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

Sponsor
Bristol-Myers Squibb
Study ID
NCT04772079
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent 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 children and adolescent 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 children and adolescent participants with psoriasis who have completed Parts A or B of the study.

Key Dates

Start date
Mar 23, 2021
Status verified
May 2026
Primary completion
Jan 1, 2029
Completion
Sep 8, 2033

Study Design

Enrollment
153 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Active treatment deucravacitinib standard dose
  • Experimental: Active treatment deucravacitinib half-standard dose
  • Placebo Comparator: Placebo

Primary Outcome Measure

Observed average concentration at steady state for deucravacitinib at Week 2 [ Time Frame: Week 2 ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

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