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

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

Secondary Outcome Measures

Name	Time	Method

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