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/study/NCT02763969




Registration number
NCT02763969
Ethics application status
Date submitted
4/05/2016
Date registered
5/05/2016
Date last updated
3/08/2017

Titles & IDs
Public title
Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis
Scientific title
Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986202 in Healthy Subjects and to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of BMS-986202 in Subjects With Moderate to Severe Psoriasis
Secondary ID [1] 0 0
IM016-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Part A: Single Ascending Dose - BMS-986202 or Placebo specified dose on specified days

Experimental: Part B: Multiple Ascending Dose - BMS-986202 or Placebo + Interferon alpha-2a recombinant specified dose on specified days

Experimental: Part C: Multiple Ascending Dose-Japanese descent - BMS-986202 or Placebo specified dose on specified days in patients of Japanese descent

Experimental: Part D: Relative Bioavailability - BMS-986202 (Liquid) or BMS-986202 (Capsule) + Famotidine specified dose on specified days

Experimental: Part E: Proof of Mechanism - BMS-986202 or Placebo + Ustekinumab specified dose on specified days
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of a single oral dose of BMS-986202 based on number of incidence of AEs, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Timepoint [1] 0 0
4 weeks after the start of treatment
Primary outcome [2] 0 0
Safety of a multiple oral dose of BMS-986202 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Timepoint [2] 0 0
4 weeks after the start of treatment
Primary outcome [3] 0 0
Change from baseline in the psoriasis area
Timepoint [3] 0 0
4 weeks after the start of treatment
Primary outcome [4] 0 0
Severity index (PASI) score
Timepoint [4] 0 0
4 weeks after the start of treatment
Secondary outcome [1] 0 0
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)
Timepoint [1] 0 0
Approximately 3 months
Secondary outcome [2] 0 0
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Timepoint [2] 0 0
Approximately 3 months
Secondary outcome [3] 0 0
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Timepoint [3] 0 0
Approximately 3 months
Secondary outcome [4] 0 0
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Timepoint [4] 0 0
Approximately 3 months
Secondary outcome [5] 0 0
Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E)
Timepoint [5] 0 0
Approximately 3 months

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



* Healthy Male and Female participants
* 18 to 50 years of age (Parts A-D)
* 18 to 70 years of age (Part E)
* Diagnosed with plaque psoriasis (Part E)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Participants that had recent infections
* Participants with Low Blood Pressure
* Participants with any heart related problems
* Participants with cancer
* Participants with any other major medical illness

Other protocol defined inclusion/exclusion criteria could 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
Factorial
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/12/2016
Sample size
Target
Accrual to date
Final
357
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02763969