Moderate to Severe Genital Psoriasis
Conditions
Brief summary
Tildrakizimab vs placebo at week 16: Proportion of subjects with a modified sPGA-G score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline
Detailed description
Proportion of subjects, with a baseline score of ≥4, who achieve at-least 4-point improvement in weekly average of GPI- NRS, Mean change from baseline in the affected BSA, Change from baseline in GPSS total score and individual items scores, Proportion of subjects with PASI 75 response (≥ 75% reduction from baseline in PASI score), Proportion of subjects with PASI 90 response (≥ 90% reduction from baseline in PASI score), Proportion of subjects with PASI 100 response (100% reduction from baseline in PASI score), insubjects with BSA <10%
Interventions
DRUGTILDRAKIZUMAB
DRUGTildrakizumab Placebo Solution for Injection
Sponsors
Sun Pharmaceutical Industries Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tildrakizimab vs placebo at week 16: Proportion of subjects with a modified sPGA-G score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects, with a baseline score of ≥4, who achieve at-least 4-point improvement in weekly average of GPI- NRS, Mean change from baseline in the affected BSA, Change from baseline in GPSS total score and individual items scores, Proportion of subjects with PASI 75 response (≥ 75% reduction from baseline in PASI score), Proportion of subjects with PASI 90 response (≥ 90% reduction from baseline in PASI score), Proportion of subjects with PASI 100 response (100% reduction from baseline in PASI score), insubjects with BSA <10% | — |
Countries
Bulgaria, Hungary, Poland
Outcome results
None listed