A Multicenter, Randomized, Double-blind, Vehicle-controlled Phase 3 Clinical Study To Evaluate The Efficacy and Safety Of Roflumilast Cream 0.3% (Zoryve®) in the Treatment of Plaque Psoriasis In China
This study is a multi-center, randomized, double-blind, vehicle-controlled phase III study to evaluate the efficacy, safety, and PK profile of roflumilast cream 0.3% in Chinese subjects ≥6 years of age with plaque psoriasis.
• 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 ≥ 6 years at the time of signing the ICF, male or female.
• Clinical diagnosis of plaque psoriasis before the first dose in this study, with a disease duration of ≥ 6 months (for those aged ≥ 12 years) or ≥ 3 months (for those aged 6-11 years) and stable for the last 4 weeks.
• Patients are required to meet the following requirements at screening and baseline:
‣ Psoriasis involving 2%-20% BSA (excluding the scalp, palms, and soles);
⁃ IGA score of ≥ 2 points;
⁃ PASI score of ≥ 2 points (excluding the scalp, palms, and soles).
• Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline. FOCBP must agree to take at least one reliable form of birth control, including oral/implantable/injectable/transdermal contraceptive, intrauterine device, bilateral tubal ligation/occlusion, partner's vasectomy, and barrier contraception (used correctly throughout sexual intercourse), from 4 weeks before the first dose of the IMP until 2 months after the last dose. 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 if the subject is no longer abstinent. Male subjects will be required to have no plans to have children, no plans to donate sperm, and agree to use highly effective contraception. from the first dose of the investigational medicinal product until 4 months after the last dose.
• Note: FOCBP are defined as female subjects who have experienced menarche, have not reached a postmenopausal state (amenorrhea for at least 12 consecutive months, with no clear cause other than menopause and confirmd by FSH), and have no surgical (i.e., bilateral oophorectomy and/or bilateral salpingectomy and/or hysterectomy) or investigator-determined causes of permanent infertility (e.g., mullerian agenesis, etc.).
• Subjects were assessed by the investigator to be free of other medical conditions that would interfere with the assessment of safety and efficacy based on medical history, physical examination, routine blood, blood biochemistry, urine, and other laboratory tests.