A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis

NCT06611163 Phase 3 ACTIVE_NOT_RECRUITING

Phase 3 study to evaluate the efficacy and safety of subcutaneous tildrakizumab in subjects with moderate to severe genital psoriasis.

Details

Lead sponsor	Sun Pharmaceutical Industries Limited
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	206
Start date	2025-03-21
Completion	2027-02

Conditions

• Moderate to Severe Genital Psoriasis

Interventions

• Tildrakizumab 100 mg
• Placebo

Primary outcomes

• Proportion of subjects with a modified sPGA-G score of clear (0) or minimal (1) with at-least a 2- point reduction from baseline — Week 16
  sPGA-G scale is a 6-point numerical scale that ranges from 0 (clear) to 5 (very severe)

Countries

United States, Bulgaria, Georgia, Hungary, Poland