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Idiopathic Pulmonary FibrosisPhase 2NCT07036523

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 Phase 2 study testing BI 765423 in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 46 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
BI 765423
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
46 sitesin 10 countries
Study dates
13 Nov 2025to 22 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 40 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 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"
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  • 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 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.
  • 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.
  • Further inclusion criteria apply.

Who cannot join

  • 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
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  • 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 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.
  • 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).
  • Further exclusion criteria apply.

Trial locations and contacts

46 sites in 10 countries.

46 sites in 10 countries

United States15 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • University of Missouri Health System

    Columbia, Missouri, 65212

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Clinical Trials Center of Middle Tennessee, LLC

    Franklin, Tennessee, 37067

  • University of Florida

    Gainesville, Florida, 32610

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Kansas Medical Center

    Kansas City, Kansas, 66103-2937

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • New York Presbyterian Hospital -Columbia University

    New York, New York, 10032

  • Weill Cornell Medical College

    New York, New York, 10065

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Temple University

    Philadelphia, Pennsylvania, 19140

Other trials in United States

Japan6 sites

  • Tosei General Hospital

    Aichi, Seto, 489-8642

  • University of Fukui Hospital

    Fukui, Yoshida-gun, 910-1193

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Osaka, Sakai, 591-8555

  • Hamamatsu University Hospital

    Shizuoka, Hamamatsu, 431-3192

Other trials in Japan

Italy5 sites

  • ASST Papa Giovanni XXIII

    Bergamo, 24127

  • A. O. Universitaria Careggi

    Florence, 50137

  • Azienda Ospedaliera dei Colli

    Naples, 80131

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

    Torino, 10126

Other trials in Italy

Canada4 sites

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • Kelowna Respirology & Allergy Research

    Kelowna, British Columbia, V1Y 3H5

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0A9

  • Synergy Respiratory Care

    Sherwood Park, Alberta, T8H 0N2

Other trials in Canada

Spain4 sites

  • Hospital Vall Hebron

    Barcelona, 08035

  • Hospital Universitari de Bellvitge

    L Hospitalet Del Llobregat, 08907

  • Hospital Universitario De La Princesa

    Madrid, 08035

  • Hospital Virgen del Rocio

    Seville, 41013

Other trials in Spain

Australia3 sites

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Monash Health

    Clayton, Victoria, 3168

  • Institute for Respiratory Health

    Nedlands, Western Australia, 6009

Other trials in Australia

South Korea3 sites

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, Gyeonggi-do, 14584

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Soonchunhyang University Hospital Seoul

    Seoul, 04401

Other trials in South Korea

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Yvoir - UNIV UCL de Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Germany2 sites

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239

  • Medizinische Hochschule Hannover

    Hanover, 30625

Other trials in Germany

Switzerland2 sites

  • Cantonal Hospital of Aarau

    Aarau, 5001

  • Universitätsspital Basel

    Basel, 4031

Other trials in Switzerland

About this study

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

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.

Being tested
BI 765423, Placebo
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 765423Drug

    BI 765423

  • PlaceboDrug

    Placebo to BI 765423

Study groups in NCT07036523
Study groupRoleWhat they receive
BI 765423ExperimentalNot described
Receives: Drug: BI 765423
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change from baseline in FVC (mL) at 12 weeks

    Measured: Baseline, 12 weeks

Secondary outcomes (8)

  1. Absolute change from baseline in log 10- transformed SP-D plasma concentration at 12 weeks

    SP-D=Surfactant protein D

    Measured: Baseline, 12 weeks

  2. Absolute change from baseline in distance walked (m) during 6MWT at 12 weeks

    6MWT=6-minute walk test

    Measured: Baseline, 12 weeks

  3. Absolute change from baseline in FVC % predicted at 12 weeks

    Measured: Baseline, 12 weeks

  4. Absolute change from baseline in DLCO % predicted at 12 weeks

    DLCO=Diffusing Capacity of the Lungs for Carbon Monoxide

    Measured: Baseline, 12 weeks

  5. Absolute change from baseline in SpO2 on room air at rest at 12 weeks

    SPO2=Oxygen saturation

    Measured: Baseline, 12 weeks

  6. Absolute change from baseline in FVC (mL) at 24 weeks

    Measured: Baseline, 24 weeks

  7. Absolute change from baseline in DLCO % predicted at 24 weeks

    Measured: Baseline, 24 weeks

  8. Absolute change from baseline in distance walked (m) during 6MWT at 24 weeks

    The six-minute walk test (6MWT) is a self-paced performance outcome test of walking capacity. Patients are asked to walk as far as possible in 6 min along a flat corridor.

    Measured: Baseline, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2025
  2. Study start13 Nov 2025
  3. Primary completion11 Mar 2027 (estimated)
  4. Study completion22 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07036523
Sponsor's protocol ID
1493-0002
Other IDs
2025-520658-12-00, U1111-1317-7542, 2025
Status last verified
Oct 2026
First submitted
17 Jun 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 765423 in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 46 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Japan, Italy, Canada, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute change from baseline in FVC (mL) at 12 weeks (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07036523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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