A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis
Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis
Eligibility
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Participants must have stable plaque psoriasis for 6 months or more prior to Screening. * Participants must have moderate to severe psoriasis defined by:. i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1. ii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1. iii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1. \- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:. i) Is n…
Interventions
- DrugDeucravacitinib
Specified dose on specified days
- OtherPlacebo
Specified dose on specified days
Locations (120)
- Local Institution - 0261Birmingham, Alabama
- Local Institution - 0041Birmingham, Alabama
- Local Institution - 0053Phoenix, Arizona
- Local Institution - 0025Fountain Valley, California
- Center For Dermatology Clinical Research, Inc.Fremont, California
- Dermatology Research AssociatesLos Angeles, California