ACTRN12618001084279招募中不适用
A randomised, double-blind, placebo-controlled study to evaluate the efficacy of cyclosporin in subjects with moderate to severe alopecia areata with roll-over extension phase to evaluate efficacy of tofacitinib
Sinclair Dermatology0 个研究点目标入组 38 人开始时间: 2018年6月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
- •1.Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •2.Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •3.Male or female subjects between 18 to 65 years of age, inclusive, at time of informed consent.
- •4.Female subjects (except those at least 2 years post-menopausal or surgically sterile) with a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline.
- •5.Male subjects able to father children and female subjects of childbearing potential must agree to the use of highly effective contraception (methods which result in low failure rate, i.e. less than 1% per year, when used consistently and correctly) throughout the study and until 30 days after the last dose of assigned treatment.
- •6.Must meet the following alopecia areata criteria:
- •a.Have a clinical diagnosis of moderate to severe alopecia areata (at least 50% hair loss of the scalp without evidence of hair regrowth within 6 months) at the screening and baseline visits;
- •b.Current episode of hair loss at most 7 years.
排除标准
- •Subjects with any of the following characteristics/conditions will not be included in the study:
- •1.Other acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •2.Subjects have other types of alopecia (including but not limited to traction, scarring, androgenetic alopecia).
- •3.Currently have active forms of other inflammatory skin diseases or evidence of skin conditions (e.g. psoriasis, seborrheic dermatitis, lupus) at the time of Screening or Day 1 that in the opinion of the investigator would interfere with evaluation of AA or response to treatment.
- •4.Have received any of the following treatment regimens specified in the timeframes outlined below:
- •a.Within 6 months of first dose of study drug:
- •i.Any cell-depleting agents including but not limited to rituximab: within 6 months of first dose of study drug, or 5 half-lives (if known), or until lymphocyte count returns to normal, whichever is longer.
- •b.Within 12 weeks of first dose of study drug:
- •i.Cyclosporin
- •ii.Biologics: within 8 weeks of first dose of study drug or within 5 half-lives (if known), whichever is longer.
- •c.Within 8 weeks of first dose of study drug:
- •i.Systemic treatments that could affect AA within 8 weeks of first dose of study drug or within 5 half-lives (if known), whichever is longer.
- •ii.Use of oral immune suppressants (e.g. azathioprine, methotrexate, systemic corticosteroids, mycophenolate-mofetil) within 8 weeks of first dose of study drug or within 5 half-lives (if known), whichever is longer.
- •iii.Intralesional steroid injection within 8 weeks of first dose of study drug or within 5 half-lives (if known), whichever is longer.
- •iv.Participation in other studies involving investigational drug(s) within 8 weeks of first dose of study drug or within 5 half-lives (if known), whichever is longer.
- •d.Within 6 weeks of first dose of study drug:
- •i.Have been vaccinated with live or attenuated live vaccine.
- •e.Within 4 weeks of first dose of study drug:
- •i.Ultra-Violet B (UVB) phototherapy and/or Psoralen Ultra-Violet A therapy.
- •f.Within 2 weeks of first dose of study drug:
- •i.Topical treatments that could affect AA (e.g. steroid cream, medicated shampoo, herbal hair care that could affect AA).
- •5.Female subjects of childbearing potential and fertile male subjects who are unwilling or unable to use highly effective contraception as outlined in this protocol for the duration of the study and for at least 30 days after the last dose of investigational product.
- •6.Pregnant or breastfeeding female subjects
- •7.Have current or recent history of clinically significant severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, psychiatric, immunologic/rheumatologic or neurologic disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; or in the opinion of the investigator, the subject is inappropriate for entry into this study, or unwilling/unable to comply with study procedures.
- •8.Have a history of
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