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BI 1015550 for Interstitial Lung Disease
Phase 3
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed).
Patients ≥18 years old at the time of signed informed consent
Must not have
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
Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 31 months
Awards & highlights
Summary
This trial tests if BI 1015550 can help adults with certain progressive lung diseases. Participants take the medicine as tablets, and their lung function is checked over time to see if it improves. The study aims to find out if this new treatment can slow down the worsening of their lung condition.
Who is the study for?
Adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) other than Idiopathic Pulmonary Fibrosis can join this study. They must have a certain level of lung function, not have had recent severe respiratory infections or lung exacerbations, and women must use effective birth control. People with recent major surgeries or certain liver issues cannot participate.
What is being tested?
The trial is testing BI 1015550 to see if it improves lung function in PF-ILD patients. Participants are randomly assigned to receive either different doses of BI 1015550 or a placebo, resembling the actual drug but without active ingredients, for up to two and a half years with regular health checks.
What are the potential side effects?
While specific side effects aren't listed here, participants' health will be monitored for any unwanted effects throughout the study period. This includes checking for any adverse reactions related to the medication or placebo.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My doctor confirmed I have a worsening lung condition that is not IPF.
Select...
I am 18 years old or older.
Select...
My doctor confirmed I have a worsening lung condition that is not IPF.
Select...
I am using or willing to use effective birth control methods if I can have children.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had cancer, except for certain skin or cervical cancers, in the last 5 years.
Select...
I do not have HIV or hepatitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 31 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 31 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52
+1 moreSide effects data
From 2021 Phase 2 trial • 147 Patients • NCT0441950631%
Diarrhoea
8%
Nasopharyngitis
8%
Cough
6%
Headache
4%
Condition aggravated
4%
Flatulence
4%
Dyspepsia
2%
Fatigue
2%
Vasculitis
2%
Constipation
2%
Peripheral nerve paresis
2%
Nausea
2%
Asthenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
BI 1015550 - Antifibrotics at Baseline
Placebo - Antifibrotics at Baseline
Placebo - Non-antifibrotics at Baseline
BI 1015550 - Non-antifibrotics at Baseline
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 1015550 low doseExperimental Treatment1 Intervention
Group II: BI 1015550 high doseExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1015550
2023
Completed Phase 2
~600
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Interstitial Lung Disease (ILD) include antifibrotic agents like nintedanib and pirfenidone. Nintedanib works by inhibiting multiple tyrosine kinases involved in the fibrotic process, such as PDGF, FGF, and VEGF receptors, thereby slowing disease progression.
Pirfenidone has antifibrotic and anti-inflammatory effects, likely through the inhibition of TGF-β synthesis. These mechanisms are important for ILD patients as they can help slow lung fibrosis progression, improve lung function, and reduce acute exacerbations, ultimately enhancing the quality of life.
Treatment of connective tissue disease-associated interstitial lung disease: the pulmonologist's point of view.Emerging drugs for idiopathic pulmonary fibrosis.
Treatment of connective tissue disease-associated interstitial lung disease: the pulmonologist's point of view.Emerging drugs for idiopathic pulmonary fibrosis.
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,534 Previous Clinical Trials
11,378,963 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer, except for certain skin or cervical cancers, in the last 5 years.You must be able to breathe out a certain amount of air, which is at least 45% of what is expected for someone your age and size.Your lung function test shows that you have trouble breathing out air.I haven't had, nor do I plan to have, any major surgeries like a hip replacement during the trial.My doctor confirmed I have a worsening lung condition that is not IPF.Your liver tests show high levels of AST or ALT, or high levels of bilirubin.Your lung function test shows that the amount of oxygen your lungs can transfer to your blood is between 25% and 90% of what is expected for someone your age and size.I have been on a stable dose of immunosuppressants like MTX or AZA for at least 12 weeks.I developed lung issues from COVID-19 within the last year.Your lung function, measured by forced vital capacity, is at least 45% of what is expected for someone your age and size.I am 18 years old or older.My doctor confirmed I have a worsening lung condition that is not IPF.I haven't had a worsening of my lung condition in the last 3 months.I am using or willing to use effective birth control methods if I can have children.According to the doctor, you have other important lung problems.I do not have HIV or hepatitis.Your lung function is at least 25% of what is expected for someone of your age and size.I have signed and understand the consent form for this trial.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: BI 1015550 low dose
- Group 3: BI 1015550 high dose
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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