A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric 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 pediatric 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 pediatric participants with psoriasis who have completed Parts A or B of the study.

Official Title
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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

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Deucravacitinib
* Other: Placebo matching deucravacitinib


Participation Criteria
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Eligibility Criteria
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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 active comparator Evidence of active TB for LTE period Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment deucravacitinib standard dose<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>|
| Experimental: Active treatment deucravacitinib half-standard dose<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo matching deucravacitinib<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2 | Part A | Week 2 | 
| Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2 | Part A | Week 2 | 
| Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 2 | Part A | Week 2 | 
| Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16 | Part B | 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 | Part B | Week 16 | 
| Incidence of Adverse Events (AEs) | Long-term extension (LTE) Period | Up to 316 weeks | 
| Incidence of serious adverse events (SAEs) | LTE Period | Up to 316 weeks | 
| Monitoring of growth: Body weight | LTE Period | Up to 316 weeks | 
| Monitoring of growth: Height | LTE Period | Up to 316 weeks | 
| Monitoring of growth: Tanner staging (sexual maturation) | LTE Period | Up to 316 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) | Part A and Part B | Up to 424 days | 
| Incidence of serious adverse events (SAEs) | Part A and Part B | Up to 466 days | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Part A and Part B | Up to 466 days | 
| Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests | Part A and Part B | Up to 466 days | 
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Part A and Part B | Up to 466 days | 
| Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests | Part A and Part B | Up to 410 days | 
| Incidence of clinically significant changes in clinical laboratory results: Infectious serologies tests | Part A and Part B | Up to 42 days | 
| Incidence of clinically significant changes in clinical laboratory results: Tuberculosis (TB) tests | Part A and Part B | Up to 42 days | 
| Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests | Part A and Part B | Up to 368 days | 
| Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests | Part A and Part B | Up to 368 days | 
| Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests | Part A and Part B | Up to 368 days | 
| Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only | Part A and Part B | Up to 466 days | 
| Incidence of clinically significant changes in lymphocyte subsets and function | Part A and Part B | Up to 466 days | 
| Incidence of clinically significant changes in cytokine levels | Part A and Part B | Up to 466 days | 
| Incidence of clinically significant changes in physical examination findings | Part A and Part B | Up to 466 days | 
| Incidence of clinically significant changes in vital signs: Body temperature | Part A and Part B | Up to 466 days | 
| Incidence of clinically significant changes in vital signs: Respiratory rate | Part A and Part B | Up to 466 days | 
| Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure | Part A and Part B | Up to 466 days | 
| Incidence of clinically significant changes in vital signs: Heart rate | Part A and Part B | Up to 466 days | 
| Monitoring of growth: Body weight | Part A and Part B | Up to 466 days | 
| Monitoring of growth: Height | Part A and Part B | Up to 466 days | 
| Monitoring of growth: Tanner staging (sexual maturation) | Part A and Part B | Up to 466 days | 
| Proportion of subjects with at least 75% improvement in PASI (PASI 75) at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo | Part B | Week 16 | 
| Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16 for the comparison of the half-standard dose of deucravacitinib vs placebo | Part B | Week 16 | 
| Proportion of subjects with at least 90% improvement in PASI (PASI 90) at Week 16 for the comparison of deucravacitinib vs placebo | Part B | Week 16 | 
| Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo | Part B | Week 16 | 
| Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo | Part B | Week 16 | 
| Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo | Part B | Week 16 | 
| Change from baseline in subject reported visual analog scale (VAS) for subject's assessment of joint pain at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo | Part B | Week 16 | 
| Change from baseline in VAS for subject's Global Assessment of Joint Disease; at Week 16 (only for subjects with confirmed JPsA prior to baseline) for comparison of deucravacitinib vs placebo | Part B | Week 16 | 
| Proportion of subjects achieving American College of Rheumatology Pediatric 30 (ACR Pedi 30) response at Week 16 for subjects with confirmed JPsA prior to baseline | Part B ACR Pedi 30 response is defined as subjects with at least 30% improvement from baseline in 3 of any 6 variables in the core set, while no more than one of the remaining variables can worsen by > 30% for comparison of deucravacitinib vs placebo | Week 16 | 
| Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo | Part B | Week 16 | 
| Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16 | Part B | Week 16 | 
| Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 16 | Part B | Week 16 | 
| Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 16 | Part B | Week 16 | 
| Trough observed plasma concentration (Ctrough) for deucravacitinib at Week 16 | Part B | Week 16 | 
| Proportion of participants with 75% improvement in PASI (PASI 75) over time | LTE Period | Up to 316 weeks | 
| Proportion of participants with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline over time | LTE Period | Up to 316 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent Psoriasis, BMS-986165, Clinical trial, Deucravacitinib, Pediatric, Pediatric Psoriasis, Plaque Psoriasis, Psoriasis