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BI 1015550 for Pulmonary Fibrosis (FIBRONEER™-ON Trial)

Phase 3
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

"This trial is for people with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis who have completed treatment with a medicine called BI 1015550 in a previous study. The goal is to see how

Who is the study for?
This trial is for people with idiopathic or progressive pulmonary fibrosis who completed a previous study (1305-0014 or 1305-0023) without dropping out early. They must consent to the study's rules and, if they can have children, agree to use effective birth control during the trial.
What is being tested?
The trial tests long-term tolerance of BI 1015550 in patients with pulmonary fibrosis. It aims to see if this drug improves lung function and delays worsening symptoms, hospital visits, or death. Participants take BI 1015550 tablets alongside their usual treatments for up to one year and ten months.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored regularly for any health issues that arise during treatment with BI 1015550.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BI 1015550 treatment groupExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1015550
2023
Completed Phase 2
~600

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,554 Previous Clinical Trials
15,895,595 Total Patients Enrolled
52 Trials studying Idiopathic Pulmonary Fibrosis
46,241 Patients Enrolled for Idiopathic Pulmonary Fibrosis
~1133 spots leftby Apr 2027
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