A Randomized Parallel-Group Study to Evaluate the Efficacy and Tolerability of Two Dosing Regimens of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
研究概览
简要总结
This study will evaluate the efficacy and tolerability of once-daily versus twice-daily dosing of CTP-543, in adult patients with chronic, moderate to severe alopecia areata.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Definitive diagnosis of 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.
- •Clinical lab results within the normal range
排除标准
- •Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis on the scalp.
- •Treatment with systemic immunosuppressive medications or biologics.
- •Vaccination with herpes zoster vaccine or any live virus within 6 weeks of screening or during the study
研究组 & 干预措施
CTP-543 8 mg BID
Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks.
干预措施: CTP-543 Matching Placebo (Drug)
CTP-543 8 mg BID
Participants received 1 x 8 mg CTP-543 tablet and 1 x CTP-543 matching placebo tablet, twice daily (BID) for 24 weeks.
干预措施: CTP-543 (Drug)
CTP-543 16 mg QD
Participants received 16 mg (2 x 8 mg) CTP-543 tablets, once daily (QD) and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
干预措施: CTP-543 (Drug)
CTP-543 16 mg QD
Participants received 16 mg (2 x 8 mg) CTP-543 tablets, once daily (QD) and after 12 hours, received 2 x CTP-543 matching placebo tablets, QD for 24 weeks.
干预措施: CTP-543 Matching Placebo (Drug)
结局指标
主要结局
Relative Change From Baseline in Severity of Alopecia Tool (SALT) Score at Week 24
时间窗: Baseline, Week 24
The SALT is a quantitative assessment of scalp hair loss. SALT scores range in severity from 0 (no hair loss) to a maximum of 100 (complete hair loss). Relative change (percent change) to baseline is calculated as: 100 x (\[baseline SALT score - follow-up SALT score\]/baseline SALT score).
次要结局
- Absolute 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 Participants Achieving at Least a 90%, 75%, and 50% Relative Reduction in SALT Score From Baseline(Baseline, Weeks 4, 8, 12, 16, 20, and 24)
- Relative Change in SALT Scores From Baseline at Weeks 4, 8, 12, 16 and 20(Baseline, Weeks 4, 8, 12, 16 and 20)
- Percentage of Participants With Change in Satisfaction of Hair Coverage(Baseline, Week 24)