Clinical trial • Not applicable • Respiratory
BI 1015550 for Interstitial lung disease | Familial pulmonary fibrosis | Pulmonary fibrosis
Not applicable trial of BI 1015550 for Interstitial lung disease | Familial pulmonary fibrosis | Pulmonary fibrosis.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Interstitial lung disease | Familial pulmonary fibrosis | Pulmonary fibrosis
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 29-10-2025
- First CTIS Authorization Date
- 03-03-2026
Trial design
Randomised, placebo matching bi 1015550 (oral matching placebo). dose/schedule for placebo not specified.-controlled Not applicable trial in Belgium, France, Germany and others.
- Randomised
- Yes
- Comparator
- Placebo matching BI 1015550 (oral matching placebo). Dose/schedule for placebo not specified.
- Target Sample Size
- 49
- Trial Duration For Participant
- 730
Eligibility
Recruits 49 No vulnerable population selected (isVulnerablePopulationSelected=false). Informed consent is to be provided by participants (adults); no assent or parental consent procedures are described in the CTIS record..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). Informed consent is to be provided by participants (adults); no assent or parental consent procedures are described in the CTIS record.
Inclusion criteria
- {"criterion_text":"- 1. Individuals ≥40 years of age at the time of first signed informed consent at Visit 1a\n- 2. Participants must have at least 1 first-degree relative (biological parent, sibling, or child) with confirmed pulmonary fibrosis (idiopathic pulmonary fibrosis [IPF], idiopathic nonspecific interstitial pneumonia [NSIP], and/or pulmonary fibrosis due to known genetic cause [e.g. short telomere syndrome, MUC5B mutation, surfactant protein mutations])\n- 3. HRCT scan with evidence of interstitial lung abnormalities involving at least 5% of a single lung zone, or ILD, based on central evaluation.\n- 4. FVC ≥80% of predicted normal at Visit 1b\n- 5. Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥70% of predicted normal at Visit 1b\n- 6. Further inclusion criteria apply."}
Exclusion criteria
- {"criterion_text":"- 1. Prior known pulmonary fibrosis that, in the opinion of the Investigator, requires treatment with approved therapies\n- 2. Prebronchodilator FEV1/FVC <0.7 at Visit 1b\n- 3. HRCT findings consistent with probable or definite usual interstitial pneumonia (UIP) pattern\n- 4. Any medical condition that is known to predispose to the development of pulmonary fibrosis (e.g. known connective tissue disease)\n- 5. Prior or current use of nerandomilast, nintedanib, or pirfenidone\n- 6. Further exclusion criteria apply."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Time to physiologic or radiologic worsening of ILA/ILD (defined as: relative decline in FVC % predicted of >10% from baseline; or absolute decline in DLCO % predicted >10% from baseline; or absolute increase in weighted reticulovascular score (wRVS) >2% and total disease extent (TDE) >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring, from baseline) over the whole trial","definition_or_measurement_approach":"Defined/measured as: relative decline in FVC % predicted >10% from baseline; or absolute decline in DLCO % predicted >10% from baseline; or absolute increase in wRVS >2% and TDE >2.5% on chest HRCT measured by e-Lung Quantitative HRCT scoring, from baseline, over the whole trial."}
Secondary endpoints
- {"endpoint_text":"- Absolute change from baseline in wRVS on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104","definition_or_measurement_approach":"Measured by e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104; absolute change from baseline."}
- {"endpoint_text":"- Absolute change from baseline in TDE on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104","definition_or_measurement_approach":"Measured by e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104; absolute change from baseline."}
- {"endpoint_text":"- Absolute change from baseline in FVC (% predicted) at weeks 26, 52, and 104","definition_or_measurement_approach":"Forced vital capacity (% predicted) measured at weeks 26, 52, and 104; absolute change from baseline."}
- {"endpoint_text":"- Absolute change from baseline in DLCO (% predicted) at weeks 26, 52, and 104","definition_or_measurement_approach":"DLCO (% predicted) measured at weeks 26, 52, and 104; absolute change from baseline."}
- {"endpoint_text":"- Time to relative decline from baseline in FVC (% predicted) of >10% over 52 weeks and over the whole trial","definition_or_measurement_approach":"Time-to-event endpoint using relative decline in FVC % predicted >10% from baseline, assessed over 52 weeks and over the whole trial."}
- {"endpoint_text":"- Time to absolute decline from baseline in FVC (% predicted) of >5% over 52 weeks and over the whole trial","definition_or_measurement_approach":"Time-to-event endpoint using absolute decline in FVC % predicted >5% from baseline, assessed over 52 weeks and over the whole trial."}
- {"endpoint_text":"- Time to absolute decline from baseline in DLCO (% predicted) of >10% over 52 weeks and over the whole trial","definition_or_measurement_approach":"Time-to-event endpoint using absolute decline in DLCO % predicted >10% from baseline, assessed over 52 weeks and over the whole trial."}
- {"endpoint_text":"- Time to absolute increase in wRVS >2% and TDE >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring over 52 weeks and over the whole trial","definition_or_measurement_approach":"Time-to-event endpoint defined by absolute increase in wRVS >2% and TDE >2.5% on chest HRCT measured by e-Lung Quantitative HRCT scoring, over 52 weeks and over the whole trial."}
- {"endpoint_text":"- Time to physiologic or radiologic worsening of ILA/ILD over 52 weeks","definition_or_measurement_approach":"As defined for the primary endpoint (decline in FVC, decline in DLCO, or increase in HRCT scores), assessed over 52 weeks."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 49
- Recruitment Window Months
- 40
- Consent Approach
- Informed consent is obtained from participants (adults ≥40 years). Participant information and informed consent forms are provided in multiple languages (English, Dutch, French, German, Spanish, Italian as evidenced by l1_icf-main-*.pdf documents). No assent or parental consent processes are described in the CTIS record.
Methods
- Belgium: Recruitment materials including posters and information brochures (documents titled k2_recruitment-material-poster-be-eng, k2_recruitment-material-info-brochure-be, k1_recruitment-arrangements-icf-prr-be) — channel: printed posters and brochures; target audience: individuals with interstitial lung abnormalities and family history of pulmonary fibrosis.
- France: Recruitment arrangements and information brochures (documents associated with entity 272889 such as k1_recruitment-arrangements-icf-pr-fr, k2_recruitment-material-information-brochure-fr) — channel: clinical-site materials and brochures; target audience: eligible high-risk individuals.
- Germany: Advertisement visuals, digital and print, and information brochures (documents such as k2_recruitment-material-adv-poster-de, k1_recruitment-arrangements-adv-visuals-digital-de) — channel: digital and print advertising; target audience: potential participants with family history of pulmonary fibrosis.
- Italy: GP letter and recruitment brochures (documents associated with entity 277342 such as k1_recruitment-arrangements-adv-gp-letter-it, k2_recruitment-material-info-brochure-it) — channel: general practitioner outreach and brochures; target audience: patients identified via GPs and clinical sites.
- Spain: Recruitment posters, digital visuals and brochures (documents such as k2_recruitment-material-poster-es, k1_recruitment-arrangements-visuals-digital-es, k2_recruitment-material-info-brochure-es) — channel: posters, digital adverts and brochures; target audience: eligible individuals at clinical sites and via digital adverts.
- Netherlands: Recruitment information brochure and local recruitment arrangements (documents associated with entity 293698 such as k2_recruitment-material-information-brochure-nl, k1_recruitment-arrangements-nl) — channel: brochures and site-level recruitment arrangements; target audience: eligible high-risk individuals.
Geography
- Total Number Of Sites
- 20
- Total Number Of Participants
- 28
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-02-2026
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 29
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- UZ Leuven
- Department Name
- Department of Respiratory Medicine
- Principal Investigator Name
- Wim Wuyts
- Principal Investigator Email
- wim.wuyts@uzleuven.be
- Contact Person Name
- Wim Wuyts
- Contact Person Email
- wim.wuyts@uzleuven.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Pulmonary Medicine
- Principal Investigator Name
- Antoine Froidure
- Principal Investigator Email
- antoine.froidure@saintluc.uclouvain.be
- Contact Person Name
- Antoine Froidure
- Contact Person Email
- antoine.froidure@saintluc.uclouvain.be
France
- Earliest CTIS Part Ii Submission Date
- 19-01-2026
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 43
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service de Pneumologie
- Principal Investigator Name
- Vincent Cottin
- Principal Investigator Email
- vincent.cottin@chu-lyon.fr
- Contact Person Name
- Vincent Cottin
- Contact Person Email
- vincent.cottin@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service Pneumo Immuno Allergologie
- Principal Investigator Name
- Lidwine Wemeau
- Principal Investigator Email
- lidwine.wemeau@chu-lille.fr
- Contact Person Name
- Lidwine Wemeau
- Contact Person Email
- lidwine.wemeau@chu-lille.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Centre d’Investigation Clinique - Pneumologie
- Principal Investigator Name
- Raphaël Borie
- Principal Investigator Email
- raphael.borie@aphp.fr
- Contact Person Name
- Raphaël Borie
- Contact Person Email
- raphael.borie@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Département de Pneumologie
- Principal Investigator Name
- Grégoire Prevot
- Principal Investigator Email
- prevotinvestigateur31@gmail.com
- Contact Person Name
- Grégoire Prevot
- Contact Person Email
- prevotinvestigateur31@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Centre Cardio-Pneumologique - Service de Pneumologie
- Principal Investigator Name
- Stephane Jouneau
- Principal Investigator Email
- stephane.jouneau@chu-rennes.fr
- Contact Person Name
- Stephane Jouneau
- Contact Person Email
- stephane.jouneau@chu-rennes.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 30-01-2026
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 33
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Krankenhaus Bethanien gGmbH
- Department Name
- Innere Medizin und Pneumologie, Allergologie, Schlafmedizin
- Principal Investigator Name
- Lars Hagmeyer
- Principal Investigator Email
- lars.hagmeyer@klinik-bethanien.de
- Contact Person Name
- Lars Hagmeyer
- Contact Person Email
- lars.hagmeyer@klinik-bethanien.de
- Site Name
- Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
- Department Name
- am Universitätsklinikum Essen gGmbH, Abteilung Pneumologie und Allergologie
- Principal Investigator Name
- Francesco Bonella
- Principal Investigator Email
- francesco.bonella@rlk.uk-essen.de
- Contact Person Name
- Francesco Bonella
- Contact Person Email
- francesco.bonella@rlk.uk-essen.de
- Site Name
- Lungenfachklinik
- Department Name
- Fachklinik für Lungenerkrankungen
- Principal Investigator Name
- Peter Hammerl
- Principal Investigator Email
- hammerl@lungenfachklinik-immenhausen.de
- Contact Person Name
- Peter Hammerl
- Contact Person Email
- hammerl@lungenfachklinik-immenhausen.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Pneumologie/Studienzentrum
- Principal Investigator Name
- Jonas Christian Schupp
- Principal Investigator Email
- schupp.jonas@mh-hannover.de
- Contact Person Name
- Jonas Christian Schupp
- Contact Person Email
- schupp.jonas@mh-hannover.de
Italy
- Earliest CTIS Part Ii Submission Date
- 03-02-2026
- Latest Decision Or Authorization Date
- 03-03-2026
- Processing Time Days
- 28
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- U.O. Pneumologia
- Principal Investigator Name
- Elisabetta Balestro
- Principal Investigator Email
- elisabetta.balestro@aopd.veneto.it
- Contact Person Name
- Elisabetta Balestro
- Contact Person Email
- elisabetta.balestro@aopd.veneto.it
- Site Name
- Multimedica S.p.A.
- Department Name
- U.O. pneumologia
- Principal Investigator Name
- Sergio Harari
- Principal Investigator Email
- sergioharari0@gmail.com
- Contact Person Name
- Sergio Harari
- Contact Person Email
- sergioharari0@gmail.com
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC di Pneumologia
- Principal Investigator Name
- Luca Richeldi
- Principal Investigator Email
- luca.richeldi@policlinicogemelli.it
- Contact Person Name
- Luca Richeldi
- Contact Person Email
- luca.richeldi@policlinicogemelli.it
Spain
- Earliest CTIS Part Ii Submission Date
- 20-11-2025
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 104
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Bellvitge University Hospital
- Department Name
- Servicio de Neumología
- Principal Investigator Name
- Maria Molina Molina
- Principal Investigator Email
- mariamolinamolina@hotmail.com
- Contact Person Name
- Maria Molina Molina
- Contact Person Email
- mariamolinamolina@hotmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Servicio Neumología
- Principal Investigator Name
- José Antonio Rodríguez Portal
- Principal Investigator Email
- josearportal@gmail.com
- Contact Person Name
- José Antonio Rodríguez Portal
- Contact Person Email
- josearportal@gmail.com
- Site Name
- Hospital De Galdakao Usansolo
- Department Name
- Servicio de Neumología
- Principal Investigator Name
- Myriam Aburto Barrenetxea
- Principal Investigator Email
- myriam.aburtobarreneche@osakidetza.eus
- Contact Person Name
- Myriam Aburto Barrenetxea
- Contact Person Email
- myriam.aburtobarreneche@osakidetza.eus
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Servicio Neumología
- Principal Investigator Name
- Claudia Valenzuela
- Principal Investigator Email
- claudiavale@hotmail.com
- Contact Person Name
- Claudia Valenzuela
- Contact Person Email
- claudiavale@hotmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 12-02-2026
- Latest Decision Or Authorization Date
- 03-04-2026
- Processing Time Days
- 50
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Department of ILD
- Principal Investigator Name
- Marlies Wijsenbeek-Lourens
- Principal Investigator Email
- m.wijsenbeek-lourens@erasmusmc.nl
- Contact Person Name
- Marlies Wijsenbeek-Lourens
- Contact Person Email
- m.wijsenbeek-lourens@erasmusmc.nl
- Site Name
- Sint Antonius Ziekenhuis Stichting
- Department Name
- Polikliniek Longziekten
- Principal Investigator Name
- Marcel Veltkamp
- Principal Investigator Email
- m.veltkamp@antoniusziekenhuis.nl
- Contact Person Name
- Marcel Veltkamp
- Contact Person Email
- m.veltkamp@antoniusziekenhuis.nl
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- BI 1015550
- Active Substance
- BI 1015550
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus=1)
- Dose Levels
- max daily dose amounts recorded: 36 mg (product PRD10442862) and 18 mg (product PRD10855744); maxTotalDoseAmount values 41328 mg and 20664 mg respectively
- Maximum Dose
- 36 mg (one product record); 18 mg (alternative product record) - max daily dose amounts provided in product records
- Investigational Product Name
- Placebo matching BI 1015550
- Modality
- Other
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