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

Hangzhou Zhongmei Huadong Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: MC2-01 vehicle; Drug: MC2-01 cream; Drug: CAL/BDP Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT07357831

HDM3015-301

Details and patient eligibility

About

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.

Enrollment: 537 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. Aged ≥ 18 years at the time of signing the ICF, male or female.

3. 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.

4. 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.

5. 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

1. Be diagnosed with non-stable psoriasis or non-plaque psoriasis.
2. Presence of other inflammatory skin conditions in the treatment site that may confound the investigator's assessment of psoriasis.
3. Presence of significant pigmentary changes, scarring, sunburn, and other skin abnormalities in the treatment site that affect the assessment of psoriasis efficacy.
4. 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.
5. Known hypersensitivity to any component of the test product or control product.
6. 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).
7. Systemic treatment with biological therapies.
8. 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.
9. 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.
10. 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.
11. Clinical signs of skin infection with bacteria, viruses, or fungi
12. Known Human Immunodeficiency Virus (HIV) infection, or hepatitis B, or hepatitis C, or syphilis.
13. 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.
14. 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.
15. 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.
16. Women who are pregnant, lactating, or planning to become pregnant during the study.
17. Major surgery within 4 weeks before the baseline visit or planned major surgery during the study.
18. Active infection requiring the application of oral or intravenous antibiotics, antifungals, or antivirals within 7 days before the baseline visit.
19. Cancer within 5 years before the first dose of this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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537 participants in 3 patient groups

MC2-01 Cream

Experimental group

Description:

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

Treatment:

Drug: MC2-01 cream

MC2-01 Vehicle

Sham Comparator group

Description:

One application daily for 8 weeks.

Treatment:

Drug: MC2-01 vehicle

CAL/BDP Gel

Active Comparator group

Description:

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

Treatment:

Drug: CAL/BDP Gel