A Phase III Trial To Evaluate The Efficacy And Safety Of MC2-01 Cream Compared To CAL/BDP Gel and… (NCT07357831) | Clinical Trial Compass
RecruitingPhase 3
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
China537 participantsStarted 2025-12-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
✕. 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.
What they're measuring
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
. 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.