A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
- Registration Number
- NCT05321082
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1178
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 1015550 high dose BI 1015550 - Placebo Placebo - BI 1015550 low dose BI 1015550 -
- Primary Outcome Measures
Name Time Method Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52 at baseline, at week 52
- Secondary Outcome Measures
Name Time Method Time to first acute Interstitial Lung Disease (ILD) exacerbation or death over the duration of trial up to 31 months 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 31 months Key secondary endpoint
Time to hospitalization for respiratory cause or death over the duration of trial up to 31 months Time to death over the duration of trial up to 31 months Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52 at 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.Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial 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 up to 31 months Absolute change from baseline in DLCO % predicted at Week 52 at baseline, at week 52 Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score at Week 52 at baseline, at week 52 The L-PF is a 44-item questionnaire divided into two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module assesses shortness of breath, cough and fatigue in the past 24 hours.
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 52 at baseline, at week 52 Absolute change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score at Week 52 at baseline, at week 52 The L-PF is a 44-item questionnaire divided into two modules: Symptoms (23 items) and Impacts (21 items).
The Symptoms module assesses shortness of breath, cough and fatigue in the past 24 hours.
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.
Trial Locations
- Locations (403)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Arizona
🇺🇸Tucson, Arizona, 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
St. Francis Medical Institute
🇺🇸Clearwater, Florida, United States
Scroll for more (393 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States