E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-infectious Intermediate, Posterior, or Pan- Uveitis. |
Uveite intermedia non infettiva, uveite posteriore o pan-uveite. |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic non-infectious uveitis. |
Uveite cronica non infettiva. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022557 |
E.1.2 | Term | Intermediate uveitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036370 |
E.1.2 | Term | Posterior uveitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042745 |
E.1.2 | Term | Sympathetic uveitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012692 |
E.1.2 | Term | Diabetic uveitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
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 |
The objective of this study is to demonstrate the superiority of gevokizumab compared to placebo in reducing the risk of recurrent uveitic disease in subjects with non-infectious intermediate, posterior, or pan- uveitis currently controlled with systemic treatment. |
L'obiettivo primario di questo studio è dimostrare la superiorità di gevokizumab rispetto al placebo, nel ridurre il rischio di riacutizzazioni dell'uveite in pazienti con uveite intermedia non infettiva, uveite posteriore o pan-uveite, attualmente controllati con terapia sistemica. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess the effect of gevokizumab on the other efficacy endpoints and to evaluate its safety. |
Gli obiettivi secondari sono di valutare gli effetti di gevokizumab su altri endpoint di efficacia e di valutare la sua sicurezza. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Diagnosis of non-infectious intermediate, posterior, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (SUN criteria) of intermediate, posterior, or pan- uveitis confirmed by documented medical history; - Controlled uveitic disease in both eyes, defined by no active inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber cell grade < or = 0.5+ according to SUN criteria, Vitrous Haze grade < or = 0.5+ according to the SUN/NEI Scoring for Vitrous Haze; - Best Corrected Visual Acuity of 35 letters or more in both eyes; - Patients with a stable dose of oral corticosteroids, alone or in combination with selected stable immunosuppressive therapy; - Male or female, age ≥18 (or legal age of majority in the country) at selection; - For subjects with reproductive potential, a willingness to use highly effective contraceptive measures. |
- Diagnosi di uveite intermedia non infettiva, uveite posteriore o pan-uveite in almeno un occhio, rispondente agli International Study Group Classification Criteria (criteri Standardization of Uveitis Nomenclature [SUN]) per uveite intermedia non infettiva, uveite posteriore o pan-uveite, confermata mediante anamnesi medica documentata; - Uveite controllata in entrambi gli occhi, definita come assenza di lesioni corioretiniche infiammatorie e/o lesioni vascolari retiniche infiammatorie attive, conta delle cellule della camera anteriore di grado < o = 0,5+ secondo i criteri SUN, offuscamento del corpo vitreo (haze) di grado < o = 0,5+ secondo il punteggio SUN/NEI per l'offuscamento del corpo vitreo; - Miglior acuità visiva corretta (BCVA) mediante ETDRS di 35 lettere o più in entrambi gli occhi; - Pazienti con una dose stabile di corticosteroidi orali, da soli o in combinazione con terapia immunosoppressiva a dosi stabili; - Uomini o donne, età > o = 18 anni (o di età maggiorenne) alla selezione; - Per pazienti in grado di procreare, la disponibilità a prendere misure contraccettive altamente efficaci. |
|
E.4 | Principal exclusion criteria |
- Infectious uveitis and masquerade syndromes ; - Isolated anterior uveitis; - Best corrected visual acuity < 35 letters in both eyes or monocular vision; - Presence of severe cataract or severe posterior capsular opacification; - Contraindication to mydriatics or presence of posterior synechiae, in either eye; - Active TB disease; - History of severe allergic or anaphylactic reactions to monoclonal antibodies; - History of malignancy within 5 years prior to Selection; - Infectious disease; - Known immunodeficiency; - Pregnancy, breastfeeding or possibility to become pregnant during the study. |
- Uveite infettiva e sindromi mascherate; - Uveite anteriore isolata; - Migliore acuità visiva < 35 lettere (ad entrambi gli occhi o visione monuculare); - Presenza di grave cataratta o di opacizzazione capsulare posteriore; - Controindicazione ai midiatrici o presenza di sinechie posteriori in uno degli occhi; - TB attiva; - Anamnesi di grave reazione allergica o anafilattica agli anticorpi monoclinali; - Anamnesi di tumori maligni nei 5 anni che precedono la selezione; - Malattia infettiva; - Immunodeficienza accertata; - Donne in gravidanza, che allattano o con possibilità di una gravidanza durante lo studio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with an occurence of uveitic disease. |
Percentuale dei pazienti con un episodio di uveite. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From inclusion to D168 |
Dalla inclusione fino al Giorno 168 |
|
E.5.2 | Secondary end point(s) |
- Time to first occurence of uveitic disease, - Mean change from baseline BCVA at D168; - Proportion of subjects who reach zero corticosteroids without an occurence of uveitic disease; - Ophthalmologic assessments (visual acuity, vitreous haze score); - Safety measurements (adverse events, optical coherence tomography, intraocular pressure, vital signs, chest X rays, standard 12-lead ECG, laboratory parameters). |
- Tempo al primo episodio di uveite; - Cambiamento medio rispetto al basale della BCVA al Giorno 168; - Percentuale di pazienti che sospendono completamente i corticosteroidi senza un episodio di uveite; - Valutazioni oftalmologiche (acuità visiva, offuscamento del corpo vitreo); - Misure di sicurezza (eventi avversi, tomografia a coerenza ottica, pressione intraoculare, segni vitali, radiografie toraciche, elettrocardiogrammi (ECG) standard a 12 derivazioni, parametri di laboratorio). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Ophthalmologic endpoints: at each visit until D168, and at D280, D392, OL-0, OL-112, and OL-224; - Safety measurements : from selection to the end of the trial. |
Endpoints oftalmologici: ad ogni visita fino alla visita G168, e a visita G280, G392, OL-0, OL-112 e OL-224; - Misure di sicurezza: dalla selezione alla fine dello studio. |
|
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 | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Schema di trattamento in aperto pazienti sottoposti con successo a terapia di salvataggio |
Open label treatment schedule for patients successfully rescued during the study |
|
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
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 | No |
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 |
Argentina |
Australia |
Brazil |
China |
Hong Kong |
India |
Korea, Republic of |
Mexico |
Russian Federation |
Saudi Arabia |
Switzerland |
Taiwan |
Tunisia |
Turkey |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 23 |
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 |