Trial Review

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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/NCT02864264




Registration number
NCT02864264
Ethics application status
Date submitted
9/08/2016
Date registered
11/08/2016
Date last updated
20/10/2017

Titles & IDs
Public title
Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis
Scientific title
Double-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative Colitis
Secondary ID [1] 0 0
2016-000895-72
Secondary ID [2] 0 0
IM012-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986184
Treatment: Drugs - Placebo matching BMS-986184

Experimental: Single Ascending Dose (SAD) - IV Panel - Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184

Experimental: Single Ascending Dose (SAD) - SC Panel - Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184

Experimental: Multiple Ascending Dose (MAD) - IV Panel - Multiple IV doses of BMS-986184 or placebo matching BMS-986184

Experimental: Proof of Mechanism (POM) - IV Panel - Multiple IV doses of BMS-986184 or placebo matching BMS-986184


Treatment: Drugs: BMS-986184


Treatment: Drugs: Placebo matching BMS-986184
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements
Timepoint [1] 0 0
Up to 183 days
Primary outcome [2] 0 0
Composite of safety and tolerability of BMS-986184 as assessed by physical examination findings
Timepoint [2] 0 0
Up to 183 days
Primary outcome [3] 0 0
Composite of safety and tolerability of BMS-986184 as assessed by clinical laboratory test results
Timepoint [3] 0 0
Up to 183 days
Primary outcome [4] 0 0
Composite of safety and tolerability of BMS-986184 as assessed by Electrocardiogram (ECG) assessments
Timepoint [4] 0 0
Up to 183 days
Primary outcome [5] 0 0
Composite of incidence, severity and outcome of all Adverse Events (AEs)
Timepoint [5] 0 0
Up to 183 days

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



- Women of childbearing potential must have a negative serum pregnancy test within 24
hours prior to the start of study drug

- Diagnosis of ulcerative colitis confirmed by endoscopic and histologic evidence (if no
previous confirmation of diagnosis is available or if diagnosis is not conclusive, at
time of baseline endoscopy, histology must be performed and read locally to confirm
diagnosis)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or
hepatitis C

- Subjects with history of cancer, lymphoproliferative disease, class III or IV
congestive heart failure, myocardial infarction, unstable angina pectoris, or any
history of significant ocular disease such as glaucoma or retinal disease

Other protocol defined inclusion/exclusion criteria could apply

Study design
Purpose of the study
Screening
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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
14/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/09/2017
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Georgia
State/province [1] 0 0
Tbilisi
Country [2] 0 0
Moldova, Republic of
State/province [2] 0 0
Chisinau

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of this study is to determine if single and multiple doses of BMS-986184
are safe and well tolerated in healthy male and female subjects. The primary purpose of the
proof of mechanism study is to determine safety and efficacy in patients with ulcerative
colitis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02864264
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/NCT02864264