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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
357
Local Institution
Melbourne, Victoria, Australia
Local Institution
Melbourne, Australia
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
Time frame: 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
Time frame: 4 weeks after the start of treatment
Change from baseline in the psoriasis area
Time frame: 4 weeks after the start of treatment
Severity index (PASI) score
Time frame: 4 weeks after the start of treatment
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)
Time frame: 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)
The interval from the beginning of the P wave to the beginning of the QRS complex (PR interval)
Time frame: Approximately 3 months
Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)
The interval from the beginning of the Q wave and the end of the S wave (QRS interval)
Time frame: Approximately 3 months
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Effect of BMS-986202 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D)
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)
Time frame: Approximately 3 months
Safety of multiple oral doses of BMS-986202 in subjects with moderate to severe psoriasis (Part E)
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
Time frame: Approximately 3 months