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 |
Lung scarring of unknown origin |
Cicatrici sui polmoni di origine sconosciuta |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021240 |
E.1.2 | Term | Idiopathic pulmonary fibrosis |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate, in comparison with placebo, the efficacy of 2 dose levels of SAR156597 administered subcutaneously during 52 weeks on lung function of patients with IPF. |
Valutazione della funzione polmonare dell'efficacia di 2 livelli/regimi di dosaggio di SAR156597 somministrati per via sottocutanea per 52 settimane rispetto al placebo in pazienti affetti da IPF |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of 2 dose levels of SAR156597 compared to placebo on IPF disease progression. - To evaluate the safety of 2 dose levels of SAR156597 compared to placebo in patients with IPF. |
- Valutazione dell'efficacia di 2 livelli/regimi di dosaggio di SAR156597 rispetto al placebo sulla progressione della IPF - Valutazione della sicurezza di 2 livelli/regimi di dosaggio di SAR156597 rispetto al placebo in pazienti affetti da IPF |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult male or female patients - Documented diagnosis of IPF according to the current American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ American Latin Thoracic Association (ATS/ERS/JRS/ALAT) guidelines - Signed written informed consent |
- Pazienti di sesso maschile o femminile - Diagnosi documentata di IPF in base alle attuali linee guida ATS/ERS/JRS/ALAT - Consenso informato scritto
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E.4 | Principal exclusion criteria |
- Age =40 years - IPF disease diagnosis >5 years - Forced vital capacity (FVC) <40% of predicted value - Carbon monoxide diffusing lung capacity (DLco) corrected for hemoglobin <30% of predicted value - Severe chronic obstructive bronchitis as characterized by forced expiratory volume in 1 second /forced vital capacity (FEV1/FVC) <0.70 - Need for 24 hrs of oxygen therapy or oxygen saturation <88% after 10 minutes breathing ambient air at rest - Known diagnosis of significant respiratory disorders other than IPF - Pulmonary artery hypertension requiring a specific treatment - Currently listed and/or anticipated to be listed for lung transplantation within the next 6 months (on an active list) - History of vasculitis or connective tissue disorders. - Known human immunodeficiency virus (HIV) or chronic viral hepatitis - Patients with active tuberculosis or incompletely treated latent tuberculosis infection - Use of any cytotoxic/immunosuppressive agent including but not limited to azathioprine, cyclophosphamide, methotrexate, and cyclosporine within 4 weeks prior to screening - Use of any cytokine modulators (etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab, rituximab) within 12 weeks or 5 half-lives of screening (24 weeks for rituximab and 24 months for alefacept) |
- Età =40 anni - Diagnosi di IPF >5 anni - Capacità vitale forzata (FVC) <40% del valore previsto - Capacità di diffusione del monossido di carbonio (DLCO) corretta per l'emoglobina <30% del valore previsto - Bronchite ostruttiva cronica grave caratterizzata da FEV1/FVC <0,70 - Necessità di ossigenoterapia per 24 ore o saturazione dell'ossigeno <88% dopo 10 minuti di respirazione in aria ambiente a riposo - Diagnosi nota di disturbi respiratori significativi (ad es. asma, tubercolosi, sarcoidosi, aspergillosi o fibrosi cistica) diversi dall'IPF - Ipertensione arteriosa polmonare che richieda un trattamento specifico - Pazienti in lista di attesa o con previsione di inserimento nella lista di attesa per un trapianto di polmone nei 6 mesi successivi (lista attiva) - Anamnesi di vasculite o di alterazioni del tessuto connettivo - Virus noto dell'immunodeficienza umana (HIV) o epatite virale cronica - I pazienti con tubercolosi attiva o non completamente trattati, latente infezione tubercolare - L'uso di qualsiasi agente citotossico / immunosoppressivo compreso ma non limitato di azatioprina, ciclofosfamide, metotrexate, ciclosporina nelle 4 settimane precedenti lo screening - L'utilizzo di modulatori citochine (etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab, rituximab) entro 12 settimane o 5 emivita allo screening (24 settimane per rituximab e 24 mesi per alefacept). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Mean absolute change from baseline in percent predicted FVC at 52 weeks |
Variazione assoluta della % dell’atteso dell’FVC a 52 settimane rispetto al basale |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Proportion of patients with disease progression; Number of deaths (all causes) |
Proporzione di pazienti con progressione della malattia ; Numero di decessi (tutte le cause) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 year; 1 year |
un anno; un anno |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | 3 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 33 |
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 |
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E.8.7 | Trial has a data monitoring committee | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |