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Juvenile Psoriatic ArthritisPhase 3NCT06869551

A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis

A Phase 3 study testing Deucravacitinib in people with Juvenile Psoriatic Arthritis, run by Bristol-Myers Squibb at 48 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

The purpose of this study is to evaluate the drug levels, efficacy, and safety of Deucravacitinib (BMS-986165) in pediatric participants with juvenile psoriatic arthritis. Read more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Juvenile Psoriatic Arthritis
What is being tested?
Deucravacitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
48 sitesin 11 countries
Study dates
13 Mar 2025to 4 Mar 2031
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

48 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

48 sites in 11 countries

Brazil13 sites, 9 recruiting

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

    Filipe Maciel, Site 0030, +5531984545405

    Recruiting

  • Local Institution - 0032

    Cuiabá, Mato Grosso, 78020-500

    Withdrawn

  • Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância

    Curitiba, Paraná, 80250-060

    Marcia Bandeira, Site 0072, 4133101356

    Recruiting

  • Local Institution - 0013

    Curitiba, Paraná, 80250-060

    Withdrawn

  • Centro de Oncologia Leonardo Da Vinci - ATO Terapias

    Fortaleza, Ceará, 60140-025

    Miria Cavalcante, Site 0068, +558532240552

    Recruiting

  • Local Institution - 0033

    Porto Alegre, Rio Grande do Sul, 90020-090

    Withdrawn

  • LMK Serviços Médicos S/S

    Porto Alegre, Rio Grande do Sul, 90480-000

    maria Picarelli, Site 0008, 5551999897478

    Recruiting

  • Hospital Das Clinicas Ufpe

    Recife, Pernambuco, 50670-420

    André Cavalcanti, Site 0007, +5581999983400

    Recruiting

  • Local Institution - 0027

    Rio de Janeiro, 21941-612

    Site 0027

    Not yet recruiting

  • Santa Casa Instituto de Pesquisa

    São Paulo, 01223-001

    Maria dos Santos, Site 0047, 11996588290

    Recruiting

  • Local Institution - 0010

    São Paulo, 04022-001

    Withdrawn

  • PSEG- Pesquisa Clínica

    Vila Clementino, São Paulo-SP, 04038-002

    Maria Victoria Suarez Restrepo, Site 0073, 11974912009

    Recruiting

  • Hospital Lifeplus Litoral Norte

    Xangri-lá, Rio Grande do Sul, 95588-000

    Penelope Esther Palominos, Site 0069

    Recruiting

Other trials in Brazil

China8 sites, 8 recruiting

  • Local Institution - 0074

    Beijing, Beijing Municipality, 100020

    Site 0074

    Not yet recruiting

  • Local Institution - 0049

    Beijing, Beijing Municipality, 100045

    Site 0049

    Not yet recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

    sirui yang, Site 0053, 13500889222

    Recruiting

  • The Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400065

    Xuemei Tang, Site 0056, 13012352441

    Recruiting

  • Guangzhou Women and Children's Medical Center

    Guangzhou, Guangdong, 510000

    Ping Zeng, Site 0060, +8613160897678

    Recruiting

  • The Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310057

    Meiping Lu, Site 0051, 13685773988

    Recruiting

  • Childrens Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210008

    Haiguo Yu, Site 0052, 111111

    Recruiting

  • Children's Hospital of Fudan University

    Shanghai, 201102

    Li Sun, Site 0050, 862164931122

    Recruiting

Other trials in China

United States7 sites

  • Local Institution - 0036

    Austin, Texas, 78723

    Withdrawn

  • Local Institution - 0020

    Chicago, Illinois, 60611

    Withdrawn

  • Local Institution - 0065

    Cincinnati, Ohio, 45229

    Withdrawn

  • Local Institution - 0066

    Cleveland, Ohio, 44109

    Withdrawn

  • Local Institution - 0023

    Indianapolis, Indiana, 46202

    Withdrawn

  • Local Institution - 0038

    Lancaster, California, 93534

    Withdrawn

  • Local Institution - 0059

    North New Hyde Park, New York, 11040

    Withdrawn

Other trials in United States

Turkey (Türkiye)4 sites, 4 recruiting

  • Local Institution - 0061

    Ankara, 06170

    Site 0061

    Not yet recruiting

  • Local Institution - 0044

    Ankara, 06230

    Site 0044

    Not yet recruiting

  • Umraniye Training and Research Hospital

    Istanbul, 34766

    Betul Sozeri, Site 0045, +905327629003

    Recruiting

  • Istanbul Universitesi Cerrahpasa

    Istanbul- Fatih, Istanbul, 34098

    Ozgur Kasapcopur, Site 0043, +905322129111

    Recruiting

Other trials in Turkey (Türkiye)

Bulgaria3 sites, 2 recruiting

  • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

    Plovdiv, 4002

    Krastina Stefanova-Kelly, Site 0054, +359876324578

    Recruiting

  • Medical Center for Specialized Medical Care of Cardiovascular Diseases

    Sofia, 1309

    Stefan Stefanov, Site 0077

    Recruiting

  • Local Institution - 0062

    Sofia, 1797

    Withdrawn

Other trials in Bulgaria

Romania3 sites, 2 recruiting

  • Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca

    Cluj-Napoca, Cluj, 400177

    Mihaela Sparchez, Site 0067, +40723400453

    Recruiting

  • Local Institution - 0048

    Iași, Iaşi, 700135

    Withdrawn

  • Sc Medaudio-Optica Srl

    Râmnicu Vâlcea, Vâlcea County, 247065

    RAZVAN IONITESCU, Site 0040, 0040722557297

    Recruiting

Other trials in Romania

Spain3 sites, 3 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

    Mireia Corbeto, Site 0046, 667517630

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

    Alina Lucica Boteanu, Site 0041, +34913368571

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    LUCIA LACRUZ PEREZ, Site 0042, +34961244792

    Recruiting

Other trials in Spain

Czechia2 sites, 2 recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, Olomouc Region, 779 00

    Katerina Bouchalova, Site 0003, +420602668887

    Recruiting

  • Fakultni nemocnice v Motole

    Prague, Praha 5, 150 06

    Rudolf Horvath, Site 0002, 420727812317

    Recruiting

Other trials in Czechia

Germany2 sites, 2 recruiting

  • Kinderklinik des Uni-Klinikums Erlangen

    Erlangen, 91054

    Tobias Krickau, Site 0063, 091318533118

    Recruiting

  • Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

    Hamburg, 22081

    Ivan Foeldvari, Site 0026, 00494020923698

    Recruiting

Other trials in Germany

Italy2 sites, 2 recruiting

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    Florence, Tuscany, 50139

    Gabriele Simonini, Site 0004, +393297973141

    Recruiting

  • University of Naples Federico II

    Naples, Campania, 80131

    Roberta Naddei, Site 0005, 00393272022085

    Recruiting

Other trials in Italy

Puerto Rico1 site

  • Local Institution - 0017

    San Juan, 00917

    Withdrawn

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Children and Adolescents From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis

The purpose of this study is to evaluate the drug levels, efficacy, and safety of Deucravacitinib (BMS-986165) in pediatric participants with juvenile psoriatic arthritis.

Being tested
Deucravacitinib, Placebo
Keywords
Juvenile Psoriatic Arthritis (JPsA), Juvenile Idiopathic Arthritis (JIA), Pediatric PsA, Deucravacitinib, BMS-986165
Medical subject headings
Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DeucravacitinibDrug

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT06869551
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Drug: Deucravacitinib
Arm BPlacebo comparatorNot described
Receives: Drug: Deucravacitinib; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first flare during the withdrawal period

    Measured: From week 16 up to week 42

Secondary outcomes (17)

  1. Trough concentration at steady state (Cminss)

    Measured: At week 16

  2. Time-averaged steady-state concentration (Cavgss)

    Measured: At week 16

  3. Steady-state maximum observed concentration (Cmaxss)

    Measured: At week 16

  4. Number of participants with flare during the withdrawal period

    Measured: From week 16 up to week 42

  5. Number of participants achieving low disease activity (Juvenile arthritis disease activity 71-joint score based on C-reactive protein (JADAS71-CRP) score: for oligoarthritis 1.1 to 2; for polyarthritis 1.1 to 3.8)

    Measured: Through week 16 and up to week 42

  6. Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1)

    Measured: Through week 16 and up to week 42

  7. Number of participants attaining clinical remission for at least 6 consecutive months

    Measured: At week 42

  8. Number of participants achieving psoriasis area and severity index (PASI) 75

    Measured: At week 42

  9. Number of participants with adverse events (AEs)

    Measured: Up to week 42

  10. Number of participants with adverse event of special interest (AESIs)

    Measured: Up to week 42

  11. Number of participants with AEs leading to discontinuation

    Measured: Up to week 42

  12. Number of participants with serious adverse events (SAEs)

    Measured: Up to week 42

  13. Number of participants with Uveitis

    Measured: Up to week 42

  14. Number of participants achieving each of juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) (30/50/70/90)

    Measured: Through week 16 and up to week 42

  15. Change from baseline in juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) Core Criteria

    Measured: Through week 16 and up to week 42

  16. Number of participants for each assessment who evaluate palatability scale as ≥ 3 (good or better), swallowability scale as ≤ 4 (neutral or easier), and taste scales (Sweetness, Bitterness, Flavor, and Overall Taste) as "None" or "Weak"

    Measured: At week 16

  17. Assessment of exposure-response (E-R) utilizing steady-state exposure of deucravacitinib from the pharmacokinetic (PK) analysis and efficacy results using JIA-ACR 30

    Measured: At week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start13 Mar 2025
  3. Primary completion6 Mar 2030 (estimated)
  4. Study completion4 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06869551
Sponsor's protocol ID
IM011-1071
Other IDs
2024-517262-41, U1111-1311-9059
Status last verified
Oct 2026
First submitted
6 Mar 2025
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

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