E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 16.0 |
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 |
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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 the efficacy of sarilumab at week 16 in patients with non-infectious uveitis (NIU). |
Evaluar la eficacia de sarilumab en la semana 16 en pacientes con uveítis no infecciosa (NIU) |
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E.2.2 | Secondary objectives of the trial |
To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of subcutaneous sarilumab in patients with NIU. To evaluate the change in other signs of ocular inflammation. |
Evaluar el cambio en la mejor agudeza visual corregida(MAVC). Evaluar la seguridad de sarilumab subcutáneo en pacientes con NIU. Evaluar el cambio en otros signos de inflamación ocular. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
sup or equal 18 years of age. Non-infectious intermediate-, posterior-, or pan-uveitis in the study eye. Active disease at screening or evidence of activity within the 3 months prior to screening visit. On stable dose of prednisone or equivalent steroid compound for at least 4 weeks prior to randomization. Signed written informed consent. |
I 01. sup o igual 18 años de edad. I 02. Uveítis no infecciosa intermedia, posterior o panuveítis en el ojo de estudio. I 03. Enfermedad activa en la selección o evidencia de actividad en los 3 meses previos a la visita de selección, demostrado por VH sup o igual a 4+ en la escala de 9 pasos de Davis, edema macular (CRT sup o igual a 300 micrones) u otros signos de inflamación intraocular (p. ej., revestimiento perivascular de los vasos retinianos o fuga en la angiografía con fluoresceína (AF). I 04. Prednisona oral a una dosis de > 0,2 mg/kg/día (o corticosteroide oral equivalente) como terapia inmunosupresora sola o en combinación con metotrexato (MTX) [10 a 25 mg/semana por vía oral, intravenosa, intramuscular o subcutánea]. Las dosis no deberán haberse cambiado antes de la visita de aleatorización: durante al menos 4 semanas para los esteroides y 6 semanas para el MTX. I 05. La dosis inicial de prednisona oral debe ser mayor o igual a 15 mg/día y menor de 80 mg/día. I 06. Consentimiento informado por escrito firmado. |
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E.4 | Principal exclusion criteria |
Patient with best-corrected visual acuity worse than 20 ETDRS letters in at least one eye. Patient with confirmed or suspected uveitis of infectious etiology or uveitis of traumatic etiology. Patient with primary diagnosis of anterior uveitis. Prior treatment with anti-IL-6 or IL-6R antagonist therapies, including tocilizumab and sarilumab. |
E 01. Paciente con mejor agudeza visual corregida (MAVC) peor que 20 letras ETDRS (aproximado al equivalente de Snellen de 20/400) en al menos un ojo. E 02. Paciente con confirmación o sospecha de uveítis de etiología infecciosa o uveítis de etiología traumática. E 03. Paciente con diagnóstico principal de uveítis anterior. E 04. Tratamiento previo con anti-IL-6 o antagonistas de IL-6R, incluidos tocilizumab y sarilumab. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients with at least 2-step reduction in Vitreous Haze OR dose of prednisone < 10 mg/day |
Porcentaje de pacientes con al menos una reducción de 2 grados del nivel de opacidad vítrea (según la escala de 9 grados de J. Davis) O una dosis de prednisona < 10 mg/día (o corticosteroide oral equivalente) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 16 weeks |
En la semana 16 |
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E.5.2 | Secondary end point(s) |
1) Percentage of patients with anterior chamber score = 0 or at least 2-step reduction in score (Tyndall and flare according to the SUN classification) 2) Mean change from baseline in BCVA (ETDRS letters score) 3) Number of patients experiencing adverse events |
1) Porcentaje de pacientes con una puntuación en la cámara anterior = 0 o por lo menos una reducción de 2 grados en la puntuación (efecto Tyndall y brillos según la clasificación de la Standardization of Uveitis Nomenclature [normalización de la nomenclatura de la uveítis, SUN] 2) Cambio medio desde el momento basal en la MAVC (puntuación de letras ETDRS) 3) Número de pacientes que experimenten acontecimientos adversos |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1/2) At 16 weeks 3) Up to 16 weeks |
1/2) En la semana 16 3) Más allà de la semana 16 |
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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 | No |
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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 |
Switzerland |
Turkey |
United States |
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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
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LVLS |
Última visita del último paciente |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 24 |
E.8.9.2 | In all countries concerned by the trial days | 0 |