EUCTR2019-004167-45-IT进行中（未招募）1 期
A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. -
BOEHRINGER-INGELHEIM ITALIA S.P.A.0 个研究点目标入组 233 人开始时间: 2021年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 233
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients aged >=40 years when signing the informed consent.
- •- Diagnosis:
- •-- a. IPF based on 2018 ATS/ERS/JRS/ALAT Guideline [R18-2794] as
- •confirmed by the investigator based on chest HRCT scan taken within 12
- •months of Visit 1 and if available surgical lung biopsy. and
- •-- b. UIP or probable UIP HRCT pattern consistent with the clinical
- •diagnosis of IPF
- •- Stable for at least 8 weeks prior to Visit 1. Patients have to be either :
- •-- not on therapy with nintedanib or pirfenidone for at least 8 weeks
- •prior to Visit 1 (combination of nintedanib plus pirfenidone not allowed),
- •-- on stable* therapy with nintedanib or pirfenidone for at least 8 weeks
- •prior to Visit 1 and planning to stay stable on this background therapy
- •after randomisation.
- •- Forced Vital Capacity (FVC) >=45% of predicted normal at Visit 1
- •- DLCO (corrected for haemoglobin [Hb] [Visit 1]) >= 25% to < 80% of
- •predicted normal at Visit 1.
- •- Signed and dated written informed consent in accordance with ICHGCP
- •and local legislation prior to admission to the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Relevant airways obstruction (pre-bronchodilator FEV1/FVC < 0.7) at
- •- In the opinion of the Investigator, other clinically significant pulmonary
- •abnormalities.
- •- Acute IPF exacerbation within 4 months prior to screening and/or
- •during the screening period (investigator-determined).
- •- Lower respiratory tract infection requiring antibiotics within 4 weeks
- •prior to Visit 1 and/or during the screening period.
- •- Major surgery (major according to the investigator's assessment)
- •performed within 3 months prior to Visit 1 or planned during the course
- •of the trial. (Being on a transplant list is allowed).
- •- Any documented active or suspected malignancy or history of
- •malignancy within 5 years prior to Visit 1, except appropriately treated
- •basal cell carcinoma of the skin, under surveillance prostate cancer or
- •in situ carcinoma of uterine cervix.
- •- Evidence of active infection (chronic or acute) based on clinical exam
- •or laboratory findings (see table 5.2.3 :1) at Visit 1 or at Visit 2.
- •- Any suicidal behaviour in the past 2 years (i.e. actual attempt,
- •interrupted attempt, aborted attempt, or preparatory acts or behavior).
- •- Further criteria apply.
研究者
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