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 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: HDM3015-301
• Study Type: interventional
• Target: 537
• Locations: 1 country
• Sites: 55

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Percent change from baseline in mPASI after 8 weeks of treatment

  Baseline and 8-week

• Assessment of Psoriasis Treatment Convenience Scale (PTCS) at week 8 of treatment

  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

  Baseline and 8-week

• Safety with MC2-01 cream in subjects with plaque psoriasis

  8-week

• Incidence of local skin reactions

  8 week

Study Arms (3)

MC2-01 Cream

EXPERIMENTAL

MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream. One application daily for 8 weeks

Drug: MC2-01 cream

MC2-01 Vehicle

SHAM COMPARATOR

One application daily for 8 weeks.

Drug: MC2-01 vehicle

CAL/BDP Gel

ACTIVE COMPARATOR

Calcipotriene/betamethasone (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%). One application daily for 8 weeks.

Drug: CAL/BDP Gel

Interventions

MC2-01 vehicle DRUG

Vehicle Cream

MC2-01 Vehicle

CAL/BDP Gel DRUG

calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%

CAL/BDP Gel

MC2-01 cream DRUG

MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream

MC2-01 Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• BSA of psoriatic involvement on body (trunk and/or limbs) ranging from 2% to 30%, with total BSA not exceeding 30% if scalp involvement is present;
• Body (trunk and/or limbs) PGA score of 2 or 3;
• mPASI score ≥3.
• 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.

You may not qualify if:

• Be diagnosed with non-stable psoriasis or non-plaque psoriasis.
• Presence of other inflammatory skin conditions in the treatment site that may confound the investigator's assessment of psoriasis.
• Presence of significant pigmentary changes, scarring, sunburn, and other skin abnormalities in the treatment site that affect the assessment of psoriasis efficacy.
• The treatment site is expected to be excessively exposed to natural/artificial light, tanning beds, or other LEDs within 4 weeks before the baseline visit and throughout the study.
• Known hypersensitivity to any component of the test product or control product.
• Current or prior hypercalcemia, vitamin D toxicity, severe renal insufficiency (Creatinine clearance \<30 mL/min using the Cockcroft-Gault formula), or severe hepatic impairment (according to Child-Pugh C classification).
• Systemic treatment with biological therapies.
• Use of systemic agents for the treatment of psoriasis or any other agents which may influence the efficacy assessment of psoriasis within 4 weeks before the baseline visit or planned use during the study.
• Use of psoralen plus ultraviolet A (PUVA) or ultraviolet B (UVB) phototherapy within 4 weeks before the first dose of this study or planned use during the study.
• Use of topical medications for the treatment of psoriasis or any other agents which may influence the efficacy assessment of psoriasis within 2 weeks before the baseline visit.
• Clinical signs of skin infection with bacteria, viruses, or fungi
• Known Human Immunodeficiency Virus (HIV) infection, or hepatitis B, or hepatitis C, or syphilis.
• Any chronic or acute medical condition that may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial.
• Planned initiation or change in the use of an existing treatment that, in the opinion of the investigator, can affect the assessment of psoriasis efficacy.
• Current participation in any other interventional clinical trial; or previous participation in a pharmaceutical clinical trial within 3 months or 5 half-lives (whichever is longer) or any other interventional clinical trial within 3 months prior to the first dose of this study.

Sponsors & Collaborators

• MC2 Therapeutics: collaborator
• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (55)

The Second Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

Beijing Aerospace General Hospital

Beijing, Beijing Municipality, China

Location

Bejjing Friendship Hospital，Capital Medical University

Beijing, Beijing Municipality, China

Location

Chongqing Hospital of Traditional Chinese Medicine

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

The Second Affiliated Hospital of Xiamen medical college

Xiamen, Fujian, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Location

Southern Medical University Dermatology Hospital

Guangzhou, Guangdong, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Sun Yat-sen University Third Affiliated Hospital

Guangzhou, Guangdong, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Shenzhen Nanshan District People's Hospital

Shenzhen, Guangdong, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Location

The First Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Location

Haikou Fifth People's Hospital

Haikou, Hainan, China

Location

Chengde Medical University Affiliated Hospital

Chengde, Hebei, China

Location

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Henan University of Science and Technology Second Affiliated Hospital

Luoyang, Henan, China

Location

Nanyang Central Hospital

Nanyang, Henan, China

Location

Sanmenxia Central Hospital

Sanmenxia, Henan, China

Location

Zhengzhou Central Hospital

Zhengzhou, Henan, China

Location

Jingzhou Central Hospital

Jingzhou, Hubei, China

Location

Shiyan Renmin Hospital

Shiyan, Hubei, China

Location

Taihe Hospital

Shiyan, Hubei, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Hunan University of Medicine General Hospital

Huaihua, Hunan, China

Location

Inner Mongolia Baogang Hospital

Baotou, Inner Mongolia, China

Location

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

Location

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Location

Wuxi People's Hospital

Wuxi, Jiangsu, China

Location

Wuxi Second People's Hospital

Wuxi, Jiangsu, China

Location

The Affiliated Hospital Of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Yancheng NO.1 People's Hospital

Yancheng, Jiangsu, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Location

The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Shenyang Medical College Affiliated Central Hospital

Shenyang, Liaoning, China

Location

Jinan Central Hospital

Jinan, Shandong, China

Location

Jining NO.1 People's Hospital

Jining, Shandong, China

Location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Location

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China

Location

Taiyuan Central Hospital

Taiyuan, Shanxi, China

Location

Chengdu Second People 's Hospital

Chengdu, Sichuan, China

Location

Suining Central Hospital

Suining, Sichuan, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Location

The First Affiliated Hospital of NingBo University

Ningbo, Zhejiang, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 22, 2026
• Study Start: December 26, 2025
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): December 17, 2026
• Last Updated: June 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (55)