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临床试验/NCT03137381
NCT03137381已完成2 期

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

Concert Pharmaceuticals13 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2017年8月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
149
试验地点
13
主要终点
Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24

研究概览

简要总结

This study will evaluate the safety and efficacy of CTP-543 on hair loss in adults with chronic, moderate to severe alopecia areata.

详细描述

This is a double-blind, randomized, placebo-controlled multi-center study consisting of 3 cohorts to assess the safety and efficacy of CTP-543. Each Cohort will be initiated sequentially in ascending dose order. Participants will be randomized to either an active dose of CTP-543 or placebo for a 24-week treatment period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
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

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

Cohort 1: CTP-543 4 mg BID

Experimental

Participants will receive CTP-543 4 mg tablets, twice daily for up to 24 weeks.

干预措施: CTP-543 (Drug)

Cohort 2: CTP-543 8 mg BID

Experimental

Participants will receive CTP-543 8 mg tablets, twice daily for up to 24 weeks.

干预措施: CTP-543 (Drug)

Cohort 3: CTP-543 12 mg BID

Experimental

Participants will receive CTP-543 12 mg tablets, twice daily for up to 24 weeks.

干预措施: CTP-543 (Drug)

Combined Placebo

Placebo Comparator

Participants will receive CTP-543 matched placebo tablets, twice daily for up to 24 weeks in Cohorts 1, 2, and 3.

干预措施: CTP-543 matching placebo (Drug)

结局指标

主要结局

Percentage of Participants Achieving at Least a 50% Relative Reduction in Severity of Alopecia Tool (SALT) Score From Baseline at Week 24

时间窗: 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). Responders were defined as participants achieving at least a 50% relative reduction in SALT score from baseline at Week 24.

Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE)

时间窗: From first dose of study drug up to safety follow up at Week 28

An adverse event is any untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an adverse event. TEAE is defined as any adverse event that occurs after administration of the first dose of study drug.

次要结局

未报告次要终点

研究者

发起方
Concert Pharmaceuticals
申办方类型
Industry
责任方
Sponsor

研究点 (13)

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