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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• 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

+ 51 more sites.

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04772079.