Actively Recruiting
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
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2026-01-27
537
Participants Needed
55
Research Sites
9 weeks
Total Duration
On this page
Sponsors
H
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Lead Sponsor
M
MC2 Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of MC2-01 cream for treating plaque psoriasis in Chinese adults aged 18 years and older. This phase 3, multi-center, randomized, and investigator-blinded study compares MC2-01 cream to CAL/BDP gel and a vehicle cream in participants with stable plaque psoriasis affecting the body and/or scalp. The study includes a screening period, treatment period, and safety follow-up to assess outcomes carefully. Participants will apply one of the study treatments—MC2-01 cream, MC2-01 vehicle cream, or CAL/BDP gel—once daily for 8 weeks. Each treatment contains calcipotriene and betamethasone dipropionate in specified concentrations, except the vehicle cream which does not contain active ingredients. The study treatment is delivered topically to areas affected by plaque psoriasis, primarily on the trunk, limbs, and scalp. Throughout the study, participants will attend visits to evaluate their psoriasis using tools like the Physician's Global Assessment (PGA) and modified Psoriasis Area and Severity Index (mPASI). Other assessments include safety monitoring through skin reactions, vital signs, and ECGs. Researchers will also gather information on treatment convenience and perform follow-up safety checks after treatment ends. Total involvement includes screening, 8 weeks of treatment, and additional safety follow-up to monitor participant well-being.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and agree to participate voluntarily, and able to complete all study visits
- Aged 18 years or older, male or female
- Clinically diagnosed plaque psoriasis on the body (trunk and/or limbs) with disease duration of at least 6 months, stable for the last 4 weeks
- Body surface area (BSA) affected by psoriasis from 2% to 30% on trunk and/or limbs, total BSA not exceeding 30% if scalp is involved
- Physician's Global Assessment (PGA) score of 2 or 3 on trunk and/or limbs
- Modified Psoriasis Area and Severity Index (mPASI) score of 3 or higher
- Women of childbearing potential must have negative pregnancy tests and agree to use effective contraception during and 3 months after treatment; men must agree to contraception and avoid sperm donation during this time
You will not qualify if you...
- Diagnosed with non-stable or non-plaque psoriasis
- Other inflammatory skin conditions in treatment area that may affect psoriasis assessment
- Significant pigment changes, scarring, sunburn, or other skin abnormalities in treatment area
- Treatment area exposed to natural/artificial light or tanning devices within 4 weeks before baseline or during study
- Known allergy to any component of study or control products
- History of hypercalcemia, vitamin D toxicity, severe kidney or liver impairment
- Use of biological systemic treatments or other systemic agents affecting psoriasis within 4 weeks before baseline or planned during study
- Use of PUVA or UVB phototherapy within 4 weeks before first dose or planned during study
- Use of topical psoriasis treatments within 2 weeks before baseline
- Clinical signs of skin infection
- Known HIV, hepatitis B or C, or syphilis infection
- Any medical condition posing safety risks or interfering with study assessments
- Planned changes in treatments affecting psoriasis during study
- Participation in other interventional trials within 3 months or 5 half-lives prior to study
- Pregnant, breastfeeding, or planning pregnancy during study
- Major surgery within 4 weeks before baseline or planned during study
- Active infections requiring systemic antibiotics, antifungals, or antivirals within 7 days before baseline
- Cancer diagnosed within 5 years before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants apply MC2-01 cream, CAL/BDP gel, or vehicle cream once daily to affected areas for plaque psoriasis.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 55 locations
1
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Actively Recruiting
2
Beijing Aerospace General Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Bejjing Friendship Hospital，Capital Medical University
Beijing, Beijing Municipality, China
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4
Chongqing Hospital of Traditional Chinese Medicine
Chongqing, Chongqing Municipality, China
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5
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
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6
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
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7
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
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8
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
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9
The Second Affiliated Hospital of Xiamen medical college
Xiamen, Fujian, China
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10
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
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11
Southern Medical University Dermatology Hospital
Guangzhou, Guangdong, China
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12
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
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13
Sun Yat-sen University Third Affiliated Hospital
Guangzhou, Guangdong, China
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14
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
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15
Shenzhen Nanshan District People's Hospital
Shenzhen, Guangdong, China
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16
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
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17
The First Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
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18
Haikou Fifth People's Hospital
Haikou, Hainan, China
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19
Chengde Medical University Affiliated Hospital
Chengde, Hebei, China
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20
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
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21
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
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22
Henan University of Science and Technology Second Affiliated Hospital
Luoyang, Henan, China
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23
Nanyang Central Hospital
Nanyang, Henan, China
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24
Sanmenxia Central Hospital
Sanmenxia, Henan, China
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25
Zhengzhou Central Hospital
Zhengzhou, Henan, China
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26
Jingzhou Central Hospital
Jingzhou, Hubei, China
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27
Shiyan Renmin Hospital
Shiyan, Hubei, China
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28
Taihe Hospital
Shiyan, Hubei, China
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29
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
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30
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
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31
Xiangya Hospital of Central South University
Changsha, Hunan, China
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32
Hunan University of Medicine General Hospital
Huaihua, Hunan, China
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33
Inner Mongolia Baogang Hospital
Baotou, Inner Mongolia, China
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34
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
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35
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
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36
Wuxi People's Hospital
Wuxi, Jiangsu, China
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37
Wuxi Second People's Hospital
Wuxi, Jiangsu, China
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38
The Affiliated Hospital Of Xuzhou Medical University
Xuzhou, Jiangsu, China
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39
Yancheng NO.1 People's Hospital
Yancheng, Jiangsu, China
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40
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
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41
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
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42
The First Hospital of Jilin University
Changchun, Jilin, China
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43
Shenyang Medical College Affiliated Central Hospital
Shenyang, Liaoning, China
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44
Jinan Central Hospital
Jinan, Shandong, China
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45
Jining NO.1 People's Hospital
Jining, Shandong, China
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46
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
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47
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
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48
Taiyuan Central Hospital
Taiyuan, Shanxi, China
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49
Chengdu Second People 's Hospital
Chengdu, Sichuan, China
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50
Suining Central Hospital
Suining, Sichuan, China
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51
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
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52
Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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53
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
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54
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Actively Recruiting
55
The First Affiliated Hospital of NingBo University
Ningbo, Zhejiang, China
Actively Recruiting
Research Team
H
Huadong Medicine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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