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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Specified dose on specified days
Specified dose on specified days
Time to first flare during the withdrawal period
Time frame: From week 16 up to week 42
Trough concentration at steady state (Cminss)
Time frame: At week 16
Time-averaged steady-state concentration (Cavgss)
Time frame: At week 16
Steady-state maximum observed concentration (Cmaxss)
Time frame: At week 16
Number of participants with flare during the withdrawal period
Time frame: From week 16 up to week 42
Number of participants achieving each of American College of Rheumatology (ACR) Pedi (30/50/70/90)
Time frame: At week 16 and week 42
Change from baseline in juvenile idiopathic arthritis-American College of Rheumatology (JIA-ACR) Pedi Core Criteria
Time frame: 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)
Time frame: At week 16 and week 42
Number of participants achieving inactive disease (JADAS71-CRP score ≤ 1)
Time frame: At week 16 and week 42
Number of participants attaining clinical remission for at least 6 consecutive months
Time frame: At week 42
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Local Institution - 0038
Lancaster, California, United States
NOT_YET_RECRUITINGLocal Institution - 0020
Chicago, Illinois, United States
NOT_YET_RECRUITINGLocal Institution - 0023
Indianapolis, Indiana, United States
NOT_YET_RECRUITINGLocal Institution - 0059
North New Hyde Park, New York, United States
NOT_YET_RECRUITINGLocal Institution - 0065
Cincinnati, Ohio, United States
NOT_YET_RECRUITINGLocal Institution - 0066
Cleveland, Ohio, United States
NOT_YET_RECRUITINGLocal Institution - 0036
Austin, Texas, United States
NOT_YET_RECRUITINGLocal Institution - 0068
Fortaleza, Ceará, Brazil
NOT_YET_RECRUITINGLocal Institution - 0032
Cuiabá, Mato Grosso, Brazil
WITHDRAWNLocal Institution - 0030
Belo Horizonte, Minas Gerais, Brazil
NOT_YET_RECRUITING...and 36 more locations
Number of participants achieving psoriasis area and severity index (PASI) 75
Time frame: 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"
Time frame: 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
Time frame: At week 16
Number of participants with adverse events (AEs)
Time frame: Up to week 42
Number of participants with adverse event of special interest (AESIs)
Time frame: Up to week 42
Number of participants with AEs leading to discontinuation
Time frame: Up to week 42
Number of participants with serious adverse events (SAEs)
Time frame: Up to week 42
Number of participants with Uveitis
Time frame: Up to week 42