NCT05865041招募中2 期
A Parallel Group Treatment, Phase 2a, Double-blind, Two-arm Study to Investigate the Efficacy and Safety of Farudodstat Tablets Compared With Its Placebo in Male or Female Alopecia Areata Participants Aged 18 Years and Older With 30% or Greater Scalp Hair Loss
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
研究概览
简要总结
The main purpose of this study is to measure the efficacy of farudodstat compared to placebo at Week 12 from the treatment start, in adult participants with Alopecia Areata (AA) with 30% or greater scalp hair loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥18 years of age and a weight of ≥40 kg at the time of signing the informed consent)
- •Moderate, severe, or very severe Alopecia Areata (AA), as determined by meeting the following criteria:
- •Clinical diagnosis of AA with no other etiology of hair loss (e.g., telogen effluvium, androgenetic alopecia, etc.)
- •At least 30% scalp hair loss, as defined by a SALT score ≥30
- •Current episode of hair loss lasting at least 6 months and not exceeding 7 years at the time of Screening. Participants who have AA for longer than 7 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 7 years
- •No appreciable change (i.e., change exceeding 20 points on SALT score) in terminal hair regrowth within 6 months
排除标准
- •Known history of androgenic alopecia or female pattern hair loss prior to AA
- •Other types of alopecia (including, but not limited to traction and scarring alopecia, telogen effluvium, diffuse type of AA)
- •History or presence of hair transplants
- •Other scalp disease that may impact AA assessment or require topical treatment (including, but not limited to scalp psoriasis, seborrheic dermatitis, actinic keratosis)
研究组 & 干预措施
Farudodstat for 12 weeks followed by placebo for 12 weeks
Experimental
Farudodstat 100mg twice daily for 12 weeks followed by matching Placebo twice daily for 12 weeks
干预措施: Farudodstat (Drug)
Farudodstat for 12 weeks followed by placebo for 12 weeks
Experimental
Farudodstat 100mg twice daily for 12 weeks followed by matching Placebo twice daily for 12 weeks
干预措施: Placebo (Drug)
Placebo for 12 weeks followed by farudodstat for 12 weeks
Experimental
Matching Placebo twice daily for 12 weeks followed by farudodstat 100mg twice daily for 12 weeks
干预措施: Farudodstat (Drug)
Placebo for 12 weeks followed by farudodstat for 12 weeks
Experimental
Matching Placebo twice daily for 12 weeks followed by farudodstat 100mg twice daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
时间窗: Treatment Start to Week 12
The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Number of participants with clinically significant Electrocardiogram (ECG) parameters
时间窗: Treatment Start to Week 28
Incidence of adverse events (AEs) up to Week 28
时间窗: Treatment Start to Week 28
Number of participants with clinically significant laboratory parameters
时间窗: Treatment Start to Week 28
次要结局
- Change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.(Treatment Start to Week 12)
- Proportion of participants achieving Severity of Alopecia Tool (SALT) ≤20 at Week 12 from the treatment start.(Treatment Start to Week 12)
- Proportion of participants achieving 75% Improvement of Severity of Alopecia Tool (SALT) (SALT75) at Week 12 from the treatment start.(Treatment Start to Week 12)
- Time to Severity of Alopecia Tool (SALT) score improvement of 75% by Week 12 from the treatment start.(Treatment Start to Week 12)
- Proportion of participants with Scalp Hair Assessment Patient Reported Outcome (PRO)™ score of 0 or 1 with a ≥2-point improvement at Week 12 from the treatment start among participants with a score of ≥3 at baseline.(Treatment Start to Week 12)
- Time to Severity of Alopecia Tool (SALT) score improvement of 50% by Week 12 from the treatment start.(Treatment Start to Week 12)
- Proportion of participants achieving Clinician Reported Outcome (ClinRO) measure for Eyelash Hair Loss™ 0 or 1 with ≥2-point improvement from baseline (among participants with scores ≥2 at baseline) at Week 12 from the treatment start.(Treatment Start to Week 12)
- Proportion of participants achieving Patient Reported Outcome (PRO) Measure for Eyebrows™ 0 or 1 with ≥2-point improvement from baseline (among participants with scores ≥2 at baseline) at Week 12 from the treatment start.(Treatment Start to Week 12)
- Proportion of participants achieving Patient Reported Outcome (PRO) Measure for Eyelashes™ 0 or 1 with ≥2-point improvement from baseline (among participants with scores ≥2 at Baseline) at Week 12 from the treatment start.(Treatment Start to Week 12)
- Proportion of participants achieving 50% Improvement of Severity of Alopecia Tool (SALT) (SALT50) at Week 12 from the treatment start.(Treatment Start to Week 12)
- Proportion of participants achieving Clinician Reported Outcome (ClinRO) measure for Eyebrow Hair Loss™ 0 or 1 with ≥2-point improvement from baseline (Among Participants with scores ≥2 at Baseline) at Week 12 from the treatment start.(Treatment Start to Week 12)
- Proportion of participants achieving any amount of hair regrowth at Week 12 after treatment start among participants with alopecia totalis/alopecia universalis (AT/AU)(Treatment Start to Week 12)
研究者
研究点 (2)
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