NCT05233410撤回3 期
Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2 (TRuE-CHE2): A Phase 3, 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
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 38
- 主要终点
- Percentage of Participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Recent history (within the past 1 year of baseline) of inadequate response to treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or oral alitretinoin; or intolerance or contraindication to TCS or TCI or oral alitretinoin.
- •Willingness to avoid pregnancy or fathering children based on the criteria below.
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.
- •Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
- •Participants with concurrent conditions and history of other diseases such as other active skin disease or infection on the hands; immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with study assessments or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids; current or history of hepatitis B or C virus infection.
- •Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- •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.
- •Further exclusion criteria 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 achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)
时间窗: Week 16
The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (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 with a ≥ 2-point improvement in CHE-related Skin Pain NRS score(Baseline to Week 16)
- Percentage of participants with HECSI-75(Weeks 2, 8, 16, 32)
- Percentage of Participants with a ≥ 4-point improvement in chronic hand eczema (CHE)-related Itch Numerical Rating Scale (NRS) score(Baseline to Week 16)
- Change from baseline in CHE-related Itch NRS score (weekly average)(Up to Week 32)
- Change from baseline in CHE-related Skin Pain NRS score (weekly average)(Up to Week 32)
- Time to ≥ 2-point improvement in CHE-related Skin Pain NRS score(Up to Week 32)
- Percentage change in Hand Eczema Severity Index (HECSI)(Baseline to Week 16)
- Percentage of participants with HECSI-90(Weeks 2, 8, 16, 32)
- Change from baseline in the mTLSS (modified Total Lesion Symptom Score(Up to Week 32)
- Percentage of Participants achieving an IGA CHE-TS(Up to Week 32)
- Time to ≥ 4-point improvement in CHE-related Itch NRS score(Up to Week 32)
- Change from baseline in EQ-5D-5L score(Up to Week 32)
- Change from baseline in Work Productivity and Activity Impairment Questionnaire Specific Health Problem v2.0 in Chronic Hand Eczema (WPAI-SHP-CHE)(Up to week 32, followed by 30 days follow-up.)
- Number of Participants with Treatment Emergent Adverse Events (TEAE)(Up to 40 weeks)
- Percentage of participants with a score of either 1 or 2 on the PGIC(Up to Week 32)
- Mean Patient Global Impression of Change (PGIC) score(Up to Week 32)
- Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) score(Up to Week 32)
- Percentage of participants with each score on the PGIC(Up to Week 32)
- Change from baseline in Dermatology Life Quality Index (DLQI) score(Up to Week 32)
- Change from baseline in Working Limitations Questionnaire (WLQ) score(Up to Week 32)
研究者
研究点 (38)
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