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RECRUITING
NCT07036523
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

BI 765423

BI 765423

DRUG

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