A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

Phase 3

Recruiting

Conditions: PF-ILD
progressive fibrosing interstitial lung diseases
10038716

Registration Number: NL-OMON53889

Lead Sponsor: Boehringer Ingelheim

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 29

Inclusion Criteria

1. Patients >=18 years old at the time of signed informed consent 2. Progressive
fibrosing ILD other than IPF based on predefined criteria 3. Forced Vital
Capacity (FVC) >=45% of predicted normal 4. DLCO >=25% of predicted normal
corrected for Haemoglobin (Hb) 5. 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 6. Signed and dated written informed consent
in accordance with ICH-GCP and local legislation prior to admission to the
trial

Exclusion Criteria

1.Prebronchodilator FEV1/FVC <0.7) 2. Acute IPF exacerbation within 3 months
and / or during the screening period 3. Treated with prednisone >15mg/day or
equivalent within 4 weeks; cyclophosphamide, tocilizumab, mycophenolate,
pirfenidone within 8 weeks; rituximab within 6 months 4. Active, unstable or
uncontrolled vasculitis within 8 weeks 5. Any suicidal behavior in the past 2
years 6. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3
months 7. In the opinion of the Investigator, other clinically significant
pulmonary abnormalities

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to demonstrate a reduction in lung function decline as<br /><br>measured by the change from baseline in FVC for BI 1015550 compared to placebo<br /><br>in patients with progressive fibrosing ILDs.<br /><br><br /><br>The primary endpoint of the study is the absolute change from baseline in<br /><br>forced vital capacity (FVC) [ml] at week 52.</p><br>

Secondary Outcome Measures