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A study to find out whether BI 1015550 improves lung function in people with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
EU CTIS ID: 2024-512803-37-00
What this study is testing
"The trial will evaluate efficacy and safety of BI 1015550. 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."
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients ≥18 years old at the time of signed informed consent.
- Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial.
- Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed; see study protocol)
- 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."
- Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1
- DLCO corrected for Hemoglobin (Hb) [Visit 1] ≥25% predicted of normal at Visit 1.
You likely can't join if
- Prebronchodilator FEV1/FVC <0.7 at Visit 1
- In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
- Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
- Patients having developed ILD due to SARS-CoV-2 infection/COVID-19 within 12 months of screening (based on investigators judgement).
- 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."
See the full eligibility criteria
- Patients ≥18 years old at the time of signed informed consent.
- Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial.
- Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed; see study protocol)
- 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."
- Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1
- DLCO corrected for Hemoglobin (Hb) [Visit 1] ≥25% predicted of normal at Visit 1.
- 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.
- 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.
- Prebronchodilator FEV1/FVC <0.7 at Visit 1
- In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
- Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
- Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
- Patients having developed ILD due to SARS-CoV-2 infection/COVID-19 within 12 months of screening (based on investigators judgement).
- 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."
- 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.
- AST or ALT >2.5 x ULN or total Bilirubin >1.5 x ULN at Visit 1.
- Further exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- New Zealand
- Saudi Arabia
- Switzerland
- Georgia
- Australia
- Japan
- Serbia
- India
- South Africa
- Singapore
- China
- Thailand
- Brazil
- Korea, Republic of
- Turkey
- Argentina
- Israel
- Taiwan
- Malaysia
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; New Zealand; Saudi Arabia; Switzerland; Georgia; Australia and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.