Granulomatous ColitisPhase 2NCT03599622

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

A Phase 2 study testing BMS-986165 in people with Granulomatous Colitis and Crohn's Disease, run by Bristol-Myers Squibb at 259 sites in 26 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Granulomatous Colitis, Crohn's Disease, Crohn's Enteritis
What is being tested?: BMS-986165
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 239 participants
Where: 259 sitesin 26 countries
Study dates: 16 Jul 2018to 23 Oct 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

259 sites in 26 countries.

Country

City, postcode or hospital

259 sites in 26 countries

United States52 sites

Local Institution - 0264
Arlington, Texas, 76012
Local Institution - 0247
Aurora, Colorado, 80014
Local Institution - 0105
Charleston, South Carolina, 29406
Local Institution - 0003
Chesterfield, Michigan, 48047
Local Institution - 0218
Chesterfield, Michigan, 48047
Local Institution - 0319
Chicago, Illinois, 60637
Local Institution - 0255
Clearwater, Florida, 33756-3839
Local Institution - 0246
Garland, Texas, 75044
Local Institution - 0346
Glenview, Illinois, 60026
Local Institution - 0001
Hamden, Connecticut, 06518
Local Institution - 0238
Hershey, Pennsylvania, 17033
Local Institution - 0301
Indianapolis, Indiana, 46202
Local Institution - 0253
Iowa City, Iowa, 52242
Local Institution - 0231
Jackson, Mississippi, 39216
Local Institution - 0259
Jacksonville, Florida, 32207-4958
Local Institution - 0261
Jacksonville, Florida, 32224
Local Institution - 0043
Lake Success, New York, 11042
Local Institution - 0276
Largo, Florida, 33777
Local Institution - 0011
Las Vegas, Nevada, 89123
Local Institution - 0258
Los Angeles, California, 90067-2015
Local Institution
Lynchburg, Virginia, 24502
Local Institution - 0232
Miami, Florida, 33136
Local Institution - 0356
Milwaukee, Wisconsin, 53215-5217
Local Institution - 0226
Monroe, North Carolina, 28112
Local Institution - 0072
Nashville, Tennessee, 37204
Local Institution - 0162
New Port Richey, Florida, 34653
Local Institution - 0308
New York, New York, 10032
Local Institution - 0156
Ocean Springs, Mississippi, 39564
Local Institution - 0349
Oklahoma City, Oklahoma, 73112
Local Institution - 0201
Orlando, Florida, 32808
Local Institution - 0249
Orlando, Florida, 32832
Local Institution - 0125
Pittsburgh, Pennsylvania, 15213
Local Institution - 0224
Richmond, Virginia, 23249
Local Institution - 0252
San Antonio, Texas, 78229
Local Institution - 0307
San Antonio, Texas, 78229
Local Institution - 0122
Sayre, Pennsylvania, 18840
Local Institution - 0327
Seattle, Washington, 98101
Local Institution - 0266
Seattle, Washington, 98104
Local Institution - 0191
Seattle, Washington, 98195
Local Institution - 0282
Shreveport, Louisiana, 71105
Local Institution - 0073
Southlake, Texas, 76092
Local Institution - 0240
Spring, Texas, 77379
Local Institution - 0359
St Louis, Missouri, 63130
Local Institution - 0277
Suwanee, Georgia, 30024
Local Institution - 0358
Suwanee, Georgia, 30024
Local Institution - 0166
Tampa, Florida, 33606
Local Institution - 0302
Tyler, Texas, 75701
Local Institution - 0331
Vancouver, Washington, 98664
Local Institution - 0047
Wyoming, Michigan, 49519
Local Institution - 0357
Wyomissing, Pennsylvania, 19610
Local Institution - 0223
Ypsilanti, Michigan, 48197
Local Institution - 0248
Zephyrhills, Florida, 33542

Other trials in United States

Japan24 sites

Local Institution - 0213
Bunkyo-ku, Tokyo, 113-8519
Local Institution - 0204
Chikushino-shi, Fukuoka, 818-8502
Local Institution - 0326
Fukui-shi, Fukui, 910-8526
Local Institution - 0189
Hamamatsu, Shizuoka, 431-3192
Local Institution - 0199
Hirosaki, Aomori, 036-8545
Local Institution - 0188
Hiroshima, 734-8551
Local Institution - 0187
Kurume-shi, Fukuoka, 830-0011
Local Institution - 0206
Kyoto, 6128555
Local Institution - 0195
Minato-ku, Tokyo, 105-8471
Local Institution - 0214
Miyazaki, 8891692
Local Institution - 0183
Nishinomiya, Hyōgo, 663-8501
Local Institution - 0194
Omura-shi, Nagasaki, 8568562
Local Institution - 0185
Ōtsu, Shiga, 520-2192
Local Institution - 0196
Saga, 849-8501
Local Institution - 0207
Sagamihara-shi, Kanagawa, 2520375
Local Institution - 0205
Sakura-shi, Chiba, 285-8741
Local Institution - 0323
Sapporo, Hokkaido, 0608543
Local Institution - 0217
Sapporo, Hokkaido, 065-0033
Local Institution - 0203
Sapporo, 0600033
Local Institution - 0200
Sendai, Miyagi, 983-8520
Local Institution - 0179
Suita-shi, Osaka, 5650871
Local Institution - 0328
Tōon, Ehime, 791-0295
Local Institution - 0182
Toyoake, Aichi-ken, 470-1192
Local Institution - 0318
Urasoe-Shi, Okinawa, 901-2132

Other trials in Japan

Poland16 sites

Local Institution - 0245
Bydgoszcz, 85-231
Local Institution - 0177
Bydgoszcz, 85-794
Local Institution - 0065
Krakow, 31-501
Local Institution - 0284
Lodz, 90-153
Local Institution - 0098
Lodz, 90-302
Local Institution - 0291
Lublin, 20-582
Local Institution - 0278
Nowy Targ, 34-400
Local Institution - 0176
Olsztyn, 10-117
Local Institution - 0082
Sopot, 81-756
Local Institution - 0063
Tychy, 43-100
Local Institution - 0271
Warsaw, 00-728
Local Institution - 0288
Warsaw, 02-507
Local Institution - 0026
Warsaw, 03-580
Local Institution - 0279
Warsaw, 04-141
Local Institution - 0160
Wroclaw, 52-210
Local Institution - 0034
Wroclaw, 52-416

Other trials in Poland

Germany14 sites

Local Institution - 0099
Berlin, 10117
Local Institution - 0090
Berlin, 13353
Local Institution - 0339
Brandenburg an der Havel, 14770
Local Institution - 0212
Frankfurt, 60590
Local Institution - 0178
Halle, 06108
Local Institution
Halle, 06120
Local Institution - 0294
Hanover, 30625
Local Institution - 0089
Jena, 07747
Local Institution - 0190
Kiel, 24105
Local Institution - 0321
Mannheim, 68167
Local Institution - 0140
Münster, 48159
Local Institution - 0257
Regensburg, D-93053
Local Institution - 0340
Tübingen, 72076
Local Institution - 0102
Ulm, 89081

Other trials in Germany

Italy14 sites

Local Institution - 0290
Bologna, 40138
Local Institution - 0298
Castellana Grotte, 70013
Local Institution - 0171
Catanzaro, 88100
Local Institution - 0056
Messina, 98125
Local Institution - 0304
Milan, 20122
Local Institution - 0115
Milan, 20142
Local Institution - 0311
Milan, 20157
Local Institution - 0297
Monserrato, 09042
Local Institution - 0310
Negrar, 37024
Local Institution - 0128
Padova, 35128
Local Institution - 0170
Pavia, 27100
Local Institution - 0161
Roma, 00168
Local Institution - 0119
Rozzano, 20089
Local Institution - 0285
Torino, 10128

Other trials in Italy

Russia14 sites

Bioterm
Barnaul, 656015
Hospital Irkutsk Scientific Center
Irkutsk, 664033
Republican Clinical Hospital Ministry of Health Republic of Tatarstan
Kazan', 420064
City Clinical Hospital Number 24
Moscow, 127015
Medical Center SibNovoMed
Novosibirsk, 630005
Novosibirsk Gastrocenter
Novosibirsk, 630007
Novosibirsk State Regional Clinical Hospital
Novosibirsk, 630087
Medical Center Healthy Family
Novosibirsk, 630099
Clinic Ultrasound 4D
Pyatigorsk, 357502
Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, 195257
Saratov Regional Clinical Hospital
Saratov, 410038
Tomsk Regional Clinical Hospital
Tomsk, 634063
Multidisciplinary Consultative and Diagnostic Center
Tyumen, 625026
Novgorod Regional Clinical Hospital
Velikiy Novgorod, 173008

Other trials in Russia

Spain12 sites

Local Institution - 0329
Alicante, 03011
Local Institution - 0274
Barcelona, 08036
Local Institution - 0154
Fuenlabrada, 28942
Local Institution - 0080
Girona, 17007
Local Institution - 0021
Las Palmas de Gran Canaria, 35010
Local Institution
LHospitalet de Llobregat, 08907
Local Institution - 0325
Sabadell, 08208
Local Institution - 0113
Santander, 39008
Local Institution - 0309
Santiago de Compostelle, 15702
Local Institution - 0313
Seville, 41009
Local Institution - 0107
Seville, 41013
Local Institution - 0004
Valencia, 46010

Other trials in Spain

Hungary11 sites

Local Institution - 0104
Békéscsaba, 5600
Local Institution - 0242
Budapest, 1062
Local Institution - 0263
Budapest, 1083
Local Institution - 0211
Budapest, 1088
Local Institution - 0100
Budapest, 1097
Local Institution - 0292
Budapest, 1136
Local Institution - 0054
Debrecen, 4032
Local Institution - 0083
Gyöngyös, 3200
Local Institution - 0210
Mohács, 7700
Local Institution - 0243
Szeged, 6725
Local Institution - 0164
Vác, 2600

Other trials in Hungary

China10 sites

Local Institution - 0250
Changchun, Jilin, 130033
Local Institution - 0221
Changsha, Hunan, 410011
Local Institution - 0225
Guangzhou, Guangdong, 510080
Local Institution - 0228
Guangzhou, Guangdong, 510655
Local Institution - 0220
Nanjing, Jiangsu, 210011
Local Institution - 0306
Nanjing, Jiangsu, 210029
Local Institution - 0219
Shanghai, Shanghai Municipality, 200025
Local Institution - 0234
Shanghai, Shanghai Municipality, 200120
Local Institution - 0299
Shenyang, Liaoning, 110022
Local Institution - 0280
Xiamen, Fujian, 361004

Other trials in China

South Korea10 sites

Local Institution - 0158
Ansan-si, 152-703
Local Institution - 0149
Busan, 48108
Local Institution - 0064
Daegu, 42415
Local Institution - 0061
Daegu, 700-721
Local Institution - 0150
Incheon, 22332
Local Institution - 0046
Seongnam-si, Gyeonggi-do, 13496
Local Institution - 0015
Seoul, 03181
Local Institution - 0016
Seoul, 06591
Local Institution - 0012
Wŏnju, 26426
Local Institution - 0032
Yangsan, 50612

Other trials in South Korea

Australia9 sites

Local Institution - 0265
Adelaide, South Australia, 5000
Local Institution - 0042
Ballarat, Victoria, 3350
Local Institution - 0041
Clayton, Victoria, 3168
Local Institution - 0040
Melbourne, Victoria, 3065
Local Institution - 0351
Melbourne, Victoria, 3181
Local Institution - 0275
Murdoch, Western Australia, 6150
Local Institution - 0268
South Brisbane, Queensland, 4101
Local Institution - 0289
Woodville, South Australia, 5011
Local Institution - 0254
Woolloongabba, Queensland, 4102

Other trials in Australia

Brazil9 sites

Local Institution - 0058
Botucato, São Paulo, 18618-970
Local Institution - 0069
Juiz de Fora, Minas Gerais, 26033-318
Local Institution - 0086
Porto Alegre, Rio Grande do Sul, 90035-003
Local Institution - 0017
Rio de Janeiro, 21941-913
Local Institution - 0256
Salvador, Estado de Bahia, 40110-060
Local Institution - 0262
Salvador, Estado de Bahia, 40150-150
Local Institution - 0059
Santo André, São Paulo, 09060-650
Local Institution - 0045
São Bernardo do Campo, São Paulo, 09715-090
Local Institution - 0085
São José do Rio Preto, São Paulo, 15090-000

Other trials in Brazil

Canada8 sites

Local Institution - 0048
Calgary, Alberta, T2N 4Z6
Local Institution - 0324
Edmonton, Alberta, T5R 1W2
Local Institution - 0300
Edmonton, Alberta, T6K 4B2
Local Institution - 0283
Etobicoke, Ontario, M9V 4B8
Local Institution - 0312
London, Ontario, N6A 5A5
Local Institution - 0317
Montreal, Quebec, H3G 1A4
Local Institution - 0236
Toronto, Ontario, M4N 3M5
Local Institution - 0159
Vancouver, British Columbia, V5Z1M9

Other trials in Canada

United Kingdom8 sites

Local Institution - 0341
Birmingham, B9 5SS
Local Institution - 0144
Blackpool, FY3 8NR
Local Institution - 0235
Cambridge, CB2 0QQ
Local Institution - 0354
Cannock, WS11 0BN
Local Institution - 0165
Cheshire, WA5 1QG
Local Institution - 0157
Glasgow, G51 4TF
Local Institution - 0353
Manchester, M13 9NQ
Local Institution - 0208
Swansea, SA6 6NL

Other trials in United Kingdom

Czechia7 sites

Local Institution - 0337
Brno, 602 00
Local Institution - 0360
Brno, 602 00
Local Institution - 0057
Hradec Králové, 500 12
Local Institution - 0352
Ostrava, 702 00
Local Institution - 0071
Ostrava, 708 52
Local Institution - 0350
Pardubice, 532 03
Local Institution - 0075
Prague, 190 00

Other trials in Czechia

France6 sites

Local Institution - 0110
Clichy, 92110
Local Institution - 0168
Colombes, 92701
Local Institution - 0343
Montpellier, 34295
Local Institution - 0084
Saint-Etienne, 42055
Local Institution - 0127
Toulouse, 31059
Local Institution - 0167
Toulouse, 31300

Other trials in France

Romania6 sites

Local Institution - 0067
Bucharest, 010719
Local Institution - 0044
Bucharest, 020125
Local Institution - 0163
Bucharest, 031784
Local Institution - 0074
Bucharest, 050098
Local Institution - 0005
Timișoara, 300002
Local Institution - 0060
Timișoara, 300158

Other trials in Romania

Ireland5 sites

Local Institution - 0335
Ballinasloe, Galway, H53 T971
Local Institution - 0336
Drogheda, Louth, A92 VW28
Local Institution - 0330
Dublin, D15 X40D
Local Institution - 0332
Galway, H91 yR71
Local Institution - 0348
Tallaght, Dublin, 0

Other trials in Ireland

Mexico5 sites

Local Institution - 0009
Cuernavaca, Morelos, 62290
Local Institution - 0106
Guadalajara, Jalisco, 44500
Local Institution - 0007
Mexico City, Mexico City, 06700
Local Institution - 0109
Monterrey, Nuevo León, 64060
Local Institution - 0029
Querétaro, 76070

Other trials in Mexico

Belgium4 sites

Local Institution - 0316
Antwerp, 2018
Local Institution - 0305
Edegem, 2650
Local Institution - 0322
Ghent, 9000
Local Institution - 0314
Yvoir, 5530

Other trials in Belgium

Israel4 sites

Local Institution - 0197
Beersheba, 8410101
Local Institution - 0186
Nahariya, 2210001
Local Institution - 0184
Petah Tikva, 49100
Local Institution - 0198
Rehovot, 7661041

Other trials in Israel

Taiwan4 sites

Local Institution - 0173
Kaohsiung City, 83301
Local Institution - 0148
Taichung, 404
Local Institution - 0267
Taipei, 10002
Local Institution - 0152
Taoyuan, 333

Other trials in Taiwan

Denmark3 sites

Local Institution - 0192
Aalborg, 9210
Local Institution - 0202
Copenhagen NV, 2400
Local Institution - 0320
Odense, 5000

Other trials in Denmark

Portugal2 sites

Local Institution - 0174
Guimarães, 4835-044
Local Institution - 0216
Santa Maria da Feira, 4520-211

Other trials in Portugal

Netherlands1 site

Local Institution - 0303
Amsterdam, 1105 AZ

Other trials in Netherlands

Switzerland1 site

Local Institution - 0180
Bern, CH-3012

Other trials in Switzerland

About this study

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

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.

Conditions: Granulomatous Colitis, Crohn's Disease, Crohn's Enteritis, Granulomatous Enteritis
Being tested: BMS-986165, Placebo
Medical subject headings: Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMS-986165Drug
Specified dose on specified days
PlaceboOther
Specified dose on specified days

Study groups in NCT03599622
Study group	Role	What they receive
BMS-986165 Dose 1	Experimental	Not described Receives: Drug: BMS-986165
BMS-986165 Dose 2	Experimental	Not described Receives: Drug: BMS-986165
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 12 weeks after first dose

Secondary outcomes (3)

Percent of Participants Achieving Clinical Response at Week 12
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.
Measured: 12 weeks after first dose
Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12
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.
Measured: 12 weeks after first dose
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
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.
Measured: 12 weeks after first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 201823 Oct 2023

First posted26 Jul 2018
Study start16 Jul 2018
Primary completion12 Dec 2022
Study completion23 Oct 2023

Why it stopped: Trial terminated because of lack of efficacy in the short term acute phase

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Granulomatous ColitisStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03599622
Sponsor's protocol ID: IM011-023
Other IDs: 2017-001976-48, 2017
Status last verified: Jun 2024
First submitted: 11 Jul 2018
Last updated: 3 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
Crohn's Disease
RecruitingObservational study
Family Members at INcreased-risk for Developing Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
RecruitingPhase 1/2
Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis
Chronic Granulomatous Disease-associated Colitis
Recruiting
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
Inflammatory Bowel Diseases, Crohn Disease

All Granulomatous Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03599622
Acronym / sponsor ID: IM011-023
Conditions: Granulomatous Colitis, Crohn's Disease, Crohn's Enteritis, Granulomatous Enteritis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Trial terminated because of lack of efficacy in the short term acute phase
Enrolment: 239 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 16 Jul 2018 (actual)
Primary completion: 12 Dec 2022 (actual)
Study completion: 23 Oct 2023 (actual)
First posted: 26 Jul 2018 (actual)
Results: Posted 3 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
BMS-986165 Dose 1	Experimental	Drug: BMS-986165
BMS-986165 Dose 2	Experimental	Drug: BMS-986165
Placebo	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BMS-986165Specified dose on specified days	Drug	BMS-986165 Dose 1, BMS-986165 Dose 2
PlaceboSpecified dose on specified days	Other	Placebo

Primary outcome

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.
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.

3 secondary outcomes

Percent of Participants Achieving Clinical Response at Week 12
Time frame: 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
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Time frame: 12 weeks after first dose

Results and safety

Results posted to the registry on 3 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	60	59
3 mg BMS-986165	86	84
6 mg BMS-986165	84	83
12 mg BMS-986165	9	9

Primary outcome: Percent of Participants Achieving Clinical Remission at Week 12

Time frame: 12 weeks after first dose. Number (95% Confidence Interval). Unit: Percent of Participants

Measure	Placebo n = 60	3 mg BMS-986165 n = 86	6 mg BMS-986165 n = 84	12 mg BMS-986165 n = 9
Value	28.3 (16.9 to 39.7)	32.6 (22.7 to 42.5)	21.4 (12.7 to 30.2)	22.2 (0.0 to 49.4)

Placebo vs 3 mg BMS-986165: Risk Difference (RD): 4.3 (95% CI -11.0 to 19.5), p = 0.5812, Mantel Haenszel
Placebo vs 3 mg BMS-986165: Odds Ratio (OR): 1.2 (95% CI 0.6 to 2.5), p = 0.5812, Mantel Haenszel
Placebo vs 6 mg BMS-986165: Risk Difference (RD): -6.3 (95% CI -20.2 to 7.6), p = 0.3720, Mantel Haenszel

Population analysed: All randomized participants.

Primary outcome: Percent of Participants Achieving Endoscopic Response at Week 12

Time frame: 12 weeks after first dose. Number (95% Confidence Interval). Unit: Percent of Participants

Measure	Placebo n = 60	3 mg BMS-986165 n = 86	6 mg BMS-986165 n = 84	12 mg BMS-986165 n = 9
Value	8.3 (1.3 to 15.3)	23.3 (14.3 to 32.2)	16.7 (8.7 to 24.6)	33.3 (2.5 to 64.1)

Placebo vs 3 mg BMS-986165: Risk Difference (RD): 15.0 (95% CI 3.7 to 26.3), p = 0.0198, Mantel Haenszel
Placebo vs 3 mg BMS-986165: Odds Ratio (OR): 3.4 (95% CI 1.2 to 9.8), p = 0.0198, Mantel Haenszel
Placebo vs 6 mg BMS-986165: Risk Difference (RD): 8.2 (95% CI -2.6 to 19.0), p = 0.1584, Mantel Haenszel

Population analysed: All randomized participants.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 63 months). SAEs and Other AEs were assessed from first dose to 30 days after last dose of study therapy (assessed for an average of 11 months up to approximately 24 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	6 of 59 (10.2%)	33 of 59 (55.9%)	0 of 60
3 mg BMS-986165	11 of 84 (13.1%)	55 of 84 (65.5%)	0 of 86
6 mg BMS-986165	5 of 83 (6%)	55 of 83 (66.3%)	0 of 84
12 mg BMS-986165	2 of 9 (22.2%)	7 of 9 (77.8%)	0 of 9
6 mg BMS-986165 - Open Label	15 of 161 (9.3%)	86 of 161 (53.4%)	0 of 161
12 mg BMS-986165 - Open Label	1 of 6 (16.7%)	3 of 6 (50%)	0 of 6

Limitations and caveats (from the sponsor): Trial terminated because of lack of efficacy in the short term acute phase.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

259 sites in 26 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986165 in people with Granulomatous Colitis and Crohn's Disease, run by Bristol-Myers Squibb at 259 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 259 sites in United States, Japan, Poland, Germany, Italy and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Participants Achieving Clinical Remission at Week 12 (time frame: 12 weeks after first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03599622.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.