Recruiting
Phase 3

Deucravacitinib

Sponsor:

Bristol-Myers Squibb

Code:

NCT04772079

Conditions

Plaque Psoriasis

Eligibility Criteria

Sex: All

Age: 4 - 18

Healthy Volunteers: Not accepted

Interventions

Deucravacitinib

Placebo matching deucravacitinib

Study Details

Brief summary:

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.

Conditions

Plaque Psoriasis

Study ID

NCT04772079

Start date

Mar 23, 2021

Status verified date

Aug, 2026

Completion date

Sep 8, 2033

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 18

Healthy Volunteers: Not accepted

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 another active comparator.
  • Evidence of active TB for LTE period.
  • Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Enrollment

153 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active treatment deucravacitinib standard dose

experimental: Active treatment deucravacitinib half-standard dose

placebo comparator: Placebo

Interventions

Deucravacitinib

Specified dose on specified days

Placebo matching deucravacitinib

Specified dose on specified days

Primary outcome measure

  • Observed average concentration at steady state for deucravacitinib at Week 2 [ Time Frame: Week 2 ]
  • Maximum observed plasma concentration at steady state for deucravacitinib at Week 2 [ Time Frame: Week 2 ]
  • Trough observed plasma concentration for deucravacitinib at Week 2 [ Time Frame: Week 2 ]
  • Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16 [ Time Frame: Week 16 ]
  • Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 [ Time Frame: Week 16 ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 316 weeks ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 316 weeks ]
  • Monitoring of growth: Body weight [ Time Frame: Up to 316 weeks ]
  • Monitoring of growth: Height [ Time Frame: Up to 316 weeks ]
  • Monitoring of growth: Tanner staging (sexual maturation) [ Time Frame: Up to 316 weeks ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Alberta Dermasurgery Centre

Recruiting

Edmonton, Alberta, Canada, T6G 1C3

Contacts

Jaggi Rao, Site 0037

587-487-0187

Lynderm Research Inc.

Recruiting

Markham, Ontario, Canada, L3P 1X3

Contacts

Charles Lynde, Site 0008

9054718011

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Rebecca Levy, Site 0050

4168137654x428232

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Adolescent Psoriasis
  • BMS-986165
  • Clinical trial
  • Deucravacitinib
  • Children Psoriasis
  • Pediatric Psoriasis
  • Plaque Psoriasis
  • Psoriasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-18.