jRCT2031250163招募中不适用
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Dose-Ranging Study to Investigate the Efficacy and Safety of PF-07275315 in Adult Participants With Inadequately Controlled Moderate-to-Severe Asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 252
- 主要终点
- Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 70age old under（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Must meet the following asthma criteria:
- •1.History of persistent, moderate-to-severe asthma for at least 12 months prior to screening.
- •2.Must have experienced at least 1 asthma exacerbation requiring treatment with systemic steroids (oral or parenteral) for 3 days or more within 12 months of the screening visit.
- •3.Pre-bronchodilator FEV1 of >=30% to <80% of predicted normal values during screening period.
- •4.Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period.
- •5.Maintenance (controller) treatment that minimally includes a medium to high dose ICS - LABA combination consistent with GINA Step 4/5 (either Track 1 or Track 2) for 12 months prior to the screening visit and at a stable dose for at least 3 months prior to the screening visit.
- •6.ACQ-5 score of >=1.5 at screening visit and prior to randomization.
- •Other Inclusion Criteria:
- •7.Body mass index between 18~40 kg/m2 at screening.
排除标准
- •Exclusion Criteria:
- •Medical Conditions:
- •1.Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •2.Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the screening visit, as per local standard of care, including but not limited to: Chronic obstructive pulmonary disease, Other emphysematous lung disease such as alpha-1 antitrypsin disease, Cystic fibrosis, Emphysema, Idiopathic pulmonary fibrosis, Churg-Strauss syndrome, Allergic bronchopulmonary aspergillosis, Sarcoidosis
- •3.Diagnosed with any of the following acute or chronic infections or infection history:
- •Active helminth or parasitic infection requiring treatment within 2 weeks prior to screening;
- •Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;
- •Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day
- •Prior/Concomitant Therapy:
- •4.Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- •5.Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4Ralpha, TSLP, IL-5, or IgE) or targeted synthetic drugs (such as JAK inhibitors) for the treatment of asthma or other type 2 inflammatory diseases, including but not limited to: AD, EoE, CRS.
- •6.Treatment with any dose level of systemic (oral or injectable) corticosteroids within 28 days of the screening visit through the end of study (except to treat an acute exacerbation).
- •7.Prior (within 12 weeks prior to screening) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).
- •8.History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products.
- •9.Bronchial thermoplasty within the previous 24 months.
- •Prior/Concurrent Clinical Study Experience:
- •10.Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
结局指标
主要结局
Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12
时间窗: Week 12
* FEV1: the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, obtained from spirometry
次要结局
未报告次要终点
研究者
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