A Phase 2 Randomized, Double-blind Placebo-Controlled Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety and Efficacy of WIN378 in Adult Participants With Moderate or Severe Asthma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 64
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs) during the study
研究概览
简要总结
This study is trying to identify the right dose of a long-acting medicine called WIN378 for people with moderate or severe asthma. WIN378 blocks the action of a protein called TSLP which causes inflammation in the lung and may contribute to your asthma control and symptoms. The study will test how doses of WIN378 are handled by your body (pharmacokinetics) and assess the safety of the medicine and will assess markers of asthma inflammation in your breath and in your blood, lung function and asthma control (pharmacodynamics).
详细描述
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy and pharmacokinetics of WIN378 in adult participants with moderate to severe asthma. Participants will continue their standard background asthma therapy according to GINA Steps 3-5. Eligible participants will be randomized to receive WIN378 or placebo administered subcutaneously over a 48-week treatment period, followed by a 12-week safety follow-up.
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
Double-blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent Form
- •Females that are not pregnant or breastfeeding with following condition: not a woman of childbearing potential or woman of childbearing potential using a highly effective contraception method
- •Physician-diagnosis of asthma and documented evidence of airway reversibility during prior 24 months or during screening
- •Airflow limitation as indicated by pre-BD FEV1 value of ≥ 30% and ≤ 90%, predicted at two visits at Screening
- •Low, medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline)
排除标准
- •Participants with a known, pre-existing, clinically important lung condition other than asthma
- •Active tuberculosis or treatment required for tuberculosis within 12 months
- •Current or former smokers ≥10 pack years
- •History of cancer
- •Receipt of any marketed biologic agent within 4 months or 5 half-lives prior to screening; receipt of immunoglobulin or blood products within 30 days prior to screening or during the Screening Run-in period; receipt of any live or attenuated vaccines within 15 days prior to screening
- •Helminth infection within 24 weeks prior to screening
- •Use of immunosuppressive medication within 3 months prior to Screening Visit or during the Screening Run-in period
- •Participants who are pregnant, lactating or breastfeeding
研究组 & 干预措施
WIN378
WIN378 SC injections
干预措施: WIN378 (Drug)
Placebo
Placebo SC Injections
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs) during the study
时间窗: Week 0 - Week 60
Number of participants with treatment-emergent serious adverse events (TESAEs) during the study
时间窗: Week 0 - Week 60
Number of participants with abnormal vital signs during the study
时间窗: Week 0 - Week 60
Number of participants with abnormal laboratory assessments during the study
时间窗: Week 0 - Week 60
Number of participants with Clinically significant abnormal ECG results during the study
时间窗: Week 0 - Week 60
WIN 378 Pharmacokinetics: concentration at trough [Ctrough]
时间窗: Week 0 - Week 60
WIN 378 Pharmacokinetics: area under the concentration time curve [AUC]
时间窗: Week 0 - Week 60
WIN 378 Pharmacokinetics: maximum observed concentration [Cmax])
时间窗: Week 0 - Week 60
Number of participants with positive anti-drug antibodies (ADA) during the study
时间窗: Week 0 - Week 60
次要结局
- Change from baseline in FeNO at Week 24 and Week 48(Week 0 - Week 24, Week 48)
- Change from Baseline in Blood eosinophil count at Week 24 and Week 48(Week 0 - Week 24, Week 48)
- Change in pre-BD and post-BD FEV1 at Week 24 and Week 48(Week 0 - Week 24, Week 48)
- Change in pre-BD and post-BD forced vital capacity (FVC) at Week 24 and Week 48(Week 0 - Week 24, Week 48)
- Annualized asthma exacerbation rate (AAER) over 48 weeks(Week 0 - Week 48)
- Annualized rate of severe asthma exacerbations over 48 weeks(Week 0 - Week 48)
- Time to first asthma exacerbation/severe asthma exacerbation over 48 weeks(Week 0 - Week 48)
- Proportion of participants with 1 or more asthma exacerbations/severe asthma exacerbations over 48 weeks(Week 0 - Week 48)
- Change from baseline in asthma symptoms (daytime and nighttime symptom frequency and severity, activity avoidance and limitation, asthma-related stress and fatigue as well as rescue asthma medication use) as measured by the Asthma Symptom Diary(Week 0 - Week 48)
- Change from baseline in Asthma Control Questionnaire (ACQ-6) at Week 48(Week 0 - Week 48)
- Change from baseline in Asthma Quality of Life Questionnaire (Standardised) + 12 at Week 48(Week 0 - Week 48)
- Change from baseline in European Quality of Life - 5 Dimensions 5 Level Version (EQ-5D-5L) at Week 48(Week 0 - Week 48)