A Study to Test Whether BI 3810477 Helps People With Idiopathic Pulmonary Fibrosis When Taken With or Without Standard Treatment

November 3, 2026 updated by: Boehringer Ingelheim

A Randomised, Double-blind, Placebo-controlled Phase IIa Trial to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of BI 3810477 With or Without Standard of Care in Patients With Idiopathic Pulmonary Fibrosis

This study is for adults aged 40 and older who have idiopathic pulmonary fibrosis (IPF). Women can only participate if they cannot get pregnant. The purpose of this study is to find out whether a medicine called BI 3810477 can slow down the worsening of lung function in people with IPF.

Participants are put into 2 groups randomly, which means by chance. One group receives BI 3810477 and the other group receives placebo. Placebo looks like BI 3810477 but does not contain any medicine. Participants receive BI 3810477 or placebo for 12 weeks. Participants may continue their regular treatment for IPF during the study.

Participants are in the study for about 6 to 7 months. During this time, they visit the study site regularly, about 18 times. Some of the visits may be done at the participant's home instead of the study site. Doctors regularly test how well the lungs work by doing lung function tests. They also look at lung scans and measure markers in the blood that are linked to lung health. The results are compared between the 2 groups to see whether BI 3810477 works. The doctors also regularly check participants' health and note any unwanted effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
  • Finland
      • Helsinki, Finland, 00290
      • Tampere, Finland, 33520
      • Turku, Finland, 20521
        • Turku University Hospital / TYKS
        • Contact:
  • Germany
      • Aachen, Germany, 52074
      • Berlin, Germany, 12351
      • Donaustauf, Germany, 93093
      • Solingen, Germany, 42699
      • Stralstund, Germany, 18435
  • Japan
      • Fukui, Yoshida-gun, Japan, 910-1193
      • Fukuoka, Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center
        • Contact:
      • Hokkaido, Sapporo, Japan, 060-8543
        • Sapporo Medical University Hospital
        • Contact:
      • Kanagawa, Yokohama, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
        • Contact:
      • Kumamoto, Kumamoto, Japan, 861-4193
      • Osaka, Sakai, Japan, 591-8555
        • National Hospital Organization Kinki-Chuo Chest Medical Center
        • Contact:
      • Shizuoka, Hamamatsu, Japan, 431-3192
  • Mexico
      • Distrito Federal, Mexico, 14080
        • Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
        • Contact:
      • León, Mexico, 37160
        • Centro de Investigacion Farmacologica del Bajío, S.C.
        • Contact:
      • Monterrey, Nuevo León, Mexico, C.P. 64460
        • Hospital Universitario Nuevo de Nuevo León - CEPREP
        • Contact:
  • South Korea
      • Seoul, South Korea, 03080
      • Seoul, South Korea, 05505
      • Seoul, South Korea, 06351
  • Spain
      • Barcelona, Spain, 08035
      • L'Hospitalet Del LLobregat, Spain, 08907
      • Madrid, Spain, 28006
        • Hospital Universitario De La Princesa
        • Contact:
      • Seville, Spain, 41013
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
    • Connecticut
      • New Haven, Connecticut, United States, 06520
    • Florida
      • Pensacola, Florida, United States, 32503
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15801
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Texas
      • Dallas, Texas, United States, 75246
    • Utah
      • Salt Lake City, Utah, United States, 84108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of idiopathic pulmonary fibrosis (IPF).

  2. Participants may be either:

    - On stable monotherapy with nintedanib, pirfenidone, or nerandomilast for at least 12 weeks prior to Visit 1 and are planning to stay on this background treatment through the screening period and during the treatment period.

    OR

    - Not currently on treatment with nintedanib, pirfenidone, or nerandomilast for at least 12 weeks prior to Visit 1 (i.e. either antifibrotic-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment during the screening or the treatment periods.

  3. Patients with an extent of fibrosis ≥10% as per a high-resolution computed tomography (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.

  4. Patients with a forced vital capacity (FVC) ≥45% predicted at Visit 1. Predicted normal values will be calculated according to Global Lung Function Initiative (GLI).

  5. Diffusing capacity of the lung for carbon monoxide (DLCO) ≥25% and <80% of predicted normal corrected for haemoglobin (Hb) at Visit 1.

  6. 40 years of age or older at the time of informed consent signature.

  7. 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.

  8. Males or females of non-childbearing potential

    • A woman of non-childbearing potential is considered eligible for participation if nonfertile, i.e. postmenopausal (defined as no menses for 12 months without an alternative medical cause) or after permanent sterilisation which must have included a bilateral oophorectomy. Not eligible for the trial are women that still have the potential for future oocyte donation for in vitro fertilisation methods, including women that have had a hysterectomy or bilateral salpingectomy without bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilization.

  9. Further inclusion criteria apply.

Exclusion Criteria:

  1. Acute exacerbation of idiopathic pulmonary fibrosis (IPF) within at least 12 weeks prior to Visit 1 and/or during the screening period (per investigator judgment).
  2. Relevant airways obstruction (pre-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <0.7) at Visit 1.
  3. Exclusion of patients with emphysema >15 % of total lung volume on high-resolution computed tomography (HRCT) on central review.
  4. In the opinion of the investigator, other clinically significant pulmonary abnormalities.
  5. Lower respiratory tract infection requiring treatment within 4 weeks prior to Visit 1 and/or during the screening period.
  6. Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomisation or planned during the trial, e.g. hip replacement.
  7. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.
  8. Cardiovascular comorbidities including: Severe hypertension (uncontrolled under treatment ≥160/100 mmHg at multiple occasions per investigator judgment) 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.
  9. Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo

Placebo
Experimental: BI 3810477
Biological: BI 3810477

BI 3810477

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 12
Time Frame: At baseline and at Week 12.
At baseline and at Week 12.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Absolute change from baseline in quantitative lung fibrosis (QLF) Draft[%] on high-resolution computed tomography (HRCT) at Week 12
Time Frame: At baseline and at Week 12.
At baseline and at Week 12.
Absolute change from baseline in log10-transformed Surfactant protein-D (SP-D) plasma concentration [ng/mL] at Week 12
Time Frame: At baseline and at Week 12.
At baseline and at Week 12.
Absolute change from baseline in FVC % predicted at Week 12
Time Frame: At baseline and at Week 12.
At baseline and at Week 12.
Absolute change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO) % predicted at Week 12
Time Frame: At baseline and at Week 12.
At baseline and at Week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 27, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1530-0005
  • 2026-527098-13-00 (Registry Identifier: CTIS (EU))
  • U1111-1341-7731 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.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 on the website.

IPD Sharing 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.

IPD Sharing 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's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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