Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03599622




Registration number
NCT03599622
Ethics application status
Date submitted
11/07/2018
Date registered
26/07/2018
Date last updated
3/07/2024

Titles & IDs
Public title
An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease
Scientific 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
Secondary ID [1] 0 0
2017-001976-48
Secondary ID [2] 0 0
IM011-023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Granulomatous Colitis 0 0
Crohn's Disease 0 0
Crohn's Enteritis 0 0
Granulomatous Enteritis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986165
Other interventions - Placebo

Experimental: BMS-986165 Dose 1 -

Experimental: BMS-986165 Dose 2 -

Placebo comparator: Placebo -


Treatment: Drugs: BMS-986165
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of Participants Achieving Clinical Remission at Week 12
Timepoint [1] 0 0
12 weeks after first dose
Primary outcome [2] 0 0
Percent of Participants Achieving Endoscopic Response at Week 12
Timepoint [2] 0 0
12 weeks after first dose
Secondary outcome [1] 0 0
Percent of Participants Achieving Clinical Response at Week 12
Timepoint [1] 0 0
12 weeks after first dose
Secondary outcome [2] 0 0
Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12
Timepoint [2] 0 0
12 weeks after first dose
Secondary outcome [3] 0 0
Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
Timepoint [3] 0 0
12 weeks after first dose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/10/2023
Sample size
Target
Accrual to date
Final
239
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0268 - South Brisbane
Recruitment hospital [2] 0 0
Local Institution - 0254 - Woolloongabba
Recruitment hospital [3] 0 0
Local Institution - 0265 - Adelaide
Recruitment hospital [4] 0 0
Local Institution - 0289 - Woodville
Recruitment hospital [5] 0 0
Local Institution - 0042 - Ballarat
Recruitment hospital [6] 0 0
Local Institution - 0041 - Clayton
Recruitment hospital [7] 0 0
Local Institution - 0040 - Melbourne
Recruitment hospital [8] 0 0
Local Institution - 0351 - Melbourne
Recruitment hospital [9] 0 0
Local Institution - 0275 - Murdoch
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3350 - Ballarat
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Melbourne
Recruitment postcode(s) [8] 0 0
3181 - Melbourne
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Belgium
State/province [24] 0 0
Antwerpen
Country [25] 0 0
Belgium
State/province [25] 0 0
Edegem
Country [26] 0 0
Belgium
State/province [26] 0 0
Gent
Country [27] 0 0
Belgium
State/province [27] 0 0
Yvoir
Country [28] 0 0
Brazil
State/province [28] 0 0
Bahia
Country [29] 0 0
Brazil
State/province [29] 0 0
Minas Gerais
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio Grande Do Sul
Country [31] 0 0
Brazil
State/province [31] 0 0
Sao Paulo
Country [32] 0 0
Brazil
State/province [32] 0 0
SAO Paulo
Country [33] 0 0
Brazil
State/province [33] 0 0
Rio de Janeiro
Country [34] 0 0
Canada
State/province [34] 0 0
Alberta
Country [35] 0 0
Canada
State/province [35] 0 0
British Columbia
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
China
State/province [38] 0 0
Fujian
Country [39] 0 0
China
State/province [39] 0 0
Guangdong
Country [40] 0 0
China
State/province [40] 0 0
Hunan
Country [41] 0 0
China
State/province [41] 0 0
Jiangsu
Country [42] 0 0
China
State/province [42] 0 0
Jilin
Country [43] 0 0
China
State/province [43] 0 0
Liaoning
Country [44] 0 0
China
State/province [44] 0 0
Shanghai
Country [45] 0 0
Czechia
State/province [45] 0 0
Brno
Country [46] 0 0
Czechia
State/province [46] 0 0
Hradec Kralove
Country [47] 0 0
Czechia
State/province [47] 0 0
Ostrava
Country [48] 0 0
Czechia
State/province [48] 0 0
Pardubice
Country [49] 0 0
Czechia
State/province [49] 0 0
Praha 9
Country [50] 0 0
Denmark
State/province [50] 0 0
Aalborg
Country [51] 0 0
Denmark
State/province [51] 0 0
Copenhagen NV
Country [52] 0 0
Denmark
State/province [52] 0 0
Odense
Country [53] 0 0
France
State/province [53] 0 0
Clichy Cedex
Country [54] 0 0
France
State/province [54] 0 0
Colombes
Country [55] 0 0
France
State/province [55] 0 0
Montpellier cedex 5
Country [56] 0 0
France
State/province [56] 0 0
Saint-Etienne
Country [57] 0 0
France
State/province [57] 0 0
Toulouse Cedex 9
Country [58] 0 0
France
State/province [58] 0 0
Toulouse
Country [59] 0 0
Germany
State/province [59] 0 0
Berlin
Country [60] 0 0
Germany
State/province [60] 0 0
Brandenburg An Der Havel
Country [61] 0 0
Germany
State/province [61] 0 0
Frankfurt
Country [62] 0 0
Germany
State/province [62] 0 0
Halle
Country [63] 0 0
Germany
State/province [63] 0 0
Hannover
Country [64] 0 0
Germany
State/province [64] 0 0
Jena
Country [65] 0 0
Germany
State/province [65] 0 0
Kiel
Country [66] 0 0
Germany
State/province [66] 0 0
Mannheim
Country [67] 0 0
Germany
State/province [67] 0 0
Munster
Country [68] 0 0
Germany
State/province [68] 0 0
Regensburg
Country [69] 0 0
Germany
State/province [69] 0 0
Tubingen
Country [70] 0 0
Germany
State/province [70] 0 0
Ulm
Country [71] 0 0
Hungary
State/province [71] 0 0
Bekescsaba
Country [72] 0 0
Hungary
State/province [72] 0 0
Budapest
Country [73] 0 0
Hungary
State/province [73] 0 0
Debrecen
Country [74] 0 0
Hungary
State/province [74] 0 0
Gyongyos
Country [75] 0 0
Hungary
State/province [75] 0 0
Mohacs
Country [76] 0 0
Hungary
State/province [76] 0 0
Szeged
Country [77] 0 0
Hungary
State/province [77] 0 0
Vac
Country [78] 0 0
Ireland
State/province [78] 0 0
Dublin
Country [79] 0 0
Ireland
State/province [79] 0 0
Galway
Country [80] 0 0
Ireland
State/province [80] 0 0
Louth
Country [81] 0 0
Israel
State/province [81] 0 0
Beer Sheva
Country [82] 0 0
Israel
State/province [82] 0 0
Nahariya
Country [83] 0 0
Israel
State/province [83] 0 0
Petah Tikva
Country [84] 0 0
Israel
State/province [84] 0 0
Rehovot
Country [85] 0 0
Italy
State/province [85] 0 0
Bologna
Country [86] 0 0
Italy
State/province [86] 0 0
Castellana Grotte
Country [87] 0 0
Italy
State/province [87] 0 0
Catanzaro
Country [88] 0 0
Italy
State/province [88] 0 0
Messina
Country [89] 0 0
Italy
State/province [89] 0 0
Milano
Country [90] 0 0
Italy
State/province [90] 0 0
Monserrato
Country [91] 0 0
Italy
State/province [91] 0 0
Negrar
Country [92] 0 0
Italy
State/province [92] 0 0
Padova
Country [93] 0 0
Italy
State/province [93] 0 0
Pavia
Country [94] 0 0
Italy
State/province [94] 0 0
Roma
Country [95] 0 0
Italy
State/province [95] 0 0
Rozzano
Country [96] 0 0
Italy
State/province [96] 0 0
Torino
Country [97] 0 0
Japan
State/province [97] 0 0
Aichi
Country [98] 0 0
Japan
State/province [98] 0 0
Aomori
Country [99] 0 0
Japan
State/province [99] 0 0
Chiba
Country [100] 0 0
Japan
State/province [100] 0 0
Ehime
Country [101] 0 0
Japan
State/province [101] 0 0
Fukui
Country [102] 0 0
Japan
State/province [102] 0 0
Fukuoka
Country [103] 0 0
Japan
State/province [103] 0 0
Hokkaido
Country [104] 0 0
Japan
State/province [104] 0 0
Hyogo
Country [105] 0 0
Japan
State/province [105] 0 0
Kanagawa
Country [106] 0 0
Japan
State/province [106] 0 0
Miyagi
Country [107] 0 0
Japan
State/province [107] 0 0
Nagasaki
Country [108] 0 0
Japan
State/province [108] 0 0
Okinawa
Country [109] 0 0
Japan
State/province [109] 0 0
Osaka
Country [110] 0 0
Japan
State/province [110] 0 0
Shiga
Country [111] 0 0
Japan
State/province [111] 0 0
Shizuoka
Country [112] 0 0
Japan
State/province [112] 0 0
Tokyo
Country [113] 0 0
Japan
State/province [113] 0 0
Hiroshima
Country [114] 0 0
Japan
State/province [114] 0 0
Kyoto
Country [115] 0 0
Japan
State/province [115] 0 0
Miyazaki
Country [116] 0 0
Japan
State/province [116] 0 0
Saga
Country [117] 0 0
Japan
State/province [117] 0 0
Sapporo
Country [118] 0 0
Korea, Republic of
State/province [118] 0 0
Gyeonggi-do
Country [119] 0 0
Korea, Republic of
State/province [119] 0 0
Ansan-si
Country [120] 0 0
Korea, Republic of
State/province [120] 0 0
Busan
Country [121] 0 0
Korea, Republic of
State/province [121] 0 0
Daegu
Country [122] 0 0
Korea, Republic of
State/province [122] 0 0
Incheon
Country [123] 0 0
Korea, Republic of
State/province [123] 0 0
Seoul
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Wonju-si
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Yangsan-si
Country [126] 0 0
Mexico
State/province [126] 0 0
Distrito Federal
Country [127] 0 0
Mexico
State/province [127] 0 0
Jalisco
Country [128] 0 0
Mexico
State/province [128] 0 0
Morelos
Country [129] 0 0
Mexico
State/province [129] 0 0
Nuevo LEON
Country [130] 0 0
Mexico
State/province [130] 0 0
Queretaro
Country [131] 0 0
Netherlands
State/province [131] 0 0
Amsterdam
Country [132] 0 0
Poland
State/province [132] 0 0
Bydgoszcz
Country [133] 0 0
Poland
State/province [133] 0 0
Krakow
Country [134] 0 0
Poland
State/province [134] 0 0
Lodz
Country [135] 0 0
Poland
State/province [135] 0 0
Lublin
Country [136] 0 0
Poland
State/province [136] 0 0
Nowy Targ
Country [137] 0 0
Poland
State/province [137] 0 0
Olsztyn
Country [138] 0 0
Poland
State/province [138] 0 0
Sopot
Country [139] 0 0
Poland
State/province [139] 0 0
Tychy
Country [140] 0 0
Poland
State/province [140] 0 0
Warszawa
Country [141] 0 0
Poland
State/province [141] 0 0
Wroclaw
Country [142] 0 0
Portugal
State/province [142] 0 0
Guimaraes
Country [143] 0 0
Portugal
State/province [143] 0 0
Santa Maria da Feira
Country [144] 0 0
Romania
State/province [144] 0 0
Bucharest
Country [145] 0 0
Romania
State/province [145] 0 0
Bucuresti
Country [146] 0 0
Romania
State/province [146] 0 0
Timisoara
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Barnaul
Country [148] 0 0
Russian Federation
State/province [148] 0 0
Irkutsk
Country [149] 0 0
Russian Federation
State/province [149] 0 0
Kazan
Country [150] 0 0
Russian Federation
State/province [150] 0 0
Moscow
Country [151] 0 0
Russian Federation
State/province [151] 0 0
Novosibirsk
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Pyatigorsk
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Saint-Petersburg
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Saratov
Country [155] 0 0
Russian Federation
State/province [155] 0 0
Tomsk
Country [156] 0 0
Russian Federation
State/province [156] 0 0
Tyumen
Country [157] 0 0
Russian Federation
State/province [157] 0 0
Velikij Novgorod
Country [158] 0 0
Spain
State/province [158] 0 0
Alicante
Country [159] 0 0
Spain
State/province [159] 0 0
Barcelona
Country [160] 0 0
Spain
State/province [160] 0 0
Fuenlabrada
Country [161] 0 0
Spain
State/province [161] 0 0
Girona
Country [162] 0 0
Spain
State/province [162] 0 0
Las Palmas de Gran Canaria
Country [163] 0 0
Spain
State/province [163] 0 0
LHospitalet de Llobregat
Country [164] 0 0
Spain
State/province [164] 0 0
Sabadell
Country [165] 0 0
Spain
State/province [165] 0 0
Santander
Country [166] 0 0
Spain
State/province [166] 0 0
Santiago De Compostelle
Country [167] 0 0
Spain
State/province [167] 0 0
Sevilla
Country [168] 0 0
Spain
State/province [168] 0 0
Valencia
Country [169] 0 0
Switzerland
State/province [169] 0 0
Bern
Country [170] 0 0
Taiwan
State/province [170] 0 0
Kaohsiung
Country [171] 0 0
Taiwan
State/province [171] 0 0
Taichung
Country [172] 0 0
Taiwan
State/province [172] 0 0
Taipei
Country [173] 0 0
Taiwan
State/province [173] 0 0
Taoyuan
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Birmingham
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Blackpool
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Cambridge
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Cannock
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Cheshire
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Glasgow
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Manchester
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03599622