Plaque Psoriasis
Conditions
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.
Interventions
DRUGMC2-01 cream
MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
DRUGMC2-01 vehicle
Vehicle Cream
DRUGCAL/BDP Gel
calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
MC2 Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 8-week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in mPASI after 8 weeks of treatment | Baseline and 8-week | 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. |
| Assessment of Psoriasis Treatment Convenience Scale (PTCS) at week 8 of treatment | 8-week | 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. |
| 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 | 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 |
| Safety with MC2-01 cream in subjects with plaque psoriasis | 8-week | Number of participants with adverse events and serious adverse events will be assessed. |
| Incidence of local skin reactions | 8 week | Number of subjects that experience an local skin reactions by investigator assessment and local skin reactions reported as adverse events will be assessed |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | 8 week | 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). |
| Number of Participants With Vital Signs of Potential Clinical Importance | 8 week | 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. |
Countries
China
Contacts
CONTACTHuadong Medicine
Outcome results
None listed