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

3 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

70

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Belgien
      • Liège, Belgien, 4000
        • Centre Hospitalier Universitaire de Liège
        • Kontakt:
  • Finland
      • Helsinki, Finland, 00290
      • Tampere, Finland, 33520
      • Turku, Finland, 20521
        • Turku University Hospital / TYKS
        • Kontakt:
  • Förenta staterna
    • Arizona
      • Tucson, Arizona, Förenta staterna, 85724
    • Connecticut
      • New Haven, Connecticut, Förenta staterna, 06520
    • Florida
      • Pensacola, Florida, Förenta staterna, 32503
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02114
    • Minnesota
      • Rochester, Minnesota, Förenta staterna, 55905
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
    • Ohio
      • Cleveland, Ohio, Förenta staterna, 44195
    • Pennsylvania
      • DuBois, Pennsylvania, Förenta staterna, 15801
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
    • Texas
      • Dallas, Texas, Förenta staterna, 75246
    • Utah
      • Salt Lake City, Utah, Förenta staterna, 84108
  • Japan
      • Fukui, Yoshida-gun, Japan, 910-1193
      • Fukuoka, Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center
        • Kontakt:
      • Hokkaido, Sapporo, Japan, 060-8543
        • Sapporo Medical University Hospital
        • Kontakt:
      • Kanagawa, Yokohama, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
        • Kontakt:
      • Kumamoto, Kumamoto, Japan, 861-4193
      • Osaka, Sakai, Japan, 591-8555
        • National Hospital Organization Kinki-Chuo Chest Medical Center
        • Kontakt:
      • Shizuoka, Hamamatsu, Japan, 431-3192
  • Mexiko
      • Distrito Federal, Mexiko, 14080
        • Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
        • Kontakt:
      • León, Mexiko, 37160
        • Centro de Investigacion Farmacologica del Bajío, S.C.
        • Kontakt:
      • Monterrey, Nuevo León, Mexiko, C.P. 64460
        • Hospital Universitario Nuevo de Nuevo León - CEPREP
        • Kontakt:
  • Spanien
      • Barcelona, Spanien, 08035
        • Hospital Universitari Vall d'Hebron
        • Kontakt:
      • L'Hospitalet Del LLobregat, Spanien, 08907
        • Hospital Universitari de Bellvitge
        • Kontakt:
      • Madrid, Spanien, 28006
        • Hospital Universitario De La Princesa
        • Kontakt:
      • Seville, Spanien, 41013
  • Sydkorea
      • Seoul, Sydkorea, 03080
        • Seoul National University Hospital
        • Kontakt:
      • Seoul, Sydkorea, 05505
      • Seoul, Sydkorea, 06351
  • Tyskland
      • Aachen, Tyskland, 52074
      • Berlin, Tyskland, 12351
      • Donaustauf, Tyskland, 93093
      • Solingen, Tyskland, 42699
      • Stralstund, Tyskland, 18435

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Övrig: Placebo

Placebo
Experimentell: BI 3810477
Biologisk: BI 3810477

BI 3810477

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 12
Tidsram: At baseline and at Week 12.
At baseline and at Week 12.

Sekundära resultatmått

Resultatmått
Tidsram
Absolute change from baseline in quantitative lung fibrosis (QLF) Draft[%] on high-resolution computed tomography (HRCT) at Week 12
Tidsram: 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
Tidsram: At baseline and at Week 12.
At baseline and at Week 12.
Absolute change from baseline in FVC % predicted at Week 12
Tidsram: 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
Tidsram: At baseline and at Week 12.
At baseline and at Week 12.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boehringer Ingelheim

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

13 november 2026

Primärt slutförande (Beräknad)

27 januari 2028

Avslutad studie (Beräknad)

20 april 2028

Studieregistreringsdatum

Först inskickad

3 november 2026

Först inskickad som uppfyllde QC-kriterierna

3 november 2026

Första postat (Faktisk)

9 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1530-0005
  • 2026-527098-13-00 (Registeridentifierare: CTIS (EU))
  • U1111-1341-7731 (Registeridentifierare: WHO International Clinical Trials Registry Platform (ICTRP))

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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