A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
研究概览
简要总结
Primary objective:
To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).
Secondary objectives:
To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, health-related quality of life, and health care resource utilisation compared with placebo in combination with TCS.
To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 16 weeks.
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)
盲法说明
Neither the trial participant nor any of the investigator or LEO pharma staff who are involved in the treatment or clinical evaluation and monitoring of the participants will be aware of the treatment received. The packaging and labelling of the investigational medicinal product (IMP) will contain no evidence of their identity. Since tralokinumab and placebo are visually distinct and not matched for viscosity, IMP will be handled and administered by a qualified, unblinded healthcare professional at the site who will not be involved in the management of trial participants and who will not perform any of the assessments.
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
Tralokinumab+TCS
Week 0 to Week 16: Tralokinumab will be given as subcutaneous injections. Participants will receive tralokinumab loading dose on Day 0 followed by multiple tralokinumab injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.
干预措施: Tralokinumab (Drug)
Tralokinumab+TCS
Week 0 to Week 16: Tralokinumab will be given as subcutaneous injections. Participants will receive tralokinumab loading dose on Day 0 followed by multiple tralokinumab injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.
干预措施: Topical corticosteroids (TCS) (Other)
Placebo+TCS
Week 0 to Week 16: Placebo will be given as subcutaneous injections. Participants will receive placebo loading dose on Day 0 followed by multiple placebo injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.
干预措施: Placebo (Drug)
Placebo+TCS
Week 0 to Week 16: Placebo will be given as subcutaneous injections. Participants will receive placebo loading dose on Day 0 followed by multiple placebo injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.
干预措施: Topical corticosteroids (TCS) (Other)
结局指标
主要结局
Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
时间窗: Week 16
IGA is an instrument used in clinical trials to rate the severity of the participant's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
时间窗: Week 0 to Week 16
Eczema Area and Severity Index (EASI) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. EASI is a composite index with scores ranging from 0 to 72, where higher values indicate a more severe or more extensive condition.
次要结局
- Change in Scoring Atopic Dermatitis (SCORAD) Total Score From Baseline to Week 16(Week 0 to Week 16)
- Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16.(Week 0 to Week 16)
- Number of Treatment-emergent Adverse Events From Baseline to Week 16 Per Subject(Week 0 to Week 16)
- At Least 90% Reduction in EASI (EASI90) at Week 16(Week 0 to Week 16)
- Percentage Change in EASI Score From Baseline to Week 16(Week 0 to Week 16)
- Change in Worst Daily Pruritus NRS Score (Weekly Average) From Baseline to Week 16(Week 0 to Week 16)
- Change in Eczema-related Sleep NRS Score (Weekly Average) From Baseline to Week 16(Week 0 to Week 16)
- Number of Subjects With Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16(Week 0 to Week 16)
- Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) Score (Weekly Average) of at Least 4 From Baseline to Week 16(Week 0 to Week 16)
- At Least 50% Reduction in EASI (EASI50) at Week 16(Week 0 to Week 16)
- Change in Patient-Oriented Eczema Measure (POEM) Score Form Baseline to Week 16(Week 0 to Week 16)