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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522383-33 | Registry Identifier | CTIS | |
| U1111-1322-6453 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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This study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. People can join if a lung scan shows early changes in the lung, called interstitial lung abnormalities, which may lead to lung scarring. People with family members who have pulmonary fibrosis are more likely to develop it themselves. That is why it is important to check early for lung changes and find ways to prevent the condition from getting worse. The purpose of this study is to find out whether a medicine called nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis.
Participants are put into one of 2 groups randomly, which means the group is chosen by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet twice a day for about 2 to 3 years. There is a 3 out of 5 chance that participants will receive nerandomilast instead of the placebo.
Participants are in the study for about 2 to 3 years. Participants visit the study site multiple times: more frequently during the first 2 years (about every 3 months), and then every 6 months thereafter. In the 3rd year, participants also have phone calls with the site staff every 3 months.
Doctors regularly test lung function and take chest scans to see if the treatment works. The results are compared between the 2 groups to see if nerandomilast helps. The doctors also check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerandomilast | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerandomilast | Drug | Nerandomilast |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to physiologic or radiologic worsening of ILA/ILD over the whole trial | Defined as relative decline in forced vital capacity (FVC) % predicted of >10% from baseline; or absolute decline in diffusing capacity of the lungs for carbon monoxide (DLCO) % predicted >10% from baseline; or absolute increase in weighted reticulovascular score (wRVS) >2% and total disease extent (TDE) >2.5% on chest high resolution CT scan (HRCT), as measured by e-Lung Quantitative HRCT scoring, from baseline | up to 164 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in wRVS on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104 | at baseline, at weeks 26, 52 and 104 | |
| Absolute change from baseline in TDE on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104 | at baseline, at weeks 26, 52 and 104 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Not yet recruiting | Los Angeles | California | 90095 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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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 in the website.
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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.
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.
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| Placebo | Drug | Placebo |
|
| Absolute change from baseline in FVC (% predicted) at weeks 26, 52, and 104 | at baseline, at weeks 26, 52 and 104 |
| Absolute change from baseline in DLCO (% predicted) at weeks 26, 52, and 104 | at baseline, at weeks 26, 52 and 104 |
| Time to relative decline from baseline in FVC (% predicted) of >10% over 52 weeks and over the whole trial | up to 164 weeks |
| Time to absolute decline from baseline in FVC (% predicted) of >5% over 52 weeks and over the whole trial | up to 164 weeks |
| Time to absolute decline from baseline in DLCO (% predicted) of >10% over 52 weeks and over the whole trial | up to 164 weeks |
| 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 | up to 164 weeks |
| Time to physiologic or radiologic worsening of ILA/ILD over 52 weeks | up to 52 weeks |
| University of Colorado Denver | Not yet recruiting | Aurora | Colorado | 80045 | United States |
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| Clinical Research Specialists LLC - Kissimmee | Recruiting | Kissimmee | Florida | 34746 | United States |
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| University of Kansas Medical Center | Not yet recruiting | Kansas City | Kansas | 66160 | United States |
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| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| University of Michigan | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
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| University of Minnesota | Not yet recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Weill Cornell Medicine-New York-60569 | Not yet recruiting | New York | New York | 10065 | United States |
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| University of Pennsylvania | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Medical University of South Carolina | Not yet recruiting | Charleston | South Carolina | 29425 | United States |
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| Vanderbilt University Medical Center | Not yet recruiting | Nashville | Tennessee | 37204 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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| Virginia Commonwealth University | Not yet recruiting | Richmond | Virginia | 23219 | United States |
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| Centro de Investigaciones Metabolicas (CINME) | Not yet recruiting | Buenos Aires | C1056ABJ | Argentina |
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| Hospital Italiano de Buenos Aires | Recruiting | CABA | 1181 | Argentina |
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| Centro de InvestigaciĂłn Clinica Belgrano | Recruiting | CABA | 1425 | Argentina |
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| CEDIC - Centro de Investigacion Clinica | Recruiting | CABA | C1060ABN | Argentina |
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| Consultorios Médicos del Buen Ayre | Recruiting | Capital Federal | 1425 | Argentina |
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| Royal Prince Alfred Hospital | Not yet recruiting | Camperdown | New South Wales | 2050 | Australia |
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| Lung Research Queensland | Recruiting | Chermside | Queensland | 4032 | Australia |
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| The Prince Charles Hospital | Recruiting | Chermside | Queensland | 4032 | Australia |
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| The Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
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| Cliniques Universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
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| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| QEII Health Sciences Centre | Not yet recruiting | Halifax | Nova Scotia | B3H 3A7 | Canada |
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| St. Joseph's Healthcare Hamilton | Not yet recruiting | Hamilton | Ontario | L8N 4A6 | Canada |
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| McGill University Health Centre (MUHC) | Not yet recruiting | Montreal | Quebec | H4A 3J1 | Canada |
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| HĂ´pital Louis Pradel | Recruiting | Bron | 69677 | France |
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| INS Coeur Poumon | Recruiting | Lille | 59037 | France |
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| HOP Bichat | Recruiting | Paris | 75877 | France |
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| HOP Pontchaillou | Recruiting | Rennes | 35033 | France |
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| HĂ´pital Larrey - CHU de Toulouse | Not yet recruiting | Toulouse | 31059 | France |
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| Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH | Not yet recruiting | Essen | 45239 | Germany |
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| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
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| Lungenfachklinik Immenhausen | Not yet recruiting | Immenhausen | 34376 | Germany |
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| Krankenhaus Bethanien gGmbH | Not yet recruiting | Solingen | 42699 | Germany |
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| IRCCS MultiMedica | Recruiting | Milan | 20123 | Italy |
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| Azienda Ospedaliera Universitaria di Padova | Not yet recruiting | Padova | 35128 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
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| Tosei General Hospital | Not yet recruiting | Aichi, Seto | 489-8642 | Japan |
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| Tsuboi Hospital | Recruiting | Fukushima, Koriyama | 963-0197 | Japan |
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| Kanagawa Cardiovascular and Respiratory Center | Recruiting | Kanagawa, Yokohama | 236-0051 | Japan |
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| National Hospital Organization Kinki-Chuo Chest Medical Center | Recruiting | Osaka, Sakai | 591-8555 | Japan |
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| Hamamatsu University Hospital | Recruiting | Shizuoka, Hamamatsu | 431-3192 | Japan |
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| National Center for Global Health and Medicine | Recruiting | Tokyo, Shinjuku-ku | 162-8655 | Japan |
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| St. Antonius Ziekenhuis | Recruiting | Nieuwegein | 3435 CM | Netherlands |
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| Erasmus Medisch Centrum | Not yet recruiting | Rotterdam | 3015 GD | Netherlands |
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| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
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| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
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| Samsung Medical Center | Not yet recruiting | Seoul | 06351 | South Korea |
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| Hospital de Galdakao | Recruiting | Galdakao | 48960 | Spain |
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| Hospital Universitari de Bellvitge | Recruiting | L'Hospitalet Del Llobregat | 08907 | Spain |
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| Hospital Universitario De La Princesa | Not yet recruiting | Madrid | 28006 | Spain |
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| Hospital Virgen del RocĂo | Recruiting | Seville | 41013 | Spain |
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| Royal Devon and Exeter Hospital, Wonford | Recruiting | Exeter | EX2 5DW | United Kingdom |
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| Royal Brompton Hospital | Recruiting | London | SW3 6HP | United Kingdom |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
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