BI 1015550 - Treatment for Interstitial Lung Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Interstitial Lung DiseaseBI 1015550 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligible Conditions
  • Interstitial Lung Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 18 Secondary · Reporting Duration: up to 32 months

Week 52
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 Forced Vital Capacity (FVC) (mL) at Week 52
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
Key secondary endpoint: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms cough domain score at Week 52
Key secondary endpoint: Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms dyspnea domain score at Week 52
up to 31 months
Time to absolute decline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % predicted of >15% from baseline or death over the duration of the trial
Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial
Time to death over the duration of trial
Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the duration of trial
Time to hospitalization for respiratory cause or death over the duration of trial
Time to the first occurrence of any of the components of the composite endpoint: time to first acute ILD exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trial
up to 32 months
Time to 10% absolute FVC drop from baseline or death over the whole trial
Time to death over the whole trial
Time to first acute ILD exacerbation over the whole trial
Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the whole trial
Time to hospitalization for respiratory cause or death over the whole trial

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

BI 1015550 - Antifibrotics at Baseline
31%Diarrhoea
8%Nasopharyngitis
8%Cough
6%Headache
4%Flatulence
4%Condition aggravated
4%Dyspepsia
2%Nausea
2%Fatigue
2%Constipation
2%Vasculitis
2%Peripheral nerve paresis
2%Asthenia
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT04419506) in the BI 1015550 - Antifibrotics at Baseline ARM group. Side effects include: Diarrhoea with 31%, Nasopharyngitis with 8%, Cough with 8%, Headache with 6%, Flatulence with 4%.

Trial Design

4 Treatment Groups

BI 1015550 - Treatment
1 of 4
BI 1015550 low dose
1 of 4
BI 1015550 high dose
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

1041 Total Participants · 4 Treatment Groups

Primary Treatment: BI 1015550 - Treatment · Has Placebo Group · Phase 3

BI 1015550 - Treatment
Drug
Experimental Group · 1 Intervention: BI 1015550 · Intervention Types: Drug
BI 1015550 low dose
Drug
Experimental Group · 1 Intervention: BI 1015550 · Intervention Types: Drug
BI 1015550 high dose
Drug
Experimental Group · 1 Intervention: BI 1015550 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1015550
2018
Completed Phase 2
~360

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 32 months

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,385 Previous Clinical Trials
9,802,916 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have given informed consent to participate in the trial.
You have a forced vital capacity (FVC) ≥45% of predicted normal at visit 1.
DLCO corrected for Hb ≥25% and <90% predicted of normal at Visit 1.