Juvenile Psoriatic Arthritis
Conditions
Keywords
Juvenile Psoriatic Arthritis (JPsA), Juvenile Idiopathic Arthritis (JIA), Pediatric PsA, Deucravacitinib, BMS-986165
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.
Interventions
DRUGDeucravacitinib
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first flare during the withdrawal period | From week 16 up to week 42 |
Secondary
| Measure | Time frame |
|---|---|
| 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 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) | Through week 16 and up to week 42 |
| Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1) | Through week 16 and up to 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 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 |
| Number of participants achieving each of juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) (30/50/70/90) | Through week 16 and up to week 42 |
| Change from baseline in juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) Core Criteria | Through week 16 and up to 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 JIA-ACR 30 | At week 16 |
Countries
Brazil, Bulgaria, China, Czechia, Germany, Italy, Puerto Rico, Romania, Spain, Turkey (Türkiye), United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed