A Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects with Moderate to Severe Plaque Psoriasis

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051220141

Enrollment

153

Registered

2022-12-26

Start date

2023-01-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Interventions

Active treatment deucravacitinib standard dose Arm Drug: Deucravacitinib Specified dose on specified days Active treatment deucravacitinib half-standard dose Arm Drug: Deucravacitinib Specified dose

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
-Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at 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	—

Secondary

Measure	Time frame
-Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo -Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo -Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo -Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo -Incidence of AEs/SAEs	—

Measure

Time frame

-Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo -Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo -Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo -Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo -Incidence of AEs/SAEs

—

Countries

Argentina, Australia, Brazil, Canada, France, Germany, Japan, Korea, Mexico, Poland, Romania, Spain, UK

Contacts

Public ContactJudilyn Duculan

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026