Clinical trial NCT06869551: A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Juvenile Psoriatic Arthritis
Keywords: Juvenile Psoriatic Arthritis (JPsA)
Juvenile Idiopathic Arthritis (JIA)
Pediatric PsA
Deucravacitinib
BMS-986165
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Time to first flare during the withdrawal period
timeFrame: From week 16 up to week 42
Secondary outcomes:
measure: Trough concentration at steady state (Cminss)
timeFrame: At week 16
measure: Time-averaged steady-state concentration (Cavgss)
timeFrame: At week 16
measure: Steady-state maximum observed concentration (Cmaxss)
timeFrame: At week 16
measure: Number of participants with flare during the withdrawal period
timeFrame: From week 16 up to week 42
measure: Number of participants achieving each of American College of Rheumatology (ACR) Pedi (30/50/70/90)
timeFrame: At week 16 and week 42
measure: Change from baseline in juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) Pedi Core Criteria
timeFrame: At week 16 and week 42
measure: 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)
timeFrame: At week 16 and week 42
measure: Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1)
timeFrame: At week 16 and week 42
measure: Number of participants attaining clinical remission for at least 6 consecutive months
timeFrame: At week 42
measure: Number of participants achieving psoriasis area and severity index (PASI) 75
timeFrame: At week 42
measure: 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"
timeFrame: At week 16
measure: Assessment of exposure-response (E-R) utilizing steady-state exposure of deucravacitinib from the pharmacokinetic (PK) analysis and efficacy results using ACR Pedi 30
timeFrame: At week 16
measure: Number of participants with adverse events (AEs)
timeFrame: Up to week 42
measure: Number of participants with adverse event of special interest (AESIs)
timeFrame: Up to week 42
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to week 42
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to week 42
measure: Number of participants with Uveitis
timeFrame: Up to week 42
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Local Institution - 0038
state: California
city: Chicago
country: United States
facility: Local Institution - 0020
state: Illinois
city: Indianapolis
country: United States
facility: Local Institution - 0023
state: Indiana
city: N. New Hyde Park
country: United States
facility: Local Institution - 0059
state: New York
city: Cincinnati
country: United States
facility: Local Institution - 0065
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 0066
state: Ohio
city: Austin
country: United States
facility: Local Institution - 0036
state: Texas
city: Cuiabá
country: Brazil
facility: Local Institution - 0032
state: Mato Grosso
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0030
state: Minas Gerais
city: Recife
country: Brazil
facility: Local Institution - 0007
state: Pernambuco
city: Porto Alegre
country: Brazil
facility: Local Institution - 0033
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution - 0008
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0027
city: São Paulo
country: Brazil
facility: Local Institution - 0047
city: São Paulo
country: Brazil
facility: Local Institution - 0010
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
city: Sofia
country: Bulgaria
facility: Local Institution - 0062
city: Beijing
country: China
facility: Local Institution - 0049
state: Beijing
city: Chongqing
country: China
facility: Local Institution - 0056
state: Chongqing
city: Guangzhou
country: China
facility: Local Institution - 0060
state: Guangdong
city: Nanjing
country: China
facility: Local Institution - 0052
state: Jiangsu
city: Changchun
country: China
facility: Local Institution - 0053
state: Jilin
city: Shanghai
country: China
facility: Local Institution - 0050
state: Shanghai
city: Hangzhou
country: China
facility: Local Institution - 0051
state: Zhejiang
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
state: Olomoucký Kraj
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole
state: Praha 5
city: Erlangen
country: Germany
facility: Kinderklinik des Uni-Klinikums Erlangen
city: Hamburg
country: Germany
facility: Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
city: Hannover
country: Germany
facility: Local Institution - 0025
city: Napoli
country: Italy
facility: University of Naples Federico II
state: Campania
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Meyer IRCCS
state: Toscana
city: San Juan
country: Puerto Rico
facility: Local Institution - 0017
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii Cluj-Napoca
state: Cluj
city: Iasi
country: Romania
facility: Local Institution - 0048
state: Iași
city: Râmnicu Vâlcea
country: Romania
facility: Sc Medaudio-Optica Srl
state: Vâlcea
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad De
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Istanbul- Fatih
country: Turkey
facility: Local Institution - 0043
state: İstanbul
city: Ankara
country: Turkey
facility: Local Institution - 0061
city: Ankara
country: Turkey
facility: Local Institution - 0044
city: Istanbul
country: Turkey
facility: Local Institution - 0045
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: