A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With 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
- 277
- 试验地点
- 1
- 主要终点
- At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to 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 severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA).
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 to placebo in combination with TCS.
To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.
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)
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 or more
- •Subjects with a history within 1 year prior to screening of inadequate response to treatment with topical medications or subjects for whom topical treatments are otherwise medically inadvisable
- •AD involvement of 10% (or more) body surface area at screening and baseline (visit 3) according to component A of SCORAD
- •Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted
- •Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation
排除标准
- •Subjects for whom TCSs are medically inadvisable in the opinion of the investigator
- •Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to randomisation
- •Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to randomisation
- •Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to randomisation
- •Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents or dupilumab) within 6 months prior to randomisation or until cell counts return to normal, whichever is longer
- •History of any active skin infection within 1 week prior to randomisation
- •History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomisation
- •A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
- •Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care
- •History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the subject taking antiretroviral medications
研究组 & 干预措施
Tralokinumab + TCS
4 subcutaneous (SC) injections of tralokinumab 150 mg as a loading dose on Day 0, followed by 2 SC injections of tralokinumab 150 mg every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.
干预措施: Tralokinumab (Drug)
Placebo + TCS
4 subcutaneous (SC) injections of placebo as a loading dose on Day 0, followed by 2 SC injections of placebo every 2 weeks (Q2W) regimen for 26 weeks. The last administration of the Investigational Medicinal Product (IMP) occurred at Week 24. From Day 0 to Week 24, a Topical corticosteroid (TCS) cream was dispensed to the participants at each IMP dosing visit (e.g., Q2W). Participants were instructed to treat active lesions as needed and to discontinue the TCS treatment when control was achieved.
干预措施: Placebo (Other)
结局指标
主要结局
At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 16
时间窗: Week 0 to Week 16
EASI (Eczema Area and Severity Index) is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
次要结局
- Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 16(Week 0 to Week 16)
- Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 16(Week 0 to Week 16)
- Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 26(Week 0 to Week 26)
- Frequency of Anti-drug Antibodies (ADA) From Week 0 to Week 40(Week 0 to Week 40)
- Number of Adverse Events From Week 0 to Week 40(Week 0 to Week 40)
- Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16(Week 16)
- At Least 75% Reduction in Eczema Area and Severity Index (EASI75) From Week 0 to Week 26(Week 0 to Week 26)
- Reduction of Worst Daily Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Week 0 to Week 26(Week 0 to Week 26)
- Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 26(Week 26)
- Change in Dermatology Life Quality Index (DLQI) Score From Week 0 to Week 16(Week 0 to Week 16)
- Change in Scoring Atopic Dermatitis (SCORAD) From Week 0 to Week 26(Week 0 to Week 26)