Safety Study of BMS-986202 in Healthy Subjects and to Treat Psoriasis
- Conditions
- Psoriasis
- Interventions
- Registration Number
- NCT02763969
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 357
- 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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Part E: Proof of Mechanism BMS-986202 BMS-986202 or Placebo + Ustekinumab specified dose on specified days Part A: Single Ascending Dose BMS-986202 BMS-986202 or Placebo specified dose on specified days Part A: Single Ascending Dose Placebo BMS-986202 or Placebo specified dose on specified days Part B: Multiple Ascending Dose BMS-986202 BMS-986202 or Placebo + Interferon alpha-2a recombinant specified dose on specified days Part B: Multiple Ascending Dose Placebo BMS-986202 or Placebo + Interferon alpha-2a recombinant specified dose on specified days Part B: Multiple Ascending Dose Interferon alpha-2a recombinant BMS-986202 or Placebo + Interferon alpha-2a recombinant specified dose on specified days Part C: Multiple Ascending Dose-Japanese descent BMS-986202 BMS-986202 or Placebo specified dose on specified days in patients of Japanese descent Part C: Multiple Ascending Dose-Japanese descent Placebo BMS-986202 or Placebo specified dose on specified days in patients of Japanese descent Part D: Relative Bioavailability BMS-986202 BMS-986202 (Liquid) or BMS-986202 (Capsule) + Famotidine specified dose on specified days Part D: Relative Bioavailability Famotidine BMS-986202 (Liquid) or BMS-986202 (Capsule) + Famotidine specified dose on specified days Part E: Proof of Mechanism Placebo BMS-986202 or Placebo + Ustekinumab specified dose on specified days Part E: Proof of Mechanism Ustekinumab BMS-986202 or Placebo + Ustekinumab specified dose on specified days
- Primary Outcome Measures
Name Time Method Severity index (PASI) score 4 weeks after the start of treatment Change from baseline in the psoriasis area 4 weeks after the start of treatment 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 4 weeks after the start of treatment 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 4 weeks after the start of treatment
- Secondary Outcome Measures
Name Time Method Effect of BMS-986202 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D) Approximately 3 months Effect of BMS-986202 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D) Approximately 3 months The interval from the beginning of the P wave to the beginning of the QRS complex (PR interval)
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D) Approximately 3 months The interval from the beginning of the Q wave and the end of the S wave (QRS interval)
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D) Approximately 3 months The interval from the beginning of the Q wave to the end of the T wave (QT interval).
The QT interval corrected for heart rate (QTc interval)Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E) Approximately 3 months Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E) based on number of incidence of adverse events(AEs), serious adverse events(SAEs), AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Trial Locations
- Locations (1)
Local Institution
🇦🇺Melbourne, Australia