Moderate to Severe Plaque Psoriasis
Conditions
Brief summary
Static Physician’s Global Assessment (sPGA) 0/1 response: Assessed as proportion of subjects achieving an sPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline at Week 16., Psoriasis Area and Severity Index (PASI)-75 response: Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16.
Detailed description
PASI Response: Proportion of subjects achieving PASI-75 (versus apremilast), PASI-90, or PASI-100 at Week 16 or Week 24., Enhanced sPGA response: Proportion of subjects achieving an sPGA of clear (0) at Week 16, Changes in severity of psoriasis on the scalp, nail, body surface area, hands and feet using ssPGA, NAPSI, BSA, and PGA of the hands and/or feet
Interventions
Sponsors
Takeda Development Center Americas Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Static Physician’s Global Assessment (sPGA) 0/1 response: Assessed as proportion of subjects achieving an sPGA of clear (0) or almost clear (1) with a ≥2-point decrease from baseline at Week 16., Psoriasis Area and Severity Index (PASI)-75 response: Assessed as proportion of subjects achieving ≥75% improvement from baseline in PASI score at Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| PASI Response: Proportion of subjects achieving PASI-75 (versus apremilast), PASI-90, or PASI-100 at Week 16 or Week 24., Enhanced sPGA response: Proportion of subjects achieving an sPGA of clear (0) at Week 16, Changes in severity of psoriasis on the scalp, nail, body surface area, hands and feet using ssPGA, NAPSI, BSA, and PGA of the hands and/or feet | — |
Countries
Germany, Italy, Poland
Outcome results
None listed