E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-infectious Intermediate, Posterior, or Pan- Uveitis |
Uveítis no infecciosa activa, posterior o panuveítis |
|
E.1.1.1 | Medical condition in easily understood language |
chronic non-infectious uveitis |
Uveítis no infecciosa crónica |
|
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 | PT |
E.1.2 | Classification code | 10069034 |
E.1.2 | Term | Tubulointerstitial nephritis and uveitis syndrome |
E.1.2 | System Organ Class | 10038359 - Renal and urinary 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 | 10033687 |
E.1.2 | Term | Panuveitis |
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 | 10071139 |
E.1.2 | Term | Behcet's uveitis |
E.1.2 | System Organ Class | 100000004870 |
|
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 | 10066681 |
E.1.2 | Term | Acute 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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10046851 |
E.1.2 | Term | 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 the treatment of subjects with active non infectious intermediate, posterior, or pan- uveitis. |
El objetivo de este estudio es demostrar la superioridad de Gevokizumab comparado conplacebo en el tratamiento de sujetos con uveítis no infecciosa activa intermedia, posterior o panuveítis |
|
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. |
Los objetivos secundarios son evaluar el efecto de gevokizumab otros aspectos de eficacia así como evaluar su seguridad. |
|
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 - Active uveitic disease, defined by the presence of ? 2+ vitreous haze score in at least one eye - Best Corrected Visual Acuity of 10 to 75 letters in the study eye - Patients with a stable background treatment of oral corticosteroids, selected immunosuppressive therapy, or combination of both. - 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. |
- Diagnóstico de uveítis no infecciosa intermedia, posterior o panuveítis en al menos un ojo cumpliendo los criterios de clasificación del grupo de estudio internacional ( criterios de SUN ) de uveítis intermedia, posterior o panuveítis confirmado por la historia clínica documentada - Uveítis activa definida por la presencia de una puntuación de la opacidad del vítreo de ? 2+ en al menos un ojo - Mejor agudeza visual corregida de entre 10 a 75 letras en el ojo estudiado - Pacientes con un tratamiento previo estable de corticosteroides orales, terapia con inmunosuresores seleccionados o la combinación de ambos . - Hombre o mujer , edad ?18 (o mayoría de edad legal ) en la selección - Para pacientes con potencial reproductivo, la voluntad de utilizar un método anticonceptivo altamente eficaz |
|
E.4 | Principal exclusion criteria |
- Infectious uveitis and masquerade syndromes - Isolated anterior uveitis - Best corrected visual acuity < 35 letters in the non-study eye or monocular vision - Presence of severe cataract or severe posterior capsular opacification. - Contraindication to mydriatics or presence of posterior synechiae. - 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 |
- Uveitis infecciosa o síndromes mascarada - Uveítis anterior aislada - Agudeza visual mejorada < 35 letras en el ojo no estudiado o visión monocular - Presencia de cataratas u opacificación capsular grave - Contraindicación de uso de midriáticos o presencia de sinequiaas posteriores - Enfermedad tuberculosis activa. - Antecedentes de reacción alérgica o anafiláctica grave a anticuerpos monoclonales - Antecedentes de neoplasia en lops 5 años previos a la selección. - Enfermedad infecciosa - Inmunodeficiencia conocida. - Embarazo, lactancia o posibilidad de quedarse embarazada durante el estudio |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of responders at D56 |
Proporción de respondedores en D56 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From inclusion to D56. |
Desde la inclusión hasta D56 |
|
E.5.2 | Secondary end point(s) |
- Proportions of responders at D28, - Proportion at responders at other visits, - 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,...) |
- Proporción de respondedores en D28, - Proporción de respondedores en otras visitas , - Evaluaciones oftalmológicas (agudeza visual, valor de la opacidad del vítreo , ...) - Medidas de seguridad (aconetcimientos adversos, tomografía de coherencia óptica, presión intraocular, signos vitales, radiografía de tórax , ECG de 12 derivaciones estándar, parámetros de 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. |
-Objetivos oftalmológicos: en cada visita hasta D168, y en D280, D392, OL-0, OL-112, y OL-224. -Medidas de seguridad: desde la selección hasta el final del ensayo . |
|
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 |
Esquema de tratamiento en abierto para pacientes que hayan sido rescatado con éxito |
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 | 24 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 28 |
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 |
Germany |
Greece |
Hong Kong |
India |
Korea, Republic of |
Mexico |
Poland |
Portugal |
Russian Federation |
Saudi Arabia |
Spain |
Switzerland |
Taiwan |
Tunisia |
Turkey |
United Kingdom |
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
|
The end of trial is defined as the Last Visit of the Last Participant as stated in the clinical protocol. |
El final del ensayo se define como la última visita del último particpante tal y como se especifica en el protocolo |
|
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 | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |