E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic Lupus Erythematosus |
Lupus eritematoso sistemico |
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E.1.1.1 | Medical condition in easily understood language |
Systemic lupus erythematosus (SLE) is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue |
El lupus eritematoso sistémico (LES) es una enfermedad autoinmune en la cual el sistema inmune del cuerpo ataca por error al tejido sano. |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042945 |
E.1.2 | Term | Systemic lupus erythematosus |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue 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 long-term safety of GDC-0853 over an extended treatment period of up to 48 weeks |
•Evaluar la seguridad a largo plazo de GDC-0853 durante un periodo de tratamiento extendido de hasta 48 semanas. |
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E.2.2 | Secondary objectives of the trial |
•To evaluate the clinical efficacy of GDC-0853 in combination with standard of care over time •To characterize the pharmacokinetics (PK) of GDC-0853 in patients using a population PK approach |
•Evaluar la eficacia clínica de GDC-0853 en combinación con el tratamiento de referencia con el paso del tiempo •Caracterizar la farmacocinética de GDC-0853 en los pacientes con un enfoque FC de población |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age 18−76 years - Completion of Study GA30044 up to 48 weeks - Acceptable safety and tolerability during Study GA30044 as determined by the investigator - Women of childbearing potential must have a negative urine pregnancy test at baseline - For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 60 days after the last dose of study drug - For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm resulting in a failure rate of < 1% per year during the treatment period and for at least 120 days (4 months) after the last dose of study treatment |
-Edad 18-76 años -Haber completado el estudio GA30044 hasta las 48 semanas -Seguridad y tolerabilidad aceptables durante el estudio GA30044 según lo determine el investigador -Las mujeres en edad fértil deben presentar una prueba de embarazo en orina negativa al inicio -En las mujeres en edad fértil: Aceptación de mantener la abstinencia sexual o usar un método anticonceptivo con un índice de fallo del < 1 % al año durante el periodo de tratamiento y durante un mínimo de 60 días tras la última dosis del fármaco del estudio. -En el caso de los hombres: aceptación de mantener la abstinencia sexual o usar medidas anticonceptivas y aceptar no donar esperma resultando en un índice de fallo del < 1 % al año durante el periodo del tratamiento y durante un mínimo de 120 días (4 meses) tras la última dosis del tratamiento del estudio. |
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E.4 | Principal exclusion criteria |
- Met protocol-defined treatment-stopping criteria during Study GA30044 - An adverse event in Study GA30044 that required permanent discontinuation of study drug - During Study GA30044, treatment with any therapy that is prohibited in this study - In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA30044), significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that 1) requires medications not allowed in this protocol or 2) could put the patient at undue risk from a safety perspective - Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of study drug - Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the patient’s participation in the study in the opinion of the investigator in consultation with the Medical Monitor |
-Cumplan con alguno de los criterios de interrupción del tratamiento definidos por protocolo durante el estudio GA30044 -Sufrieran un acontecimiento adverso en el estudio GA30044 que requiriera la interrupción permanente del fármaco del estudio -Durante el estudio GA30044, el tratamiento con cualquier tratamiento que esté prohibido en este estudio -En opinión del investigador, cualquier comorbilidad nueva, significativa y no controlada (desde la inscripción inicial en el estudio de fase II GA30044) o manifestación clínica nueva (relacionada o no con el LES) que 1) requiera administrar medicamentos no permitidos en este protocolo o 2) pueda poner al paciente en riesgo excesivo desde la perspectiva de la seguridad -Embarazada, en período de lactancia o intentando quedarse embarazada durante el estudio o en los 60 días posteriores a la última dosis del fármaco del estudio -Cualquier anomalía clínica no controlada clínicamente significativa que pudiera afectar a la seguridad o a la interpretación de los datos del estudio, así como a la participación del paciente en el estudio, a juicio del investigador y en consulta con el Monitor médico |
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E.5 End points |
E.5.1 | Primary end point(s) |
1.The nature, frequency, severity, and timing of adverse events 2.Changes in vital signs, physical findings, ECGs, and clinical laboratory results during and following GDC 0853 administration |
1. Naturaleza, frecuencia, intensidad y momento de los acontecimientos adversos 2. Cambios en las constantes vitales, hallazgos físicos, los ECG y los resultados clínicos de laboratorio tras la administración de GDC-0853 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1-2. Up to 56 weeks |
1-2. Hasta un máximo de 56 semanas |
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E.5.2 | Secondary end point(s) |
1.SLE Responder Index -4 response up to Week 48 2.Steady-state PK parameters such as area under the concentration–time curve from time 0 to time t (AUC0-t), Ctrough, half-life (t1/2), and apparent clearance (CL/F) |
1. Respuesta SRI-4 hasta la semana 48 2. Parámetros de FC en estado de equilibrio: ABC0-t, Cmín, t1/2 y CL/F aparente |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.Up to Week 48 2.Baseline (Day 1), Week 24, Week 48, at unscheduled visit, flare visit and early terminate |
1. Hasta la semana 48 2. Basal (dia 1), semana 24, semana 48, visita no programada, visita flare y terminacion temprana |
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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 | 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) | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 |
Brazil |
Bulgaria |
Chile |
Colombia |
Germany |
Korea, Republic of |
Mexico |
Portugal |
Spain |
Taiwan |
United Kingdom |
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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The end of this study is defined as the date when the last patient, last visit occurs. The end of the study is expected to occur 56 weeks after the last patient is enrolled. The total length of the study, from enrollment of the first patient to the end of the study, is expected to be approximately 3.5 years. |
El fin de este estudio se define como la fecha en la que se produce la última visita del último paciente. Se espera que el fin del estudio se produzca 56 semanas después de inscribir al último paciente. La duración total del estudio, desde la inscripción del primer paciente hasta el fin del estudio se espera que sea de aproximadamente 3,5 años. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |