E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Spontaneous Urticaria |
Urticaria Crónica Espontánea |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Hives |
Urticaria Crónica |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009159 |
E.1.2 | Term | Chronic urticaria |
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 |
The primary objective of this study is to assess the long-term safety of QGE031 (240 mg s.c.) given every 4 weeks for 12 months in patients who completed study CQGE301C2201 by evaluation of: - Incidence and severity of all adverse events - Changes in vital signs, laboratory assessments, and ECGs |
El objetivo principal de este estudio es evaluar la seguridad a largo plazo de QGE031 (240 mg s.c.) administrado cada 4 semanas a lo largo de 12 meses en pacientes que hayan completado el estudio CQGE301C2201 mediante la evaluación de: - Incidencia e intensidad de todos los acontecimientos adversos. - Cambios en las constantes vitales, pruebas analíticas y ECG. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate long-term treatment outcomes of QGE031 in adult patients with CSU by evaluation of: - Sustained remission defined as maintaining UAS7 ? 6 over 48 weeks post-treatment follow up epoch among the subjects achieving remission at the end of treatment epoch |
Evaluar los resultados del tratamiento a largo plazo de QGE031 en pacientes adultos con UEC mediante la evaluación de: - Remisión sostenida definida como mantener UAS7 ? 6 durante la fase de seguimiento posterior al tratamiento de 48 semanas entre los sujetos que alcanzan una remisión en la fase de fin de tratamiento |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients who complete study treatment epoch and at least visit 203 in the follow-up epoch in study QGE031C2201 - Present with active disease as defined by UAS7 ?12 |
- Pacientes que hayan completado la fase de tratamiento del estudio y al menos la visita 203 en la fase de seguimiento del estudio QGE031C2201. - Presente enfermedad activa. |
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E.4 | Principal exclusion criteria |
- New onset of chronic urticaria other than CSU during the follow-up epoch of study CQGE031C2201. |
- Nueva aparición de urticaria crónica distinta a UEC durante la fase de seguimiento del estudio CQGE031C2201 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
assess the long-term safety of QGE031 in adult CSU patients who completed the core study CQGE031C2201 using the following evaluations: - Incidence and severity of non-serious and serious adverse events including any events of special interest - Changes in vital signs, laboratory assessments, and ECGs |
evaluar la seguridad a largo plazo de QGE031 en pacientes adultos con UEC que hayan completado el estudio principal CQGE031C2201 mediante las siguientes evaluaciones: - Incidencia y gravedad de los acontecimientos adversos graves y no graves que incluyen cualquier acontecimiento de interés especial. - Cambios en las constantes vitales, pruebas analíticas y ECG. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Sustained remission defined as maintaining UAS7 ? 6 over 48 weeks post-treatment follow up epoch among the subjects achieving remission at the end of treatment epoch |
- Remisión sostenida definida como mantener UAS7 ? 6 durante la fase de seguimiento posterior al tratamiento de 48 semanas entre los sujetos que alcanzan una remisión en la fase de fin de tratamiento. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Quality of Life |
Calidad de Vida |
|
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 18 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
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 |
Australia |
Canada |
Germany |
Greece |
Japan |
Russian Federation |
Spain |
Taiwan |
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
|
Completion of the study will be considered when all patients will have completed 52 weeks of treatment epoch and the full follow up epoch or have prematurely withdrawn from the study |
La finalización del estudio tendrá lugar cuando todos los pacientes hayan completado la fase de tratamiento de 52 semanas y toda la fase de seguimiento o se hayan retirado prematuramente del estudio. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 11 |