A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects with Severe Alopecia Areata
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 82
- 主要终点
- Study 1 and Study 2 The primary endpoint is the achievement of SALT score ≤ 20 at Week 24, defined as less than or equal to 20% scalp hair loss.
研究概览
简要总结
Objective: Study 1 and Study 2 Double-blind Period, Baseline to Week 24 (Period A): ·To assess the efficacy, safety, and tolerability of upadacitinib 15 mg once daily (QD) and 30 mg QD compared with placebo for the treatment of signs and symptoms of severe AA in adult subjects, or in adolescent (outside United States and European Union [outside US/EU] where permitted) and adult subjects Study 3 Blinded Extension Period, Week 24 to Week 52 (Period B): ·To evaluate the efficacy, safety, and tolerability of upadacitinib 15 mg QD and 30 mg QD in extended treatment in adult subjects with severe AA, or in adolescent (outside US/EU where permitted) and adult subjects with severe AA Rerandomized Blinded Extension Period, Week 52 to Week 160: ·To assess the long-term safety and efficacy of the following treatments in adult subjects with severe AA, or in adolescent (OUS where permitted) and adult subjects with severe AA: ·Continuous upadacitinib 30 mg QD treatment ·Dose reduction to 15 mg QD in subjects who achieve sustained response in Study 1 or Study 2, defined as a Severity of Alopecia Tool (SALT) score ≤ 20 at Week 40 and Week 52 ·Continuous upadacitinib 15 mg QD treatment ·Dose escalation to 30 mg QD in subjects who have not achieved a SALT score ≤ 20 at Week 52 in Study 1 or Study 2 or who lose response during Study 3
研究设计
- 分配方式
- Randomized
- 主要目的
- 160 Weeks Randomized, Placebo-controlled, Double-blind Study
- 盲法
- Double (Investigator, Analyst, Subject, Monitor, Carer)
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Eligible subjects will be adults < 64 years old at Baseline and, where permitted outside US/EU adolescents at least 12 years old at Screening with a diagnosis of severe AA with SALT score ≥ 50 scalp hair loss at Screening and Baseline and no spontaneous scalp hair regrowth over the past 6 months AND no significant scalp hair loss over the past 3 months
- •Must have current episode of AA of less than 8 years.
排除标准
- •Subject has a diagnosis of primarily diffuse type of AA
- •Subject has a diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris, discoid lupus, frontal fibrosing alopecia, central centrifugal cicatricial alopecia, folliculitis decalvans, trichotillomania, and telogen effluvium.
- •Subject has a diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA, including but not limited to seborrheic dermatitis, scalp psoriasis, AD, and tinea capitis.
结局指标
主要结局
Study 1 and Study 2 The primary endpoint is the achievement of SALT score ≤ 20 at Week 24, defined as less than or equal to 20% scalp hair loss.
Study 1 and Study 2 The primary endpoint is the achievement of SALT score ≤ 20 at Week 24, defined as less than or equal to 20% scalp hair loss.
次要结局
- Achievement of SALT score <= 10 at Week 24
- Achievement of SALT score <= 20 at Week 12
- Achievement of ClinRO measure for Eyebrow Hair Loss of 0 or 1 at Week 24 with a ≥ 2-point improvement (reduction) from Baseline among subjects with Baseline score ≥ 2
- Achievement of ClinRO measure for Eyelash Hair Loss of 0 or 1 at Week 24 with a ≥ 2-point improvement (reduction) from Baseline among subjects with Baseline score ≥ 2
- Achievement of SALT 75 at Week 24
- Achievement of SALT 90 (at least a 90% improvement [decrease] from Baseline in SALT score) at Week 24
- Percent change from Baseline in SALT score at Week 24
- Achievement of PaGIC-AA score of 1 "much better" or 2 "moderately better" at Week 24
- Achievement of PRO for Scalp Hair Assessment 0/1 with ≥ 2-point improvement (reduction) from Baseline at Week 24 among subjects with Baseline score ≥ 3
- Change from Baseline in Skindex-16 AA Emotions Domain scores at Week 24
- Change from Baseline in Skindex-16 AA Functioning Domain scores at Week 24
- Change from Baseline in AASIS Interference Subscale score at Week 24
- Change from Baseline in AASIS Symptoms Subscale score at Week 24
- ·Achievement of HADS-A < 8 and HADS-D < 8 at Week 24 among subjects with HADS-A ≥ 8 or HADS-D ≥ 8 at Baseline
- Achievement of SALT score 0 at Week 24
- Achievement of SALT score ≤ 20 at Week 8
- Achievement of PaGIC-AA score of 1 "much better" or 2 "moderately better" at Week 4
- Achievement of SALT score ≤ 20 at Week 4
- Achievement of SALT score <= 20 at Week 24, for the comparison of upadacitinb 15 mg QD versus placebo
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG