A Double-Blind, Randomized, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of Deuruxolitinib in Adolescent Patients With Severe Alopecia Areata With an Open-label Extension Period
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 355
- 试验地点
- 64
- 主要终点
- Safety and tolerability of deuruxolitinib will be assessed by evaluating adverse events, vital signs, electrocardiograms, and clinical laboratory results, as well as physical examinations
研究概览
简要总结
This study evaluates the safety and effectiveness of deuruxolitinib in adolescents aged 12 to less than 18 years who have 50% or greater scalp hair loss.
详细描述
The efficacy and safety of deuruxolitinib in adolescent subjects with severe alopecia areata will be evaluated in this study, beginning with a double-blind, randomized, placebo-controlled Treatment Period of 24 weeks. Subjects 12 to <18 years of age having at least 50% hair loss as measured by SALT and meeting eligibility criteria will be randomized to deuruxolitinib or placebo treatment. In the Open-label Extension part of the study, participants from the Treatment Period will receive deuruxolitinib for 52 weeks.
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)
盲法说明
All study subjects, Investigators, and site study staff will be blinded to study [Treatment Period] followed by None [Open-Label Extension]
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical presentation compatible with alopecia areata with a current episode lasting at least 6 months and not exceeding 10 years.
- •Between 12 to <18 years of age
- •At least 50% scalp hair loss, as defined by a Severity of Alopecia Tool (SALT) score ≥
- •Willing to comply with the study visits and requirements of the study protocol
排除标准
- •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 at Screening and/or Baseline
- •Treatment with other medications or agents within 28 days of Baseline or during the study that may affect hair regrowth or immune response.
- •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
Treatment Period: Deuruxolitinib 8 mg
Deuruxolitinib tablets, orally, twice daily (BID) for up to 24 weeks
干预措施: Deuruxolitinib (Drug)
Treatment Period: Placebo
Deuruxolitinib-matched placebo tablets, orally, BID for up to 24 weeks
干预措施: Placebo (Drug)
Open-Label Extension: Deuruxolitinib 8 mg BID
Deuruxolitinib tablets, orally, BID for up to 52 weeks
干预措施: Deuruxolitinib (Drug)
结局指标
主要结局
Safety and tolerability of deuruxolitinib will be assessed by evaluating adverse events, vital signs, electrocardiograms, and clinical laboratory results, as well as physical examinations
时间窗: Week 24
Summary of participants who experience Treatment emergent adverse events (TEAEs) and serious TEAEs will be provided. An AE is defined as any untoward medical occurrence that may appear or worsen in a subject during the course of a study. Adverse events will be considered treatment-emergent if the onset is after the first dose of study drug. Summaries will be provided of participants who experience potentially clinically significant post-baseline changes in: hematology, chemistry and lipid results, vital signs (blood pressure, pulse rate, respiratory rate, temperature), electrocardiogram parameters (heart rate, PR, QT, QTcF, QRS, and RR) and physical examination findings.
Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) score ≤20
时间窗: Week 24
SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).
次要结局
- Mean percent change (ie, relative change) in SALT scores from baseline(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of responders (defined as "much improved" or "very much improved") using the Clinical Global Impression of Improvement (CGI-I)(Weeks 12, 16, 20, and 24)
- Percentage of responders (defined as "much improved" or "very much improved") using the Patient Global Impression of Improvement (PGI-I)(Weeks 12, 16, 20, and 24)
- Mean change from baseline in the Clinical Global Impression of Severity (CGI-S)(Weeks 12, 16, 20, and 24)
- Mean change from baseline in the Patient Global Impression of Severity (PGI-S)(Weeks 12, 16, 20, and 24)
- Percentage of subjects achieving an absolute SALT score of ≤10(Weeks 4, 8, 12, 16, 20, and 24)
- Mean change from baseline on the Eyebrow Clinician-Reported Outcome (ClinRO) score(Weeks 4, 8, 12, 16, 20, and 24)
- Mean change from baseline on the Eyelash Clinician-Reported Outcome (ClinRO) score(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of responders (defined as "satisfied" or "very satisfied") on the Satisfaction of Hair Patient Reported Outcome (SPRO) scale(Weeks 4, 8, 12, 16, 20, and 24)
- Mean change from baseline in the SPRO scale(Weeks 4, 8, 12, 16, 20, and 24)
- Percentage of subjects achieving SALT score of ≤ 20 at Week 24 whose SPRO rating shifted from Very Dissatisfied or Dissatisfied to Very Satisfied or Satisfied(Week 24)
- Percentage of subjects achieving SALT score of ≤ 10 at Week 24 whose SPRO rating shifted from Very dissatisfied or Dissatisfied to Very Satisfied or Satisfied(Week 24)
- Percentage of subjects achieving an absolute SALT score of ≤20(Weeks 4, 8, 12, 16, and 20)
- Mean change from baseline on the individual items of the Quality of Hair Patient Reported Outcome (QPRO) scale(Weeks 4, 8, 12, 16, 20 and 24)
- Mean change from baseline in total score of the Hospital Anxiety and Depression Scale (HADS)(Weeks 12 and 24)
- Mean change from baseline in the depression scale of the HADS(Weeks 12 and 24)
- Mean change from baseline in the anxiety scale of the HADS(Weeks 12 and 24)
- Percentage of subjects achieving a ≥ 6-point change from baseline in total score of the HADS(Weeks 12 and 24)
- Percentage of subjects achieving a ≥ 3-point change from baseline in the depression scale of the HADS(Weeks 12 and 24)
- Percentage of subjects achieving a ≥ 4-point change from baseline in the anxiety scale in total score of the HADS(Weeks 12 and 24)
- Proportion of Participants with Suicidal Ideation or Behavior Per the Columbia-Suicide Severity Rating Scale (C-SSRS)(Week 24)
- Safety and tolerability of deuruxolitinib will be assessed by evaluating adverse events, vital signs, electrocardiograms, and clinical laboratory results, as well as physical examinations(Up to Week 80)
- Effect of deuruxolitinib on treating Hair Loss as Measured by the Severity of Alopecia Tool (SALT)(Up to Week 76)