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
Who is this study for? Patients with Plaque Psoriasis
What treatments are being studied? BMS-986165
Status: Recruiting
Location: See all (63) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Argentina
Centro de Investigaciones Metabólicas (CINME)
RECRUITING
Buenos Aires
CONEXA Investigacion Clinica S.A.
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Caba
Instituto de Neumonologia Y Dermatologia
RECRUITING
Ciudad Autonoma De Buenos Aires
Psoriahue
RECRUITING
Ciudad Autonoma De Buenos Aires
Consultora Integral de Salud
RECRUITING
Córdoba
Australia
Queensland Children's Hospital
RECRUITING
Brisbane
Monash Health
RECRUITING
Clayton
The Skin Hospital
RECRUITING
Darlinghurst
Local Institution - 0001
COMPLETED
Melbourne
Local Institution - 0002
WITHDRAWN
Westmead
Veracity Clinical Research
RECRUITING
Woolloongabba
Brazil
Hospital Moinhos de Vento
RECRUITING
Porto Alegre
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP
RECRUITING
Ribeirão Preto
Local Institution - 0083
NOT_YET_RECRUITING
Rio De Janeiro
Centro de Pesquisas da Clínica IBIS
RECRUITING
Salvador
Local Institution - 0067
WITHDRAWN
São Paulo
Canada
Local Institution - 0010
COMPLETED
Calgary
Alberta Dermasurgery Centre
RECRUITING
Edmonton
Local Institution - 0039
WITHDRAWN
Hamilton
Lynderm Research Inc.
RECRUITING
Markham
The Hospital for Sick Children
RECRUITING
Toronto
France
Centre Hospitalier de Calais
RECRUITING
Calais
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology
RECRUITING
Dijon
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
RECRUITING
Nice
Local Institution - 0021
COMPLETED
Paris
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
RECRUITING
Berlin
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Kath. Kinderkrankenhaus Wilhelmstift
RECRUITING
Hamburg
Universitätsmedizin Johannes Gutenberg Universität Mainz
RECRUITING
Mainz
Universitätsklinikum Münster
RECRUITING
Münster
Japan
Fukuoka University Hospital
RECRUITING
Fukuoka, Jonan-ku
Local Institution - 0040
WITHDRAWN
Isehara
Teikyo University Hospital
RECRUITING
Itabashi-ku
Nagoya City University Hospital
RECRUITING
Nagoya
Nippon Life Hospital
RECRUITING
Osaka
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Mie University Hospital
RECRUITING
Tsu
Mexico
Crea de Guadalajara
RECRUITING
Guadalajara
Grupo Clínico CATEI S.C.
RECRUITING
Guadalajara
RM Pharma Specialists
RECRUITING
Mexico City
Arké SMO S.A de C.V
RECRUITING
Veracruz
Poland
Local Institution - 0011
COMPLETED
Krakow
Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
RECRUITING
Lodz
Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii
RECRUITING
Warsaw
WroMedica
RECRUITING
Wroclaw
Republic of Korea
Local Institution - 0047
COMPLETED
Seoul
Local Institution - 0048
COMPLETED
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital
RECRUITING
Seoul
Romania
CCBR Clinical Research
RECRUITING
Bucharest
Local Institution - 0080
WITHDRAWN
Bucharest
Local Institution - 0081
WITHDRAWN
Bucharest
Local Institution - 0088
WITHDRAWN
Bucharest
Lotus-Med Tunari
RECRUITING
Bucharest
Spitalul clinic de urgenta pentru copii Sf. Maria
RECRUITING
Iași
Spitalul Clinic Judetean Mures
RECRUITING
Târgu Mureş
Spain
Hospital General Universitario de Alicante-Dermatology
RECRUITING
Alicante
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology
RECRUITING
Barakaldo
Hospital Sant Joan de Déu-URC Dermatology
RECRUITING
Esplugues De Llobregat
Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
RECRUITING
Las Palmas De Gc
Hospital Universitario 12 de Octubre-DERMATOLOGY
RECRUITING
Madrid
Hospital Universitario La Paz-UCICEC/DERMA
RECRUITING
Madrid
United Kingdom
Mounts Bay Medical
RECRUITING
Connor Downs
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2021-03-23
Estimated Completion Date: 2033-09-08
Participants
Target number of participants: 153
Treatments
Experimental: Active treatment deucravacitinib standard dose
Experimental: Active treatment deucravacitinib half-standard dose
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb