A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 487
- 试验地点
- 1
- 主要终点
- Number of Participants With IGA-CHE TS at Week 16
研究概览
简要总结
This is a 16-week study in adult participants with chronic hand eczema (CHE). 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 is to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.
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
- Double (Participant, Investigator)
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 16 weeks
干预措施: Delgocitinib cream (Drug)
Cream vehicle
Twice-daily topical application for 16 weeks
干预措施: Cream vehicle (Drug)
结局指标
主要结局
Number of Participants With IGA-CHE TS at Week 16
时间窗: 16 weeks
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
- Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2(2 weeks)
- Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8(8 weeks)
- Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4(4 weeks)
- Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16(16 weeks)
- Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 8(8 weeks)
- Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 4(4 weeks)
- Number of Participants With HECSI-90 at Week 16(16 weeks)
- Number of Participants With HECSI-75 at Week 16(16 weeks)
- Number of Participants With HECSI-75 at Week 8(8 weeks)
- Percentage Change in HECSI Score From Baseline to Week 16(16 weeks)
- Change in DLQI Score From Baseline to Week 16(16 weeks)
- Change in HESD Score (Weekly Average) From Baseline to Week 16(16 weeks)
- Change in HESD Itch Score (Weekly Average) From Baseline to Week 16(16 weeks)
- Change in HESD Pain Score (Weekly Average) From Baseline to Week 16(16 weeks)
- Change in HEIS Score From Baseline to Week 16(16 weeks)
- Change in HEIS PDAL Score From Baseline to Week 16(16 weeks)
- Reduction of DLQI Score of ≥4 Points From Baseline at Week 16(16 weeks)
- Number of Treatment-emergent AEs From Baseline up to End of Trial(16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403]))
- Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16(16 weeks)
- Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16(16 weeks)
- Number of Participants With IGA-CHE TS at Week 8(8 weeks)
- Number of Participants With IGA-CHE TS at Week 4(4 weeks)
- Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8(8 weeks)
- Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4(4 weeks)