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 (86) 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
California
Local Institution - 0025
NOT_YET_RECRUITING
Fountain Valley
Local Institution - 0090
NOT_YET_RECRUITING
Fremont
Local Institution - 0214
NOT_YET_RECRUITING
Northridge
Local Institution - 0077
NOT_YET_RECRUITING
Sacramento
Local Institution - 0243
NOT_YET_RECRUITING
Walnut Creek
Colorado
Paradigm Clinical Research, LLC
RECRUITING
Wheat Ridge
Florida
Local Institution - 0021
NOT_YET_RECRUITING
Clearwater
Local Institution - 0185
NOT_YET_RECRUITING
Margate
Local Institution - 0014
NOT_YET_RECRUITING
Miami Lakes
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
RECRUITING
Tampa
Georgia
Local Institution - 0244
NOT_YET_RECRUITING
Atlanta
Indiana
Local Institution - 0003
NOT_YET_RECRUITING
Indianapolis
Louisiana
Local Institution - 0202
NOT_YET_RECRUITING
Metairie
Massachusetts
Kuchnir Dermatology & Dermatologic Surgery
RECRUITING
Milford
Maryland
Local Institution - 0061
NOT_YET_RECRUITING
Rockville
Michigan
Local Institution - 0095
NOT_YET_RECRUITING
Detroit
Missouri
Local Institution - 0233
NOT_YET_RECRUITING
Columbia
North Carolina
Local Institution - 0234
NOT_YET_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
Tennessee
ObjectiveHealth - Goodlettsville Dermatology Research
RECRUITING
Goodlettsville
Local Institution - 0248
NOT_YET_RECRUITING
Nashville
Texas
Local Institution - 0033
NOT_YET_RECRUITING
San Antonio
Virginia
Local Institution - 0045
NOT_YET_RECRUITING
Norfolk
Washington
Local Institution - 0071
NOT_YET_RECRUITING
Mill Creek
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
Local Institution - 0209
NOT_YET_RECRUITING
Brussels
Local Institution - 0210
WITHDRAWN
Brussels
Local Institution - 0207
NOT_YET_RECRUITING
Ghent
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
Local Institution - 0242
NOT_YET_RECRUITING
St. John's
AvantDerm
RECRUITING
Toronto
Local Institution - 0240
NOT_YET_RECRUITING
Toronto
Local Institution - 0164
NOT_YET_RECRUITING
Winnipeg
China
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 - 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
Local Institution - 0211
NOT_YET_RECRUITING
Berlin
Local Institution - 0204
NOT_YET_RECRUITING
Dresden
Local Institution - 0193
NOT_YET_RECRUITING
Erlangen
Local Institution - 0194
NOT_YET_RECRUITING
Mainz
Local Institution - 0195
NOT_YET_RECRUITING
Münster
Hungary
Local Institution - 0153
NOT_YET_RECRUITING
Budapest
Mexico
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 - 0096
NOT_YET_RECRUITING
Veracruz
Local Institution - 0238
NOT_YET_RECRUITING
Zapopan
Poland
Local Institution - 0103
NOT_YET_RECRUITING
Bialystok
Local Institution - 0177
NOT_YET_RECRUITING
Lublin
Local Institution - 0178
NOT_YET_RECRUITING
Warsaw
Local Institution - 0212
NOT_YET_RECRUITING
Warsaw
Puerto Rico
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
Local Institution - 0173
NOT_YET_RECRUITING
Iași
Local Institution - 0181
NOT_YET_RECRUITING
Iași
Local Institution - 0200
NOT_YET_RECRUITING
Timișoara
Spain
Local Institution - 0218
NOT_YET_RECRUITING
Esplugues De Llobregat
Local Institution - 0216
NOT_YET_RECRUITING
Madrid
Local Institution - 0197
NOT_YET_RECRUITING
Santiago De Compostela
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
8559073286
Backup
First line of the email MUST contain the NCT# and Site#
Time Frame
Start Date:2025-09-25
Estimated Completion Date:2034-08-12
Participants
Target number of participants:366
Treatments
Active_comparator: Administration of Deucravacitinib