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
NCT07357831 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 537
Last updated 2026-01-27
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
Interventions
- 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%
Sponsors & Collaborators
-
MC2 Therapeutics
collaborator INDUSTRY -
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-26
- Primary Completion
- 2026-10-10
- Completion
- 2026-12-17
Countries
- China
Study Locations
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