A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 546
- 试验地点
- 96
- 主要终点
- Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20
研究概览
简要总结
The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.
- •Have severe or very 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, as measured by SALT (AA-IGA of 3 or 4) at screening and baseline.
- •No spontaneous improvement over the past 6 months.
- •Current episode of severe or very severe AA of less than 8 years. Note: participants who have severe or very severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.
- •Male or nonpregnant, nonbreastfeeding female participants.
排除标准
- •Primarily "diffuse" type of AA.
- •Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA.
- •Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).
研究组 & 干预措施
4 Milligram (mg) Baricitinib
Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.
干预措施: Placebo (Drug)
4 Milligram (mg) Baricitinib
Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.
干预措施: Baricitinib (Drug)
2 mg Baricitinib
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
干预措施: Baricitinib (Drug)
2 mg Baricitinib
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
干预措施: Placebo (Drug)
Placebo
Participants received two placebo tablets administered orally QD to maintain the blind.
干预措施: Placebo (Drug)
4 mg Baricitinib Maximum Extended Enrollment (MEE)
Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.
干预措施: Baricitinib (Drug)
4 mg Baricitinib Maximum Extended Enrollment (MEE)
Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.
干预措施: Placebo (Drug)
2 mg Baricitinib MEE
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.
干预措施: Baricitinib (Drug)
Placebo MEE
Participants received two placebo tablets administered orally QD to maintain the blind.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20
时间窗: Week 36
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
次要结局
- Percentage of Participants With Patient-Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥2-point Improvement From Baseline Among Participants With a Score of ≥3 at Baseline(Week 36)
- Percentage of Participants Achieving Clinician-Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥2 at Baseline)(Week 36)
- Change From Baseline in Skindex-16 AA Functioning Domain Score at Week 36(Baseline, Week 36)
- Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)(Week 12)
- Percentage of Participants Achieving Patient-Reported Outcome (PRO) Measure for EB 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥2 at Baseline)(Week 36)
- Percent Change From Baseline in SALT Score at Week 36(Baseline, Week 36)
- Time for Participants to Achieve SALT ≤ 20(Week 52)
- Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥2 at Baseline)(Week 36)
- Percentage of Participants Achieving PRO Measure for EL 0 or 1 With ≥2-point Improvement From Baseline (Among Participants With PRO Measure EL ≥2 at Baseline)(Week 36)
- Change From Baseline in Skindex-16 Alopecia Areata (AA) Symptoms Domain Score(Baseline, Week 36)
- Change From Baseline in Skindex-16 AA Emotions Domain Score at Week 36(Baseline, Week 36)
- Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score at Week 36(Baseline, Week 36)
- Mean Change From Baseline in HADS Depression Score at Week 36(Baseline,Week 36)