The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
366
Specified dose on specified days
Specified dose on specified days
Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
Time frame: At week 16
Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline
Time frame: At week 16
Number of participants achieving at least 90% improvement in PASI (PASI 90)
Time frame: At week 16
Change from baseline in PASI
Time frame: At week 16
Change from baseline in body surface area (BSA) involvement
Time frame: At week 16
Change from baseline in worst itch numeric rating scale (WI-NRS)
Time frame: At week 16
Number of participants achieving ≥ 4 improvement from baseline in the WI-NRS score (in participants with baseline score ≥ 4)
Time frame: At week 16
Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score
Time frame: At week 16
Number of participants achieving CDLQI 0/1 (among participants with a baseline CDLQI score ≥ 2)
Time frame: At week 16
Number of participants with treatment emergent adverse events
Time frame: Up to 5 years
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Local Institution - 0261
Birmingham, Alabama, United States
NOT_YET_RECRUITINGLocal Institution - 0041
Birmingham, Alabama, United States
NOT_YET_RECRUITINGLocal Institution - 0053
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITINGLocal Institution - 0025
Fountain Valley, California, United States
NOT_YET_RECRUITINGLocal Institution - 0090
Fremont, California, United States
NOT_YET_RECRUITINGDermatology Research Associates
Los Angeles, California, United States
RECRUITINGNorthridge Clinical Trials
Northridge, California, United States
RECRUITINGLocal Institution - 0077
Sacramento, California, United States
NOT_YET_RECRUITINGGolden State Dermatology - Walnut Creek - Ygnacio Valley Road
Walnut Creek, California, United States
RECRUITINGParadigm Clinical Research, LLC
Wheat Ridge, Colorado, United States
RECRUITING...and 104 more locations
Number of participants with serious adverse events
Time frame: Up to 5 years
Number of participants with clinically significant changes in laboratory parameters
Time frame: Up to 5 years
Number of participants with clinically significant changes in physical examinations
Time frame: Up to 5 years
Number of participants with clinically significant changes in vital signs
Time frame: Up to 5 years
Number of participants with protective titers of antibodies to measles
Time frame: At week 16
Number of participants with protective titers of antibodies to tetanus
Time frame: At week 16
Number of participants with protective titers of antibodies to pertussis
Time frame: At week 16
Body weight
Time frame: Up to 5 years
Height
Time frame: Up to 5 years
Sexual maturation
Time frame: Up to 5 years