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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 de noviembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

70

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Alemania
      • Aachen, Alemania, 52074
        • Universitätsklinikum Aachen, AöR
        • Contacto:
      • Berlin, Alemania, 12351
      • Donaustauf, Alemania, 93093
        • Caritas-Krankenhaus St. Maria gGmbH
        • Contacto:
      • Solingen, Alemania, 42699
      • Stralstund, Alemania, 18435
  • Bélgica
      • Liège, Bélgica, 4000
        • Centre Hospitalier Universitaire de Liège
        • Contacto:
  • Corea del Sur
      • Seoul, Corea del Sur, 03080
        • Seoul National University Hospital
        • Contacto:
      • Seoul, Corea del Sur, 05505
        • Asan Medical Center
        • Contacto:
      • Seoul, Corea del Sur, 06351
        • Samsung Medical Center
        • Contacto:
  • España
      • Barcelona, España, 08035
        • Hospital Universitari Vall d'Hebron
        • Contacto:
      • L'Hospitalet Del LLobregat, España, 08907
        • Hospital Universitari de Bellvitge
        • Contacto:
      • Madrid, España, 28006
        • Hospital Universitario De La Princesa
        • Contacto:
      • Seville, España, 41013
        • Hospital Virgen del Rocio
        • Contacto:
  • Estados Unidos
    • Arizona
      • Tucson, Arizona, Estados Unidos, 85724
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06520
        • Yale University School of Medicine
        • Contacto:
    • Florida
      • Pensacola, Florida, Estados Unidos, 32503
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
    • Pennsylvania
      • DuBois, Pennsylvania, Estados Unidos, 15801
        • Clinical Research Associates of Central PA
        • Contacto:
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Medical University of South Carolina
        • Contacto:
    • Texas
      • Dallas, Texas, Estados Unidos, 75246
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84108
        • University of Utah Health Sciences Center
        • Contacto:
  • Finlandia
      • Helsinki, Finlandia, 00290
        • Helsinki University Hospital
        • Contacto:
      • Tampere, Finlandia, 33520
        • Tampere University Hospital
        • Contacto:
      • Turku, Finlandia, 20521
        • Turku University Hospital / TYKS
        • Contacto:
  • Japón
      • Fukui, Yoshida-gun, Japón, 910-1193
        • University of Fukui Hospital
        • Contacto:
      • Fukuoka, Fukuoka, Japón, 810-8563
        • National Hospital Organization Kyushu Medical Center
        • Contacto:
      • Hokkaido, Sapporo, Japón, 060-8543
        • Sapporo Medical University Hospital
        • Contacto:
      • Kanagawa, Yokohama, Japón, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
        • Contacto:
      • Kumamoto, Kumamoto, Japón, 861-4193
        • Saiseikai Kumamoto Hospital
        • Contacto:
      • Osaka, Sakai, Japón, 591-8555
        • National Hospital Organization Kinki-Chuo Chest Medical Center
        • Contacto:
      • Shizuoka, Hamamatsu, Japón, 431-3192
        • Hamamatsu University Hospital
        • Contacto:
  • México
      • Distrito Federal, México, 14080
        • Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
        • Contacto:
      • León, México, 37160
        • Centro de Investigacion Farmacologica del Bajío, S.C.
        • Contacto:
      • Monterrey, Nuevo León, México, C.P. 64460
        • Hospital Universitario Nuevo de Nuevo León - CEPREP
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Otro: Placebo

Placebo
Experimental: BI 3810477
Biológico: BI 3810477

BI 3810477

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 12
Periodo de tiempo: At baseline and at Week 12.
At baseline and at Week 12.

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Boehringer Ingelheim

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

13 de noviembre de 2026

Finalización primaria (Estimado)

27 de enero de 2028

Finalización del estudio (Estimado)

20 de abril de 2028

Fechas de registro del estudio

Enviado por primera vez

3 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Publicado por primera vez (Actual)

9 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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.

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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