NCT06611163

A Study to Evaluate the Efficacy and Safety of Subcutaneous Tildrakizumab in Subjects With Moderate to Severe Genital Psoriasis.

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Moderate to Severe Genital Psoriasis

Interventions

Type	Name	Description
DRUG	Tildrakizumab 100 mg	Tildrakizumab 100 mg SC injection on Day 1, Week 4 and every 12 weeks thereafter
DRUG	Placebo	Placebo SC injection at Day 1 and Week 4

Timeline

• Start date: 2025-03-21
• Primary completion: 2026-01-21
• Completion: 2027-02-01
• First posted: 2024-09-24
• Last updated: 2026-03-25

Locations

56 sites across 5 countries: United States, Bulgaria, Georgia, Hungary, Poland

Regulatory

• FDA-regulated drug study