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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 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

70

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Annen: Placebo

Placebo
Eksperimentell: BI 3810477
Biologisk: BI 3810477

BI 3810477

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

13. november 2026

Primær fullføring (Antatt)

27. januar 2028

Studiet fullført (Antatt)

20. april 2028

Datoer for studieregistrering

Først innsendt

3. november 2026

Først innsendt som oppfylte QC-kriteriene

3. november 2026

Først lagt ut (Faktiske)

9. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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