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 |
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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 |
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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 |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Judilyn Fuentes Duculan |
Address | 1-2-1 Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004 |
Telephone | +81-120-093-507 |
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 |
mg-jp-clinical_trial@bms.com | |
Affiliation | Bristol-Myers Squibb |