Informations générales (source: ClinicalTrials.gov)
An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON) (FIBRONEER™-ON)
Interventional
Phase 3
Boehringer Ingelheim (Voir sur ClinicalTrials)
septembre 2024
mai 2027
28 décembre 2024
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 (study 1305-0014 or
1305-0023).
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | ALEXANDRE CHABROL | 30/12/2024 08:02:35 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Avicenne | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Bichat | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Europeen Georges Pompidou | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HOP Bicêtre - 94275 - Le Kremlin-Bicêtre - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Charles Nicolle - 76031 - Rouen - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Côte de Nacre - 14033 - Caen - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP de la Cavale Blanche - 29609 - Brest - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Haut-Lévêque - 33604 - Pessac - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Larrey - 31059 - Toulouse - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Louis Pradel - 69677 - Bron - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Michallon - 38700 - La Tronche - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Nord - 13915 - Marseille - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Nord Laennec - 44093 - Nantes - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Pasteur - 06001 - Nice - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Pontchaillou - 35033 - Rennes - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Robert Debré - 51100 - Reims - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| INS Coeur Poumon - 59037 - Lille - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
1. Patients who completed treatment in the parent trials (1305-0014 or 1305-0023)
without prematurely discontinuing treatment permanently according to protocol (i.e.
completed treatment with or without temporary treatment interruption)
2. Signed and dated written informed consent in accordance with ICH-GCP and local
legislation prior to admission to the trial
3. Women of childbearing potential (WOCBP) must be ready and able to use highly
effective methods of birth control per ICH M3 (R2) that result in a low failure rate
of less than 1% per year when used consistently and correctly. WOCBP taking oral
contraceptives (OCs) also have to ensure the use of one barrier method during sexual
intercourse with their partner, e.g., condom to account for the risk of potentially
reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For
France, fertile males must be ready and able to use acceptable methods of birth
control
1. Patients who completed treatment in the parent trials (1305-0014 or 1305-0023)
without prematurely discontinuing treatment permanently according to protocol (i.e.
completed treatment with or without temporary treatment interruption)
2. Signed and dated written informed consent in accordance with ICH-GCP and local
legislation prior to admission to the trial
3. Women of childbearing potential (WOCBP) must be ready and able to use highly
effective methods of birth control per ICH M3 (R2) that result in a low failure rate
of less than 1% per year when used consistently and correctly. WOCBP taking oral
contraceptives (OCs) also have to ensure the use of one barrier method during sexual
intercourse with their partner, e.g., condom to account for the risk of potentially
reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For
France, fertile males must be ready and able to use acceptable methods of birth
control
1. Any disease that may put the patient at risk when participating in this trial at
investigator's discretion.
2. Patient exhibits suicidality, in the clinical judgment of the investigator or
according to the following criteria at Visit 1:
- any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted
attempt, or preparatory acts or behaviour)
- any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating
Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific
plan, or active suicidal thought with plan and intent)
3. Patients with clinically relevant severe depression at investigator's discretion or
a Hospital Anxiety and Depression Scale (HADS) subscore >14 at Visit 1.
4. An occurrence of malignant neoplasm other than appropriately treated basal cell
carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of
uterine cervix at Visit 1.
5. Patient will undergo lung transplantation, with an assigned date of surgery.
6. Patients with a Body Mass index (BMI) <18.5 kg/m² that experienced an additional,
unexplained and clinically significant (>10%) weight loss during the parent trial
7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI)
(suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led
to temporary treatment interruption in the parent trial
8. Patients who must or wish to take restricted medications or any drug considered
likely to interfere with the safe conduct of the trial.
Further exclusion criteria apply.