NCT02557074已完成3 期
TREg Activation in the Treatment of the PELADE (Alopecia Areata). Double Blind Randomized Placebo Controlled Comparative Study Using Low Doses of IL2
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Score Salt
研究概览
简要总结
In a prospective pilot study the investigators showed that low doses of IL2 could be beneficial for severe AA inducing a long lasting regrowth in 4 out of the 5 patients treated.
The objective of this study is to compare the long term efficacy of low doses of IL2 versus placebo in a multicenter prospective randomized double blind study.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Of more than 18 years old,
- •Affiliated to the social security system,
- •Clinical diagnosis of alopecia areata,
- •50 % of the surface of the scalp affected
- •Last flaire started less than one year
- •Alopecia areata resisting to at least 1 systematic treatment including phototherapy (UVB or PUVA), general corticosteroid therapy or methotrexate
- •Signature of the informed consent
排除标准
- •Pregnancy or refusal of contraception at the women old enough to procreate,
- •Refusal of contraception at the men
- •Local treatment (dermocorticoïdes, minoxidil) or systematism (oral corticosteroid therapy, méthotrexate or the other immunosuppresseur) since less than 2 less,
- •Evolutionary autoimmune cancer or disease or in forgiveness
- •Excessive grip(taking) of alcohol (upper to 3 glasses of wine a day or one pre-lunch drink a day)
- •Seropositivity VHC, VHB, or HIV
- •Patient presenting a severe renal and/or hepatic insufficiency,
- •Presenting patient one zoned, the chicken pox, the herpes, the tuberculosis, an evolutionary infectious disease, a respiratory failure …
- •Vulnerable person (nobody under guardianship minor(miner), adults, deprived of freedom)
- •IC in the treatment(processing) by IL-2R
- •Presenting a contraindication to ProleukinR
研究组 & 干预措施
IL2 - Group A
Experimental
Patient will received IL2 low doses (1.5 to 3MUI/d) -
- IL2 1.5MUI/d SC from day 1 to day 5 for the first course of treatment
- IL2 3MUI/d SC from day 1 to day 5 for the 3 following courses
干预措施: IL2 (Drug)
Placebo - Group B
Placebo Comparator
NaCl 9% serum (placebo) NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment
干预措施: placebo (Drug)
结局指标
主要结局
Score Salt
时间窗: Once : at 12 months post-treatment
Success defined by a SALT score lower or equal to 25 at the end the study (12 months post-treatment). It will be calculated by 2 physicians blinded to the treatment received on standardized pictures.
次要结局
- Quality of life(at one day, 22 days, 43 days, 64 days, 251 days, 434 days)
- Adverse Event(at one day, 22 days, 43 days, 64 days, 251 days, 434 days)
- Satisfaction of patient(at 12 months post-treatment)
研究者
研究点 (6)
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