NCT05906628已完成2 期
A Phase 2, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 35
- 主要终点
- Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Week 16
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CHE for at least 6 months prior to screening. Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3 months or ≥ 2 flares within the previous 12 months.
- •Screening and baseline IGA-CHE 3 or
- •Baseline CHE-related Itch NRS ≥
- •Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated.
- •Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol.
排除标准
- •Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study.
- •Any serious illness or medical, physical, or psychiatric condition(s).
- •Laboratory values outside of the protocol-defined criteria.
- •Use of protocol-defined treatments within the indicated washout period before baseline.
- •Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline.
- •Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
Ruxolitinib
Experimental
Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.
干预措施: Ruxolitinib cream (Drug)
Vehicle
Placebo Comparator
Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.
干预措施: Vehicle (Drug)
结局指标
主要结局
Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Week 16
时间窗: Baseline; Week 16
The Investigator's Global Assessment-Chronic Hand Eczema (IGA-CHE) is an instrument used to rate the severity of the participant's global CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe) (1, almost clear; 2, mild eczema; 3, moderate eczema). IGA-CHE TS is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from Baseline.
次要结局
- Percentage of Participants Achieving ITCH4 Response at Day 3 and Week 1 (Day 7)(Baseline; Day 3; Week 1 (Day 7))
- Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit(Baseline; Weeks 2, 4, 8, 12, 16, 24, and 32)
- Change From Baseline in CHE-related Itch NRS Score at Each Post-Baseline Visit(Baseline; Weeks 1-32)
- Time to ≥4-point Improvement From Baseline in CHE-related Itch NRS Score(Baseline; up to Week 32)
- Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit(Baseline; Weeks 1-32)
- Percentage of Participants Achieving ≥2-point Improvement in CHE-related Skin Pain NRS Score From Baseline to Week 16(Baseline; up to Week 16)
- Time to ≥2-point Improvement From Baseline in CHE-related Skin Pain NRS Score(Baseline; up to Week 32)
- Percentage Change in Hand Eczema Severity Index (HECSI) Score From Baseline to Week 16(Baseline; up to Week 16)
- Patient Global Impression of Change (PGIC) Score at Each Post-Baseline Visit(Baseline; up to Week 32)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 2, 4, 8, 12, 16, 24, and 32(Baseline; up to Week 32)
- Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32(Baseline; up to Week 32)
- Percentage of Participants Achieving ITCH4 Response at Weeks 4 and 16(Baseline; Weeks 4 and 16)
- Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32(Baseline; up to Week 32)
- Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up(Baseline; up to Week 36)
- Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up(Baseline; up to Week 36)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the DBVC Period(up to Week 16)
- Number of Participants With Any ≥Grade 3 TEAE in the DBVC Period(up to Week 16)
- Number of Participants With Any TEAE in the OLE Period(up to Week 36)
- Number of Participants With Any ≥Grade 3 TEAE in the OLE Period(up to Week 36)
- Number of Participants With Clinically Meaningful Changes or Trends in Laboratory (Hematology and Serum Chemistry) Parameters or Vital Signs in the DBVC Period(up to Week 16)
- Number of Participants With Clinically Meaningful Changes or Trends in Laboratory (Hematology and Serum Chemistry) Parameters or Vital Signs in the OLE Period(up to Week 36)
研究者
研究点 (35)
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