A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 801
- 试验地点
- 6
- 主要终点
- Number of Treatment-emergent Adverse Events From Baseline up to Week 38
研究概览
简要总结
The purpose of this extension trial is to evaluate the long-term safety of delgocitinib.
Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.
详细描述
Subject who completed 16 weeks of treatment with delgocitinib cream 20 mg/g or vehicle cream twice daily in trials DELTA 1 or DELTA 2 will be offered to roll-over to this extension trial.
Subjects will be treated with delgocitinib cream 20 mg/g twice daily only if they need it to control their chronic hand eczema. In the periods when the disease is controlled, no treatment will be administered.
Clinic visits every 4 weeks are planned (with the possibility of unscheduled visits) to investigate safety and efficacy of treatment, as well as its effect on patient-reported outcomes (PROs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants must have met eligibility criteria at screening and baseline in the parent trial (DELTA 1 or DELTA 2).
- •Participants must have completed the treatment period in the parent trial (to be assessed at baseline visit in this extension trial).
- •Participants must have complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
- •A woman of childbearing potential must use an acceptable method of birth control throughout the trial up until the end-of-treatment/early termination visit.
排除标准
- •Participants who prematurely discontinued treatment with IMP or initiated rescue medication in the parent trial.
- •Participants who experienced any adverse event (AE) during participation in the parent trial, which precludes further treatment with delgocitinib cream 20 mg/g in the judgement of the investigator.
- •Any medical or psychiatric condition that could put the participant at undue risk by participating in the trial, or which, by the investigator's judgment, makes the participant inappropriate for the trial.
研究组 & 干预措施
As-needed treatment with delgocitinib
Subjects will be treated with delgocitinib cream 20 mg/g twice daily as needed.
干预措施: Delgocitinib (Drug)
结局指标
主要结局
Number of Treatment-emergent Adverse Events From Baseline up to Week 38
时间窗: From baseline up to Week 38
An AE will be considered treatment emergent if it started after the baseline visit
次要结局
- Number of Participants With IGA-CHE Score at Each Scheduled Visit From Baseline up to Week 36(From baseline up to Week 38)
- Number of Participants With IGA-CHE Score of 0 (Clear) or 1 (Almost Clear) at Each Scheduled Visit From Baseline up to Week 36.(From baseline up to Week 38)
- HECSI Score at Each Scheduled Visit From Baseline up to Week 36(From baseline up to Week 38)
- Number of Participants With HECSI-75 at Each Scheduled Visit From Baseline up to Week 36(From baseline up to Week 38)
- Number of Participants With HECSI-90 at Each Scheduled Visit From Baseline up to Week 36(From baseline up to Week 38)