A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 718
- 试验地点
- 153
- 主要终点
- Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24
研究概览
简要总结
This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of alopecia areata with no other cause of hair loss
- •≥50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months
- •Current episode of hair loss ≤10 years
排除标准
- •Other types of alopecia or other diseases that can cause hair loss
- •Other scalp diseases that could interfere with assessment of hair loss/regrowth
- •Subjects with shaved heads must not enter the study until hair has grown back & is considered stable by the investigator
- •Any previous use of any Janus kinase (JAK) inhibitor
研究组 & 干预措施
Sequence B
Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks
干预措施: PF-06651600 Maintenance Dose #2 (Drug)
Sequence C
Maintenance dose #1 given QD for 48 weeks
干预措施: PF-06651600 Maintenance Dose #1 (Drug)
Sequence D
Maintenance dose #2 given QD for 48 weeks
干预措施: PF-06651600 Maintenance Dose #2 (Drug)
Sequence E
Maintenance dose #3 given QD for 48 weeks
干预措施: PF-06651600 Maintenance Dose #3 (Drug)
Sequence A
Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks
干预措施: PF-06651600 Induction Dose (Drug)
Sequence A
Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks
干预措施: PF-06651600 Maintenance Dose #1 (Drug)
Sequence B
Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks
干预措施: PF-06651600 Induction Dose (Drug)
Sequence F
Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks
干预措施: PF-06651600 Induction Dose (Drug)
Sequence F
Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks
干预措施: PF-06651600 Maintenance Dose #1 (Drug)
Sequence F
Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks
干预措施: Placebo (Drug)
Sequence G
Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks
干预措施: PF-06651600 Maintenance Dose #1 (Drug)
Sequence G
Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With an Absolute Severity of Alopecia Tool (SALT) Score of Less Than or Equal to 20 at Week 24
时间窗: Week 24
SALT is a quantitative assessment of AA severity based on the scalp hair loss. The SALT score can vary from 0 (normal) to 100 (severe), with higher scores representing increased severity of disease. In this outcome measure, percentage of participants with SALT score less than or equal to (\<=) 20 at week 24 were reported.
次要结局
- Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 4(Week 24)
- Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 24: Analysis 1(Week 24)
- Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 20 at Week 24: Maximum Effect (Emax) Model(Week 24)
- Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyebrow Assessment (EBA) Score (Among Participants Without Normal EBA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48(Week 4, 8, 12, 18, 24, 28, 34, 40, and 48)
- Percentage of Participants With at Least a 2 Grade Improvement From Baseline or a Score of 3 in Eyelash Assessment (ELA) Score (Among Participants Without Normal ELA at Baseline) at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48(Week 4, 8, 12, 18, 24, 28, 34, 40, and 48)
- Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 4, 8, 12, 18, and 24: Emotional Symptoms and Activity Limitations(Baseline (Day 1), Week 4, 8, 12, 18, and 24)
- Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 24(Week 24)
- Exposure Response of PF-06651600 on Regrowth of Lost Hair Based on Absolute SALT Score of Less Than or Equal to 10 at Week 24: Maximum Effect (Emax) Model(Week 24)
- Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 10 at Week 4, 8, 12, 18, 28, 34, 40, and 48(Week 4, 8, 12, 18, 28, 34, 40, and 48)
- Percentage of Participants With at Least 75% Improvement in SALT Score (SALT75) From Baseline at Week 4, 8, 12, 18, 24, 28, 34, 40, and 48(Week 4, 8, 12, 18, 24, 28, 34, 40, and 48)
- Change From Baseline in SALT Score at Week 4, 8, 12, 18, and 24(Baseline (Day 1), Week 4, 8, 12, 18, and 24)
- Percentage of Participants With Patient Global Impression of Change (PGI-C) Score of Moderately Improved or Greatly Improved at Week 4, 8, 12, 18, 24, 34, 40, and 48(Week 4, 8, 12, 18, 24, 34, 40, and 48)
- Percentage of Participants With an Absolute SALT Score of Less Than or Equal to 20 at Week 4, 8, 12, 18, 28, 34, 40, and 48(Week 4, 8, 12, 18, 28, 34, 40, and 48)
- Change From Baseline in SALT Score at Week 28, 34, 40, and 48(Baseline (Day 1), Week 28, 34, 40, and 48)
- Change From Baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) Domain Scores at Week 34, 40, and 48: Emotional Symptoms and Activity Limitations(Baseline (Day 1), Week 34, 40, and 48)
- Percentage of Participants With Improvement From Baseline on Alopecia Areata Patient Priority Outcomes (AAPPO) Items 1-4 at Week 4, 8, 12, 18, 24, 34, 40, and 48(Week 4, 8, 12, 18, 24, 34, 40, and 48)