Psoriasis
Conditions
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.
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * 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)
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Change from baseline in the psoriasis area | 4 weeks after the start of treatment |
| Severity index (PASI) score | 4 weeks after the start of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| 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) |
Countries
Australia
Outcome results
None listed