A Study to Evaluate Maintenance of Hair Regrowth Following Dose Reduction 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
- 317
- 试验地点
- 37
- 主要终点
- Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction
研究概览
简要总结
This study is designed to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with 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
- 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
- •Definitive diagnosis of alopecia areata with a current episode of scalp hair loss 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
Part A: Period 2 - CTP-543 12 mg BID to Placebo
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.
干预措施: Placebo (Drug)
Part A: Period 1 - CTP-543 8 mg BID
Participants received CTP-543 8 milligrams (mg) tablets, orally, twice daily (BID) for up to 24 weeks.
干预措施: CTP-543 (Drug)
Part A: Period 1 - CTP-543 12 mg BID
Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks.
干预措施: CTP-543 (Drug)
Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks.
干预措施: CTP-543 (Drug)
Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID
Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
干预措施: CTP-543 (Drug)
Part A: Period 2 - CTP-543 8 mg BID to Placebo
Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks.
干预措施: Placebo (Drug)
Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
干预措施: CTP-543 (Drug)
Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 8 mg during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks.
干预措施: CTP-543 (Drug)
Part B: CTP-543 8 mg BID to Placebo to 8 mg BID
Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks.
干预措施: CTP-543 (Drug)
Part B: CTP-543 12 mg BID to Placebo to 12 mg BID
Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of > 20), received re-treatment with 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
Part A, Period 2: Percentage of Participants Achieving Loss of Regrowth Maintenance (LOM) Criteria Defined by Severity of Alopecia Tool (SALT) Score > 20 Following Dose Reduction
时间窗: From Week 24 to Week 48
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \>20. The percentage of participants achieving LOM criteria (SALT \>20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose reduction conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.
Part A, Period 2: Percentage of Participants Achieving LOM Criteria Defined by SALT Score > 20 Following Drug Discontinuation
时间窗: From Week 24 to Week 48
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). LOM is defined as an absolute SALT score \>20. The percentage of participants achieving LOM criteria (SALT \>20) was compared to the percentage of participants maintaining treatment success (SALT ≤ 20) for each of the following dose discontinuation conditions. Due to the variable time on study for each participant within Part A Period 2, the primary analysis visit was at the end of Part A Period 2, where the last observed non-missing SALT value was selected for each participant.
Part B: Percentage of Participants by Dose Group Who Achieved Restoration of Regrowth (ROR) at Week 24
时间窗: Week 24 of re-treatment
SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss). ROR is defined as the participant's attainment of an absolute SALT score of ≤20 at Week 24 of re-treatment.
次要结局
- Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT Score > 20 Following Dose Reduction Conditions at Weeks 28, 32, 36, 40, 44, and 48(Weeks 28, 32, 36, 40, 44, and 48)
- Part A, Period 2: Percentage of Participants Who Achieved LOM Criteria Defined by SALT > 20 Following Drug Discontinuation Conditions at Weeks 28, 32, 36, 40, 44, and 48(Weeks 28, 32, 36, 40, 44, and 48)
- Part A, Period 1: Percentage of Responders as Assessed on the Hair Satisfaction Patient Reported Outcome (SPRO) Scale at Weeks 12, 16, 20, and 24(Weeks 12, 16, 20, and 24)
- Part A, Period 1: Percentage of Participants Who Achieved an Absolute SALT Score ≤20 at Weeks 4, 8, 12, 16, 20, and 24(Weeks 4, 8, 12, 16, 20, and 24)
- Part A, Period 1: 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)
- Part A, Period 1: 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)
- Part A, Period 1: 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)
- Part A, Period 1: 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)
- Part A, Period 1: 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)
- Part A, Period 1: 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)
- Part B: Percentage of Participants Who Achieved Restoration of Regrowth Criteria at Weeks 4, 8, 12, 16, 20, and 24(Weeks 4, 8, 12, 16, 20, and 24 of re-treatment)
- Part B: Relative Change in SALT Scores From Part B Baseline at Weeks 4, 8, 12, 16, 20, and 24(Baseline, Weeks 4, 8, 12, 16, 20, and 24 of re-treatment)
- Number of Participants Experiencing at Least One Treatment-Emergent Adverse Events (TEAEs)(From first dose of study drug up to last follow up visit (Week 76))