Status:

RECRUITING

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Plaque Psoriasis

Eligibility:

All Genders

4-18 years

Phase:

PHASE3

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    March 23 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 8 2033

    Estimated Enrollment :

    153 Patients enrolled

    Trial Details

    Trial ID

    NCT04772079

    Start Date

    March 23 2021

    End Date

    September 8 2033

    Last Update

    September 25 2025

    Active Locations (63)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 16 (63 locations)

    1

    Instituto de Neumonologia Y Dermatologia

    Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425

    2

    Psoriahue

    Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DKG

    3

    CONEXA Investigacion Clinica S.A.

    Buenos Aires, Argentina, 1012

    4

    Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, Argentina, C1056ABI