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NCT07036523PHASE2Recruiting

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

Boehringer Ingelheim

Start Date

11/13/2025

Completion Date

6/22/2027

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 3-6 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 up to 11 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.

Eligibility Criteria

Age Range: 40 years to No maximum

Inclusion Criteria : 1. 40 years of age or older at the time of informed consent signature. 2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. 3. Male or female patients. Male patients must not donate sperm while taking part in this study and for a specific period after the last dose of the IMP. Male patients with woman of childbearing potential (WOCBP) sexual partners must use contraception (male condom) to avoid exposure via seminal fluid during treatment and for a specific period after last drug intake. Women can only be included if they are of non-childbearing potential, defined as meeting at least one of the below conditions: * Permanently surgically sterilised (hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy) * Postmenopausal, defined as no menses for 12 months without an alternative medical cause. In questionable cases wherein the menopausal status is uncertain and cannot be clearly determined, the following should be taken into consideration by the investigator: * Women not using sex hormone medication such as hormone replacement therapy may be included if a blood sample confirms levels of follicle stimulating hormone (FSH) \> 40 U/L and estradiol \< 30 ng/L" 4. Patients with a documented diagnosis of IPF prior to Visit 1, confirmed by the investigator as per the 2022 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) Guideline and, if available, surgical lung biopsy or transbronchial lung cryobiopsy histopathology report. 5. Patients with a high-resolution computed tomography (HRCT) taken within 12 months of Visit 1 (or during the screening period, if not available) confirming "UIP" or "probable UIP" HRCT pattern consistent with the clinical diagnosis of IPF by central review (prior to Visit 2). * Patients with an "indeterminate" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed based on an historical histopathology report of a surgical lung biopsy or cryobiopsy demonstrating a "UIP" or "Probable UIP" pattern or Multidisciplinary Discussion and Diagnosis as per ATS guidelines. * Patients with an "alternative diagnosis" HRCT finding are eligible if a clinical diagnosis of IPF can be confirmed based on an historical histopathology report of a surgical lung biopsy or cryobiopsy demonstrating a "UIP" pattern Multidisciplinary Discussion and Diagnosis as per ATS guidelines. 6. Patients with an extent of fibrosis ≥20% as per an HRCT of the chest performed within 12 months prior to Visit 1 or during the screening period (if not available) and confirmed by central review. 7. Patients with a Forced vital capacity (FVC) ≥45% predicted at Visit 1. Predicted normal values will be calculated according to Global Lung Initiative (GLI). 8. Patients with haemoglobin-corrected diffusing capacity of the lungs for carbon monoxide (DLCO) ≥20% predicted at Visit 1. Further inclusion criteria apply. Exclusion criteria: 1. Acute exacerbation of IPF within at least 12 weeks prior to Visit 1 and/or during the screening period (investigator-determined). 2. Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC \<0.7) at Visit 1. 3. Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period. 4. Significant PH defined by any of the following: * Previous clinical or echocardiographic evidence of significant right heart failure according to investigator's judgement * History of right heart catheterisation showing a cardiac index ≤2 L/min/m\^² * PH requiring parenteral therapy with prostanoids 5. On nintedanib or pirfenidone treatment for less than 12 weeks prior Visit 1, planning to start nintedanib or pirfenidone within the first 12 weeks of investigational medicinal product (IMP) treatment or on combined nintedanib plus pirfenidone treatment. Newly diagnosed patients considered in need of SoC treatment during the next 12 weeks by the treating physician, who would be withheld SoC treatment only for the sake of participation in the trial, should also be excluded. 6. Cardiovascular comorbidities including * Severe hypertension (uncontrolled under treatment≥160/100 mmHg at multiple occasions) within 3 months of Visit 1 * Myocardial infarction, stroke, or transient ischemic attack within 6 months of Visit 1 * Unstable cardiac angina within 6 months of Visit 1 7. Life expectancy for any concomitant disease other than IPF \<2.5 years (investigator assessment). Further exclusion criteria apply.

Interventions

DRUG

BI 765423

DRUG

Placebo

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Conditions

Idiopathic Pulmonary Fibrosis

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

University of Florida

Gainesville, Florida 32610

United States

Renstar Medical Research

Ocala, Florida 34470

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242

United States

University of Kansas Medical Center

Kansas City, Kansas 66103-2937

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

The Lung Research Center, LLC

Chesterfield, Missouri 63017

United States

University of Missouri Health System

Columbia, Missouri 65212

United States

Columbia University Medical Center-New York Presbyterian Hospital

New York, New York 10032

United States

Weill Cornell Medical College

New York, New York 10065

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45267

United States

Temple University

Philadelphia, Pennsylvania 19140

United States

Clinical Trials Center of Middle Tennessee, LLC

Franklin, Tennessee 37067

United States

University of Virginia Health System

Charlottesville, Virginia 22903

United States

The Prince Charles Hospital

Chermside, Queensland 4032

Australia

Monash Health

Clayton, Victoria 3168

Australia

Institute for Respiratory Health

Nedlands, Western Australia 6009

Australia

Cliniques Universitaires Saint-Luc

Brussels, 1200

Belgium

Yvoir - UNIV UCL de Mont-Godinne

Yvoir, 5530

Belgium

Synergy Respiratory Care

Sherwood Park, Alberta T8H 0N2

Canada

Kelowna Respirology & Allergy Research

Kelowna, British Columbia V1Y 3H5

Canada

QEII Health Sciences Centre

Halifax, Nova Scotia B3H 3A7

Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec H2X 0A9

Canada

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45239

Germany

Medizinische Hochschule Hannover

Hanover, 30625

Germany

ASST Papa Giovanni XXIII

Bergamo, 24127

Italy

A. O. Universitaria Careggi

Florence, 50137

Italy

Azienda Ospedaliera dei Colli

Naples, 80131

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168

Italy

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

Torino, 10126

Italy

Tosei General Hospital

Aichi, Seto, 489-8642

Japan

University of Fukui Hospital

Fukui, Yoshida-gun, 910-1193

Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, 810-8563

Japan

Kanagawa Cardiovascular and Respiratory Center

Kanagawa, Yokohama, 236-0051

Japan

National Hospital Organization Kinki-Chuo Chest Medical Center

Osaka, Sakai, 591-8555

Japan

Hamamatsu University Hospital

Shizuoka, Hamamatsu, 431-3192

Japan

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, 14584

South Korea

Inje University Haeundae Paik Hospital

Busan, 48108

South Korea

Soonchunhyang University Hospital Seoul

Seoul, 04401

South Korea

Hospital Vall Hebron

Barcelona, 08035

Spain

Hospital Universitari de Bellvitge

L Hospitalet Del Llobregat, 08907

Spain

Hospital Universitario De La Princesa

Madrid, 08035

Spain

Hospital Virgen del Rocío

Seville, 41013

Spain

Cantonal Hospital of Aarau

Aarau, 5001

Switzerland

Universitätsspital Basel

Basel, 4031

Switzerland