CTRI/2025/10/096069尚未招募3 期
A Phase III, randomised, 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)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,680
- 试验地点
- 8
- 主要终点
- To demonstrate superiority of BI 1291583 2.5 mg compared to placebo on the primary endpoint, the annualized rate of adjudicated pulmonary exacerbations in participants with bronchiectasis
研究概览
简要总结
The intent of this study is to evaluate the efficacy, safety, and tolerability of BI 1291583 2.5 mg q.d. compared to placebo in participants with bronchiectasis independent of underlying etiologies. The ability of BI 1291583 2.5 mg in reducing the number of pulmonary exacerbations over a treatment period of at least 52 weeks and up to 76 weeks along with a favourable benefit-risk ratio in patients with bronchiectasis will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female participants WOCBP1 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 1percent 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 more than equals to 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 (see the SOA).
- •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 more than 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
- •Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).
- •An absolute blood neutrophil count more than 1,000/mm3 (equivalent to more than 1,000 cells/micro L or more than 109 Cells per L) at Visit
- •eGFR according to CKD-EPI formula more than 30 mL per min at Visit
- •Total IgG levels more than 5g per l at Visit
- •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.
- •(Laboratory parameters from Visit 1 have to satisfy the laboratory threshold values as shown above.
- •Visit 2 laboratory results will be available only after randomisation.
- •In case at Visit 2 the results do no longer satisfy the entry criteria, the Investigator has to decide whether it is justified that the participant remains in the trial.
- •The justification for decision needs to be documented).
- •Relevant chronic or acute infections including but not limited to HIV and viral hepatitis.
- •Criteria for assessment of exclusionary lab tests for HIV and viral hepatitis.
结局指标
主要结局
To demonstrate superiority of BI 1291583 2.5 mg compared to placebo on the primary endpoint, the annualized rate of adjudicated pulmonary exacerbations in participants with bronchiectasis
时间窗: Week 76
次要结局
- To demonstrate a reduction in lung function decline as measured by the change from baseline in FEV1 %pred and FVC %pred, an improvement in the respiratory symptoms as measured by the absolute change from baseline in QOL-B respiratory symptoms score, a risk reduction in pulmonary exacerbations and a reduction in the annualized rate of severe pulmonary exacerbations for BI 1291583 2.5 mg when compared to placebo(Week 76)
研究者
研究点 (8)
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