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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (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 active comparator. - Evidence of active TB for LTE period. - Other protocol-defined inclusion/exclusion criteria apply. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Deucravacitinib

Specified dose on specified days

OTHER

Placebo matching deucravacitinib

Specified dose on specified days

Locations (20)

Instituto de Neumonologia Y Dermatologia
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Psoriahue
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
CONEXA Investigacion Clinica S.A.
Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
CABA, Argentina
Consultora Integral de Salud
Córdoba, Argentina
The Skin Hospital
Darlinghurst, New South Wales, Australia
Local Institution - 0002
Westmead, New South Wales, Australia
Queensland Children's Hospital
Brisbane, Queensland, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Local Institution - 0001
Melbourne, Victoria, Australia
Centro de Pesquisas da Clínica IBIS
Salvador, Estado de Bahia, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP
Ribeirão Preto, São Paulo, Brazil
Local Institution - 0083
Rio de Janeiro, Brazil
Local Institution - 0067
São Paulo, Brazil
Local Institution - 0010
Calgary, Alberta, Canada
Alberta Dermasurgery Centre
Edmonton, Alberta, Canada
Local Institution - 0039
Hamilton, Ontario, Canada