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

JRCT ID: jRCT2051220141

Registered date:26/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Plaque Psoriasis
• Date of first enrollment: 20/01/2023
• Target sample size: 153
• Countries of recruitment: Spain,Japan,UK,Japan,France,Japan,Poland,Japan,Australia,Japan,Canada,Japan,Korea,Japan,Mexico,Japan,Argentina,Japan,Brazil,Japan,Germany,Japan,Romania,Japan
• Study type: Interventional

Intervention(s)

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

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

Placebo Arm
Other: Placebo matching deucravacitinib
Specified dose on specified days

Outcome(s)

Primary Outcome

-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 Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: >= 4age old
• Age maximum: < 18age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Duculan Fuentes Judilyn