An Open-label, Single-arm, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Administered by an Autoinjector 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
- 136
- 试验地点
- 2
- 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
The purpose of this trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (SC) injection by an autoinjector in adults and adolescents (age 12 to 17 years) with moderate-to-severe atopic dermatitis (AD).
详细描述
This is a single-arm, phase 3 trial designed to evaluate the efficacy and safety of tralokinumab when administered by an autoinjector in adults and adolescent subjects with moderate-to-severe AD. At baseline, the subjects will receive an initial SC dose of 600 mg tralokinumab. For the rest of the treatment period, all subjects will self-administer a dose of 300 mg tralokinumab every other week for 14 weeks.
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
- •Age 12 years and above.
- •Subject able and willing to self-administer tralokinumab with Device A.
- •Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- •History of AD for ≥1 year.
- •A recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medication or for whom topical treatments are otherwise medically inadvisable.
- •AD involvement of ≥10% body surface area at screening and baseline.
- •An EASI score of ≥12 at screening and ≥16 at baseline.
- •An IGA score of ≥3 at screening and at baseline.
- •Applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
排除标准
- •Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
- •Use of tanning beds or phototherapy within 4 weeks prior to baseline.
- •Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to baseline.
- •Treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase 4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to baseline.
- •Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to baseline.
- •Active skin infections within 1 week prior to baseline.
- •Clinically significant infection within 4 weeks prior to baseline.
- •A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
- •Tuberculosis requiring treatment within 12 months prior to screening.
- •Known primary immunodeficiency disorder.
研究组 & 干预措施
Tralokinumab subcutaneous dosing by an autoinjector
An initial SC dose of 600 mg tralokinumab at baseline followed by self-administration of a 300 mg dose of tralokinumab every other week for 14 weeks.
干预措施: Tralokinumab (Drug)
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: At 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: At 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
- Presence of Treatment-emergent Anti-drug Antibodies (ADA) From Baseline to Week 16(From Week 0 to Week 16)
- Number of Treatment-emergent Adverse Events (AEs) From Baseline to Week 16(From Week 0 to Week 16)