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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
Sponsor: Boehringer Ingelheim
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.
Official title: A Double-blind, Randomised, Placebo-controlled, Parallel Group, Phase IIa Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BI 765423 Administered Intravenously With or Without Standard of Care in Patients With Idiopathic Pulmonary Fibrosis
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2025-11-13
Completion Date
2027-09-02
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
BI 765423
BI 765423
Placebo
Placebo to BI 765423
Locations (50)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner - University Medical Center Tucson
Tucson, Arizona, United States
University of Florida
Gainesville, Florida, United States
Renstar Medical Research
Ocala, 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
University of Missouri Health System
Columbia, 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
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
The Oregon Clinic
Portland, Oregon, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, United States
University of Virginia Health System
Charlottesville, Virginia, United States
The Prince Charles Hospital
Chermside, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Institute for Respiratory Health
Nedlands, Western Australia, Australia
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, Belgium
Synergy Respiratory Care
Sherwood Park, Alberta, Canada
Kelowna Respirology & Allergy Research
Kelowna, British Columbia, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
ASST Papa Giovanni XXIII
Bergamo, Italy
A. O. Universitaria Careggi
Florence, Italy
A.O. dei Colli
Naples, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Torino, Italy
Tosei General Hospital
Aichi, Seto, Japan
University of Fukui Hospital
Fukui, Yoshida-gun, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, Japan
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Soonchunhyang University Hospital Seoul
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Hospital Vall Hebron
Barcelona, Spain
Hospital Universitari de Bellvitge
L Hospitalet Del Llobregat, Spain
Hospital Universitario De La Princesa
Madrid, Spain
Hospital Virgen del Rocío
Seville, Spain
Cantonal Hospital of Aarau
Aarau, Switzerland
Universitätsspital Basel
Basel, Switzerland