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  • NCT04772079

Recruiting

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis - IM011-126

Updated: 31 October, 2024   |   ClinicalTrials.gov

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Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 4-18

    Age Range

  • 35

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Active treatment deucravacitinib half-standard dose
Drug: Deucravacitinib
Experimental: Active treatment deucravacitinib standard dose
Drug: Deucravacitinib
Placebo Comparator: Placebo
Other: Placebo matching deucravacitinib

Key Eligibility Criteria

Inclusion Criteria: - 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 Criteria: - 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 Other protocol-defined inclusion/exclusion criteria apply

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MLTNO2000046