NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051220141

Registered date:26/12/2022

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPlaque Psoriasis
Date of first enrollment20/01/2023
Target sample size153
Countries of recruitmentSpain,Japan,UK,Japan,France,Japan,Poland,Japan,Australia,Japan,Canada,Japan,Korea,Japan,Mexico,Japan,Argentina,Japan,Brazil,Japan,Germany,Japan,Romania,Japan
Study typeInterventional
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
GenderBoth
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

Contact

Public contact
Name Judilyn Fuentes Duculan
Address 1-2-1 Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004
Telephone +81-120-093-507
E-mail MG-JP-RCO-JRCT@bms.com
Affiliation Bristol-Myers Squibb
Scientific contact
Name Judilyn Fuentes Duculan
Address 1-2-1 Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004
Telephone +81-120-093-507
E-mail mg-jp-clinical_trial@bms.com
Affiliation Bristol-Myers Squibb