A Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib(BMS-986165) in Pediatric Subjects with Moderate to Severe Plaque Psoriasis
Phase 3
Recruiting
- Conditions
- Plaque Psoriasis
- Registration Number
- JPRN-jRCT2051220141
- Lead Sponsor
- Duculan Fuentes Judilyn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 153
Inclusion Criteria
Males and females aged 12 to <18 years for Cohort 1. Males and females aged 4 to <12 years for Cohort 2.
-Plaque psoriasis for at least 6 months
-Moderate to severe disease
-Candidate for phototherapy or systemic therapy
-Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period
Exclusion Criteria
-Participants weighing <- 30.0 kg at screening for Cohort 1 (age 12 to < 18 years), Part A and Part B. Participants weighing <- 13.0 kg at screening for Cohort 2 (age 4 to < 12 years), Part A and Part B.
-Other forms of psoriasis
-History of recent infection
-Prior exposure to deucravacitinib (BMS-986165) or active comparator
-Evidence of active TB for LTE period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method