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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-18
SponsorBristol-Myers Squibb

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 another active comparator.

Trial design

Treatments tested in this trial

  • Deucravacitinib
  • Placebo matching deucravacitinib

Treatment groups

153 Participants
are divided into 3 treatment groups

Sponsors and collaborators