A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Subjects With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 380
- 试验地点
- 63
- 主要终点
- Participants With 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 demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to 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, and health-related quality of life 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 32 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 subject nor any of the investigator or LEO staff who are involved in the treatment or clinical evaluation and monitoring of the subjects will be aware of the treatment received. The packaging and labelling of the investigational medicinal products (IMPs) 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 health-care professional at the site who will not be involved in the management of trial subjects 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
- •Age 18 and above.
- •Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- •History of AD for ≥1 year.
- •Subjects who have a recent history of inadequate response to treatment with topical medications.
- •AD involvement of ≥10% body surface area at screening and baseline.
- •Stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
排除标准
- •Subjects for whom TCS are medically inadvisable e.g., due to important side effects or safety risks in the opinion of the investigator.
- •Active dermatologic conditions that may confound the diagnosis of AD.
- •Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
- •Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
- •Treatment with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation.
- •Receipt of any marketed biological therapy (i.e. immunoglobulin, anti- immunoglobulin E) including dupilumab or investigational biologic agents within 3 months or 5 half-lives, whichever is longer prior to randomisation.
- •Active skin infection within 1 week prior to randomisation.
- •Clinically significant infection within 4 weeks prior to randomisation.
- •A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
- •Tuberculosis requiring treatment within the 12 months prior to screening.
- •Known primary immunodeficiency disorder.
研究组 & 干预措施
Tralokinumab(initial)responders-> Tralokinumab(continuation A)
Week 0 to 16 (initial period):
Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A.
Week 16 to 32 (continuation period):
Tralokinumab continuation SC injection regimen A.
干预措施: Tralokinumab (Drug)
Tralokinumab(initial)responders-> Tralokinumab(continuation B)
Week 0 to 16 (initial period):
Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A.
Week 16 to 32 (continuation period):
Tralokinumab continuation SC injection regimen B.
干预措施: Tralokinumab (Drug)
Tralokinumab(initial)non-respon-> Tralokinumab(continuation A)
Week 0 to 16 (initial period):
Tralokinumab loading SC injection on Day 0 followed by tralokinumab injection regimen A.
Week 16 to 32 (continuation period):
Tralokinumab continuation SC injection regimen A.
干预措施: Tralokinumab (Drug)
Placebo (initial)non-respon-> Tralokinumab(continuation A)
Week 0 to 16 (initial period):
Placebo loading SC injection on Day 0 followed by placebo injection regimen A.
Week 16 to 32 (continuation period):
Tralokinumab continuation SC injection regimen A.
干预措施: Tralokinumab (Drug)
Placebo (initial)non-respon-> Tralokinumab(continuation A)
Week 0 to 16 (initial period):
Placebo loading SC injection on Day 0 followed by placebo injection regimen A.
Week 16 to 32 (continuation period):
Tralokinumab continuation SC injection regimen A.
干预措施: Placebo (Drug)
Placebo(initial)responders-> Placebo(continuation A)
Week 0 to 16 (initial period):
Placebo loading SC injection on Day 0 followed by placebo injection regimen A.
Week 16 to 32 (continuation period):
Placebo continuation SC injection regimen A.
干预措施: Placebo (Drug)
结局指标
主要结局
Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
时间窗: Week 16
IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).
Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16
时间窗: Week 16
EASI is used to evaluate the extent and severity of atopic dermatitis. It is a composite score ranging from 0 to 72 with a higher score indicating a more extensive and/or severe condition.
次要结局
- Change in Dermatology Life Quality Index (DLQI) Score From Baseline to Week 16(Week 0 to Week 16)
- Number of Atopic Dermatitis Flares Through Week 16(Week 0 to Week 16)
- Participants Achieving at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16(Week 16)
- Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 32 Among Participants With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab(Week 32)
- Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16(Week 0 to Week 16)
- Participants Achieving at Least 50% Reduction in Eczema Area and Severity Index (EASI) at Week 16(Week 16)
- Change From Baseline to Week 16 in Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average)(Week 0 to Week 16)
- Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16(Week 0 to Week 16)
- Frequency of Anti-drug Antibodies (ADA)(Week 0 to Week 16, Week 16 to Week 32)
- Number of Days Without Topical Treatment Use From Baseline to Week 16(Week 1 to Week 16)
- Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming no TCS Used From the Non-returned Tubes(Week 1-2 to Week 15-16)
- Amount of Topical Corticosteroid (TCS) Used Through Week 16 Assuming All TCS Used From the Non-returned Tubes(Week 1-2 to Week 15-16)
- Participants Achieving at Least 90% Reduction in Eczema Area and Severity Index (EASI) at Week 16(Week 16)
- Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score(Week 0 to Week 16)
- Participants Achieving at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD) at Week 16(Week 16)
- Reduction From Baseline to Week 16 of Dermatology Life Quality Index (DLQI) of at Least 4 Points Among Participants With Baseline DLQI ≥4(Week 0 to Week 16)
- Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 32 Among Participants Who Had Achieved at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab(Week 32)