A study to test how taking BI 1015550 for 12 weeks affects lung function in people with idiopathic pulmonary fibrosis (IPF).
- Conditions
- Idiopathic Pulmonary FibrosisMedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2019-004167-45-IT
- Lead Sponsor
- BOEHRINGER-INGELHEIM ITALIA S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 233
- 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),
or
-- 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
- Relevant airways obstruction (pre-bronchodilator FEV1/FVC < 0.7) at
Visit 1.
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To investigate the efficacy of BI 1015550 compared to placebo based on the change from baseline in Forced Vital Capacity (FVC).<br>- To investigate safety and tolerability of BI 1015550 in the overall trial population.;Secondary Objective: Not applicable;Primary end point(s): 1) The primary endpoint is the change from baseline in FVC;Timepoint(s) of evaluation of this end point: 1) 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) The percentage N (%) of patients with Treatment Emergent Adverse<br>Events (TEAE).;Timepoint(s) of evaluation of this end point: 1) 13 weeks