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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/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
Treatment: Drugs - BMS-986202
Treatment: Drugs - Placebo
Treatment: Drugs - Interferon alpha-2a recombinant
Treatment: Drugs - Famotidine
Treatment: Drugs - Ustekinumab

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


Treatment: Drugs: BMS-986202


Treatment: Drugs: Placebo


Treatment: Drugs: Interferon alpha-2a recombinant


Treatment: Drugs: Famotidine


Treatment: Drugs: Ustekinumab
Intervention code [1] 0 0
Treatment: Drugs
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
The purpose of this study is to establish if BMS-986202 is safe and effective at treating
autoimmune diseases such as psoriasis. BMS-986202 which has shown some promise in preclinical
studies for inhibiting autoimmune conditions such as psoriasis. This study will be the first
time this drug is given to humans.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02763969
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/NCT02763969