NCT06648772

Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study

A Multicenter, Randomized, Double-blind, Vehicle-controlled Phase 3 Clinical Study To Evaluate The Efficacy and Safety Of Roflumilast Cream 0.3% (Zoryve®) in the Treatment of Plaque Psoriasis In China

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 189 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center, randomized, double-blind, vehicle-controlled phase III study to evaluate the efficacy, safety, and PK profile of roflumilast cream 0.3% in Chinese subjects ≥6 years of age with plaque psoriasis.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Roflumilast Cream 0.3%	Roflumilast Cream 0.3%
DRUG	Vehicle cream	Vehicle cream

Timeline

• Start date: 2024-11-14
• Primary completion: 2025-06-28
• Completion: 2025-07-04
• First posted: 2024-10-18
• Last updated: 2025-05-16

Locations

31 sites across 1 country: China

Regulatory

• FDA-regulated drug study