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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03599622
• Other study ID #: IM011-023
• Secondary ID: 2017-001976-48
• Status: Terminated
• Phase: Phase 2
• Start date: July 16, 2018
• Est. completion date: October 23, 2023

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 241
• Est. completion date: October 23, 2023
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Crohn's Enteritis
• Enteritis
• Granulomatous Colitis
• Granulomatous Enteritis

Intervention

Drug:
• BMS-986165
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution - 0265	Adelaide	South Australia
Australia	Local Institution - 0042	Ballarat	Victoria
Australia	Local Institution - 0041	Clayton	Victoria
Australia	Local Institution - 0040	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Local Institution - 0275	Murdoch	Western Australia
Australia	Local Institution - 0268	South Brisbane	Queensland
Australia	Local Institution - 0289	Woodville	South Australia
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	Local Institution - 0316	Antwerpen
Belgium	Local Institution - 0305	Edegem
Belgium	Local Institution - 0322	Gent
Belgium	Local Institution - 0314	Yvoir
Brazil	Hospital das Clinicas da Faculdade de Medicina de Botucatu	Botucato	SAO Paulo
Brazil	Local Institution - 0069	Juiz de Fora	Minas Gerais
Brazil	Local Institution - 0086	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution - 0017	Rio de Janeiro
Brazil	Local Institution - 0256	Salvador	Bahia
Brazil	Local Institution - 0262	Salvador	Bahia
Brazil	Local Institution - 0059	Santo Andre	Sao Paulo
Brazil	Local Institution - 0045	Sao Bernardo do Campo	SAO Paulo
Brazil	Local Institution - 0085	Sao Jose do Rio Preto	SAO Paulo
Canada	University of Calgary	Calgary	Alberta
Canada	Local Institution - 0324	Edmonton	Alberta
Canada	South Edmonton Gastroenterology Research Clinic	Edmonton	Alberta
Canada	Local Institution - 0312	London	Ontario
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Local Institution - 0159	Vancouver	British Columbia
Canada	Local Institution - 0283	Vaughan	Ontario
China	Local Institution - 0250	Changchun Shi	Jilin
China	Local Institution - 0221	Changsha	Hunan
China	Local Institution - 0225	Guangzhou	Guangdong
China	Local Institution - 0228	Guangzhou	Guangdong
China	Local Institution	Nanjing	Jiangsu
China	Local Institution - 0306	Nanjing	Jiangsu
China	Local Institution - 0219	Shanghai	Shanghai
China	Local Institution - 0234	Shanghai	Shanghai
China	Local Institution	Shenyang	Liaoning
China	Local Institution - 0280	XIamen	Fujian
Czechia	Local Institution - 0337	Brno
Czechia	Local Institution - 0360	Brno
Czechia	Local Institution - 0057	Hradec Kralove
Czechia	Local Institution - 0071	Ostrava
Czechia	Local Institution - 0352	Ostrava
Czechia	Local Institution - 0350	Pardubice
Czechia	Klinicke centrum ISCARE IVF a.s.	Praha 9
Denmark	Local Institution - 0192	Aalborg
Denmark	Local Institution - 0202	Copenhagen NV
Denmark	Local Institution - 0320	Odense
France	Local Institution - 0110	Clichy Cedex
France	Local Institution - 0168	Colombes
France	Local Institution - 0343	Montpellier cedex 5
France	Local Institution - 0084	Saint-Etienne
France	Local Institution - 0167	Toulouse
France	Local Institution - 0127	Toulouse Cedex 9
Germany	Charite Universitatsmedizin Berlin	Berlin
Germany	Local Institution - 0099	Berlin
Germany	Stadtisches Klinikum Brandenburg	Brandenburg An Der Havel
Germany	Local Institution - 0212	Frankfurt
Germany	Local Institution	Halle
Germany	Studiengesellschaft BSF UG	Halle
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Local Institution - 0089	Jena
Germany	Local Institution - 0190	Kiel
Germany	Local Institution - 0321	Mannheim
Germany	Local Institution - 0140	Munster
Germany	Local Institution - 0257	Regensburg
Germany	Universitatsklinikum Tubingen	Tubingen
Germany	Local Institution - 0102	Ulm
Hungary	Local Institution - 0104	Bekescsaba
Hungary	Local Institution - 0100	Budapest
Hungary	Local Institution - 0211	Budapest
Hungary	Local Institution - 0242	Budapest
Hungary	Local Institution - 0263	Budapest
Hungary	Local Institution - 0292	Budapest
Hungary	Local Institution - 0054	Debrecen
Hungary	Local Institution - 0083	Gyongyos
Hungary	Local Institution - 0210	Mohacs
Hungary	Local Institution - 0243	Szeged
Hungary	Local Institution - 0164	Vac
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 - 0348	Tallaght	Dublin
Israel	Local Institution	Beer Sheva
Israel	Local Institution - 0186	Nahariya
Israel	Local Institution - 0184	Petah Tikva
Israel	Local Institution - 0198	Rehovot
Italy	Local Institution - 0290	Bologna
Italy	Local Institution - 0298	Castellana Grotte
Italy	Local Institution - 0171	Catanzaro
Italy	Clinica Medica Azienda Ospedaliera Universitaria	Messina
Italy	ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario	Milano
Italy	Local Institution - 0304	Milano
Italy	Polo Universitario - LAzienda Ospedaliera Luigi Sacco	Milano
Italy	Local Institution - 0297	Monserrato
Italy	Local Institution - 0310	Negrar
Italy	Local Institution - 0128	Padova
Italy	Local Institution - 0170	Pavia
Italy	Local Institution - 0161	Roma
Italy	Local Institution - 0119	Rozzano
Italy	Ospedale Mauriziano Umberto I di Torino	Torino
Japan	Local Institution - 0213	Bunkyo-ku	Tokyo
Japan	Fukuoka University Chikushi Hospital	Chikushino	Fukuoka
Japan	Local Institution	Chikushino-shi	Fukuoka
Japan	Local Institution - 0326	Fukui-shi	Fukui
Japan	Local Institution - 0189	Hamamatsu	Shizuoka
Japan	Local Institution - 0199	Hirosaki	Aomori
Japan	Local Institution - 0188	Hiroshima
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Local Institution - 0206	Kyoto
Japan	Local Institution - 0195	Minato-ku	Tokyo
Japan	University of Miyazaki Hospital	Miyazaki
Japan	Local Institution - 0183	Nishinomiya	Hyogo
Japan	National Hospital Organization Nagasaki Medical Center	Omura-shi	Nagasaki
Japan	Local Institution - 0185	Otsu	Shiga
Japan	Local Institution - 0196	Saga
Japan	Local Institution - 0207	Sagamihara-shi	Kanagawa
Japan	Local Institution - 0205	Sakura-shi	Chiba
Japan	Local Institution - 0203	Sapporo
Japan	Sapporo Higashi Tokushukai Hospital	Sapporo	Hokkaido
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Local Institution - 0200	Sendai	Miyagi
Japan	Local Institution - 0179	Suita-shi	Osaka
Japan	Local Institution - 0328	Toon	Ehime
Japan	Local Institution - 0182	Toyoake	Aichi
Japan	Urasoe General Hospital	Urasoe-Shi	Okinawa
Korea, Republic of	Local Institution	Ansan-si
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution - 0061	Daegu
Korea, Republic of	Local Institution - 0064	Daegu
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution - 0046	Seongnam-si	Gyeonggi-do
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution - 0012	Wonju-si
Korea, Republic of	Local Institution	Yangsan-si
Mexico	Local Institution - 0009	Cuernavaca	Morelos
Mexico	Local Institution - 0106	Guadalajara	Jalisco
Mexico	Local Institution - 0007	Mexico	Distrito Federal
Mexico	Local Institution - 0109	Monterrey	Nuevo LEON
Mexico	Local Institution - 0029	Queretaro
Netherlands	Local Institution - 0303	Amsterdam
Poland	Local Institution - 0177	Bydgoszcz
Poland	Local Institution - 0245	Bydgoszcz
Poland	Local Institution - 0065	Krakow
Poland	Local Institution - 0098	Lodz
Poland	Local Institution - 0284	Lodz
Poland	Local Institution - 0291	Lublin
Poland	Local Institution - 0278	Nowy Targ
Poland	ETYKA Osrodek Badan Klinicznych	Olsztyn
Poland	Endoskopia	Sopot
Poland	Local Institution - 0063	Tychy
Poland	Local Institution - 0271	Warszawa
Poland	Local Institution - 0279	Warszawa
Poland	Local Institution - 0288	Warszawa
Poland	Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz	Warszawa
Poland	Centrum Medyczne Oporow	Wroclaw
Poland	PlanetMed sp.z o.o.	Wroclaw
Portugal	Local Institution - 0174	Guimaraes
Portugal	Local Institution - 0216	Santa Maria da Feira
Romania	Spitalul Universitar de Urgenta Bucuresti	Bucharest
Romania	Centrul Medical Sana	Bucuresti
Romania	Hyperclinica MedLife Grivita	Bucuresti
Romania	Local Institution - 0044	Bucuresti
Romania	Centrul Medical Tuculanu	Timisoara
Romania	Local Institution - 0005	Timisoara
Russian Federation	Bioterm	Barnaul
Russian Federation	Hospital Irkutsk Scientific Center	Irkutsk
Russian Federation	Republican Clinical Hospital Ministry of Health Republic of Tatarstan	Kazan
Russian Federation	City Clinical Hospital Number 24	Moscow
Russian Federation	Medical Center Healthy Family	Novosibirsk
Russian Federation	Medical Center SibNovoMed	Novosibirsk
Russian Federation	Novosibirsk Gastrocenter	Novosibirsk
Russian Federation	Novosibirsk State Regional Clinical Hospital	Novosibirsk
Russian Federation	Clinic Ultrasound 4D	Pyatigorsk
Russian Federation	Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth	Saint-Petersburg
Russian Federation	Saratov Regional Clinical Hospital	Saratov
Russian Federation	Tomsk Regional Clinical Hospital	Tomsk
Russian Federation	Multidisciplinary Consultative and Diagnostic Center	Tyumen
Russian Federation	Novgorod Regional Clinical Hospital	Velikij Novgorod
Spain	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	Corporacio Sanitaria Parc Tauli	Sabadell
Spain	Local Institution - 0113	Santander
Spain	Local Institution - 0309	Santiago De Compostelle
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Local Institution - 0107	Sevilla
Spain	Hospital Clinico Universitario de Valencia	Valencia
Switzerland	Local Institution - 0180	Bern
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution - 0267	Taipei City
Taiwan	Local Institution - 0152	Taoyuan
United Kingdom	Local Institution - 0341	Birmingham
United Kingdom	Blackpool Teaching Hospitals NHS Foundation Trust	Blackpool
United Kingdom	Local Institution - 0235	Cambridge
United Kingdom	MAC Clinical Research - Cannock	Cannock
United Kingdom	Warrington and Halton Hospitals NHS Foundation Trust	Cheshire
United Kingdom	Local Institution - 0157	Glasgow
United Kingdom	MAC Clinical Research - Manchester	Manchester
United Kingdom	Local Institution - 0208	Swansea
United States	Texas Clinical Research Institute	Arlington	Texas
United States	Kaiser Permanente Colorado Institute for Health Research	Aurora	Colorado
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Clinical Research Institute of Michigan	Chesterfield	Michigan
United States	Local Institution - 0003	Chesterfield	Michigan
United States	The University of Chicago Medicine	Chicago	Illinois
United States	Local Institution - 0255	Clearwater	Florida
United States	Digestive Health Associates of Texas - Richardson	Garland	Texas
United States	Illinois Gastroenterology Group	Glenview	Illinois
United States	The Medical Research Center of Connecticut	Hamden	Connecticut
United States	Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Local Institution - 0301	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Local Institution - 0261	Jacksonville	Florida
United States	University of Florida Health - Jacksonville	Jacksonville	Florida
United States	New York Langone Long Island Clinical Research Associates	Lake Success	New York
United States	Florida Center for Gastroenterology	Largo	Florida
United States	Local Institution - 0011	Las Vegas	Nevada
United States	GastroIntestinal Biosciences	Los Angeles	California
United States	Local Institution	Lynchburg	Virginia
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Local Institution - 0356	Milwaukee	Wisconsin
United States	Atrium Health	Monroe	North Carolina
United States	Vanderbilt Inflammatory Bowel Disease Clinic	Nashville	Tennessee
United States	Advanced Research Institute - New Port Richey	New Port Richey	Florida
United States	New York-Presbyterian Columbia University Medical Center	New York	New York
United States	Digestive Health Center - Ocean Springs	Ocean Springs	Mississippi
United States	Local Institution - 0349	Oklahoma City	Oklahoma
United States	Florida Hospital Orlando	Orlando	Florida
United States	Omega Research Consultants - Maitland	Orlando	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Hunter Holmes McGuire Veterans Administration Medical Center	Richmond	Virginia
United States	Local Institution - 0359	Saint Louis	Missouri
United States	Gastroenterology Research of San Antonio	San Antonio	Texas
United States	Local Institution - 0307	San Antonio	Texas
United States	Local Institution - 0122	Sayre	Pennsylvania
United States	Local Institution - 0266	Seattle	Washington
United States	Local Institution - 0327	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Local Institution - 0282	Shreveport	Louisiana
United States	Spring Gastroenterology Associates - Houston	Spring	Texas
United States	Local Institution - 0277	Suwanee	Georgia
United States	Local Institution - 0358	Suwanee	Georgia
United States	Local Institution - 0166	Tampa	Florida
United States	Local Institution - 0302	Tyler	Texas
United States	Local Institution - 0331	Vancouver	Washington
United States	Local Institution - 0047	Wyoming	Michigan
United States	US Digestive Disease Associates - Wyomissing	Wyomissing	Pennsylvania
United States	Huron Gastroenterology Associates	Ypsilanti	Michigan
United States	Florida Medical Clinic - Clinical Research Division	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants achieving clinical remission at Week 12	Clinical remission defined by Crohn's Disease Activity Index (CDAI)	Week 12
Primary	Proportion of participants achieving endoscopic response at Week 12	Endoscopic response defined by Simple Endoscopic Score for Crohn's Disease (SES-CD)	Week 12
Secondary	Proportion of participants who achieve a clinical response at Week 12		Week 12
Secondary	Proportion of participants who achieve PRO2 [Participant reported outcome based on the stool frequency and abdominal pain components of the Crohn's Disease Activity Index (CDAI)] remission at Week 12		Week 12
Secondary	Change from baseline in SES-CD (Simple Endoscopic Score for Crohn's Disease) at Week 12		Week 12

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting