A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT07036523
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to adults who are at least 40 years old and have idiopathic pulmonary fibrosis (IPF). People can participate in the study if they have a forced vital capacity (FVC) greater than or equal to 45% of the predicted value and fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan. The purpose of this study is to find out if a medicine called BI 765423 can improve lung function in people with IPF. The study will compare BI 765423 with a placebo to see if there is a difference in lung capacity after 3 months of treatment and will also look at changes in certain markers related to lung health.
Participants are put into two groups randomly, which means by chance. One group receives the study medicine, and the other group receives a placebo. Placebo looks like BI 765423 but does not contain any study medicine. The study medicine is given as an infusion into a vein every four weeks.
Participants are in the study for 8-10 months. During the study, participants may continue their regular treatment for IPF. During the study they visit the study site several times for screening, treatment, and follow-up. Doctors regularly test lung function by measuring FVC and take blood samples to measure study endpoints. The results are compared between the two groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 765423 BI 765423 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Absolute change from baseline in FVC (mL) at 12 weeks Baseline, 12 weeks
- Secondary Outcome Measures
Name Time Method Absolute change from baseline in log 10- transformed SP-D plasma concentration at 12 weeks Baseline, 12 weeks SP-D=Surfactant protein D
Absolute change from baseline in distance walked (m) during 6MWT at 12 weeks Baseline, 12 weeks 6MWT=6-minute walk test
Absolute change from baseline in FVC % predicted at 12 weeks Baseline, 12 weeks Absolute change from baseline in DLCO % predicted at 12 weeks Baseline, 12 weeks DLCO=Diffusing Capacity of the Lungs for Carbon Monoxide
Absolute change from baseline in SpO2 on room air at rest at 12 weeks Baseline, 12 weeks SPO2=Oxygen saturation
Trial Locations
- Locations (41)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
The Lung Research Center, LLC
🇺🇸Chesterfield, Missouri, United States
Columbia University Medical Center-New York Presbyterian Hospital
🇺🇸New York, New York, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Scroll for more (31 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States