A Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Tralokinumab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 58
- 主要终点
- Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12
研究概览
简要总结
The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of atopic dermatitis for greater than (>) 1 year
- •Atopic dermatitis involvement of greater than or equal to (>=) 10 percent (%) body surface area
- •EASI score of >= 12
- •SCORAD of >= 25
- •IGA score of >= 3
- •Effective birth control in line with protocol details
排除标准
- •History of anaphylaxis following any biologic therapy
- •Hepatitis B, C or human immunodeficiency virus
- •Pregnant or breastfeeding
- •History of cancer
- •Previous receipt of tralokinumab
研究组 & 干预措施
Placebo
Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
干预措施: Placebo (Other)
Tralokinumab Dose 1
Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
干预措施: Tralokinumab Dose 1 (Biological)
Tralokinumab Dose 2
Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
干预措施: Tralokinumab Dose 2 (Biological)
Tralokinumab Dose 3
Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
干预措施: Tralokinumab Dose 3 (Biological)
结局指标
主要结局
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12
时间窗: Week 12
The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
时间窗: Baseline (Day 1) and Week 12
EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(From Study Drug Administration (Day 1) to Week 22)
- Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events(From Study Drug Administration (Day 1) to Week 22)
- Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events(From Study Drug Administration (Day 1) to Week 22)
- Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events(From Study Drug Administration (Day 1) to Week 22)
- Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12(Week 12)
- Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12(Baseline (Day 1) and Week 12)
- Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12(Week 12)
- Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12(Baseline (Day 1) and Week 12)