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A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

Phase 3
Completed
Conditions
Idiopathic Pulmonary Fibrosis
Interventions
Drug: Placebo
Registration Number
NCT05321069
Lead Sponsor
Boehringer Ingelheim
Brief Summary

This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, 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 IPF.

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1177
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BI 1015550 high doseBI 1015550-
PlaceboPlacebo-
BI 1015550 low doseBI 1015550-
Primary Outcome Measures
NameTimeMethod
Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52at baseline, at week 52
Secondary Outcome Measures
NameTimeMethod
Absolute change from baseline in DLCO % predicted at Week 52at baseline, at week 52
Time to hospitalization for respiratory cause or death over the duration of trialup to 30 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 trialup to 30 months
Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death (whichever occurs first) over the duration of the trialup to 30 months

Key secondary endpoint

Time to death over the duration of trialup to 30 months
Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52at baseline, at week 52

The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items).

The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score.

Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.

Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52at baseline, at week 52

The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items).

The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score.

Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.

Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52at baseline, at week 52

The L-PF is a 49-item questionnaire with two modules: Symptoms (28 items) and Impact (21 items).

The Symptom score has three domain scores: dyspnea, cough, and fatigue, as well as a total symptom score.

Items have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely", with higher numbers indicating a greater impairment.

Absolute change from baseline in FVC % predicted at Week 52at baseline, at week 52
Time to first acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation or death over the duration of trialup to 30 months
Time to absolute decline in FVC % predicted of >10% from baseline or death over the duration of the trialup to 30 months

Trial Locations

Locations (335)

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

University of Southern California

🇺🇸

Los Angeles, California, United States

Cedars-Sinai Medical Center

🇺🇸

Los Angeles, California, United States

University of California Los Angeles

🇺🇸

Los Angeles, California, United States

University of California Davis

🇺🇸

Sacramento, California, United States

National Jewish Health

🇺🇸

Denver, Colorado, United States

Yale University School of Medicine

🇺🇸

New Haven, Connecticut, United States

Christiana Hospital

🇺🇸

Newark, Delaware, United States

Georgetown University

🇺🇸

Washington, District of Columbia, United States

St. Francis Medical Institute

🇺🇸

Clearwater, Florida, United States

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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
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