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A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis

StatusRecruiting
PhasePhase 3
Started2026-02-10
View on ClinicalTrials.gov ↗

Amendment history

2026-09-04
minor
Study Status, Contacts/Locations v25
Study sites55 entries, revised
Consultorios MédicosMedicos del Buen Ayre HôpitalHopital Louis Pradel
2026-08-17
minor
Study Status, Contacts/Locations v24
Study sites55 entries, revised
Centro de InvestigaciónInvestigacion Clinica Belgrano
2026-08-05
minor
Study Identification, Study Status, Contacts/Locations v23
Study sites56→55
2026-07-22
minor
Study Status, Contacts/Locations v22
Study sitesdetails revised at 14 of 56 sites
2026-07-08
minor
Study Status, Contacts/Locations v21
Study sitesdetails revised at 5 of 56 sites
Show 20 earlier versions
2026-06-23
minor
Study Status, Contacts/Locations v20
Study sites56 entries, revised
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
2026-06-08
minor
Study Status, Contacts/Locations v19
Study sitesdetails revised at 4 of 56 sites
2026-05-26
minor
Study Status, Contacts/Locations v18
Study sitesdetails revised at 7 of 56 sites
2026-05-13
minor
Study Status, Contacts/Locations v17
Study sites56 entries, revised
Royal Devon and Exeter Hospital, Wonford
2026-04-27
minor
Study Status, Contacts/Locations v16
Study sitesdetails revised at 2 of 56 sites
2026-04-14
minor
Study Status, Contacts/Locations v15
Study sitesdetails revised at 1 of 56 sites
2026-03-31
minor
Study Status, Contacts/Locations v14
Study sites55→56
2026-03-17
minor
Study Status, Contacts/Locations v13
Study sites55 entries, revised
Fondazione Policlinico Universitario A.Agostino Gemelli IRCCS
2026-03-02
minor
Study Status, Contacts/Locations v12
Study sites55 entries, revised
University of Michigan Health System HOPHôpital Louis Pradel
2026-02-19
minor
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 55 sites
2026-02-16
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v10
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-01-23→confirmed 2026-02-10
Study sites50→55
2026-02-04
minor
Study Status, Contacts/Locations, IPDSharing, References v9
Study sites49→50
2026-01-19
minor
Study Status, Contacts/Locations v8
Study sites48→49
2025-12-19
minor
Study Status, Contacts/Locations v7
Study sites49→48
2025-12-10
minor
Study Status, Contacts/Locations v6
Study sitescontacts updated at 6 of 49 sites
2025-11-25
minor
Study Status, Contacts/Locations v5
Study sites48→49
2025-11-10
minor
Study Status, Contacts/Locations v4
Study sites47→48
2025-10-28
minor
Study Status, Contacts/Locations v3
Study sites44→47
2025-10-13
minor
Study Status, Arms and Interventions, Contacts/Locations v2
Study sites40→44
2025-10-01
minor
Study Status, Contacts/Locations v1
Start date2026-01-19→2026-01-23
Study sites33→40
2025-09-30
minor
Original filing
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.
Trial Details
NCT Number NCT07201922
Lead Sponsor Boehringer Ingelheim
Conditions Familial Pulmonary Fibrosis, Interstitial Lung Abnormalities, Interstitial Lung Diseases
Enrollment 80 participants
Start Date 2026-02-10
Primary Completion 2029-05-14 (estimated)
Study Completion 2029-05-23 (estimated)
Updated on ClinicalTrials.gov 2026-09-30