NCT07357831

A Phase III Trial To Evaluate The Efficacy And Safety Of MC2-01 Cream Compared To CAL/BDP Gel and Vehicle In Plaque Psoriasis Subjects

A Randomized, Multicenter, Investigator-Blind Phase III Trial To Evaluate The Efficacy And Safety Of MC2-01 Cream Compared To CAL/BDP Gel and Vehicle In Chinese Subjects With Plaque Psoriasis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 537 (estimated)
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, investigator-blinded, calcipotriol and betamethasone dipropionate gel and vehicle-controlled phase 3 clinical study to evaluate the efficacy and safety of MC2-01 cream in the treatment of Chinese plaque psoriasis to assess the efficacy and safety of MC2-01 cream in Chinese subjects aged ≥ 18 years with plaque psoriasis. This study includes a screening period, a treatment period, and a safety follow-up period.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	MC2-01 cream	MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
DRUG	MC2-01 vehicle	Vehicle Cream
DRUG	CAL/BDP Gel	calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%

Timeline

• Start date: 2025-12-26
• Primary completion: 2026-10-10
• Completion: 2026-12-17
• First posted: 2026-01-22
• Last updated: 2026-01-27

Locations

55 sites across 1 country: China