A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effect of Tralokinumab on Vaccine Antibody Responses in Adults With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Positive Anti-tetanus Response at Week 16
研究概览
简要总结
The purpose of this trial is to test if treatment with the trial drug, tralokinumab, can affect the body's immune response to vaccines. The trial will also evaluate the efficacy of tralokinumab when it is given concomitantly with vaccines.
The trial includes a screening period of 2 to 6 weeks, a treatment period of 16 weeks (Weeks 0 to 16), and a 14-week off-treatment follow-up period for the assessment of safety (Weeks 16 to 30). Eligible subjects may transfer to an open-label, long-term trial at Week 16 or later.
详细描述
Subjects with atopic dermatitis (AD) will be treated with either tralokinumab or dummy treatment (placebo) for 16 weeks. All subjects will receive 2 vaccines at Week 12. The vaccines are:
- Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis (whooping cough) vaccine. This combination vaccine is also known as the Tdap vaccine and is used to prevent these 3 diseases.
- Meningococcal vaccine. This vaccine is used to prevent meningococcal diseases (infection of the brain and spinal cord) and blood poisoning.
The primary objective of the trial is to demonstrate non-inferiority of tralokinumab versus placebo with respect to immune responses to concomitantly administered vaccines.
The secondary objective is to evaluate efficacy of tralokinumab concomitantly administered with vaccines.
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 tralokinumab/placebo will contain no evidence of their identity.
Since tralokinumab and placebo are visually distinct and not matched for viscosity, they will be handled and administered by a qualified, unblinded healthcare professional at the trial site who will not be involved in the management of trial subjects.
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 54 years
- •Diagnosis of AD as defined by 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 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
- •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 administration of the meningococcal vaccine provided in this trial is contraindicated or medically inadvisable, according to local label of the vaccine
- •Subjects for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this trial is contraindicated or medically inadvisable, according to local label of the vaccine
- •Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment
- •Use of tanning beds or phototherapy within 6 weeks prior to randomization
- •Treatment with systemic immunosuppressive/immunomodulating medications and/or systemic corticosteroids within 4 weeks prior to randomization
- •Treatment with the topical medications topical corticosteroids (TCS), topical calcineurin inhibitor (TCI) or phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomization
- •Receipt of any vaccine (except influenza virus vaccines) within 3 months prior to screening, any meningococcal vaccine within 1 year prior to screening, or any tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to screening
- •Receipt of any marketed (i.e. immunoglobulin, anti-IgE) or investigational biologic agent, including dupilumab
- •History of any active skin infection within 1 week prior to randomization
- •History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomization
研究组 & 干预措施
Tralokinumab
Week 0 to 16:
Tralokinumab will be given as subcutaneous injections.
Subjects will receive a tralokinumab loading dose at Day 0 followed by tralokinumab injection regimen A. The last administration will occur at Week 14.
干预措施: Tralokinumab (Drug)
Tralokinumab
Week 0 to 16:
Tralokinumab will be given as subcutaneous injections.
Subjects will receive a tralokinumab loading dose at Day 0 followed by tralokinumab injection regimen A. The last administration will occur at Week 14.
干预措施: Tdap vaccine (Biological)
Tralokinumab
Week 0 to 16:
Tralokinumab will be given as subcutaneous injections.
Subjects will receive a tralokinumab loading dose at Day 0 followed by tralokinumab injection regimen A. The last administration will occur at Week 14.
干预措施: Meningococcal vaccine (Biological)
Placebo
Placebo (dummy treatment) will be given as subcutaneous injections.
Subjects will receive a placebo loading dose at Day 0 followed by placebo injection regimen A. The last administration will occur at Week 14.
干预措施: Placebo (Drug)
Placebo
Placebo (dummy treatment) will be given as subcutaneous injections.
Subjects will receive a placebo loading dose at Day 0 followed by placebo injection regimen A. The last administration will occur at Week 14.
干预措施: Tdap vaccine (Biological)
Placebo
Placebo (dummy treatment) will be given as subcutaneous injections.
Subjects will receive a placebo loading dose at Day 0 followed by placebo injection regimen A. The last administration will occur at Week 14.
干预措施: Meningococcal vaccine (Biological)
结局指标
主要结局
Positive Anti-tetanus Response at Week 16
时间窗: Week 12 to Week 16
The antibody response to Tdap vaccine will be assessed by measuring serum anti-tetanus IgG by an immunoassay. A positive response is defined as a 3-fold IgG increase compared to Week 12 if IgG ≤1.0 IU/mL at Week 12; or IgG ≥2.5 IU/mL if IgG \>1.0 IU/mL at Week 12.
Positive Anti-meningococcal Response at Week 16
时间窗: Week 12 to Week 16
The antibody response to meningococcal vaccine will be assessed by measuring serum anti-meningococcal IgG by an immunoassay. A positive response is defined as at least a 3-fold increase compared to Week 12.
次要结局
- Number of AEs.(Week 0 to Week 16)
- Presence of Anti-drug Antibodies (ADA).(Week 0 to Week 16)
- Participants Achieving at Least 75% Reduction in Eczema Area and Severity Index (EASI) at Week 16.(Week 0 to Week 16)
- Participants With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16(Week 0 to Week 16)