Institution - 0178
city: Halle
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution - 0294
city: Jena
country: Germany
facility: Local Institution - 0089
city: Kiel
country: Germany
facility: Local Institution - 0190
city: Mannheim
country: Germany
facility: Local Institution - 0321
city: Munster
country: Germany
facility: Local Institution - 0140
city: Regensburg
country: Germany
facility: Local Institution - 0257
city: Tubingen
country: Germany
facility: Local Institution - 0340
city: Ulm
country: Germany
facility: Local Institution - 0102
city: Bekescsaba
country: Hungary
facility: Local Institution - 0104
city: Budapest
country: Hungary
facility: Local Institution - 0242
city: Budapest
country: Hungary
facility: Local Institution - 0263
city: Budapest
country: Hungary
facility: Local Institution - 0211
city: Budapest
country: Hungary
facility: Local Institution - 0100
city: Budapest
country: Hungary
facility: Local Institution - 0292
city: Debrecen
country: Hungary
facility: Local Institution - 0054
city: Gyongyos
country: Hungary
facility: Local Institution - 0083
city: Mohacs
country: Hungary
facility: Local Institution - 0210
city: Szeged
country: Hungary
facility: Local Institution - 0243
city: Vac
country: Hungary
facility: Local Institution - 0164
city: Tallaght
country: Ireland
facility: Local Institution - 0348
state: Dublin
city: Ballinasloe
country: Ireland
facility: Local Institution - 0335
state: Galway
city: Drogheda
country: Ireland
facility: Local Institution - 0336
state: Louth
city: Dublin
country: Ireland
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city: Galway
country: Ireland
facility: Local Institution - 0332
city: Beer Sheva
country: Israel
facility: Local Institution - 0197
city: Nahariya
country: Israel
facility: Local Institution - 0186
city: Petah Tikva
country: Israel
facility: Local Institution - 0184
city: Rehovot
country: Israel
facility: Local Institution - 0198
city: Bologna
country: Italy
facility: Local Institution - 0290
city: Castellana Grotte
country: Italy
facility: Local Institution - 0298
city: Catanzaro
country: Italy
facility: Local Institution - 0171
city: Messina
country: Italy
facility: Local Institution - 0056
city: Milano
country: Italy
facility: Local Institution - 0304
city: Milano
country: Italy
facility: Local Institution - 0115
city: Milano
country: Italy
facility: Local Institution - 0311
city: Monserrato
country: Italy
facility: Local Institution - 0297
city: Negrar
country: Italy
facility: Local Institution - 0310
city: Padova
country: Italy
facility: Local Institution - 0128
city: Pavia
country: Italy
facility: Local Institution - 0170
city: Roma
country: Italy
facility: Local Institution - 0161
city: Rozzano
country: Italy
facility: Local Institution - 0119
city: Torino
country: Italy
facility: Local Institution - 0285
city: Toyoake
country: Japan
facility: Local Institution - 0182
state: Aichi
city: Hirosaki
country: Japan
facility: Local Institution - 0199
state: Aomori
city: Sakura-shi
country: Japan
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state: Chiba
city: Toon
country: Japan
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state: Ehime
city: Fukui-shi
country: Japan
facility: Local Institution - 0326
state: Fukui
city: Chikushino-shi
country: Japan
facility: Local Institution - 0204
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Local Institution - 0187
state: Fukuoka
city: Sapporo
country: Japan
facility: Local Institution - 0323
state: Hokkaido
city: Sapporo
country: Japan
facility: Local Institution - 0217
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Local Institution - 0183
state: Hyogo
city: Sagamihara-shi
country: Japan
facility: Local Institution - 0207
state: Kanagawa
city: Sendai
country: Japan
facility: Local Institution - 0200
state: Miyagi
city: Omura-shi
country: Japan
facility: Local Institution - 0194
state: Nagasaki
city: Urasoe-Shi
country: Japan
facility: Local Institution - 0318
state: Okinawa
city: Suita-shi
country: Japan
facility: Local Institution - 0179
state: Osaka
city: Otsu
country: Japan
facility: Local Institution - 0185
state: Shiga
city: Hamamatsu
country: Japan
facility: Local Institution - 0189
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0213
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution - 0195
state: Tokyo
city: Hiroshima
country: Japan
facility: Local Institution - 0188
city: Kyoto
country: Japan
facility: Local Institution - 0206
city: Miyazaki
country: Japan
facility: Local Institution - 0214
city: Saga
country: Japan
facility: Local Institution - 0196
city: Sapporo
country: Japan
facility: Local Institution - 0203
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 0046
state: Gyeonggi-do
city: Ansan-si
country: Korea, Republic of
facility: Local Institution - 0158
city: Busan
country: Korea, Republic of
facility: Local Institution - 0149
city: Daegu
country: Korea, Republic of
facility: Local Institution - 0064
city: Daegu
country: Korea, Republic of
facility: Local Institution - 0061
city: Incheon
country: Korea, Republic of
facility: Local Institution - 0150
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0015
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0016
city: Wonju-si
country: Korea, Republic of
facility: Local Institution - 0012
city: Yangsan-si
country: Korea, Republic of
facility: Local Institution - 0032
city: Mexico
country: Mexico
facility: Local Institution - 0007
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution - 0106
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Local Institution - 0009
state: Morelos
city: Monterrey
country: Mexico
facility: Local Institution - 0109
state: Nuevo LEON
city: Queretaro
country: Mexico
facility: Local Institution - 0029
city: Amsterdam
country: Netherlands
facility: Local Institution - 0303
city: Bydgoszcz
country: Poland
facility: Local Institution - 0245
city: Bydgoszcz
country: Poland
facility: Local Institution - 0177
city: Krakow
country: Poland
facility: Local Institution - 0065
city: Lodz
country: Poland
facility: Local Institution - 0284
city: Lodz
country: Poland
facility: Local Institution - 0098
city: Lublin
country: Poland
facility: Local Institution - 0291
city: Nowy Targ
country: Poland
facility: Local Institution - 0278
city: Olsztyn
country: Poland
facility: Local Institution - 0176
city: Sopot
country: Poland
facility: Local Institution - 0082
city: Tychy
country: Poland
facility: Local Institution - 0063
city: Warszawa
country: Poland
facility: Local Institution - 0271
city: Warszawa
country: Poland
facility: Local Institution - 0288
city: Warszawa
country: Poland
facility: Local Institution - 0026
city: Warszawa
country: Poland
facility: Local Institution - 0279
city: Wroclaw
country: Poland
facility: Local Institution - 0160
city: Wroclaw
country: Poland
facility: Local Institution - 0034
city: Guimaraes
country: Portugal
facility: Local Institution - 0174
city: Santa Maria da Feira
country: Portugal
facility: Local Institution - 0216
city: Bucharest
country: Romania
facility: Local Institution - 0074
city: Bucuresti
country: Romania
facility: Local Institution - 0067
city: Bucuresti
country: Romania
facility: Local Institution - 0044
city: Bucuresti
country: Romania
facility: Local Institution - 0163
city: Timisoara
country: Romania
facility: Local Institution - 0005
city: Timisoara
country: Romania
facility: Local Institution - 0060
city: Barnaul
country: Russian Federation
facility: Bioterm
city: Irkutsk
country: Russian Federation
facility: Hospital Irkutsk Scientific Center
city: Kazan
country: Russian Federation
facility: Republican Clinical Hospital Ministry of Health Republic of Tatarstan
city: Moscow
country: Russian Federation
facility: City Clinical Hospital Number 24
city: Novosibirsk
country: Russian Federation
facility: Medical Center SibNovoMed
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Gastrocenter
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Regional Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: Medical Center Healthy Family
city: Pyatigorsk
country: Russian Federation
facility: Clinic Ultrasound 4D
city: Saint-Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth
city: Saratov
country: Russian Federation
facility: Saratov Regional Clinical Hospital
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Clinical Hospital
city: Tyumen
country: Russian Federation
facility: Multidisciplinary Consultative and Diagnostic Center
city: Velikij Novgorod
country: Russian Federation
facility: Novgorod Regional Clinical Hospital
city: Alicante
country: Spain
facility: Local Institution - 0329
city: Barcelona
country: Spain
facility: Local Institution - 0274
city: Fuenlabrada
country: Spain
facility: Local Institution - 0154
city: Girona
country: Spain
facility: Local Institution - 0080
city: Las Palmas de Gran Canaria
country: Spain
facility: Local Institution - 0021
city: LHospitalet de Llobregat
country: Spain
facility: Local Institution
city: Sabadell
country: Spain
facility: Local Institution - 0325
city: Santander
country: Spain
facility: Local Institution - 0113
city: Santiago De Compostelle
country: Spain
facility: Local Institution - 0309
city: Sevilla
country: Spain
facility: Local Institution - 0313
city: Sevilla
country: Spain
facility: Local Institution - 0107
city: Valencia
country: Spain
facility: Local Institution - 0004
city: Bern
country: Switzerland
facility: Local Institution - 0180
city: Kaohsiung
country: Taiwan
facility: Local Institution - 0173
city: Taichung
country: Taiwan
facility: Local Institution - 0148
city: Taipei
country: Taiwan
facility: Local Institution - 0267
city: Taoyuan
country: Taiwan
facility: Local Institution - 0152
city: Birmingham
country: United Kingdom
facility: Local Institution - 0341
city: Blackpool
country: United Kingdom
facility: Local Institution - 0144
city: Cambridge
country: United Kingdom
facility: Local Institution - 0235
city: Cannock
country: United Kingdom
facility: Local Institution - 0354
city: Cheshire
country: United Kingdom
facility: Local Institution - 0165
city: Glasgow
country: United Kingdom
facility: Local Institution - 0157
city: Manchester
country: United Kingdom
facility: Local Institution - 0353
city: Swansea
country: United Kingdom
facility: Local Institution - 0208
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: