E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary Sjogren’s syndrome |
Síndrome de Sjögren primario |
|
E.1.1.1 | Medical condition in easily understood language |
Sjogren's syndrome |
Síndrome de Sjögren |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10040767 |
E.1.2 | Term | Sjogren's syndrome |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 demonstrate a dose response of VAY736 defined as change in multi-dimensional disease activity as assessed by the physician from baseline at 24 weeks |
Demostrar la dosis-respuesta de VAY736 definida como el cambio en la actividad multidimensional de la enfermedad medida por el investigador desde la basal hasta la semana 24. |
|
E.2.2 | Secondary objectives of the trial |
- To assess a dose response of VAY736 in the change from baseline of patient-reported disease activity measures at 24 weeks - To assess a dose response of VAY736 in the change from baseline of the patient reported outcomes at 24 weeks - To evaluate the effects of VAY736 on salivary gland function at 24 weeks - To assess PK of VAY736
Other protocol-defined secondary objectives may apply. |
- Evaluar la dosis-respuesta de VAY736 en el cambio en la evaluación de actividad de la enfermedad por parte de los pacientes desde la basal hasta la semana 24 - Evaluar la dosis-respuesta de VAY736 en el cambio en los resultados comunicados por los pacientes desde la basal a la semana 24 - Evaluar los efectos de VAY736 en la función de las glándulas salivales en la semana 24 - Evaluar la PK de VAY736
Pueden aplicar otros objetivos secundarios definidos en el protocolo. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Fulfilled revised American European US Consensus Group criteria for pSS - Seropositive at screening for anti-Ro/SSA antibodies - Documented salivary/lacrimal gland biopsy result confirming pSS diagnosis prior to the baseline visit
- Other protocol-defined inclusion/exclusion criteria may apply |
- Cumplir los criterios revisados del American European Consensus Group para la clasificación de SSp - Seropositivo en la selección para anticuerpos anti-Ro/SSA. - Resultado documentado de una biopsia de la glándula salival/lacrimal que confirme diagnóstico de SSp previo a la visita basal. - Pueden aplicar otros criterios de inclusión/ exclusión definidos en el protocolo. |
|
E.4 | Principal exclusion criteria |
- Secondary Sjogren’s syndrome - Use of other investigational drugs - Active viral, bacterial or other infections - Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening
- Other protocol-defined inclusion/exclusion criteria may apply |
- Síndrome de Sjögren secundario - Uso de otros fármacos en investigación - Infecciones activas víricas, bacterianas u otras - Hepatitis B positiva, hepatitis C, VIH o resultados de test de tuberculosis en la selección - Pueden aplicar otros criterios de inclusión/ exclusión definidos en el protocolo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Dose-response measured by change in multi-dimensional disease activity as assessed by the physician |
Evaluar la dosis-respuesta en el cambio en la actividad multidimensional de la enfermedad medida por el investigador. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Over 24 weeks |
Durante 24 semanas |
|
E.5.2 | Secondary end point(s) |
- Dose-response measured by change in patient-reported disease activity measures - Change in quality of life measured by PROs - Change in salivary gland function measured by flow rate - Pharmacokinetics of VAY736 over time - Assessment of AEs, SAEs, Immunogenicity
Other protocol defined endpoints may apply |
- Evaluar la dosis-respuesta en el cambio en la evaluación de actividad de la enfermedad por parte de los pacientes - Evaluar la calidad de vida medida mediante PROs - Cambio en la función de las glándulas salivales - Farmacocinética del VAY736 a lo largo del tiempo - Medida de AA, AAG, Inmunogenetica |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Over 24 weeks |
Durante 24 semanas |
|
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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
immunogenicity |
inmunogenética |
|
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 | 4 |
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 | 39 |
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 |
Austria |
Belgium |
Chile |
France |
Germany |
Hungary |
Israel |
Italy |
Japan |
Netherlands |
Poland |
Portugal |
Romania |
Russian Federation |
Spain |
Taiwan |
United Kingdom |
United States |
|
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
|
The study will complete when the last subject completes their Study Completion visit, and any repeat assessments associated with this visit have been documented and followed-up appropriately by the Investigator. |
El estudio se completará cuando el ultimo paciente complete su Visita de fin del estudio y cualquier evaluación repetida asociada con esta visita haya sido documentada y seguida apropiadamente por el investigador. |
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |