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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by Bristol-Myers Squibb
Sponsor
Bristol-Myers Squibb
Information Provided by (Responsible Party)
Bristol-Myers Squibb
Clinicaltrials.gov Identifier
NCT06869551
Other Study ID Numbers:
IM011-1071
First Submitted
March 5, 2025
First Posted
March 10, 2025
Last Update Posted
April 13, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Juvenile Psoriatic Arthritis
Drug: DeucravacitinibDrug: Deucravacitinib

Study Design

Study TypeInterventional
Actual Enrollment60 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateMarch 12, 2025
Actual Primary Completion Date3yrs 9mos from now
Actual Study Completion Date4yrs 9mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm A
Drug: Deucravacitinib
Specified dose on specified days
Arm B
Drug: Deucravacitinib
Specified dose on specified days

Outcome Measures

Primary Outcome Measures
  1. Time to first flare during the withdrawal period
Secondary Outcome Measures
  1. Trough concentration at steady state (Cminss)
  2. Time-averaged steady-state concentration (Cavgss)
  3. Steady-state maximum observed concentration (Cmaxss)
  4. Number of participants with flare during the withdrawal period
  5. Number of participants achieving each of American College of Rheumatology (ACR) Pedi (30/50/70/90)
  6. Change from baseline in juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) Pedi Core Criteria
  7. 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)
  8. Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1)
  9. Number of participants attaining clinical remission for at least 6 consecutive months
  10. Number of participants achieving psoriasis area and severity index (PASI) 75
  11. 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"
  12. Assessment of exposure-response (E-R) utilizing steady-state exposure of deucravacitinib from the pharmacokinetic (PK) analysis and efficacy results using ACR Pedi 30
  13. Number of participants with adverse events (AEs)
  14. Number of participants with adverse event of special interest (AESIs)
  15. Number of participants with AEs leading to discontinuation
  16. Number of participants with serious adverse events (SAEs)
  17. Number of participants with Uveitis

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion Criteria
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.
Exclusion Criteria
Inclusion Criteria
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. Exclusion Criteria
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.

Contacts and Locations

Sponsors and CollaboratorsBristol-Myers Squibb
Locations
Local Institution - 0038 | Lancaster California, United States, 93534Local Institution - 0020 | Chicago Illinois, United States, 60611Local Institution - 0023 | Indianapolis Indiana, United States, 46202Local Institution - 0059 | North New Hyde Park New York, United States, 11040Local Institution - 0065 | Cincinnati Ohio, United States, 45229Local Institution - 0066 | Cleveland Ohio, United States, 44109Local Institution - 0036 | Austin Texas, United States, 78723Local Institution - 0068 | Fortaleza Ceará, Brazil, 60140-025Local Institution - 0032 | Cuiabá Mato Grosso, Brazil, 78020-500Santa Casa de Misericordia de Belo Horizonte | Belo Horizonte Minas Gerais, Brazil, 30150-221Local Institution - 0013 | Curitiba Paraná, Brazil, 80250-060Local Institution - 0072 | Curitiba Paraná, Brazil, 80250-060Local Institution - 0007 | Recife Pernambuco, Brazil, 50670-420Local Institution - 0033 | Porto Alegre Rio Grande do Sul, Brazil, 90020-090LMK Serviços Médicos S/S | Porto Alegre Rio Grande do Sul, Brazil, 90480-000Local Institution - 0069 | Xangri-lá Rio Grande do Sul, Brazil, 95588-000Local Institution - 0073 | Vila Clementino São Paulo-SP, Brazil, 04038-002Local Institution - 0027 | Rio de Janeiro , Brazil, 21941-612Local Institution - 0047 | São Paulo , Brazil, 01223-001Local Institution - 0010 | São Paulo , Brazil, 04022-001University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD | Plovdiv , Bulgaria, 4002Local Institution - 0062 | Sofia , Bulgaria, 1797Local Institution - 0074 | Beijing Beijing Municipality, China, 100020Local Institution - 0049 | Beijing Beijing Municipality, China, 100045The Children's Hospital of Chongqing Medical University | Chongqing Chongqing Municipality, China, 400065Guangzhou Women and Children's Medical Center | Guangzhou Guangdong, China, 510000Childrens Hospital of Nanjing Medical University | Nanjing Jiangsu, China, 210008The First Hospital of Jilin University | Changchun Jilin, China, 130000The Children's Hospital of Zhejiang University School of Medicine | Hangzhou Zhejiang, China, 310057Children's Hospital of Fudan University | Shanghai , China, 201102Fakultni nemocnice Olomouc | Olomouc Olomouc Region, Czechia, 779 00Fakultni nemocnice v Motole | Prague Praha 5, Czechia, 150 06Kinderklinik des Uni-Klinikums Erlangen | Erlangen , Germany, 91054Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari | Hamburg , Germany, 22081University of Naples Federico II | Naples Campania, Italy, 80131Azienda Ospedaliera Universitaria Meyer IRCCS | Florence Tuscany, Italy, 50139Local Institution - 0017 | San Juan , Puerto Rico, 00917Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca | Cluj-Napoca Cluj, Romania, 400177Local Institution - 0048 | Iași Iaşi, Romania, 700135Sc Medaudio-Optica Srl | Râmnicu Vâlcea Vâlcea County, Romania, 247065Hospital Universitari Vall d'Hebron | Barcelona Barcelona [Barcelona], Spain, 08035Hospital Universitario Ramón y Cajal | Madrid Madrid, Comunidad de, Spain, 28034Hospital Universitari i Politecnic La Fe | Valencia , Spain, 46026Istanbul Universitesi Cerrahpasa | Istanbul- Fatih Istanbul, Turkey (Türkiye), 34098Local Institution - 0061 | Ankara , Turkey (Türkiye), 06170Local Institution - 0044 | Ankara , Turkey (Türkiye), 06230Umraniye Training and Research Hospital | Istanbul , Turkey (Türkiye), 34766
Investigators
Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb