Moderate to Severe Plaque Psoriasis
Conditions
Brief summary
PART A: Geometric mean observed average concentration at steady state (Cavg.ss), maximum observed plasma concentration at steady state (Cmax), and trough observed plasma concentration (Ctrough) for deucravacitinib., PART B: 1. Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75), PART B: 2. Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline, LTE Period: 1. AEs and SAEs, LTE Period: 2. Monitoring of growth including body weight and height and sexual maturation
Interventions
DRUGdeucravacitinib
DRUGDeucravacitinib 1 mg sachet
DRUGDeucravacitinib 2 mg sachet
DRUGDeucravacitinib 3 mg sachet
Sponsors
Bristol-Myers Squibb Services Unlimited Company
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PART A: Geometric mean observed average concentration at steady state (Cavg.ss), maximum observed plasma concentration at steady state (Cmax), and trough observed plasma concentration (Ctrough) for deucravacitinib., PART B: 1. Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75), PART B: 2. Proportion of subjects with an sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline, LTE Period: 1. AEs and SAEs, LTE Period: 2. Monitoring of growth including body weight and height and sexual maturation | — |
Countries
France, Germany, Poland, Romania, Spain
Outcome results
None listed