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Trial ID IM011-126  |   NCT04772079

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

Summary

  • Phase 3
  • Male and Female Gender icon
  • 4-18
    Age Range
  • 36
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Males and females aged 12 to <18 years for Cohort 1. Males and females aged 4 to <12 years for Cohort 2.
    1. Plaque psoriasis for at least 6 months
      1. Moderate to severe disease
        1. Candidate for phototherapy or systemic therapy
          1. Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period

            Exclusion Criteria

            Exclusion Criteria Icon
            :
            • 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.
              1. Other forms of psoriasis
                1. History of recent infection
                  1. Prior exposure to deucravacitinib (BMS-986165) or active comparator
                    1. Evidence of active TB for LTE period Other protocol-defined inclusion/exclusion criteria apply
                      Additional Information *

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      Study Arms

                      Experimental: Active treatment deucravacitinib half-standard dose

                      ASSIGNED INTERVENTION
                      • Drug: Deucravacitinib

                      Study Arms

                      Experimental: Active treatment deucravacitinib standard dose

                      ASSIGNED INTERVENTION
                      • Drug: Deucravacitinib

                      Study Arms

                      Placebo Comparator: Placebo

                      ASSIGNED INTERVENTION
                      • Other: Placebo matching deucravacitinib
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