2024-518589-29-00招募中3 期
A Phase III, randomized, double-blind, placebo-controlled study to assess the Efficacy, Safety, and Tolerability of BI 1291583 2.5 mg administered once daily for up to 76 weeks in patients with Bronchiectasis (The AIRTIVITY® Study)
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.161 个研究点 分布在 5 个国家目标入组 433 人开始时间: 2025年7月31日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 433
- 试验地点
- 161
- 主要终点
- Annualized rate of pulmonary exacerbations (number of events per person year) up to Week 76.
研究概览
简要总结
To demonstrate superiority of BI 1291583 compared to placebo on the primary endpoint, the annualized rate of adjudicated pulmonary exacerbations in participants with bronchiectasis
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female participants. WOCBP must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the participant information.
- •Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation.
- •Age of participants when signing the informed consent ≥18 (at least the legal age of consent in countries where it is greater than 18 years) years.
- •Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan. Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.
- •Participants should be able to produce sputum for screening.
- •History of documented pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either: a. at least 2 exacerbations, or b. at least 1 exacerbation and an SGRQ Symptoms score of >40 at screening Visit 1; For participants on stable oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on CFTR-MT, at least one exacerbation must have occurred since initiation of stable antibiotics or CFTR-MT.
排除标准
- •Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
- •eGFR according to CKD-EPI formula <30 mL/min at Visit
- •Previous treatment with a DPP1 (CatC) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed).
- •Further exclusion criteria apply.
- •Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
- •Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
- •Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial.
- •Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit
- •Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.
- •Major surgery (major according to the investigator’s assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.
- •Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.
- •Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).
结局指标
主要结局
Annualized rate of pulmonary exacerbations (number of events per person year) up to Week 76.
Annualized rate of pulmonary exacerbations (number of events per person year) up to Week 76.
次要结局
- Absolute change from baseline in post-bronchodilator FEV1 %pred at Week 52
- Absolute change from baseline in QOL-B respiratory symptoms domain score at Week 52
- Time to first pulmonary exacerbation up to Week 76
- Absolute change from baseline in post-bronchodilator FVC %pred at Week 52
- Annualized rate of severe pulmonary exacerbations up to Week 76
- Time to first severe pulmonary exacerbation up to Week 76
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (161)
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