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
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
3 other identifiers
interventional
71
10 countries
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2025
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedStudy Start
First participant enrolled
November 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
April 29, 2026
April 1, 2026
1.5 years
June 17, 2025
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute change from baseline in FVC (mL) at 12 weeks
Baseline, 12 weeks
Secondary Outcomes (5)
Absolute change from baseline in log 10- transformed SP-D plasma concentration at 12 weeks
Baseline, 12 weeks
Absolute change from baseline in distance walked (m) during 6MWT at 12 weeks
Baseline, 12 weeks
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
Absolute change from baseline in SpO2 on room air at rest at 12 weeks
Baseline, 12 weeks
Study Arms (2)
BI 765423
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- years of age or older at the time of informed consent signature.
- 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.
- Male or female patients. 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 of postmenopausal status:
- 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"
- 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.
- 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.
- 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."
- 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.
- Patients with a Forced vital capacity (FVC) ≥45% predicted at Visit 1. Predicted normal values will be calculated according to Global Lung Initiative (GLI).
- Patients with haemoglobin-corrected diffusing capacity of the lungs for carbon monoxide (DLCO) ≥20% predicted at Visit 1.
You may not qualify if:
- Acute exacerbation of IPF within at least 12 weeks prior to Visit 1 and/or during the screening period (investigator-determined).
- Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/FVC \<0.7) at Visit 1.
- Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
- 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
- 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 by the treating physician, who would be withheld SoC treatment only for the sake of participation in the trial, should also be excluded.
- 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
- Life expectancy for any concomitant disease other than IPF \<2.5 years (investigator assessment).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Banner - University Medical Center Tucson
Tucson, Arizona, 85724, United States
University of Florida
Gainesville, Florida, 32611, 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 Hospital
Philadelphia, Pennsylvania, 19140, United States
Clinical Trials Center of Middle Tennessee, LLC
Franklin, Tennessee, 37067, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, 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
A.O. 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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2025
First Posted
June 25, 2025
Study Start
November 13, 2025
Primary Completion (Estimated)
April 28, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor'spublication plan); 2. and upon signing of a legal agreement.
Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.