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A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
Sponsor: Bristol-Myers Squibb
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
4 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
153
Start Date
2021-03-23
Completion Date
2033-09-08
Last Updated
2025-09-25
Healthy Volunteers
No
Conditions
Interventions
Deucravacitinib
Specified dose on specified days
Placebo matching deucravacitinib
Specified dose on specified days
Locations (63)
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
Lynderm Research Inc.
Markham, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier de Calais
Calais, France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology
Dijon, France
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, France
Local Institution - 0021
Paris, France
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, Germany
Kath. Kinderkrankenhaus Wilhelmstift
Hamburg, Germany
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Fukuoka University Hospital
Fukuoka, Jonan-Ku, Fukuoka, Japan
Local Institution - 0040
Isehara, Kanagawa, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Nippon Life Hospital
Osaka, Japan
Crea de Guadalajara
Guadalajara, Jalisco, Mexico
Grupo Clínico CATEI S.C.
Guadalajara, Jalisco, Mexico
RM Pharma Specialists
Mexico City, Mexico City, Mexico
Arké SMO S.A de C.V
Veracruz, Mexico
Local Institution - 0011
Krakow, Poland
Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Poland
Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii
Warsaw, Poland
WroMedica
Wroclaw, Poland
Local Institution - 0080
Bucharest, București, Romania
Local Institution - 0081
Bucharest, București, Romania
Local Institution - 0088
Bucharest, București, Romania
CCBR Clinical Research
Bucharest, București, Romania
Lotus-Med Tunari
Bucharest, Romania
Spitalul clinic de urgenta pentru copii Sf. Maria
Iași, Romania
Spitalul Clinic Judetean Mures
Târgu Mureş, Romania
Local Institution - 0048
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0047
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Hospital General Universitario de Alicante-Dermatology
Alicante, Spain
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology
Barakaldo, Spain
Hospital Sant Joan de Déu-URC Dermatology
Esplugues de Llobregat, Spain
Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
Las Palmas de GC, Spain
Hospital Universitario 12 de Octubre-DERMATOLOGY
Madrid, Spain
Hospital Universitario La Paz-UCICEC/DERMA
Madrid, Spain
Mounts Bay Medical
Connor Downs, United Kingdom