Actively Recruiting
Phase 3 Study to Test Deucravacitinib for Moderate to Severe Plaque Psoriasis in Children and Adolescents Aged 4 to Under 18 Years
Led by Bristol-Myers Squibb · Updated on 2026-06-09
153
Participants Needed
63
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the drug Deucravacitinib in children and adolescents aged 4 to under 18 years who have moderate to severe plaque psoriasis. The study aims to evaluate the drug levels, efficacy, and safety of Deucravacitinib in this population. It includes two age groups Cohort 1 for ages 12 to under 18 years and Cohort 2 for ages 4 to under 12 years. The study is a Phase 3 randomized, double-blind, placebo-controlled trial sponsored by Bristol-Myers Squibb. The study consists of two parts for each cohort. Part A will assess the drug levels of Deucravacitinib to select two dose levels for Part B. Part B will then evaluate the efficacy and safety of these two dose levels. There is also a 5-year long-term extension period to observe the long-term safety and tolerability of Deucravacitinib in participants who completed Parts A or B. Participants will undergo assessments including measuring drug concentrations at steady state, improvement in psoriasis severity using PASI and sPGA scores, and monitoring of adverse events over time. Growth and sexual maturation will be tracked through body weight, height, and Tanner staging. Safety labs and other clinical tests will also be conducted up to 52 weeks, with longer-term monitoring for some outcomes extending up to 316 weeks.
CONDITIONS
Brief Title
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 12 to under 18 years for Cohort 1, and 4 to under 12 years for Cohort 2
- Diagnosis of plaque psoriasis for at least 6 months
- Moderate to severe plaque psoriasis
- Candidate for phototherapy or systemic therapy
- Completed Week 52 treatment period in Part A or B to join long-term extension
You will not qualify if you...
- Weighing 30 kg or less at screening for Cohort 1 (age 12 to under 18 years) in Parts A and B
- Weighing less than 18 kg at screening for Cohort 2 (age 4 to under 12 years) in Parts A and B
- Having other forms of psoriasis
- History of recent infection
- Prior exposure to Deucravacitinib or another active comparator
- Evidence of active tuberculosis during long-term extension period
- Other protocol-defined inclusion and exclusion criteria apply
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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