A study to find out whether BI 1015550 improves lung functionin people with Idiopathic Pulmonary Fibrosis (IPF)

Phase 1

• Conditions: Idiopathic Pulmonary Fibrosis (IPF); MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2022-001091-34-DK
• Lead Sponsor: Boehringer Ingelheim B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-13
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 963

Inclusion Criteria

Patients =40 years old at the time of signed consent
IPF diagnosis based on 2022 ATS/ERS/JRS/ALAT Guidelines
FVC =45% of predicted normal
DLCO =25% predicted of normal corrected for hemoglobin
On stable treatment with nintedanib or pirfenidone for at least
12 weeks or not on treatment with either nintedanib or
pirfenidone for at least 8 weeks
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 337
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 626

Exclusion Criteria

Prebronchodilator FEV1/FVC<0.7
Acute IPF exacerbation within 3 months and/or during the
screening period
Treated with immunomodulatory medications (other than oral
corticosteroids) or prednisone >15 mg/day or equivalent for
respiratory or pulmonary reasons
Active, unstable or uncontrolled vasculitis within 8 weeks
Any suicidal behaviour in the past 2 years
Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to demonstrate a reduction in lung function<br>decline as measured by the change from baseline in FVC for<br>BI 1015550 when compared to placebo in patients with IPF.;Secondary Objective: The main secondary objective of the trial is to demonstrate<br>BI 1015550’s ability in reducing the occurrence of clinically<br>meaningful events such as acute IPF exacerbation, hospitalization<br>for respiratory cause or death over the duration of the trial when<br>compared to placebo in patients with IPF. An additional secondary<br>objective of the trial is to show an effect of BI 1015550 on<br>symptoms and lung function.;Primary end point(s): The primary endpoint is the absolute change from baseline in FVC<br>[mL] at Week 52.;Timepoint(s) of evaluation of this end point: after 52 weeks of trial treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The key secondary endpoint in this trial is time to the first<br>occurrence of any of the components of the composite endpoint: time<br>to first acute IPF exacerbation, first hospitalization for respiratory<br>cause, or death (whichever occurs first) over the duration of the trial.;Timepoint(s) of evaluation of this end point: during the whole duration of the trial