Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescents With Moderate to Severe Plaque Psoriasis
Led by Bristol-Myers Squibb · Updated on 2026-05-28
366
Participants Needed
123
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescents aged 12 to 17 years with moderate to severe plaque psoriasis. This is a randomized, double-blind, placebo-controlled Phase 3 study sponsored by Bristol-Myers Squibb. The study focuses on improving psoriasis symptoms and assessing overall treatment impact in this younger population. Participants will receive either Deucravacitinib or a placebo at specified doses on certain days. The study includes a treatment period of at least 16 weeks during which drug effects will be monitored closely. The trial measures improvements in psoriasis severity, body surface area affected, itch severity, and quality of life. Long-term safety and other health parameters will be followed for up to five years. During the study, participants will undergo regular assessments including clinical evaluations of psoriasis severity using the Psoriasis Area and Severity Index and the static Physicians Global Assessment. They will also complete questionnaires related to quality of life and itch symptoms. Blood tests will monitor drug levels and antibody protection to certain vaccines. Safety monitoring will include tracking adverse events, laboratory tests, physical exams, weight, height, and sexual maturation over several years.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have stable plaque psoriasis for 6 months or more before screening.
- Participants must have moderate to severe psoriasis defined by PASI score of 12 or higher at screening and Day 1.
- Participants must have a static Physician's Global Assessment score of 3 or higher at screening and Day 1.
- Participants must have at least 10% body surface area involvement at screening and Day 1.
- Female participants assigned at birth must not be pregnant or breastfeeding.
- Female participants who can have children must use a highly effective contraceptive method during the study and for 3 days after stopping treatment and agree not to donate eggs during that time.
You will not qualify if you...
- Participants must weigh at least 30.0 kg at screening and Day 1.
- Participants must not have non-plaque psoriasis or other skin conditions that interfere with treatment assessment.
- Participants must not have had serious infections requiring hospitalization and IV antimicrobial treatment within 60 days before Day 1.
- Participants must not have untreated bacterial infections within 60 days prior to Day 1.
- Participants must not have ongoing chronic bacterial infections.
- Participants must not have herpes simplex/zoster, active tuberculosis, hepatitis B or C, or HIV.
- Participants must not have received live vaccines or BCG within 60 days before Day 1 or plan to receive live vaccines during or soon after the study.
- Participants must not have used Deucravacitinib before.
- Participants must not have taken any prohibited medications.
- Participants must not have exclusionary laboratory findings.
- Participants must not have serious or unstable medical conditions increasing study risk.
- Participants must not have cancer or lymphoproliferative disease in the past 5 years.
- Other protocol-defined inclusion/exclusion criteria apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 16 weeks
Participants receive Deucravacitinib or placebo as part of the study treatment.
Trial Site Locations
Total: 123 locations
1
Local Institution - 0261
Birmingham, Alabama, United States, 35203
Not Yet Recruiting
2
Local Institution - 0041
Birmingham, Alabama, United States, 35243
Not Yet Recruiting
3
Local Institution - 0053
Phoenix, Arizona, United States, 85006
Active, Not Recruiting
4
Local Institution - 0025
Fountain Valley, California, United States, 92708
Not Yet Recruiting
5
Center For Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
Actively Recruiting
6
Dermatology Research Associates
Los Angeles, California, United States, 90045
Actively Recruiting
7
Northridge Clinical Trials
Northridge, California, United States, 91325
Actively Recruiting
8
Local Institution - 0077
Sacramento, California, United States, 95814
Not Yet Recruiting
9
Golden State Dermatology - Walnut Creek - Ygnacio Valley Road
Walnut Creek, California, United States, 94598
Actively Recruiting
10
Paradigm Clinical Research, LLC
Wheat Ridge, Colorado, United States, 80033
Actively Recruiting
11
Local Institution - 0021
Clearwater, Florida, United States, 33756
Not Yet Recruiting
12
Life Clinical Trials
Margate, Florida, United States, 33063
Actively Recruiting
13
Skin Research of South Florida
Miami, Florida, United States, 33173
Actively Recruiting
14
Wellness Clinical Research
Miami Lakes, Florida, United States, 33016
Actively Recruiting
15
MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research
Tampa, Florida, United States, 33607
Actively Recruiting
16
USF Health
Tampa, Florida, United States, 33612
Actively Recruiting
17
Dermatology Affiliates Research Institute
Atlanta, Georgia, United States, 30305
Actively Recruiting
18
Advanced Medical Research, PC.
Sandy Springs, Georgia, United States, 30328
Actively Recruiting
19
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
Actively Recruiting
20
Local Institution - 0262
Murray, Kentucky, United States, 42071
Not Yet Recruiting
21
Local Institution - 0202
Metairie, Louisiana, United States, 70001
Not Yet Recruiting
22
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, United States, 20850
Actively Recruiting
23
Kuchnir Dermatology & Dermatologic Surgery
Milford, Massachusetts, United States, 01757
Actively Recruiting
24
Local Institution - 0095
Detroit, Michigan, United States, 48201
Not Yet Recruiting
25
Local Institution - 0233
Columbia, Missouri, United States, 65201
Not Yet Recruiting
26
Local Institution - 0266
Lee's Summit, Missouri, United States, 64064
Not Yet Recruiting
27
JDR Dermatology Research
Las Vegas, Nevada, United States, 89148
Actively Recruiting
28
Local Institution - 0281
Robbinsville, New Jersey, United States, 08691
Not Yet Recruiting
29
Local Institution - 0166
The Bronx, New York, United States, 10467
Not Yet Recruiting
30
Local Institution - 0234
Hickory, North Carolina, United States, 28602
Completed
31
Apex Clinical Research Center - Canton
Canton, Ohio, United States, 44716
Actively Recruiting
32
Local Institution - 0271
Columbus, Ohio, United States, 43228
Not Yet Recruiting
33
Local Institution - 0275
Lorain, Ohio, United States, 44053
Not Yet Recruiting
34
Apex Clinical Research Center
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
35
Paddington Testing Company
Philadelphia, Pennsylvania, United States, 19103
Actively Recruiting
36
ObjectiveHealth - Goodlettsville Dermatology Research
Goodlettsville, Tennessee, United States, 37072
Actively Recruiting
37
Local Institution - 0248
Nashville, Tennessee, United States, 37205
Completed
38
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Actively Recruiting
39
Local Institution - 0280
Southlake, Texas, United States, 76092
Not Yet Recruiting
40
Local Institution - 0045
Norfolk, Virginia, United States, 23502
Not Yet Recruiting
41
Frontier Derm Partners
Mill Creek, Washington, United States, 98012
Actively Recruiting
42
Local Institution - 0264
Spokane, Washington, United States, 99204
Not Yet Recruiting
43
Local Institution - 0115
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
Not Yet Recruiting
44
Local Institution - 0119
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DKG
Not Yet Recruiting
45
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
Actively Recruiting
46
Local Institution - 0149
Buenos Aires, Argentina, 1012
Not Yet Recruiting
47
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, 1181
Actively Recruiting
48
Hospital de Niños Dr. Ricardo Gutiérrez
Buenos Aires, Argentina, 1425
Actively Recruiting
49
Derma Internacional
Buenos Aires, Argentina, 1426
Actively Recruiting
50
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
Actively Recruiting
51
Local Institution - 0210
Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
Withdrawn
52
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
53
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium, 4000
Actively Recruiting
54
Local Institution - 0137
Salvador, Estado de Bahia, Brazil, 41820-020
Not Yet Recruiting
55
Local Institution - 0182
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Not Yet Recruiting
56
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
Actively Recruiting
57
Local Institution - 0140
Barretos, São Paulo, Brazil, 14784400
Not Yet Recruiting
58
Local Institution - 0163
Ribeirão Preto, São Paulo, Brazil, 14051-140
Not Yet Recruiting
59
Local Institution - 0170
São Paulo, Brazil, 05403-000
Not Yet Recruiting
60
Alberta Dermasurgery Centre
Edmonton, Alberta, Canada, T6G 1C3
Actively Recruiting
61
Local Institution - 0164
Winnipeg, Manitoba, Canada, R3C 0N2
Not Yet Recruiting
62
Skincare Studio
St. John's, Newfoundland and Labrador, Canada, A1E 1V4
Actively Recruiting
63
DermEffects
London, Ontario, Canada, N6H 5L5
Actively Recruiting
64
The Centre for Dermatology
Richmond Hill, Ontario, Canada, L4B 1A5
Actively Recruiting
65
AvantDerm
Toronto, Ontario, Canada, M5A 3R6
Actively Recruiting
66
Local Institution - 0240
Toronto, Ontario, Canada, M5G 1X8
Not Yet Recruiting
67
Local Institution - 0142
Montreal, Quebec, Canada, H3T 1C5
Not Yet Recruiting
68
Beijing Children's hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
69
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100091
Actively Recruiting
70
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China, 518053
Actively Recruiting
71
The Affiliated Hospital of Hebei University of Engineering
Handan, Hebei, China, 56029
Actively Recruiting
72
Local Institution - 0227
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
73
Hunan Children's Hospital
Changsha, Hunan, China, 410007
Actively Recruiting
74
Local Institution - 0265
Jinan, Shandong, China, 250022
Not Yet Recruiting
75
Local Institution - 0131
Shanghai, Shanghai Municipality, China, 200443
Not Yet Recruiting
76
Local Institution - 0228
Chengdu, Sichuan, China, 610091
Not Yet Recruiting
77
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
78
Local Institution - 0225
Medellín, Antioquia, Colombia, 050012
Not Yet Recruiting
79
Local Institution - 0124
Medellín, Antioquia, Colombia, 50021
Not Yet Recruiting
80
Local Institution - 0167
Barranquilla, Atlántico, Colombia, 080002
Not Yet Recruiting
81
Local Institution - 0125
Bogota, Cundinamarca, Colombia, 111 411
Not Yet Recruiting
82
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
83
BAG Drs. Med. Quist PartG
Mainz, Rhineland-Palatinate, Germany, 55128
Actively Recruiting
84
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, Germany, 10117
Actively Recruiting
85
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
86
Universitaetsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
87
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, Hungary, 6720
Actively Recruiting
88
Clinexpert Kft.
Budapest, Pest County, Hungary, 1033
Actively Recruiting
89
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Actively Recruiting
90
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Italy, 00168
Actively Recruiting
91
Local Institution - 0238
Zapopan, Jalisco, Mexico, 45190
Not Yet Recruiting
92
Local Institution - 0253
Mexico City, Mexico City, Mexico, 06720
Not Yet Recruiting
93
Local Institution - 0155
Monterrey, Nuevo León, Mexico, 64718
Not Yet Recruiting
94
Local Institution - 0259
Chihuahua City, Mexico, 31217
Not Yet Recruiting
95
Local Institution - 0257
Mérida, Mexico, 97070
Not Yet Recruiting
96
Local Institution - 0258
Toluca, Mexico, 50010
Not Yet Recruiting
97
Local Institution - 0096
Veracruz, Mexico, 91910
Not Yet Recruiting
98
Local Institution - 0177
Lublin, Lublin Voivodeship, Poland, 20-573
Withdrawn
99
FutureMeds - Targowek
Warsaw, Masovian Voivodeship, Poland, 03-291
Actively Recruiting
100
SPECDERM Poznanska sp.j.
Bialystok, Podlaskie Voivodeship, Poland, 15-375
Actively Recruiting
101
Local Institution - 0282
Gdansk, Pomeranian Voivodeship, Poland, 80-546
Not Yet Recruiting
102
"DERMED" Centrum Medyczne Sp. z o.o.
Lodz, Poland, 90-265
Actively Recruiting
103
ETYKA Osrodek Badan Klinicznych
Olsztyn, Poland, 10-117
Actively Recruiting
104
Klinika Ambroziak Dermatologia
Warsaw, Poland, 02-953
Actively Recruiting
105
Royalderm Agnieszka Nawrocka
Warsaw, Poland, 02-962
Actively Recruiting
106
Local Institution - 0254
Bayamón, Puerto Rico, 00960
Not Yet Recruiting
107
Local Institution - 0008
Caguas, Puerto Rico, 00725
Not Yet Recruiting
108
GCM Medical Group, PSC - Hato Rey Site
San Juan, Puerto Rico, 00917
Actively Recruiting
109
Local Institution - 0174
Bucharest, Bucharest, Romania, 020125
Withdrawn
110
Lotus-Med Tunari
Bucharest, Bucharest, Romania, 020528
Actively Recruiting
111
Local Institution - 0213
Bucharest, Bucharest, Romania, 30463
Withdrawn
112
Policlinica Providența
Iași, Romania, 700259
Actively Recruiting
113
Centrul de Medicina de Familie
Iași, Romania, 700556
Actively Recruiting
114
New Derm Clinical SRL
Timișoara, Romania, 300757
Actively Recruiting
115
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], Spain, 08950
Actively Recruiting
116
Local Institution - 0198
Barcelona, Catalunya [Cataluña], Spain, 08041
Not Yet Recruiting
117
Grupo Dermatológico y Estético Pedro Jaén S.A
Madrid, Spain, 28002
Actively Recruiting
118
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
119
CHUS - Hospital Clinico Universitario
Santiago de Compostela, Spain, 15706
Actively Recruiting
120
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
Actively Recruiting
121
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 81362
Actively Recruiting
122
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
123
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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