Actively Recruiting
A Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate Pharmacokinetics, Efficacy, and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
Led by Bristol-Myers Squibb · Updated on 2025-09-25
153
Participants Needed
63
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug levels, efficacy, and safety of Deucravacitinib in children aged 4 to less than 18 years with moderate to severe plaque psoriasis. The study includes two age groups: children 12 to less than 18 years (Cohort 1) and children 4 to less than 12 years (Cohort 2). The purpose is to understand how the drug works in these age groups and to assess its safety and effectiveness. A long-term extension lasting up to 5 years will observe the ongoing safety and tolerability in participants who complete the initial study phases. The study has two parts for each cohort. Part A focuses on measuring drug levels to select two dose levels to test further. Part B then compares the safety and effectiveness of these two doses in the pediatric participants. Participants may receive Deucravacitinib at a standard dose, a half-standard dose, or a placebo. The long-term extension period follows participants who finish Parts A or B to monitor long-term effects and safety. During the study, participants will have regular assessments including psoriasis severity scores such as the Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (sPGA). Safety is monitored through adverse event tracking, laboratory tests, and growth measurements like body weight, height, and sexual maturation stages. These evaluations occur up to 316 weeks, ensuring thorough observation of treatment impact and participant health over time.
CONDITIONS
Brief Title
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 12 to less than 18 years for Cohort 1
- Males and females aged 4 to less than 12 years for Cohort 2
- Diagnosis of plaque psoriasis for at least 6 months
- Moderate to severe plaque psoriasis
- Candidate for phototherapy or systemic therapy
- Completion of Week 52 treatment period in Part A or B for long-term extension period
You will not qualify if you...
- Participants weighing 30.0 kg or less at screening for Cohort 1 (age 12 to less than 18 years), Part A and Part B
- Participants weighing 18.0 kg or less at screening for Cohort 2 (age 4 to less than 12 years), Part A and Part B
- Presence of other forms of psoriasis
- History of recent infection
- Prior exposure to deucravacitinib (BMS-986165) or active comparator
- Evidence of active tuberculosis for long-term extension period
- Other protocol-defined inclusion or 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.
1 visit (in-person)
Duration - 16 weeks
Participants receive specified doses of the study drug or placebo according to their assigned group to evaluate the drug levels, efficacy, and safety.
Regular visits during the 16-week treatment period
Duration - Up to 316 weeks
Participants are monitored for safety, growth, and long-term treatment effects after the treatment period ends.
Periodic visits for safety and growth assessments
Trial Site Locations
Total: 63 locations
1
Instituto de Neumonologia Y Dermatologia
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
Actively Recruiting
2
Psoriahue
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DKG
Actively Recruiting
3
CONEXA Investigacion Clinica S.A.
Buenos Aires, Argentina, 1012
Actively Recruiting
4
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina, C1056ABI
Actively Recruiting
5
Hospital Italiano de Buenos Aires
CABA, Argentina, 1199
Actively Recruiting
6
Consultora Integral de Salud
Córdoba, Argentina, 5004
Actively Recruiting
7
The Skin Hospital
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
8
Local Institution - 0002
Westmead, New South Wales, Australia, 2145
Withdrawn
9
Queensland Children's Hospital
Brisbane, Queensland, Australia, 4101
Actively Recruiting
10
Veracity Clinical Research
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
11
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
12
Local Institution - 0001
Melbourne, Victoria, Australia, 3995
Completed
13
Centro de Pesquisas da Clínica IBIS
Salvador, Estado de Bahia, Brazil, 41820-020
Actively Recruiting
14
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90560032
Actively Recruiting
15
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP
Ribeirão Preto, São Paulo, Brazil, 14051-140
Actively Recruiting
16
Local Institution - 0083
Rio de Janeiro, Brazil, 22470-220
Not Yet Recruiting
17
Local Institution - 0067
São Paulo, Brazil, 05403-000
Withdrawn
18
Local Institution - 0010
Calgary, Alberta, Canada, T2J 7E1
Completed
19
Alberta Dermasurgery Centre
Edmonton, Alberta, Canada, T6G 1C3
Actively Recruiting
20
Local Institution - 0039
Hamilton, Ontario, Canada, L8N 1Y2
Withdrawn
21
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1X3
Actively Recruiting
22
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
23
Centre Hospitalier de Calais
Calais, France, 62107
Actively Recruiting
24
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology
Dijon, France, 21000
Actively Recruiting
25
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, France, 06202
Actively Recruiting
26
Local Institution - 0021
Paris, France, 75019
Completed
27
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
28
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
29
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
30
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, Germany, 10117
Actively Recruiting
31
Kath. Kinderkrankenhaus Wilhelmstift
Hamburg, Germany, 22149
Actively Recruiting
32
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
33
Fukuoka University Hospital
Fukuoka, Jonan-Ku, Fukuoka, Japan, 814-0180
Actively Recruiting
34
Local Institution - 0040
Isehara, Kanagawa, Japan, 259-1193
Withdrawn
35
Mie University Hospital
Tsu, Mie-ken, Japan, 514-8507
Actively Recruiting
36
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan, 173-8606
Actively Recruiting
37
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 160-0023
Actively Recruiting
38
Nippon Life Hospital
Osaka, Japan, 550-0006
Actively Recruiting
39
Crea de Guadalajara
Guadalajara, Jalisco, Mexico, 44600
Actively Recruiting
40
Grupo Clínico CATEI S.C.
Guadalajara, Jalisco, Mexico, 44638
Actively Recruiting
41
RM Pharma Specialists
Mexico City, Mexico City, Mexico, 03100
Actively Recruiting
42
Arké SMO S.A de C.V
Veracruz, Mexico, 91910
Actively Recruiting
43
Local Institution - 0011
Krakow, Poland, 30-438
Completed
44
Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Poland, 90-436
Actively Recruiting
45
Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii
Warsaw, Poland, 02-507
Actively Recruiting
46
WroMedica
Wroclaw, Poland, 51-620
Actively Recruiting
47
Local Institution - 0080
Bucharest, Bucharest, Romania, 012292
Withdrawn
48
Local Institution - 0081
Bucharest, Bucharest, Romania, 020125
Withdrawn
49
Local Institution - 0088
Bucharest, Bucharest, Romania, 020762
Withdrawn
50
CCBR Clinical Research
Bucharest, Bucharest, Romania, 30463
Actively Recruiting
51
Lotus-Med Tunari
Bucharest, Romania, 020528
Actively Recruiting
52
Spitalul clinic de urgenta pentru copii Sf. Maria
Iași, Romania, 700309
Actively Recruiting
53
Spitalul Clinic Judetean Mures
Târgu Mureş, Romania, 540342
Actively Recruiting
54
Local Institution - 0048
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 02447
Completed
55
Local Institution - 0047
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
Completed
56
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06591
Actively Recruiting
57
Hospital General Universitario de Alicante-Dermatology
Alicante, Spain, 03010
Actively Recruiting
58
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces-Dermatology
Barakaldo, Spain, 48903
Actively Recruiting
59
Hospital Sant Joan de Déu-URC Dermatology
Esplugues de Llobregat, Spain, 08950
Actively Recruiting
60
Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología
Las Palmas de GC, Spain, 35019
Actively Recruiting
61
Hospital Universitario 12 de Octubre-DERMATOLOGY
Madrid, Spain, 28041
Actively Recruiting
62
Hospital Universitario La Paz-UCICEC/DERMA
Madrid, Spain, 28046
Actively Recruiting
63
Mounts Bay Medical
Connor Downs, United Kingdom, TR27 5DT
Actively Recruiting
Research Team
B
BMS Study Connect Contact Center www.BMSStudyConnect.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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