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
Bristol-Myers Squibb
153 participants
Mar 23, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria5
- Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to \< 18 years), Part A and Part B. Participants weighing ≤ 18.0 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.
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Interventions
Specified dose on specified days
Specified dose on specified days
Locations(63)
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NCT04772079