Multiple Dose Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of BMS-986322 in Participants with Moderate-to-Severe Psoriasis
- Conditions
- Moderate-to-Severe Psoriasis
- Registration Number
- JPRN-jRCT2031230177
- Lead Sponsor
- Attanasio Massimo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 12
Diagnosis of plaque psoriasis (PsO) for >= 6 months.
-Body mass index 18 to 40 kg/m^2 and total body weight > 50 kg (110 lbs).
-Deemed by Investigator to be eligible for phototherapy or systemic therapy.
-Psoriatic plaques must cover >= 10% of body surface area at baseline.
-Psoriasis Area and Severity Index (PASI) score >= 12 and static Physician Global Assessment (sPGA) >= 3 at baseline.
-Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic).
-Diagnosis of uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with PsO for which a participant requires current systemic immunosuppressant medical treatment.
-Any significant acute or chronic medical illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Proportion of participants achieving 75% reduction in PASI score (PASI-75) [ Time Frame: At week 12 ]<br> -Number of participants with treatment-emergent adverse event (TEAEs) [ Time Frame: Up to 16 weeks ]<br> -Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 16 weeks ]<br> -Number of participants with TEAEs leading to treatment discontinuation [ Time Frame: Up to 16 weeks ]<br> -Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 16 weeks ]<br> -Number of participants with electrocardiogram (ECG) abnormalities [ Time Frame: Up to 16 weeks ]<br> -Number of participants with vital sign abnormalities [ Time Frame: Up to 16 weeks ]<br> -Number of participants with physical examination abnormalities [ Time Frame: Up to 16 weeks ]
- Secondary Outcome Measures
Name Time Method