An Exploratory Study to Evaluate the Safety and Efficacy of Secukinumab in the Treatment of Extensive Alopecia Areata
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50
研究概览
简要总结
Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can fall out on the scalp or elsewhere on the face and body.
Alopecia areata is an autoimmune skin disease, which means that the immune system is recognizing the hair follicles as foreign and attacking them, causing round patches of hair loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss (alopecia universalis). The scalp is the most commonly affected area, but the beard or any hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs in males and females of all ages, and is a highly unpredictable condition that tends to recur. Alopecia areata can cause significant distress to both patients and their families.
Aim: To assess the effects of a new treatment called secukinumab in patients with alopecia areata. A total of 30 patients will be included in the study, which will run for a total of 28 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject at least 18 years of age
- •If female, the subject is not pregnant or nursing
- •Subject is able to provide written informed consent and comply with the requirements of this study protocol.
- •Subjects who are women of childbearing potential must have a negative urine pregnancy test at screening and must be practicing an adequate, medically acceptable method of birth control for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Acceptable methods of birth control include intrauterine device (IUD); oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence and barrier methods with spermicide. Otherwise, if not of childbearing potential, subjects must: have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.
- •Subject with AA (unequivocal cases of AA), affecting at least 60% of the scalp, and present for at least 6 months.
- •Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) negative at the time of screening, or if patient has a history of positive PPD or QuantiFERON, he/she has completed the appropriate prophylaxis.
- •Subject is judged to be in good general health as determined by the principal investigator based upon the results of medical history, laboratory profile, and physical examination.
排除标准
- •Other concomitant types of alopecia (androgenetic, female pattern, traction, scarring and others)
- •Any subject who is pregnant or refuses to practice an acceptable method of birth control (as stated in inclusion criterion # 4)
- •History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at screening. Subjects with a positive or indeterminate PPD or QFT test may participate in the study if a full tuberculosis work up (according to local practice/guidelines) is completed within 12 weeks prior to randomization and establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated at least for 4 weeks prior to randomization and the course of prophylaxis is planned to be completed.
- •Active Crohn's disease
- •Known hypersensitivity to latex
- •Subjects with a history of HIV, or history of positive HCV or HBV
- •Previous exposure to Secukinumab or other drug targeting IL-17A or its receptor; use of sensitizing therapy for alopecia areata including DPCP, squaric acid, DNCB within 1 month; PUVA, or any form of phototherapy within 1 month; use of any immunosuppressive therapies (systemic corticosteroids, methotrexate, azathioprine, mycophenolate mofetil, cyclosporine) within 1 month; or use of topical therapies (two weeks). All the above therapies will not be allowed during this study.
研究组 & 干预措施
Secukinumab
300 mg subcutaneous injections
干预措施: Secukinumab (Drug)
Placebo
matching placebo subcutaneous injections
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50
时间窗: Week 24
Number of subjects achieving a Severity of Alopecia Tool (SALT) score of 50 at Week 24
次要结局
- Number of Subjects Achieving a SALT Score of 90 at Week 24(week 24)
- Number of Subjects With Dermatology Life Quality Index (DLQI) of 3 or Above(Week 24)
- Number of Subjects Achieving a SALT Score of 90 at Week 28(week 28)
- Number of Subjects Acheiving Physician's Global Assessment (PGA) Score of 3 or Above(Week 24)
研究者
Mark Lebwohl
Professor and System Chair, Dermatology
Icahn School of Medicine at Mount Sinai