NCT04772079

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis

A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric participants aged 4 to \<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \<18 years) and Cohort 2 (age 4 to \<12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in pediatric participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in pediatric participants with psoriasis who have completed Parts A or B of the study.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Deucravacitinib	Specified dose on specified days
OTHER	Placebo matching deucravacitinib	Specified dose on specified days

Timeline

• Start date: 2021-03-23
• Primary completion: 2029-01-01
• Completion: 2033-09-08
• First posted: 2021-02-26
• Last updated: 2025-09-25

Locations

63 sites across 13 countries: Argentina, Australia, Brazil, Canada, France, Germany, Japan, Mexico, Poland, Romania, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study