A 24 Week, Randomised, Assessor Blinded, Active-controlled, Parallel Group, Phase 3, 2 Arm Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 513
- 试验地点
- 2
- 主要终点
- Change in HECSI Score From Baseline to Week 12
研究概览
简要总结
This is a 24-week study in adult participants with severe chronic hand eczema (CHE) and with a documented inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable. Eligible participants will be randomised to receive topical administration of delgocitinib cream 20 mg/g, twice-daily, or oral administration of alitretinoin capsules 30 mg (with an option to reduce to 10 mg during trial conduct), once-daily. The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life.
The purpose of this trial is to compare the efficacy, health-related quality of life, and safety of delgocitinib cream and alitretinoin capsules.
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
- Single (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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Delgocitinib cream 20 mg/g
Twice-daily topical application for up to 24 weeks
干预措施: Delgocitinib (Drug)
Alitretinoin capsules 30 mg per capsule
1 capsule per day for up to 24 weeks
干预措施: Toctino (Drug)
结局指标
主要结局
Change in HECSI Score From Baseline to Week 12
时间窗: 12 weeks
The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers \[except fingertips\], palm of hands, back of hands, and wrists) by use of standard scales. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score) with a higher score indicating greater severity.
次要结局
- HECSI-90 at Week 12(12 weeks)
- IGA-CHE TS at Week 12.(12 weeks)
- Change in HESD Itch Score (Weekly Average) From Baseline to Week 12(12 weeks)
- Change in HESD Pain Score (Weekly Average) From Baseline to Week 12.(12 weeks)
- AUC of HECSI-90 From Baseline up to Week 24(24 weeks)
- AUC of Change From Baseline in DLQI Score up to Week 24(24 weeks)
- Change in HECSI Score From Baseline to Week 24(24 weeks)
- Number of Treatment-emergent AEs From Baseline up to Week 26(26 weeks)
- Number of Treatment-emergent SAEs From Baseline up to Week 26(26 weeks)
- Number of AEs Leading to IMP Discontinuation up to Week 24(24 weeks)