EUCTR2018-001970-66-CZ进行中（未招募）1 期
A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects with Mild-to-Moderate Psoriasis Vulgaris
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 490
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Have provided written informed consent.
- •2. Generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening;
- •3. Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration that involves the body (trunk and/or limbs) that is amenable to topical treatment with a maximum of 15 g of trial medication per day.
- •4. Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs);
- •5. Have an mPASI score of at least 3;
- •6. Have a treatment area involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%;
- •7. Female subjects must be of either:
- •Non-childbearing potential, i.e., post-menopausal for at least 1 year or have a confirmed clinical history of sterility (e.g., hysterectomy or tubal ligation) or,
- •Childbearing potential with a negative urine pregnancy test prior to initiation of trial treatment, to rule out pregnancy.
- •8. Female subjects of childbearing potential must have a negative urine pregnancy test result at Screening, and if sexually active they must agree to use a highly effective method of contraception (i.e. a method with a failure rate of less than 1% per year when used consistently and correctly) for one month prior to Visit 1 and until the follow-up visit has been performed. Highly effective contraception is defined as follows:
- •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- •o intravaginal
- •o transdermal
- •progestogen-only hormonal contraception associated with inhibition of ovulation:
- •o injectable
- •o implantable
- •intrauterine device (IUD)
- •intrauterine hormone-releasing system (IUS)
- •bilateral tubal occlusion
- •vasectomised partner (provided that is the sole sexual partner of the subject and that the vasectomised partner has received medical assessment of the surgical success.)
- •sexual abstinence (if in line with the preferred and usual lifestyle of the subject and defined as refraining from heterosexual intercourse during the entire period of the trial. Periodic methods of abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not accepted methods of contraception.)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 416
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Current diagnosis of unstable forms of psoriasis, including guttate, erythrodermic or pustular psoriasis;
- •2. Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tinea corporis);
- •3. Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas, which could interfere with the rating of efficacy parameters;
- •4. Planned excessive or prolonged exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc;
- •5. History of hypersensitivity to any component of the test product or reference product;
- •6. Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders;
- •7. Females who are pregnant, breast feeding, or planning a pregnancy;
- •8. Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1/Baseline and during the trial:
- •Etanercept – within 4 weeks prior to Visit 1/Baseline,
- •Adalimumab, Alefacept, Infliximab – within 8 weeks prior to Visit 1/Baseline,
- •Ustekinumab – within 16 weeks prior to Visit 1/Baseline,
- •Other products – within 4 weeks/5 half-lives prior to Visit 1/Baseline (whichever was longer).
- •In general, patients who are candidates for biological or other systemic therapy are excluded from the trial.
- •9. Use of systemic treatments that suppress the immune system (fumaric acid, methotrexate, retinoids, PDE4 inhibitors, corticosteroids (excluding inhaled, nasal, auricular or ocular corticosteroids), ciclosporin (cyclosporine), and other systemic chemotherapeutic antineoplastic therapy) within 4 weeks prior to Visit 1/Baseline and during the trial;
- •10. Use of phototherapy (psoralen + ultraviolet A radiation [PUVA] and ultraviolet B radiation [UVB]) within 4 weeks prior to Visit 1/Baseline and during the trial;
- •11. Use of topical treatments (e.g., corticosteroids (Class 1, 2 and 3), vitamin D analogs, retinoids, PDE4 inhibitors, salicylic acid, pimecrolimus, tacrolimus, anthralin, tar), except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to Visit 1/Baseline. Glucocorticoids Class 4 (e.g. clobetasol propionate) are prohibited within 4 weeks prior to Visit 1/baseline. Subjects using glucocorticoids Class 4 may have their treatment switched to glucocorticoids Class 1-3. However, the treatment must be stopped at least 2 weeks prior to Visit 1/Baseline (refer to Appendix 3 Classification of Topical Corticosteroids).
- •12. Presence of infections in the treatment area (e.g. skin infection with bacteria (including tuberculosis), viruses, parasites or fungi) or skin manifestations of atrophic skin, atrophic striae, skin vein fragility, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers and wound in the treatment area
- •13. Known Human Immunodeficiency Virus (HIV) infection
- •14. Have any chronic or acute medical condition that, in the opinion of the investigator, may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial;
- •15. Require the use of any concomitant medication that, in the investigator’s opinion, has the potential to cause an adverse effect when given with the investigational product (IP) or will interfere with the interpretation of the trial results;
- •16. Initia
研究者
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