NCT05496426终止2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Trial Evaluating the Safety and Efficacy of KL130008 Capsule in Patients With Severe Alopecia Areata
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 24 ]
研究概览
简要总结
The purpose of this study is to assess KL130008 is safe and effective in adults with severe alopecia areata
详细描述
This is a multi-center Phase 2 study to evaluate the safety and effectiveness of an investigational drug in adults (≥18 years and ≤65 years) who have 50% or greater scalp hair loss, including alopecia totalis (AT) and alopecia universalis (AU).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with the age of ≥18 and ≤ 65 years old at the time of informed consent.
- •Able to understand the procedures and methods of this study, and will to provide a signed and dated informed consent form.
- •Diagnosed alopecia areata(AA) without other reasons caused alopecia.
- •Have severe AA, as determined by all of the following:Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, including alopecia totalis (AT) and alopecia universalis (AU);No spontaneous improvement over the past 6 months;Current episode of severe AA of less than 8 years.
- •All women of childbearing potential and all men must be willing to use at least one highly effective method of contraception from the signing of informed consent, throughout the duration of the study, and for 3 months after the last dose of investigational drugs.
排除标准
- •1. Known history of anaphylaxis to any of the ingredients and/or other similar products.
- •2. Participated in a clinical trial of any drug or medical device and has used an investigational product (including placebo and control group) or treatment within 1 month or 5 half-lives before randomization.
- •3. Previously treated with JAK inhibitors.
- •4. Corticosteroids, finasteride, minoxidil,topical immunotherapy treated within 8 weeks before randomization.
- •5. Diphenylcyclopropenone (DPCP), HMGCoA reductase inhibitor, Chinese herbal medicine treated within 4 weeks before randomization.
- •6. With other diseases: acute "diffuse" type of AA, lymphoproliferative disease, tumor, severe chronic gastrointestinal disease, thyroid disorders, serious cardiovascular disease.
- •7. Subjects with evidence of clinical laboratory abnormalities at screening that, in the opinion of the investigator, may affect the safety of subjects or the interpretation of study results: Hemoglobin level \< 10.0 g/dL. Absolute white blood cell (WBC) count /absolute neutrophil count (NEUT)/absolute lymphocyte count(LYMPH)\ 2 × ULN, total bilirubin(TBIL)\>1.5 × ULN. QTcF\> 450ms. Subjects with eGFR ≤ 60 mL/min based on Cockcroft-Gault calculation.
- •8. The subject had or currently has a severe infection, and had a severe infection judged by the investigator within 1 month before randomization: HBV, TP-Ab, HIV, HCV, TB positive.
- •9. Subjects who are unsuitable to the trial, as identified by the investigator.
研究组 & 干预措施
KL130008 capsule Low Dose
Experimental
KL130008 capsule administered orally
干预措施: KL130008/Placebo (Drug)
KL130008 capsule High Dose
Experimental
KL130008 capsule administered orally
干预措施: KL130008/Placebo (Drug)
KL130008 capsule Middle Dose
Experimental
KL130008 capsule administered orally
干预措施: KL130008/Placebo (Drug)
Placebo
Placebo Comparator
Placebo administered orally
干预措施: KL130008/Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 24 ]
时间窗: Week 24
Percentage of Participants Achieving SALT ≤ 20
次要结局
- Percentage of Participants Achieving 75% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ](Week 24, 36)
- Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 10 [ Time Frame: Week 24, 36 ](Week 24, 36)
- Measure for Eyebrow (EB) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline [ Time Frame: Week 24, 36 ](Week 24, 36)
- Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 [ Time Frame: Week 36 ](Week 36)
- Percent Change from Baseline in SALT score [ Time Frame: Baseline, Week 24, 36 ](Week 24, 36)
- Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50) [ Time Frame: Week 24, 36 ](Week 24, 36)
- Measure for Eyelash (EL) Hair Loss 0 or 1 with ≥2-point Improvement from Baseline(Week 24, 36)
研究者
研究点 (1)
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