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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03599622




Registration number
NCT03599622
Ethics application status
Date submitted
11/07/2018
Date registered
26/07/2018
Date last updated
24/01/2024

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
Proportion of participants achieving clinical remission at Week 12
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Proportion of participants achieving endoscopic response at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of participants who achieve a clinical response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Change from baseline in SES-CD (Simple Endoscopic Score for Crohn's Disease) at Week 12
Timepoint [3] 0 0
Week 12

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
Terminated
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
241
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
Princess Alexandra Hospital - 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
The Alfred Hospital - Melbourne
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Local Institution - 0040 - Melbourne
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Local Institution - 0275 - Murdoch
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4101 - South Brisbane
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4102 - Woolloongabba
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5000 - Adelaide
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5011 - Woodville
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3350 - Ballarat
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3168 - Clayton
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3004 - Melbourne
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3065 - Melbourne
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6150 - Murdoch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03599622
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03599622