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

NCT04772079 · tracked via the Priya Life Science UK tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2021-03-23

Last updated

2026-08-18

Condition(s) studied

Plaque Psoriasis

Investigational drug(s) / intervention(s)

DeucravacitinibPlacebo matching deucravacitinib

Deucravacitinib: Specified dose on specified days

Placebo matching deucravacitinib: Specified dose on specified days

Study summary

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.

Eligibility

Sex

ALL

Min age

4 Years

Max age

18 Years

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (65)

Facility	City	Region	Status
Instituto de Neumonologia Y Dermatologia	Ciudad Autonoma de Buenos Aires	Buenos Aires	Recruiting
Psoriahue	Ciudad Autonoma de Buenos Aires	Buenos Aires	Recruiting
CONEXA Investigacion Clinica S.A.	Buenos Aires	Argentina	Recruiting
Centro de Investigaciones Metabólicas (CINME)	Buenos Aires	Argentina	Recruiting
Hospital Italiano de Buenos Aires	CABA	Argentina	Recruiting
Consultora Integral de Salud	Córdoba	Argentina	Recruiting
Local Institution - 0020	Darlinghurst	New South Wales	Active Not Recruiting
Local Institution - 0002	Westmead	New South Wales	Withdrawn
Queensland Children's Hospital	Brisbane	Queensland	Recruiting
Local Institution - 0003	Woolloongabba	Queensland	Completed
Monash Health	Clayton	Victoria	Recruiting
Local Institution - 0001	Melbourne	Victoria	Completed
Centro de Pesquisas da Clínica IBIS	Salvador	Estado de Bahia	Recruiting
Hospital Moinhos de Vento	Porto Alegre	Rio Grande do Sul	Recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP	Ribeirão Preto	São Paulo	Recruiting
Local Institution - 0083	Rio de Janeiro	Brazil	Withdrawn
Local Institution - 0067	São Paulo	Brazil	Withdrawn
Local Institution - 0010	Calgary	Alberta	Completed
Alberta Dermasurgery Centre	Edmonton	Alberta	Recruiting
Local Institution - 0039	Hamilton	Ontario	Withdrawn
Lynderm Research Inc.	Markham	Ontario	Recruiting
The Hospital for Sick Children	Toronto	Ontario	Recruiting
Centre Hospitalier de Calais	Calais	France	Recruiting
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology	Dijon	France	Recruiting
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet	Nice	France	Recruiting
Local Institution - 0021	Paris	France	Completed
Universitätsklinikum Münster	Münster	North Rhine-Westphalia	Recruiting
Universitätsmedizin Johannes Gutenberg Universität Mainz	Mainz	Rhineland-Palatinate	Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden	Dresden	Saxony	Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte	Berlin	Germany	Recruiting
Kath. Kinderkrankenhaus Wilhelmstift	Hamburg	Germany	Recruiting
Nagoya City University Hospital	Nagoya	Aichi-ken	Recruiting
Fukuoka University Hospital	Fukuoka, Jonan-Ku	Fukuoka	Recruiting
Local Institution - 0040	Isehara	Kanagawa	Withdrawn
Mie University Hospital	Tsu	Mie-ken	Recruiting
Teikyo University Hospital	Itabashi-ku	Tokyo	Recruiting
Tokyo Medical University Hospital	Shinjuku-ku	Tokyo	Recruiting
Nippon Life Hospital	Osaka	Japan	Recruiting
Crea de Guadalajara	Guadalajara	Jalisco	Recruiting
Grupo Clínico CATEI S.C.	Guadalajara	Jalisco	Recruiting

+ 25 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet) Active, not recruiting

A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis Active, not recruiting

A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis Active, not recruiting

A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis Active, not recruiting

A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04772079 on ClinicalTrials.gov ↗ ← All trials in the UK