E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic Pulmonary Fibrosis |
Fibrosi Polmonare idiopatica |
|
E.1.1.1 | Medical condition in easily understood language |
Idiopathic pulmonary fibrosis (IPF) is a form of chronic, progressive, fibrosing interstitial pneumonia of unknown etiology that occurs primarily in older adults and is limited to the lungs. |
La fibrosi polmonare idiopatica è una forma di polmonite interstiziale cronica, progressiva, fibrosante di eziologia sconosciuta che si verifica principalmente negli anziani ed è limitata ai polmoni. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Investigate the safety of CSL312 in subjects with IPF |
Indagare la sicurezza di CSL312 nei soggetti con IPF |
|
E.2.2 | Secondary objectives of the trial |
• To characterize the systemic PK of CSL312 in patients with IPF • To investigate the PD activity of CSL312 in patients with IPF |
Caratterizzare la farmacocinetica sistemica di CSL312 in pazienti con IPF • Studiare l'attività farmacodinamica di CSL312 in pazienti con IPF |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female patients, >= 40 years of age 2. Documented diagnosis of IPF |
1. Pazienti maschi o femmine, >= 40 anni di età 2. Diagnosi documentata di IPF |
|
E.4 | Principal exclusion criteria |
1. History of clinically significant cardiovascular disease, including myocardial infarction, unstable ischemic heart disease, congestive heart failure, or angina 2. Sinoatrial or atrioventricular block, uncontrolled hypertension 3. Active bleeding or current clinically significant coagulopathy |
1. Storia clinica di malattie cardiovascolari clinicamente significative, inclusi infarto del miocardio, cardiopatia ischemica instabile, insufficienza cardiaca congestizia o angina 2. Blocco senoatriale o atrioventricolare, ipertensione non controllata 3. Sanguinamento attivo o coagulopatia clinicamente significativa in corso |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of participants with treatment-emergent serious adverse events (SAEs) for CSL312 or placebo 2. Percent of participants with SAEs for CSL312 or placebo 3. Number of participants with treatment-emergent adverse events of special interest (AESIs) for CSL312 or placebo 4. Percent of participants with AESIs for CSL312 or placebo 5. Number of participants with treatment-emergent CSL312 induced antidrug antibodies (ADAs) 6. Percent of participants with CSL312 induced ADAs 7. Number of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo 8. Percent of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as AEs for CSL312 or placebo |
1. Numero di partecipanti con eventi avversi gravi (SAE) emergenti dal trattamento per CSL312 o placebo 2. Percentuale di partecipanti con SAE per CSL312 o placebo 3. Numero di partecipanti con eventi avversi di particolare interesse (AESIs) emergenti dal trattamento per CSL312 o placebo 4. Percentuale di partecipanti con AESIs per CSL312 o placebo 5. Numero di partecipanti con anticorpi anti faramaco (ADAs) indotti da CSL312 emergenti dal trattamento 6. Percentuale di partecipanti con ADAs indotti da CSL312 7. Numero di partecipanti con anomalie clinicamente significative emergenti dal trattamento nelle valutazioni di laboratorio che sono state riportate come eventi avversi (AEs) per CSL312 o placebo 8. Percentuale di partecipanti con anomalie clinicamente significative emergenti dal trattamento nelle valutazioni di laboratorio che sono riportate come eventi avversi per CSL312 o placebo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to 22 weeks 2. Up to 22 weeks 3. Up to 22 weeks 4. Up to 22 weeks 5. Up to 14 weeks 6. Up to 14 weeks 7. Up to 14 weeks 8. Up to 14 weeks |
1. Fino a 22 settimane 2. Fino a 22 settimane 3. Fino a 22 settimane 4. Fino a 22 settimane 5. Fino a 14 settimane 6. Fino a 14 settimane 7. Fino a 14 settimane 8. Fino a 14 settimane |
|
E.5.2 | Secondary end point(s) |
1. Trough plasma concentration (Ctrough) after subcutaneous (SC) administration of CSL312 2. Maximum plasma concentration (Cmax) (last SC dosing interval only) of CSL312 3. Time to maximum plasma concentration (Tmax) (last SC dosing interval only) of CSL312 4. Area under the plasma concentration-time curve after the first dose interval (AUC0-tau) (last SC dosing interval only) of CSL312 5. Ctrough after intravenous (IV) administration of CSL312 6. Cmax after IV administration of CSL312 7. Tmax after IV administration of CSL312 8. Mean change from Baseline in FXIIa-mediated kallikrein activity of CSL312 9. Mean percentage of Baseline in FXIIa-mediated kallikrein activity of CSL312
|
1. Concentrazione plasmatica minima (Ctrough) dopo somministrazione sottocutanea (SC) di CSL312 2. Concentrazione plasmatica massima (Cmax) (solo ultimo intervallo di somministrazione SC) di CSL312 3. Tempo alla concentrazione plasmatica massima (Tmax) (solo ultimo intervallo di somministrazione SC) di CSL312 4. Area sotto la curva concentrazione plasmatica-tempo dopo il primo intervallo di dose (AUC0-tau) (solo ultimo intervallo di somministrazione SC) di CSL312 5. Ctrough dopo somministrazione endovenosa (IV) di CSL312 6. Cmax dopo somministrazione endovenosa di CSL312 7. Tmax dopo somministrazione EV di CSL312 8. Cambiamento medio rispetto al basale nell'attività callicreina mediata da FXIIa di CSL312 9. Percentuale media del basale nell'attività della callicreina mediata da FXIIa di CSL312 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to 14 weeks 2. Up to 14 weeks 3. Up to 14 weeks 4. Up to 14 weeks 5. Up to 8 days 6. Up to 8 days 7. Up to 8 days 8. Up to 14 weeks 9. Up to 14 weeks |
1. Fino a 14 settimane 2. Fino a 14 settimane 3. Fino a 14 settimane 4. Fino a 14 settimane 5. Fino a 8 giorni 6. Fino a 8 giorni 7. Fino a 8 giorni 8. Fino a 14 settimane 9. Fino a 14 settimane |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
Ukraine |
United States |
Austria |
Czechia |
Denmark |
France |
Germany |
Italy |
Latvia |
Lithuania |
Norway |
Poland |
Sweden |
United Kingdom |
Switzerland |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |