Psoriasis
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Psoriasis
IM011-126 Enrolling

Plaque Psoriasis Trial for Teens (66 Weeks)


Treatment: Oral Age: 4 Years

Adolescents aged 12 to under 18 years old with stable plaque psoriasis for 6 months or more, may qualify to participate. Individuals must have moderate to severe plaque psoriasis and be able to swallow study medication. Teens with a medical history of JPsA (juvenile psoriatic arthritis) or who report symptoms suggestive of JPsA at screening, must have a confirmed diagnosis.

This study consists of 2 parts. In Part A, participants will receive investigational oral medication (active study drug) in tablet form. In Part B, participants will receive either active study drug or placebo for the first 16 weeks, followed by active study drug up to Week 52.  Study medication and study-related care will be provided at no cost. Reimbursement for study-related expenses will also be provided.

Study participation will last about 66 weeks in each part, and involve about 22 visits to the study centre in Part A, and 18 visits in Part B.


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

Official Title

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

ClinicalTrials.gov ID

NCT04772079

Sponsor

Bristol-Myers Squibb

Study Description

  • Brief 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.

  • Condition or Disease:

    Plaque Psoriasis

  • Intervention/Treatment:

    Drug: Deucravacitinib
    Drug: Deucravacitinib
    Other: Placebo matching deucravacitinib
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    4 Years and 18 Years (Child)

  • Sexes Eligible for Study:

    All

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 ≤ 13.0 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


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Canada
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Australia

Participating Experts

Dr. Alim Devani

Dermatologist

Dr. Vimal Prajapati

Dermatologist

Dr. Charles Lynde

Dermatologist

Dr. Lynda Spelman

Dermatologist

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