A study to find out whether BI 1015550 improves lung function in people with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

Phase 1

• Conditions: Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs); MedDRA version: 23.1Level: LLTClassification code 10084309Term: Progressive fibrosing interstitial lung diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2022-001134-11-NL
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-13
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1041

Inclusion Criteria

1. Patients =18 years old at the time of signed informed consent.
2. Signed and dated written informed consent in accordance with ICH-GCP and local
legislation prior to admission to the trial.
3. Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed;
Section 3.3.1)
4. Patients may be either:
-- on a stable therapy* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. *stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks.
-- not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either AF-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.
5. Forced Vital Capacity (FVC) =45% of predicted normal at Visit 1.
6. DLCO corrected for Hemoglobin (Hb) [Visit 1] =25% predicted of normal at Visit 1.
7. Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method.
8. Patients treated with permitted immunosuppressive agents (other than corticosteroids) for an underlying systemic disease (e.g. MTX, AZA) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.
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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 441

Exclusion Criteria

1. Prebronchodilator FEV1/FVC <0.7 at Visit 1
2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
3. Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
4. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
5. Patients having developed ILD due to SARS-CoV-2 infection/COVID-19 within 12 months of screening (based on investigators judgement).
6. Major surgery (major according to the investigator’s assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery.
7. 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, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
8. AST or ALT >2.5 x ULN or total Bilirubin >1.5 x ULN at Visit 1.
9. eGFR =30 mL/min/1.73 m2 at Visit 1. (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula or Japanese version of CKD-EPI for Japanese patients)
10. Patients with underlying liver disease (Child Pugh A, B, or C hepatic impairment).
11. Cardiovascular diseases, any of the following:
a. Severe hypertension (uncontrolled under treatment =160/100 mmHg at multiple occasions) within 3 months of Visit 1
b. Myocardial infarction, stroke or transient ischemic attack within 6 months of Visit 1
c. Unstable cardiac angina within 6 months of Visit 1
12. Use of any of the following medications: prednisone >15mg/day or equivalent within 4 weeks of Visit 1; cyclophosphamide, tocilizumab, mycophenolate, pirfenidone within 8 weeks of Visit 1; rituximab within 6 months of Visit 1.

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