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New drug trial aims to improve lung function in fibrosis patients

NCT ID NCT07036523

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This study tests a new medicine called BI 765423 in 71 adults with idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and breathing problems. Participants receive either the drug or a placebo by infusion every four weeks for about 3 months. The main goal is to see if the drug improves lung capacity, measured by forced vital capacity (FVC), compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 765423
What this could lead to
If it works, this could point toward a new treatment to slow lung damage in people with idiopathic pulmonary fibrosis.
What could go wrong
This is an early Phase IIa trial with only 71 participants, so results may not confirm benefit. The drug may cause side effects or fail to improve lung function compared to placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 71 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A. O. Universitaria Careggi

    RECRUITING

    Florence, 50137, Italy

  • ASST Papa Giovanni XXIII

    RECRUITING

    Bergamo, 24127, Italy

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

    RECRUITING

    Torino, 10126, Italy

  • Azienda Ospedaliera dei Colli

    RECRUITING

    Naples, 80131, Italy

  • Cantonal Hospital of Aarau

    ACTIVE_NOT_RECRUITING

    Aarau, 5001, Switzerland

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

    ACTIVE_NOT_RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Clinical Trials Center of Middle Tennessee, LLC

    ACTIVE_NOT_RECRUITING

    Franklin, Tennessee, 37067, United States

  • Cliniques Universitaires Saint-Luc

    ACTIVE_NOT_RECRUITING

    Brussels, 1200, Belgium

  • Columbia University Medical Center-New York Presbyterian Hospital

    ACTIVE_NOT_RECRUITING

    New York, New York, 10032, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    ACTIVE_NOT_RECRUITING

    Roma, 00168, Italy

  • Hamamatsu University Hospital

    ACTIVE_NOT_RECRUITING

    Shizuoka, Hamamatsu, 431-3192, Japan

  • Hospital Universitari de Bellvitge

    ACTIVE_NOT_RECRUITING

    L Hospitalet Del Llobregat, 08907, Spain

  • Hospital Universitario De La Princesa

    ACTIVE_NOT_RECRUITING

    Madrid, 08035, Spain

  • Hospital Vall Hebron

    ACTIVE_NOT_RECRUITING

    Barcelona, 08035, Spain

  • Hospital Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Inje University Haeundae Paik Hospital

    ACTIVE_NOT_RECRUITING

    Busan, 48108, South Korea

  • Institute for Respiratory Health

    ACTIVE_NOT_RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Kanagawa Cardiovascular and Respiratory Center

    ACTIVE_NOT_RECRUITING

    Kanagawa, Yokohama, 236-0051, Japan

  • Kelowna Respirology & Allergy Research

    ACTIVE_NOT_RECRUITING

    Kelowna, British Columbia, V1Y 3H5, Canada

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • Monash Health

    ACTIVE_NOT_RECRUITING

    Clayton, Victoria, 3168, Australia

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    ACTIVE_NOT_RECRUITING

    Osaka, Sakai, 591-8555, Japan

  • National Hospital Organization Kyushu Medical Center

    ACTIVE_NOT_RECRUITING

    Fukuoka, Fukuoka, 810-8563, Japan

  • QEII Health Sciences Centre

    ACTIVE_NOT_RECRUITING

    Halifax, Nova Scotia, B3H 3A7, Canada

  • Renstar Medical Research

    ACTIVE_NOT_RECRUITING

    Ocala, Florida, 34470, United States

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    RECRUITING

    Essen, 45239, Germany

  • Soon Chun Hyang University Hospital Bucheon

    RECRUITING

    Bucheon-si, Gyeonggi-do, 14584, South Korea

  • Soonchunhyang University Hospital Seoul

    ACTIVE_NOT_RECRUITING

    Seoul, 04401, South Korea

  • Synergy Respiratory Care

    ACTIVE_NOT_RECRUITING

    Sherwood Park, Alberta, T8H 0N2, Canada

  • Temple University

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • The Lung Research Center, LLC

    ACTIVE_NOT_RECRUITING

    Chesterfield, Missouri, 63017, United States

  • The Prince Charles Hospital

    ACTIVE_NOT_RECRUITING

    Chermside, Queensland, 4032, Australia

  • Tosei General Hospital

    ACTIVE_NOT_RECRUITING

    Aichi, Seto, 489-8642, Japan

  • University of Alabama at Birmingham

    ACTIVE_NOT_RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Cincinnati Medical Center

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Fukui Hospital

    ACTIVE_NOT_RECRUITING

    Fukui, Yoshida-gun, 910-1193, Japan

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    ACTIVE_NOT_RECRUITING

    Kansas City, Kansas, 66103-2937, United States

  • University of Minnesota

    ACTIVE_NOT_RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Missouri Health System

    RECRUITING

    Columbia, Missouri, 65212, United States

  • University of Virginia Health System

    NOT_YET_RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Universitätsspital Basel

    ACTIVE_NOT_RECRUITING

    Basel, 4031, Switzerland

  • Weill Cornell Medical College

    ACTIVE_NOT_RECRUITING

    New York, New York, 10065, United States

  • Yvoir - UNIV UCL de Mont-Godinne

    ACTIVE_NOT_RECRUITING

    Yvoir, 5530, Belgium

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