A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis
Status: Recruiting
Location: See all (114) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:
• Participants must have stable plaque psoriasis for 6 months or more prior to Screening.
• Participants must have moderate to severe psoriasis defined by:.
• i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1.
⁃ ii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1.
⁃ iii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1.
⁃ \- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:.
⁃ i) Is not an individual of childbearing potential (IOCBP).
⁃ ii) Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.
Locations
United States
Alabama
Local Institution - 0041
NOT_YET_RECRUITING
Birmingham
Local Institution - 0261
NOT_YET_RECRUITING
Birmingham
Arizona
Local Institution - 0053
ACTIVE_NOT_RECRUITING
Phoenix
California
Local Institution - 0025
NOT_YET_RECRUITING
Fountain Valley
Local Institution - 0090
NOT_YET_RECRUITING
Fremont
Dermatology Research Associates
RECRUITING
Los Angeles
Northridge Clinical Trials
RECRUITING
Northridge
Local Institution - 0077
NOT_YET_RECRUITING
Sacramento
Golden State Dermatology - Walnut Creek - Ygnacio Valley Road
RECRUITING
Walnut Creek
Colorado
Paradigm Clinical Research, LLC
RECRUITING
Wheat Ridge
Florida
Local Institution - 0021
NOT_YET_RECRUITING
Clearwater
Life Clinical Trials
RECRUITING
Margate
Skin Research of South Florida
RECRUITING
Miami
Wellness Clinical Research
RECRUITING
Miami Lakes
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
RECRUITING
Tampa
Georgia
Dermatology Affiliates Research Institute
RECRUITING
Atlanta
Advanced Medical Research, PC.
RECRUITING
Sandy Springs
Indiana
Dawes Fretzin Clinical Research Group, LLC
RECRUITING
Indianapolis
Kentucky
Local Institution - 0262
NOT_YET_RECRUITING
Murray
Louisiana
Local Institution - 0202
NOT_YET_RECRUITING
Metairie
Massachusetts
Kuchnir Dermatology & Dermatologic Surgery
RECRUITING
Milford
Maryland
Dermatology and Skin Cancer Specialists, LLC
RECRUITING
Rockville
Michigan
Local Institution - 0095
NOT_YET_RECRUITING
Detroit
Missouri
Local Institution - 0233
NOT_YET_RECRUITING
Columbia
Local Institution - 0266
NOT_YET_RECRUITING
Lee's Summit
North Carolina
Hickory Dermatology Research Center
RECRUITING
Hickory
Nevada
Local Institution - 0052
NOT_YET_RECRUITING
Las Vegas
New York
Local Institution - 0166
NOT_YET_RECRUITING
The Bronx
Ohio
Apex Clinical Research Center - Canton
RECRUITING
Canton
Apex Clinical Research Center
RECRUITING
Mayfield Heights
Pennsylvania
Paddington Testing Company
RECRUITING
Philadelphia
Tennessee
ObjectiveHealth - Goodlettsville Dermatology Research
RECRUITING
Goodlettsville
Belle Meade Dermatology Research
RECRUITING
Nashville
Texas
Local Institution - 0268
NOT_YET_RECRUITING
Austin
Local Institution - 0267
NOT_YET_RECRUITING
Cedar Park
Texas Dermatology and Laser Specialists
RECRUITING
San Antonio
Virginia
Local Institution - 0045
NOT_YET_RECRUITING
Norfolk
Washington
Frontier Derm Partners
RECRUITING
Mill Creek
Local Institution - 0264
NOT_YET_RECRUITING
Spokane
Other Locations
Argentina
Local Institution - 0149
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0154
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0221
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0250
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 0115
NOT_YET_RECRUITING
Ciudad Autonoma De Buenos Aires
Local Institution - 0119
NOT_YET_RECRUITING
Ciudad Autonoma De Buenos Aires
Belgium
Cliniques universitaires Saint-Luc
RECRUITING
Brussels
Local Institution - 0210
WITHDRAWN
Brussels
UZ Gent
RECRUITING
Ghent
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
RECRUITING
Liège
Brazil
Local Institution - 0140
NOT_YET_RECRUITING
Barretos
Local Institution - 0136
NOT_YET_RECRUITING
Porto Alegre
Local Institution - 0182
NOT_YET_RECRUITING
Porto Alegre
Local Institution - 0163
NOT_YET_RECRUITING
Ribeirão Preto
Local Institution - 0137
NOT_YET_RECRUITING
Salvador
Canada
Local Institution - 0241
NOT_YET_RECRUITING
Edmonton
DermEffects
RECRUITING
London
Local Institution - 0142
NOT_YET_RECRUITING
Montreal
The Centre for Dermatology
RECRUITING
Richmond Hill
Skincare Studio
RECRUITING
St. John's
AvantDerm
RECRUITING
Toronto
Local Institution - 0240
NOT_YET_RECRUITING
Toronto
Local Institution - 0164
NOT_YET_RECRUITING
Winnipeg
China
Beijing Children's hospital, Capital Medical University
RECRUITING
Beijing
Local Institution - 0222
NOT_YET_RECRUITING
Beijing
Local Institution - 0228
NOT_YET_RECRUITING
Chengdu
Local Institution - 0255
NOT_YET_RECRUITING
Handan
Local Institution - 0224
NOT_YET_RECRUITING
Hangzhou
Local Institution - 0265
NOT_YET_RECRUITING
Jinan
Local Institution - 0131
NOT_YET_RECRUITING
Shanghai
Local Institution - 0226
NOT_YET_RECRUITING
Shenzhen
Local Institution - 0227
NOT_YET_RECRUITING
Zhengzhou
Colombia
Local Institution - 0167
NOT_YET_RECRUITING
Barranquilla
Local Institution - 0125
NOT_YET_RECRUITING
Bogota
Local Institution - 0124
NOT_YET_RECRUITING
Medellín
Local Institution - 0225
NOT_YET_RECRUITING
Medellín
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
RECRUITING
Berlin
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Universitaetsklinikum Erlangen
RECRUITING
Erlangen
BAG Drs. Med. Quist PartG
RECRUITING
Mainz
Universitätsklinikum Münster
RECRUITING
Münster
Hungary
Clinexpert Kft.
RECRUITING
Budapest
Local Institution - 0203
NOT_YET_RECRUITING
Szeged
Mexico
Local Institution - 0259
NOT_YET_RECRUITING
Chihuahua City
Local Institution - 0257
NOT_YET_RECRUITING
Mérida
Local Institution - 0253
NOT_YET_RECRUITING
Mexico City
Local Institution - 0155
NOT_YET_RECRUITING
Monterrey
Local Institution - 0237
NOT_YET_RECRUITING
Puebla City
Local Institution - 0258
NOT_YET_RECRUITING
Toluca
Local Institution - 0096
NOT_YET_RECRUITING
Veracruz
Local Institution - 0238
NOT_YET_RECRUITING
Zapopan
Poland
SPECDERM Poznanska sp.j.
RECRUITING
Bialystok
DERMED Centrum Medyczne Sp. z o.o.
RECRUITING
Lodz
Local Institution - 0177
WITHDRAWN
Lublin
ETYKA Osrodek Badan Klinicznych
RECRUITING
Olsztyn
FutureMeds - Targowek
RECRUITING
Warsaw
Klinika Ambroziak Dermatologia
RECRUITING
Warsaw
Royalderm Agnieszka Nawrocka
RECRUITING
Warsaw
Puerto Rico
Local Institution - 0254
NOT_YET_RECRUITING
Bayamón
Local Institution - 0008
NOT_YET_RECRUITING
Caguas
Local Institution - 0012
NOT_YET_RECRUITING
San Juan
Romania
Local Institution - 0174
WITHDRAWN
Bucharest
Local Institution - 0213
WITHDRAWN
Bucharest
Local Institution - 0249
NOT_YET_RECRUITING
Bucharest
Centrul de Medicina de Familie
RECRUITING
Iași
Policlinica Providența
RECRUITING
Iași
New Derm Clinical SRL
RECRUITING
Timișoara
Spain
Hospital Sant Joan de Déu
RECRUITING
Esplugues De Llobregat
Grupo Pedro Jaén
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
CHUS - Hospital Clinico Universitario
RECRUITING
Santiago De Compostela
Taiwan
Kaohsiung Veterans General Hospital
RECRUITING
Kaohsiung City
Chang Gung Memorial Hospital at Kaohsiung
RECRUITING
Kaohsiung Niao Sung Dist
National Taiwan University Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan District
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date:2025-12-03
Estimated Completion Date:2034-08-12
Participants
Target number of participants:366
Treatments
Active_comparator: Administration of Deucravacitinib