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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 below
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My doctor confirmed I have a worsening lung condition that is not IPF.
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I am 18 years old or older.
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My doctor confirmed I have a worsening lung condition that is not IPF.
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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:
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I haven't had cancer, except for certain skin or cervical cancers, in the last 5 years.
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I do not have HIV or hepatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 31 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 31 months for reporting.

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 more

Side effects data

From 2021 Phase 2 trial • 147 Patients • NCT04419506
31%
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.

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

BI 1015550 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05321082 — Phase 3
Interstitial Lung Disease Research Study Groups: Placebo, BI 1015550 low dose, BI 1015550 high dose
Interstitial Lung Disease Clinical Trial 2023: BI 1015550 Highlights & Side Effects. Trial Name: NCT05321082 — Phase 3
BI 1015550 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05321082 — Phase 3
~91 spots leftby Dec 2024