NCT04797650已完成3 期
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
Concert Pharmaceuticals63 个研究点 分布在 6 个国家目标入组 517 人开始时间: 2021年6月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 517
- 试验地点
- 63
- 主要终点
- Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24
研究概览
简要总结
This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.
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
- •Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.
- •At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥50, at Screening and Baseline.
- •Willing to comply with the study visits and requirements of the study protocol.
排除标准
- •Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.
- •Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.
- •Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study.
- •Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
- •Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received CTP-543 matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.
干预措施: CTP-543 matching placebo (Drug)
CTP-543 8 mg BID
Experimental
Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks.
干预措施: CTP-543 (Drug)
CTP-543 12 mg BID
Experimental
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
干预措施: CTP-543 (Drug)
结局指标
主要结局
Percentage of Participants Achieving an Absolute Severity of Alopecia Tool (SALT) Score ≤20 at Week 24
时间窗: Week 24
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
次要结局
- Change in the Clinician Global Impression of Severity (CGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24(Baseline, Weeks 12, 16, 20, and 24)
- Percentage of Participants Achieving an Absolute SALT Score of ≤20 at Weeks 4, 8, 12, 16, and 20(Weeks 4, 8, 12, 16, and 20)
- Percentage of Responders on the Hair Satisfaction Participants Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24(Weeks 12, 16, 20, and 24)
- Change in the Patient Global Impression of Severity (PGI-S) Scores From Baseline at Weeks 12, 16, 20, and 24(Baseline, Weeks 12, 16, 20, and 24)
- Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16, 20, and 24(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of Responders Assessed Using the Patient Global Impression of Improvement (PGI-I) at Weeks 12, 16, 20, and 24(Weeks 12, 16, 20, and 24)
- Percentage of Participants Achieving at Least a 75% and 90% Relative Reduction in SALT Score From Baseline at Weeks 12 and 24(Baseline, Weeks 12, and 24)
- Change in the Brigham Eyebrow Tool for Alopecia (BETA) Scores From Baseline at Weeks 12 and 24(Baseline, Weeks 12, and 24)
- Change in the Brigham Eyelash Tool for Alopecia (BELA) Scores From Baseline at Weeks 12 and 24(Baseline, Weeks 12, and 24)
- Change in the SPRO Scale From Baseline at Weeks 12, 16, 20, and 24(Baseline, Weeks 12, 16, 20 and 24)
- Change in the Anxiety and Depression Scale Scores of the Hospital Anxiety and Depression Scale (HADS) From Baseline at Week 24(Baseline and Week 24)
- Percentage of Responders Assessed Using the Clinician Global Impression of Improvement (CGI-I) at Weeks 12, 16, 20, and 24(Weeks 12, 16, 20, and 24)
- Change in the Individual Items of the Hair Quality Patient Reported Outcome (QPRO) Scale From Baseline at Weeks 12, 16, 20, and 24(Baseline, Weeks 12, 16, 20, and 24)
- Percentage of Participants Achieving a ≥2-point Change From Baseline in the SPRO Scale at Weeks 12, 16, 20, and 24(Weeks 12, 16, 20, and 24)
- Percentage of Participants Achieving an Absolute SALT Score of ≤10 at Week 24(Week 24)
研究者
研究点 (63)
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