A Randomized, Double-Blind, Vehicle-Controlled Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ATI-50002 Topical Solution Administered Twice-Daily for 6 Months in Adolescents and Adult Subjects With Stable Patchy Alopecia Areata With Optional Long-Term Open-Label Extension
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in the Severity of Alopecia Tool Score at Week 24
研究概览
简要总结
Primary:
• To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical Solution, compared to vehicle in subjects with alopecia areata (AA)
Secondary:
• To evaluate key clinical outcome assessments
详细描述
Primary:
• To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical Solution, compared to vehicle in subjects with alopecia areata (AA)
Secondary:
• To evaluate key clinical outcome assessments
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinical diagnosis of stable patchy alopecia areata (AA) defined as no current areas of spontaneous regrowth.
- •Have a Severity of Alopecia Tool (SALT) score of at least 15% up to 95% total scalp hair loss determined by the study investigator at baseline.
- •Have a duration of the current episode of scalp hair loss of a minimum of 6 months and a maximum of 12 years.
- •If a woman of childbearing potential (WOCBP), must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2) and agree to: use a highly effective method of birth control for the duration of the study; not be planning a pregnancy during the study duration and use contraception for 30 days after last application of study medication.
排除标准
- •Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last application of study medication.
- •Diffuse alopecia areata.
- •Concomitant hair loss disorder (by history or physical exam) such as androgenetic alopecia or scarring alopecia (e.g., cicatricial alopecia, frontal fibrosing alopecia, etc.).
- •Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety.
- •Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AA or interfere with the study conduct or evaluations.
- •The presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion of the investigator, interfere with study assessments if not removed at each visit.
研究组 & 干预措施
ATI-50002 low dose Topical Solution
low dose active
干预措施: ATI-50002 low dose (Drug)
ATI-50002 high dose Topical Solution
High dose active
干预措施: ATI-50002 high dose (Drug)
Vehicle Topical Solution
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in the Severity of Alopecia Tool Score at Week 24
时间窗: Baseline - Week 24
The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth. The primary efficacy variable was the percent change from baseline in SALT score at Week 24. This was calculated as the mean of the changes from Baseline (Visit 2) SALT score to Week 24 (Visit 10) SALT score, divided by Baseline SALT score and expressed as a percentage.
次要结局
- Percent Change From Baseline in the Alopecia Density and Extent Score at Week 24(Baseline - Week 24)
- Mean Change From Baseline in Severity of Alopecia Tool Score at Week 24(Baseline - Week 24)
- Mean Change From Baseline in Alopecia Density and Extent Score at Week 24(Baseline - Week 24)
- Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Severity of Alopecia Tool Scores at Week 24(Baseline - Week 24)
- Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Alopecia Density and Extent Scores at Week 24(Baseline - Week 24)
- Proportion of Subjects With ≥2 Point Improvement in Scalp Patient Reported Outcome for Target Patch at Week 24(Baseline - Week 24)
- Proportion of Subjects With ≥1 Point Improvement in Scalp Patient Reported Outcome for Entire Scalp at Week 24(Baseline - Week 24)
- Proportion of Subjects With ≥2-Point Improvement in Scalp Clinician Reported Outcome for Target Patch at Week 24(Baseline - Week 24)
- Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24(Baseline - Week 24)
- Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24(Baseline - Week 24)
- Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24(Baseline - Week 24)
- Alopecia Impact Assessment Patient Reported Outcome Change From Baseline at Week 24(Baseline - Week 24)
- Subject Global Impression of Treatment Satisfaction at Week 24(Week 24)
- Change in Dermatology Life Quality Index Total Score Between Baseline and Week 24(Baseline - Week 24)
- Physician Global Impression of Change at Week 24(Week 24)
- Subject Global Impression of Change at Week 24(Week 24)