Actively Recruiting
A Phase 3 Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib in Children and Adolescents Aged 5 to Less Than 18 Years With Active Juvenile Psoriatic Arthritis
Led by Bristol-Myers Squibb · Updated on 2026-04-14
60
Participants Needed
47
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug Deucravacitinib (BMS-986165) in children and adolescents aged 5 to less than 18 years who have juvenile psoriatic arthritis (JPsA). This phase 3 study aims to understand the drug levels, effectiveness, and safety in treating active JPsA in this pediatric population. The trial is randomized, double-blind, and placebo-controlled to assess how well the medication works and monitor any side effects. Participants will be randomly assigned to receive either Deucravacitinib or a placebo at specified doses on certain days. The study includes a withdrawal period starting at week 16 and continuing up to week 42, during which the time to first disease flare will be closely tracked. Researchers will also measure various drug concentration levels and clinical responses at weeks 16 and 42. During the trial, participants will undergo regular assessments including joint evaluations, disease activity scores, and skin severity indexes. Safety will be monitored through reports of adverse events and specific concerns like eye inflammation (uveitis). Participants' ability to swallow and tolerate the medication will also be assessed. The total participation duration covers initial treatment and follow-up through at least week 42, enabling thorough evaluation of treatment effects and safety.
CONDITIONS
Brief Title
A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have been diagnosed with Juvenile Psoriatic Arthritis (JPsA).
- Participants must have at least three joints that are affected by arthritis.
- Participants must have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems.
You will not qualify if you...
- Participants must not have been diagnosed with JPsA before 5 years of age.
- Participants must not have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA.
- Participants must not have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months.
- 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.
1 visit (in-person)
Duration - 16 weeks
Participants receive specified doses of Deucravacitinib or placebo to evaluate efficacy and safety for Juvenile Psoriatic Arthritis.
Regular visits during treatment period
Duration - Up to 26 weeks after treatment (week 16 to week 42)
Participants are monitored for flare and safety outcomes after completing treatment.
Visits from week 16 up to week 42
Trial Site Locations
Total: 47 locations
1
Local Institution - 0038
Lancaster, California, United States, 93534
Withdrawn
2
Local Institution - 0020
Chicago, Illinois, United States, 60611
Withdrawn
3
Local Institution - 0023
Indianapolis, Indiana, United States, 46202
Withdrawn
4
Local Institution - 0059
North New Hyde Park, New York, United States, 11040
Withdrawn
5
Local Institution - 0065
Cincinnati, Ohio, United States, 45229
Withdrawn
6
Local Institution - 0066
Cleveland, Ohio, United States, 44109
Withdrawn
7
Local Institution - 0036
Austin, Texas, United States, 78723
Withdrawn
8
Local Institution - 0068
Fortaleza, Ceará, Brazil, 60140-025
Not Yet Recruiting
9
Local Institution - 0032
Cuiabá, Mato Grosso, Brazil, 78020-500
Withdrawn
10
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Actively Recruiting
11
Local Institution - 0013
Curitiba, Paraná, Brazil, 80250-060
Withdrawn
12
Local Institution - 0072
Curitiba, Paraná, Brazil, 80250-060
Not Yet Recruiting
13
Local Institution - 0007
Recife, Pernambuco, Brazil, 50670-420
Not Yet Recruiting
14
Local Institution - 0033
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Withdrawn
15
LMK Serviços Médicos S/S
Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
Actively Recruiting
16
Local Institution - 0069
Xangri-lá, Rio Grande do Sul, Brazil, 95588-000
Not Yet Recruiting
17
Local Institution - 0073
Vila Clementino, São Paulo-SP, Brazil, 04038-002
Not Yet Recruiting
18
Local Institution - 0027
Rio de Janeiro, Brazil, 21941-612
Not Yet Recruiting
19
Local Institution - 0047
São Paulo, Brazil, 01223-001
Not Yet Recruiting
20
Local Institution - 0010
São Paulo, Brazil, 04022-001
Withdrawn
21
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
Plovdiv, Bulgaria, 4002
Actively Recruiting
22
Local Institution - 0062
Sofia, Bulgaria, 1797
Not Yet Recruiting
23
Local Institution - 0074
Beijing, Beijing Municipality, China, 100020
Not Yet Recruiting
24
Local Institution - 0049
Beijing, Beijing Municipality, China, 100045
Not Yet Recruiting
25
The Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400065
Actively Recruiting
26
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
27
Childrens Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210008
Actively Recruiting
28
The First Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
29
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310057
Actively Recruiting
30
Children's Hospital of Fudan University
Shanghai, China, 201102
Actively Recruiting
31
Fakultni nemocnice Olomouc
Olomouc, Olomouc Region, Czechia, 779 00
Actively Recruiting
32
Fakultni nemocnice v Motole
Prague, Praha 5, Czechia, 150 06
Actively Recruiting
33
Kinderklinik des Uni-Klinikums Erlangen
Erlangen, Germany, 91054
Actively Recruiting
34
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
Hamburg, Germany, 22081
Actively Recruiting
35
University of Naples Federico II
Naples, Campania, Italy, 80131
Actively Recruiting
36
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, Tuscany, Italy, 50139
Actively Recruiting
37
Local Institution - 0017
San Juan, Puerto Rico, 00917
Withdrawn
38
Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca
Cluj-Napoca, Cluj, Romania, 400177
Actively Recruiting
39
Local Institution - 0048
Iași, Iaşi, Romania, 700135
Withdrawn
40
Sc Medaudio-Optica Srl
Râmnicu Vâlcea, Vâlcea County, Romania, 247065
Actively Recruiting
41
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
42
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain, 28034
Actively Recruiting
43
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
44
Istanbul Universitesi Cerrahpasa
Istanbul- Fatih, Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
45
Local Institution - 0061
Ankara, Turkey (Türkiye), 06170
Not Yet Recruiting
46
Local Institution - 0044
Ankara, Turkey (Türkiye), 06230
Not Yet Recruiting
47
Umraniye Training and Research Hospital
Istanbul, Turkey (Türkiye), 34766
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
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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