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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
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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
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Secondary ID [1]
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2017-001976-48
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Secondary ID [2]
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IM011-023
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Granulomatous Colitis
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Crohn's Disease
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Crohn's Enteritis
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Granulomatous Enteritis
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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Crohn's disease
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent of Participants Achieving Clinical Remission at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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12 weeks after first dose
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Primary outcome [2]
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Percent of Participants Achieving Endoscopic Response at Week 12
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Assessment method [2]
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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.
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Timepoint [2]
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12 weeks after first dose
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Secondary outcome [1]
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Percent of Participants Achieving Clinical Response at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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12 weeks after first dose
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Secondary outcome [2]
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Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12
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Assessment method [2]
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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.
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Timepoint [2]
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12 weeks after first dose
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Secondary outcome [3]
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Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12
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Assessment method [3]
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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.
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Timepoint [3]
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12 weeks after first dose
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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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/07/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/10/2023
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Sample size
Target
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Accrual to date
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Final
239
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0268 - South Brisbane
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Local Institution - 0254 - Woolloongabba
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Local Institution - 0265 - Adelaide
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Local Institution - 0042 - Ballarat
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Local Institution - 0041 - Clayton
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Local Institution - 0040 - Melbourne
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Local Institution - 0351 - 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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Recruitment postcode(s) [6]
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3168 - Clayton
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Recruitment postcode(s) [7]
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3065 - Melbourne
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Recruitment postcode(s) [8]
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3181 - Melbourne
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Recruitment postcode(s) [9]
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6150 - Murdoch
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Recruitment outside Australia
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Sapporo
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Gyeonggi-do
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Mexico
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Portugal
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Santa Maria da Feira
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Barnaul
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Pyatigorsk
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Tomsk
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Russian Federation
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Tyumen
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Russian Federation
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Velikij Novgorod
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Alicante
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Barcelona
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Fuenlabrada
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Girona
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Las Palmas de Gran Canaria
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Spain
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LHospitalet de Llobregat
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Spain
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Sabadell
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Spain
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Santiago De Compostelle
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Spain
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Sevilla
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Valencia
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Bern
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Kaohsiung
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Taichung
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Taipei
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Taoyuan
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United Kingdom
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Birmingham
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United Kingdom
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Blackpool
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United Kingdom
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Cambridge
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United Kingdom
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Cannock
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United Kingdom
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Glasgow
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United Kingdom
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Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT03599622
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/22/NCT03599622/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/22/NCT03599622/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03599622
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