E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Venous leg ulcer |
Ulcera venosa agli arti inferiori |
|
E.1.1.1 | Medical condition in easily understood language |
Venous leg ulcer |
Ulcera venosa agli arti inferiori |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068310 |
E.1.2 | Term | Leg ulcer |
E.1.2 | System Organ Class | 100000004858 |
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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 detect the existence of an overall dose-response relationship with S42909 on improving healing of venous leg ulcers on top of standard of care (compression and local wound care) after 4 weeks of treatment |
Determinare l’esistenza di una relazione dose-risposta globale di S42909 sul miglioramento della cicatrizzazione delle ulcere venose agli arti inferiori in aggiunta alla terapia standard (compressione e trattamento locale della ferita) dopo 4 settimane di trattamento |
|
E.2.2 | Secondary objectives of the trial |
-To assess the safety profile of each tested dose of S42909 (adverse events, laboratory parameters, physical examination, body weight, vital signs (blood pressure, heart rate), 6 or 12-lead electrocardiogram (ECG) and standard urinalysis). -To assess pharmacokinetics of S42909 and its metabolites in patients after repeated administration of S42909. |
-Valutare il profilo di sicurezza di ogni dosaggio testato di S42909 (eventi avversi, esami di biochimica, esami di ematologia, esame fisico, peso corporeo, segni vitali (pressione arteriosa, frequenza cardiaca) ECG a 6 o 12 derivazioni e analisi standard delle urine -Valutare la farmacocinetica di S42909 e dei suoi metaboliti nei pazienti dopo la somministrazione ripetuta di S42909 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Caucasian, men or women : - Age >= 18 years old. - 18.5 kg/m2 <= BMI <= 45.0 kg/m2 (= Weight (kg) / height² (m²)). - Patients with chronic venous disease documented by imaging to detect a venous disorder in the sub- and extra-fascial venous system. The examination performed within 6 months before selection can be used. - Patients with at least one active venous leg ulcer localised in the gaiter area (CEAP C6) diagnosed or reoccurred for more than 6 weeks and less than 2 years at selection and 3 cm away from other ulcers. Patients with bilateral ulcerations or multiple ulcerations on one or both legs are eligible for selection. - Size of Reference Ulcer (defined as the largest ulcer in size that is fitting the area selection criteria) should be >= 5 cm2 and <= 100 cm2 (measured by transparent sheet and confirmed with the digital 3D imaging device). |
-Uomini o donne caucasici : - Di età >= 18 -18.5 kg/m2 <= BMI <= 45.0 kg/m2 (= Peso (kg) / altezza² (m²)) - Pazienti affetti da malattia venosa cronica documentata da ultrasonografia bilaterale per rilevare un disturbo venoso nel sistema sub- ed extra fasciale. Può essere utilizzato l'esame eseguito entro 6 mesi dalla selezione. -Pazienti con almeno un’ulcera venosa attiva agli arti inferiori localizzata nella'area della "ghetta" (stadio CEAP C6) diagnosticata o ricomparsa da più di 6 settimane e da meno di 2 anni dalla selezione e distante dalle altre ulcere di almeno 3cm. Pazienti con ulcerazioni bilaterali o multiple su una o entrambe le gambe sono idonei per la selezione. - La dimensione dell'ulcera di riferimento (definita come l’ulcera più grande le cui dimensioni rispettino i criteri di selezione dell’area) deve essere >= 5 cm² e <= 100 cm² (misurata con un foglio trasparente e confermata con il dispositivo di immagine digitale 3D) |
|
E.4 | Principal exclusion criteria |
- Unlikely or unwilling to be compliant to standardized compression recommendation, study medication and visits, previous records of poor compliance to compression stockings. |
-Scarsa aderenza alle raccomandazioni di compressione standard, alle medicazioni e visite dello studio, precedenti episodi di scarso utilizzo delle calze compressive |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Relative reduction of Reference Ulcer area after 4 weeks of treatment on top of standard of care compared with baseline Reference Ulcer area (W000) assessed during study visits using a digital 3D imaging device |
Riduzione relativa dell’area dell’Ulcera di Riferimento dopo 4 settimane di trattamento in aggiunta alla terapia standard rispetto all’area dell’Ulcera di Riferimento al basale (W000), calcolata durante ogni visita dello studio utilizzando un dispositivo di immagine digitale 3D |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-Safety measurements -Assessments of laboratory parameters: biochemistry, haematology and fasting lipids |
-Misure di sicurezza -Valutazione dei parametri di laboratorio: biochimica, ematologia e lipidi a digiuno |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Safety measurements: -Physical examination (ASSE, W000, W001, W002, W003, W004, W006, W008); -6 or 12-leads electrocardiogram (ASSE, W000, W001, W002, W003, W004, W006, W008); -Laboratory assessments (ASSE, W000, W001, W002, W004, W006, W008); -Adverse events (from ASSE to W008); -Laboratory parameters: ASSE, W000, W001, W002, W004, W006, W008 |
-Misure di sicurezza: -Esame fisico (ASSE, W000, W001, W002, W003, W004, W006, W008); -ECG a 6 o 12 derivazioni (ASSE, W000, W001, W002, W003, W004, W006, W008); -Analisi di laboratorio (ASSE, W000, W001, W002, W004, W006, W008); -Eventi avversi (da ASSE a W008); -Parametri di laboratorio: ASSE, W000, W001, W002, W004, W006, W008 |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
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 | 6 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 44 |
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 |
Austria |
Canada |
Czechia |
Denmark |
Germany |
Italy |
Slovakia |
Spain |
United States |
|
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |