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BI 1015550 for Idiopathic Pulmonary Fibrosis
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 Idiopathic Pulmonary Fibrosis (IPF)
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 months
Awards & highlights
Study Summary
This trial is for adults with IPF who are 40 years or older. It is testing whether BI 1015550 helps people with IPF.
Who is the study for?
Adults aged 40 or older with Idiopathic Pulmonary Fibrosis (IPF) can join this study. They may continue existing treatments with nintedanib or pirfenidone if stable for at least 12 weeks. Participants must have a certain level of lung function and women able to bear children must use effective birth control.Check my eligibility
What is being tested?
The trial is testing BI 1015550, a new medicine for IPF, given as tablets twice daily against placebo (no active medicine). There are three groups: two different doses of BI 1015550 and one placebo group. The study lasts up to two and a half years with regular lung function tests.See study design
What are the potential side effects?
While the specific side effects of BI 1015550 aren't listed here, common side effects in trials like this could include gastrointestinal issues, skin reactions, liver enzyme changes, fatigue, and potential risks associated with long-term medication use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Idiopathic Pulmonary Fibrosis.
Select...
I have signed and understand the consent form for this trial.
Select...
I am using or willing to use effective birth control methods if I can have children.
Select...
I have been on a stable dose of either nintedanib or pirfenidone for at least 12 weeks.
Select...
I am 40 years old or older.
Select...
I haven't taken nintedanib or pirfenidone in the last 8 weeks and don't plan to start them.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Vital capacity
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
11,339,115 Total Patients Enrolled
49 Trials studying Idiopathic Pulmonary Fibrosis
43,906 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Idiopathic Pulmonary Fibrosis.I have signed and understand the consent form for this trial.I am using or willing to use effective birth control methods if I can have children.I have been on a stable dose of either nintedanib or pirfenidone for at least 12 weeks.I haven't had cancer in the last 5 years, except for certain skin or cervical cancers.I tested positive for COVID-19 and haven't fully recovered in the last 4 weeks.I haven't had, nor do I plan to have, any major surgery within 6 weeks before or during the trial.The doctor thinks you have other important lung problems.I have had a sudden worsening of my lung condition in the last 3 months.I am 40 years old or older.Your breathing test results show that you have trouble exhaling air from your lungs.Your liver tests show high levels of AST or ALT, or high levels of bilirubin.I haven't taken nintedanib or pirfenidone in the last 8 weeks and don't plan to start them.Your lung function, measured by a test called DLCO, is at least 25% of what is expected for someone your age, weight, and height.I do not have HIV or hepatitis.Your lung function, measured by Forced Vital Capacity, should be at least 45% of what is expected for someone of your age, height, and gender.
Research Study Groups:
This trial has the following groups:- Group 1: BI 1015550 low dose
- Group 2: BI 1015550 high dose
- Group 3: Placebo
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.
Idiopathic Pulmonary Fibrosis Patient Testimony for trial: Trial Name: NCT05321069 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elaborate on the potential dangers of BI 1015550 - Treatment?
"BI 1015550 - Treatment received a safety score of 3 from our analysts at Power. This is because it is a Phase 3 trial, meaning that not only does some data support efficacy, but multiple rounds of data also support safety."
Answered by AI
Who else is applying?
What state do they live in?
British Columbia
Minnesota
What site did they apply to?
Premier Pulmonary Critical Care and Sleep Medicine
Destin Pulmonary Critical Care
Minnesota Lung Center and Sleep Institute
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
The drugs that are out there my system will not tolerate. Looking for an alternative..
PatientReceived 1 prior treatment
i have tried other drug and it was working for the past 3 years and now it appears to be not working.
PatientReceived no prior treatments
I am young.My age is 32 and diagnosed with ippfe.There is no any cure for this disease so I want to try the clinical trials.Thanks.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How many visits per week?
PatientReceived 2+ prior treatments
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