A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) 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
- 301
- 试验地点
- 3
- 主要终点
- Subjects 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 evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.
Secondary objectives:
To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health-related quality of life compared with placebo.
To investigate the safety, immunogenicity, and tolerability of SC administration of tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.
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 healthcare 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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 to
- •Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- •History of AD for ≥1 year.
- •History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for whom these topical AD treatments are medically inadvisable.
- •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
- •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, 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.
- •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(Dose1) initial-> Tralokinumab(Dose1) maintenanceA
Week 0 to 16 (initial period):
Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.
Week 16 to 52 (maintenance period):
Tralokinumab (Dose 1) maintenance SC injection regimen A.
干预措施: Tralokinumab (Drug)
Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB
Week 0 to 16 (initial period):
Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.
Week 16 to 52 (maintenance period):
Tralokinumab (Dose 1) maintenance SC injection regimen B.
干预措施: Tralokinumab (Drug)
Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA
Week 0 to 16 (initial period):
Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.
Week 16 to 52 (maintenance period):
Tralokinumab (Dose 2) maintenance SC injection regimen A.
干预措施: Tralokinumab (Drug)
Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB
Week 0 to 16 (initial period):
Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.
Week 16 to 52 (maintenance period):
Tralokinumab (Dose 2) maintenance SC injection regimen B.
干预措施: Tralokinumab (Drug)
Placebo initial-> Placebo maintenance
Week 0 to 16 (initial period):
Placebo loading SC injection on Day 0 followed by placebo injection regimen A.
Week 16 to 52 (maintenance period):
Placebo continuation SC injection regimen A.
干预措施: Placebos (Drug)
Tralokinumab (Dose1) initial-> Open-label tralokinumab
Week 0 to 16 (initial period):
Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.
Week 16 to 52:
Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids
干预措施: Tralokinumab (Drug)
Tralokinumab (Dose2) initial-> Open-label tralokinumab
Week 0 to 16 (initial period):
Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.
Week 16 to 52:
Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids
干预措施: Tralokinumab (Drug)
Placebo initial-> Open-label tralokinumab
Week 0 to 16 (initial period):
Placebo loading SC injection on Day 0 followed by placebo injection regimen A.
Week 16 to 52:
Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids
干预措施: Tralokinumab (Drug)
Placebo initial-> Open-label tralokinumab
Week 0 to 16 (initial period):
Placebo loading SC injection on Day 0 followed by placebo injection regimen A.
Week 16 to 52:
Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids
干预措施: Placebos (Drug)
结局指标
主要结局
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
时间窗: At Week 16
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
时间窗: At Week 16
The EASI 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
- Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16(At Week 16)
- Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16(From Week 0 to Week 16)
- Number of Adverse Events(From Week 0 to Week 16)
- Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16(At Week 16)
- Participants With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16(At Week 16)
- Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16(At Week 52)
- Change in Children's Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16(From Week 0 to Week 16)
- Presence of Anti-drug Antibodies(From Week 0 to Week 16)
- Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.(At Week 16)
- Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.(At Week 16)
- Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16(From Week 0 to Week 16)
- Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16(At Week 16)
- Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16(From Week 0 to Week 16)
- Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16(From Week 0 to Week 16)
- Tralokinumab Serum Trough Concentration at Week 16(At Week 16)
- Tralokinumab Serum Trough Concentration at Week 66(At Week 66)
- Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16(At Week 52)