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

Phase 3

Recruiting

• Conditions: Juvenile Psoriatic Arthritis
• Interventions: Drug: Deucravacitinib; Other: Placebo

• Registration Number: NCT06869551
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-06
• Study First Posted: 2025-03-11
• Study Start: 2025-03-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-09
• Primary Completion: 2030-03-06
• Study Completion: 2031-03-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Deucravacitinib	-
Arm B	Deucravacitinib	-
Arm B	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time to first flare during the withdrawal period	From week 16 up to week 42

Secondary Outcome Measures

Name	Time	Method
Trough concentration at steady state (Cminss)	At week 16
Time-averaged steady-state concentration (Cavgss)	At week 16
Steady-state maximum observed concentration (Cmaxss)	At week 16
Number of participants with flare during the withdrawal period	From week 16 up to week 42
Number of participants achieving each of American College of Rheumatology (ACR) Pedi (30/50/70/90)	At week 16 and week 42
Change from baseline in juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) Pedi Core Criteria	At week 16 and week 42
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)	At week 16 and week 42
Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1)	At week 16 and week 42
Number of participants attaining clinical remission for at least 6 consecutive months	At week 42
Number of participants achieving psoriasis area and severity index (PASI) 75	At week 42
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"	At week 16
Assessment of exposure-response (E-R) utilizing steady-state exposure of deucravacitinib from the pharmacokinetic (PK) analysis and efficacy results using ACR Pedi 30	At week 16
Number of participants with adverse events (AEs)	Up to week 42
Number of participants with adverse event of special interest (AESIs)	Up to week 42
Number of participants with AEs leading to discontinuation	Up to week 42
Number of participants with serious adverse events (SAEs)	Up to week 42
Number of participants with Uveitis	Up to week 42

Trial Locations

Locations (37)

Fakultni nemocnice Olomouc; 🇨🇿 Olomouc, Olomoucký Kraj, Czechia

Local Institution - 0038; 🇺🇸 Lancaster, California, United States

Local Institution - 0020; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0023; 🇺🇸 Indianapolis, Indiana, United States

Local Institution - 0036; 🇺🇸 Austin, Texas, United States

Local Institution - 0032; 🇧🇷 Cuiabá, Mato Grosso, Brazil

Local Institution - 0030; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Local Institution - 0007; 🇧🇷 Recife, Pernambuco, Brazil

Local Institution - 0033; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Local Institution - 0008; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Local Institution - 0027; 🇧🇷 Rio de Janeiro, Brazil

Local Institution - 0047; 🇧🇷 São Paulo, Brazil

Local Institution - 0010; 🇧🇷 São Paulo, Brazil

University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD; 🇧🇬 Plovdiv, Bulgaria

Local Institution - 0062; 🇧🇬 Sofia, Bulgaria

Local Institution - 0049; 🇨🇳 Beijing, Beijing, China

Local Institution - 0060; 🇨🇳 Guangzhou, Guangdong, China

Local Institution - 0052; 🇨🇳 Nanjing, Jiangsu, China

Local Institution - 0053; 🇨🇳 Changchun, Jilin, China

Local Institution - 0050; 🇨🇳 Shanghai, Shanghai, China

Local Institution - 0051; 🇨🇳 Hangzhou, Zhejiang, China

Fakultni nemocnice v Motole; 🇨🇿 Praha, Praha 5, Czechia

Local Institution - 0063; 🇩🇪 Erlangen, Bayern, Germany

Local Institution - 0026; 🇩🇪 Hamburg, Germany

Local Institution - 0025; 🇩🇪 Hannover, Germany

Local Institution - 0005; 🇮🇹 Napoli, Campania, Italy

Azienda Ospedaliera Universitaria Meyer IRCCS; 🇮🇹 Firenze, Toscana, Italy

Local Institution - 0067; 🇷🇴 Cluj-Napoca, Cluj, Romania

Local Institution - 0048; 🇷🇴 Iasi, Iași, Romania

Sc Medaudio-Optica Srl; 🇷🇴 Râmnicu Vâlcea, Vâlcea, Romania

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Barcelona [Barcelona], Spain

Local Institution - 0041; 🇪🇸 Madrid, Madrid, Comunidad De, Spain

Hospital Universitari i Politecnic La Fe; 🇪🇸 València, Spain

Local Institution - 0043; 🇹🇷 Istanbul- Fatih, İstanbul, Turkey

Local Institution - 0061; 🇹🇷 Ankara, Turkey

Local Institution - 0044; 🇹🇷 Ankara, Turkey

Local Institution - 0045; 🇹🇷 Istanbul, Turkey