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A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

Study acronym: FIBRONEER™-ON
StatusActive, Not Recruiting
PhasePhase 3
Started2024-05-06
View on ClinicalTrials.gov ↗

Amendment history

The 49 most recent of 50 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-23
Enrollment closed, study ongoing
2026-08-19
Study Status, Contacts/Locations v49
Study sites373 entries, revised
AKH - Medical University of Vienna Centro de InvestigaciónInvestigacion del Maule The First hospitalHospital of Jiaxing The Affiliated Hospital, of Xuzhou Medical collegeCollege
2026-08-05
Study Status, Contacts/Locations v48
Study sites373 entries, revised
Temple University Hospital Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Wuhan Union Hospital Tongji Medical College Huazhong University of Science and Technology Second Affiliated Hospital of medical college of Xi'an JiaoTong University Universitetssjukhuset, Linköping
2026-07-08
Study Status, Contacts/Locations v47
Study sites372→373
2026-06-23
Study Status, Contacts/Locations v46
Study sites373→372
Show 45 earlier versions
2026-06-10
Study Status, Contacts/Locations v45
Study sitesdetails revised at 1 of 373 sites
2026-05-12
Study Status, Contacts/Locations v44
Study sites371→373
2026-04-28
Study Status, Contacts/Locations v43
Study sites371 entries, revised
Shaare Zedek Medical Center, Jerusalem 91031
2026-04-14
Study Status, Contacts/Locations v42
Study sites372→371
2026-04-01
Study Status, Contacts/Locations v41
Study sites372 entries, revised
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma MedicalSp. Centerz o.o. Hospital Universitari Vall D d'Hebron Royal Devon and Exeter Hospital, Wonford
2026-03-17
Study Status, Contacts/Locations v40
Study sites372 entries, revised
Instituto Ave Pulmo - Fundacion Enfisema Fondazione Policlinico Universitario A.Agostino Gemelli IRCCS CREPID Aire y Salud Integral
2026-03-03
Study Status, Contacts/Locations v39
Study sites372 entries, revised
University of Michigan Health System CIC Mauricie Inc.(Trois Rivieres) Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) HOPHôpital Louis Pradel HOPHôpital Pasteur HOPHôpital Charles Nicolle
2026-02-23
Study Status, Contacts/Locations v38
Study sitesdetails revised at 28 of 372 sites
2026-02-03
Study Status, Contacts/Locations, IPDSharing, References v37
Study sitesdetails revised at 27 of 372 sites
2026-01-27
Study Status, Contacts/Locations v36
Study sites371→372
2026-01-07
Study Status, Contacts/Locations v35
Study sites371 entries, revised
EdumedSAPIENS - EducacaoInstituto de Estudos e SaudePesquisa SAClínica Hospital das Clinicas da FMUSPFaculdade de Medicina da USP IUCPQInstitut (LavalUniversitaire University)de Cardiologie et de Pneumologie de Quebec St. Antonius ziekenhuis, locatie NieuwegeinZiekenhuis Hospital Universitario De La Princesa
2025-12-11
Study Status, Contacts/Locations v34
Study sites371 entries, revised
Azienda Ospedaliera PoliclinicoOspedaliero-Universitaria di Modena ULSCentro Hospitais da Universidade de Coimbra, E.P.E.
2025-11-25
Study Status, Contacts/Locations v33
Study sites371 entries, revised
UNIVUniversitair UZZiekenhuis Gent Thomayer University Thomayer´s Hospital
2025-10-29
Study Status, Contacts/Locations v32
Study sites371 entries, revised
Hospital Universitari de Bellvitge
2025-10-15
Study Status, Arms and Interventions, Contacts/Locations v31
InterventionsBI 1015550 (Drug)→Nerandomilast (Drug)
Study sites371 entries, revised
A.O.U. Senese Policlinico Santa Maria alle Scotte
2025-10-01
Study Status, Contacts/Locations v30
Study sites371 entries, revised
BrusselsCliniques - UNIVUniversitaires Saint-Luc Hospital das Clinicas da Universidade Federal HC-UFMGde Minas Gerais (HCUFMG) The First Affiliated Hospital of Wenzhou MedMedical CollegeUniversity Yichang NO.1Central People's Hospital Hospital Universitari Vall d'D Hebron Hospital RamónUniversitario yRamon Y Cajal
2025-08-19
Study Status, Contacts/Locations v29
Start date2024-09-24→2024-05-06
Study sites371 entries, revised
University HospitalUniversitätsspital Basel
2025-08-05
Study Status, Contacts/Locations v28
Study sites372→371
2025-07-28
Study Status, Contacts/Locations v27
Study sites372 entries, revised
ChinaLTD The First Medical University HospitalCenter
2025-07-07
Study Status, Contacts/Locations v26
Study sitesdetails revised at 1 of 372 sites
2025-06-24
Study Status, Contacts/Locations v25
Study sites372 entries, revised
West China Hospital of Sichuan University
2025-06-13
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v24
Eligibility criteria+12 characters
Inclusion Criteria: Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-00230035) without prematurely discontinuing treatment permanently ac [...]
Primary endpoints1 entry, revised
Occurrence of any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99
Study sites372 entries, revised
CREPID Aire y Salud Integral
2025-05-30
Study Status, Contacts/Locations v23
Study sites374→372
2025-05-13
Study Status, Contacts/Locations v22
Study sites340→374
2025-04-03
Study Status, Contacts/Locations v21
Study sites334→340
2025-03-18
Study Status, Contacts/Locations v20
Study sites324→334
2025-03-12
Study Status, Contacts/Locations v19
Study sites287→324
2025-02-19
Study Status, Contacts/Locations v18
Study sites301→287
2025-02-04
Study Status, Eligibility, Contacts/Locations v17
Study sites336→301
Eligibility criteria+32 characters
[...] tients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), se [...]
2025-01-13
Study Status, Contacts/Locations v16
Study sites342→336
2024-12-20
Study Identification, Study Status, Study Description, Contacts/Locations v15
Study sites351→342
Study title+6 characters
A Follow-up Study to Test Long-term Treatment With BI 1015550Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With BI 1015550Nerandomilast
2024-12-09
Study Status, Contacts/Locations v14
Study sites332→351
2024-11-27
Study Status, Contacts/Locations v13
Start date2024-07-10→2024-09-24
Study sites248→332
2024-10-31
Study Status, Contacts/Locations v12
Study sites230→248
2024-10-29
Study Status, Contacts/Locations v11
Study sites222→230
2024-10-28
Study Status, Contacts/Locations v10
Study sites188→222
2024-10-16
Study Status, Contacts/Locations v9
Study sites146→188
2024-10-02
Study Status, Contacts/Locations v8
Study sites90→146
2024-09-17
Study Status, Contacts/Locations v7
Study sites42→90
2024-09-02
Study Status, Contacts/Locations v6
Study sites15→42
2024-08-19
Study Status, Contacts/Locations v5
Study sites9→15
2024-08-07
Study Status, Contacts/Locations v4
Study sites5→9
2024-08-05
Study Status, Contacts/Locations v3
Study sites3→5
2024-07-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-07-09→confirmed 2024-07-10
Study sites0→3
2024-06-18
Study Status, Arms and Interventions v1
Start date2024-07-01→2024-07-09
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.
Trial Details
NCT Number NCT06238622
Lead Sponsor Boehringer Ingelheim
Conditions Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Enrollment 1,666 participants
Start Date 2024-05-06
Primary Completion 2027-04-28 (estimated)
Study Completion 2027-05-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-30