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Recruiting Phase 3 NCT04772079

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

Phase 3 – large-scale trial before approval
Conditions: Plaque Psoriasis

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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 can participate
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.
Locations 13
Argentina (1)
Instituto de Neumonologia Y Dermatologia
Ciudad Autonoma de Buenos Aires , Buenos Aires
Paula Luna, Site 0042
Australia (1)
The Skin Hospital
Darlinghurst , New South Wales
John Frew, Site 0020
Brazil (1)
Centro de Pesquisas da Clínica IBIS
Salvador , Estado de Bahia
Gleison Duarte, Site 0069
Canada (1)
Local Institution - 0010
Calgary , Alberta
COMPLETED
France (1)
Centre Hospitalier de Calais
Calais
Christopher COSSART, Site 0090
Germany (1)
Universitätsklinikum Münster
Münster , North Rhine-Westphalia
Nina Magnolo, Site 0077
Japan (1)
Nagoya City University Hospital
Nagoya , Aichi-ken
Akimichi Morita, Site 0033
Mexico (1)
Crea de Guadalajara
Guadalajara , Jalisco
Gabriel Vega Cornejo, Site 0054
Poland (1)
Local Institution - 0011
Krakow
COMPLETED
Romania (1)
Local Institution - 0080
Bucharest , Bucharest
WITHDRAWN
South Korea (1)
Local Institution - 0048
Seoul , Seoul-teukbyeolsi [Seoul]
COMPLETED
Spain (1)
Hospital General Universitario de Alicante-Dermatology
Alicante
laura berbegal, Site 0017
United Kingdom (1)
Mounts Bay Medical
Connor Downs
Richard Burkimsher, Site 0019
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
4 Years
Maximum age
18 Years
Healthy volunteers
No
Start date
23.03.2021
Completion date
08.09.2033
Registry ID
NCT04772079
Source
anzctr
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