NCT03989206进行中（未招募）3 期
A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Galderma R&D
- 入组人数
- 1,700
- 试验地点
- 342
- 主要终点
- Incidence of Serious TEAEs
研究概览
简要总结
Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description
详细描述
Long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD
- •Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
排除标准
- •Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject.
- •Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
- •Body weight < 30 kg
- •Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods.
- •History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
- •Any clinically significant issue, based investigator judgement
研究组 & 干预措施
Nemolizumab
Experimental
Nemolizumab administered via subcutaneous injection
干预措施: Nemolizumab (Drug)
结局指标
主要结局
Incidence of Serious TEAEs
时间窗: Baseline to Week 200
Incidence and Severity of TEAEs
时间窗: Baseline to Week 200
Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study
时间窗: Baseline to Week 200
次要结局
- Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component)(Baseline to Week 200)
- Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit(Baseline to Week 200)
- Proportion of Participants with IGA score = 0-1 at Each Visit(Baseline to Week 200)
- Change From Baseline in Work Productivity and Activity Impairment: Atopic Dermatitis (WPAI:AD) for Each Subscale at Each Visit Through Week 200(Baseline to Week 200)
- Time to First Relapse(Baseline to Week 200)
- Proportion of Participants with EASI-75 at Each Visit(Baseline to Week 200)
- Change and Percent Change From Baseline in SCORAD Score at Each Visit(Baseline to Week 200)
- Change from Baseline in Dermatology Life Quality Index (DLQI)(Baseline to Week 200)
- Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period(Baseline to Week 200)
- Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit(Baseline to Week 200)
- Proportion of Participants with IGA ≤ 2 at Each Visit(Baseline to Week 200)
- Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200(Baseline to Week 200)
- Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200(Baseline to Week 200)
- Duration of Remission(Baseline to Week 200)
- Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit(Baseline to Week 200)
- Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component)(Baseline to Week 200)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200(Baseline to Week 200)
- Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200(Baseline to Week 200)
- Time to Permanent Study Drug Discontinuation(Baseline to Week 200)
研究者
研究点 (342)
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