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| Name | Class |
|---|---|
| MC2 Therapeutics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MC2-01 Cream | Experimental | MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks |
|
| MC2-01 Vehicle | Sham Comparator | One application daily for 8 weeks. |
|
| CAL/BDP Gel | Active Comparator | Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MC2-01 cream | Drug | MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment (PGA) success rate on the body (trunk and/or limbs) after 8 weeks of treatment with MC2-01 cream compared to vehicle and CAL/BDP gel in subjects with plaque psoriasis | Proportion of subjects who achieve PGA treatment success (defined as a score of 0 or 1 plus a minimum 2-point decrease in PGA score from baseline) on the body (trunk and/or limbs) compared to after 8 weeks of treatment Psoriasis treatment success rate is measured at week 8 by the use of a Physician Global Assessment (PGA) score. Success is defined as a decrease from Baseline of minimum 2 point on a scale from 0 - 4, where: 0 = Clear; 1 = Almost clear; 2 = Mild Plaque thickening; 3 = Moderate Plaque thickening, 4 = Severe Plaque thickening. | Baseline and 8-week |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in mPASI after 8 weeks of treatment | To evaluate the improvement in Modified Psoriasis Area and Severity Index (mPASI) after 8 weeks of treatment with MC2-01 cream compared to vehicle and CAL/BDP gel in subjects with plaque psoriasis. The extent and severity of the participant's psoriasis is assessed using a modified PASI scoring system (minus scalp, face, and flexures) at each 3 areas (arms, trunk and legs) using a scale from 0 - 6, where 0 = no psoriasis involvement and 6 = 90-100% involvement. |
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Inclusion Criteria:
Fully understand the objectives and requirements of this study, voluntarily participate in the clinical trial and sign the informed consent form (ICF), and be able to complete all visits as required by the protocol.
Aged ≥ 18 years at the time of signing the ICF, male or female.
Clinical diagnosis of plaque psoriasis with involvement of the body (trunk and/or limbs) before the first dose of this study, with a disease duration of ≥ 6 months and stable for the last 4 weeks.
Subjects are required to meet the following requirements at screening and baseline:
Female of childbearing potential (WOCBP) subjects with a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline. WOCBP and male subjects who have not received a vasectomy must agree to take at least one effective method of contraception, including oral/implantable/injectable/transdermal contraceptive, intrauterine device, bilateral tubal ligation or occlusion, vasectomy, and barrier contraception (used correctly and throughout sexual intercourse), from the first dose of the study drug through 3 months after the last dose of the study drug. If the subject is routinely abstinent, the subject may use this form of contraception, but should choose a reliable form of contraception as mentioned above when the subject is no longer abstinent. Male subjects must not donate sperm from the first dose of the study drug until 3 months after the last dose.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | China | |||
| Beijing Aerospace General Hospital |
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| MC2-01 vehicle | Drug | Vehicle Cream |
|
| CAL/BDP Gel | Drug | calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064% |
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| Baseline and 8-week |
| Assessment of Psoriasis Treatment Convenience Scale (PTCS) at week 8 of treatment | Subject assessment of treatment convenience using a Psoriasis Treatment Convenience Scale is defined as a sum of questions 1-5, where each question is scored on a scale from 1-10. How easy was the treatment to apply to the skin? "Very difficult" is 1 and "Very easy" is 10 How greasy was the treatment when applying it to the skin? "Very greasy" is 1 and "Not greasy" is 10 How moisturised did your skin feel after applying the treatment? "Not moisturized" is 1 and "Very moisturized" is 10 How greasy did your skin feel after applying the treatment? "Very greasy" is 1 and "Not greasy" is 10 How much did treating your skin disrupt your daily routine? "Very disturbing" is 1 and "Not disturbing" is 10. | 8-week |
| PGA success rate on the scalp psoriasis after 8 weeks of treatment with MC2-01 cream compared to vehicle and CAL/BDP gel in subjects with plaque psoriasis | Proportion of subjects with scalp psoriasis involved, PGA ≥2 and ≥0.3% body surface area (BSA) at baseline who achieve PGA treatment success on the scalp psoriasis after 8 weeks of treatment | Baseline and 8-week |
| Safety with MC2-01 cream in subjects with plaque psoriasis | Number of participants with adverse events and serious adverse events will be assessed. | 8-week |
| Incidence of local skin reactions | Number of subjects that experience an local skin reactions by investigator assessment and local skin reactions reported as adverse events will be assessed | 8 week |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Single measurements of 12-lead ECGs were obtained at Baseline to week 8, at any visit post-screen using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc). | 8 week |
| Number of Participants With Vital Signs of Potential Clinical Importance | Body Temperature, Respiration, Pulse, and Blood Pressure were collected from participants for evaluation of vital signs by Potential Clinical Importance Criteria from Baseline to Week 8, any visit post-screen. | 8 week |
| Beijing |
| Beijing Municipality |
| China |
| Bejjing Friendship Hospital,Capital Medical University | Beijing | Beijing Municipality | China |
| Chongqing Hospital of Traditional Chinese Medicine | Chongqing | Chongqing Municipality | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China |
| The Second Affiliated Hospital of Xiamen medical college | Xiamen | Fujian | China |
| Guangzhou First People's Hospital | Guangzhou | Guangdong | China |
| Southern Medical University Dermatology Hospital | Guangzhou | Guangdong | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| Sun Yat-sen University Third Affiliated Hospital | Guangzhou | Guangdong | China |
| Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Shenzhen Nanshan District People's Hospital | Shenzhen | Guangdong | China |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | China |
| The First Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | China |
| Haikou Fifth People's Hospital | Haikou | Hainan | China |
| Chengde Medical University Affiliated Hospital | Chengde | Hebei | China |
| First Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
| Henan University of Science and Technology Second Affiliated Hospital | Luoyang | Henan | China |
| Nanyang Central Hospital | Nanyang | Henan | China |
| Sanmenxia Central Hospital | Sanmenxia | Henan | China |
| Zhengzhou Central Hospital | Zhengzhou | Henan | China |
| Jingzhou Central Hospital | Jingzhou | Hubei | China |
| Shiyan Renmin Hospital | Shiyan | Hubei | China |
| Taihe Hospital | Shiyan | Hubei | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Hunan University of Medicine General Hospital | Huaihua | Hunan | China |
| Inner Mongolia Baogang Hospital | Baotou | Inner Mongolia | China |
| The First People's Hospital of Lianyungang | Lianyungang | Jiangsu | China |
| Suzhou Municipal Hospital | Suzhou | Jiangsu | China |
| Wuxi People's Hospital | Wuxi | Jiangsu | China |
| Wuxi Second People's Hospital | Wuxi | Jiangsu | China |
| The Affiliated Hospital Of Xuzhou Medical University | Xuzhou | Jiangsu | China |
| Yancheng NO.1 People's Hospital | Yancheng | Jiangsu | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| The First Affiliated Hospital of Gannan Medical University | Ganzhou | Jiangxi | China |
| The First Hospital of Jilin University | Changchun | Jilin | China |
| Shenyang Medical College Affiliated Central Hospital | Shenyang | Liaoning | China |
| Jinan Central Hospital | Jinan | Shandong | China |
| Jining NO.1 People's Hospital | Jining | Shandong | China |
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | China |
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | China |
| Taiyuan Central Hospital | Taiyuan | Shanxi | China |
| Chengdu Second People 's Hospital | Chengdu | Sichuan | China |
| Suining Central Hospital | Suining | Sichuan | China |
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | China |
| Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China |
| The First Hospital of Jiaxing | Jiaxing | Zhejiang | China |
| The First Affiliated Hospital of NingBo University | Ningbo | Zhejiang | China |