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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • 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 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

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
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo

Placebo
Experimental: BI 3810477
Biological: BI 3810477

BI 3810477

What is the study measuring?

Primary Outcome Measures

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

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

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)

November 13, 2026

Primary Completion (Estimated)

January 27, 2028

Study Completion (Estimated)

April 20, 2028

Study Registration Dates

First Submitted

November 3, 2026

First Submitted That Met QC Criteria

November 3, 2026

First Posted (Actual)

November 9, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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