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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 31 months
Awards & highlights
Study Summary
This trialis testing a medicine to help people with Progressive Fibrosing Interstitial Lung Diseases. Participants take tablets and visit the study site for up to two and a half years for regular tests and checkups.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52
Secondary outcome measures
Absolute change from baseline in DLCO % predicted at Week 52
Absolute change from baseline in FVC % predicted at Week 52
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52
+8 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
Placebo - Antifibrotics at Baseline
BI 1015550 - 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
~470
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,339,114 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently being signed up for this clinical trial?
"That is correct. The information available on clinicaltrials.gov shows that this trial is open and recruiting patients. This study was first posted on October 5th, 2020 and was last edited on October 21st, 2020. There are 8 locations enrolling a total of 1041 participants."
Answered by AI
Has the FDA cleared BI 1015550 - Treatment for use?
"There is some evidence that this BI 1015550 - Treatment is effective, as this is a Phase 3 trial. Furthermore, there is data from multiple rounds supporting the safety of this intervention, leading to a safety score of 3."
Answered by AI
How many people meet the requirements to participate in this test?
"Yes, this is an active recruitment trial, as evidenced by the listing on clinicaltrials.gov. This particular trial was posted on October 5th, 2022 and was updated on October 21st, 2022. The study requires 1041 patients from 8 different sites."
Answered by AI
Who else is applying?
What site did they apply to?
Yale University School of Medicine
University of Minnesota
University of California Davis
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I am currently taking Ofev 2x daily.
PatientReceived 1 prior treatment
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