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

Phase 3RecruitingNCT04772079

Bristol-Myers Squibb153 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

153

Conditions

Plaque Psoriasis

Interventions

Specified dose on specified days

Placebo matching deucravacitinibOTHER

Specified dose on specified days

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 Years

Medical Language ↔ Plain English

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 another active comparator. * Evidence of active TB for LTE period. * Other protocol-defined inclusion/exclusion criteria apply.

Locations (65)

Instituto de Neumonologia Y Dermatologia

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

RECRUITING

Psoriahue

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

RECRUITING

CONEXA Investigacion Clinica S.A.

Buenos Aires, Argentina

RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

Outcomes

Primary Outcomes

Observed average concentration at steady state for deucravacitinib at Week 2

Part A

Time frame: Week 2

Maximum observed plasma concentration at steady state for deucravacitinib at Week 2

Part A

Time frame: Week 2

Trough observed plasma concentration for deucravacitinib at Week 2

Part A

Time frame: Week 2

Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16

Part B

Time frame: 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

Time frame: Week 16

Incidence of Adverse Events (AEs)

Long-term extension (LTE) Period

Time frame: Up to 316 weeks

Incidence of serious adverse events (SAEs)

LTE Period

Time frame: Up to 316 weeks

Monitoring of growth: Body weight

LTE Period

Time frame: Up to 316 weeks

Monitoring of growth: Height

LTE Period

Time frame: Up to 316 weeks

Monitoring of growth: Tanner staging (sexual maturation)

LTE Period

Time frame: Up to 316 weeks

Secondary Outcomes

Incidence of Adverse Events (AEs)

Part A and Part B

Time frame: Up to Week 52

Incidence of serious adverse events (SAEs)

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in clinical laboratory results: Hematology tests

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in clinical laboratory results: Hemoglobin A1C tests

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in clinical laboratory results: Serum immunoglobulin level tests

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in clinical laboratory results: Fasting plasma glucose tests

Part A and Part B

Time frame: Up to Week 52

Central Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Data from ClinicalTrials.gov

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Hospital Italiano de Buenos Aires

CABA, Argentina

RECRUITING

Consultora Integral de Salud

Córdoba, Argentina

RECRUITING

Local Institution - 0020

Darlinghurst, New South Wales, Australia

ACTIVE_NOT_RECRUITING

Local Institution - 0002

Westmead, New South Wales, Australia

WITHDRAWN

Queensland Children's Hospital

Brisbane, Queensland, Australia

RECRUITING

Local Institution - 0003

Woolloongabba, Queensland, Australia

COMPLETED

...and 55 more locations

Incidence of clinically significant changes in clinical laboratory results: Pregnancy test for women of childbearing potential only

Time frame: Up to Week 52

Incidence of clinically significant changes in lymphocyte subsets and function

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in cytokine levels

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in physical examination findings

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in vital signs: Body temperature

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in vital signs: Respiratory rate

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in vital signs: Systolic and diastolic blood pressure

Part A and Part B

Time frame: Up to Week 52

Incidence of clinically significant changes in vital signs: Heart rate

Part A and Part B

Time frame: Up to Week 52

Monitoring of growth: Body weight

Part A and Part B

Time frame: Up to Week 52

Monitoring of growth: Height

Part A and Part B

Time frame: Up to Week 52

Monitoring of growth: Tanner staging (sexual maturation)

Part A and Part B

Time frame: Up to Week 52

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

Time frame: 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

Time frame: 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

Time frame: Week 16

Change from baseline in PASI at Week 16 for comparison of deucravacitinib vs placebo

Part B

Time frame: Week 16

Change from baseline in BSA involvement at Week 16 for comparison of deucravacitinib vs placebo

Part B

Time frame: Week 16

Change from baseline in CDLQI score at Week 16 for comparison of deucravacitinib vs placebo

Part B

Time frame: 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

Time frame: 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

Time frame: Week 16

Proportion of subjects achieving Juvenile Idiopathic Arthritis and the American College of Rheumatology 30 (JIA-ACR 30) response at Week 16 for subjects with confirmed JPsA prior to baseline

Part B JIA-ACR 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

Time frame: Week 16

Proportion of subjects using topical corticosteroid at Week 16 for comparison of deucravacitinib vs placebo

Part B

Time frame: Week 16

Proportion of subjects with protective titers of antibodies to measles, tetanus and pertussis at Week 16

Part B

Time frame: Week 16

Observed average concentration at steady state for deucravacitinib at Week 16

Part B

Time frame: Week 16

Maximum observed plasma concentration at steady state for deucravacitinib at Week 16

Part B

Time frame: Week 16

Trough observed plasma concentration for deucravacitinib at Week 16

Part B

Time frame: Week 16

Proportion of participants with 75% improvement in PASI (PASI 75) over time

LTE Period

Time frame: 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

Time frame: Up to 316 weeks