E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS. |
Sujetos con lupus eritematoso sistémico entre moderado y severamente activo. |
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E.1.1.1 | Medical condition in easily understood language |
SYSTEMIC LUPUS ERYTHEMATOSUS. |
Lupus eritematoso sistémico. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040967 |
E.1.2 | Term | SLE |
E.1.2 | System Organ Class | 100000004859 |
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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 assess the dose-response for the efficacy of intravenous (iv) dapirolizumab pegol (DZP; 3 dose groups) at Week 24 in adult subjects with moderately to severely active SLE receiving stable standard of care treatment. |
Evaluar la relación dosis-respuesta de la eficacia de la administración por vía intravenosa (iv) de dapirolizumab pegol (DZP; 3 grupos de dosis) en la semana 24 en sujetos adultos con LES entre moderado y severamente activo, que están recibiendo medicación estable de tratamiento de referencia. |
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E.2.2 | Secondary objectives of the trial |
•To assess the efficacy of the individual dose regimens of intravenous (iv) dapirolizumab pegol (DZP) at Week 24. • To assess the safety and tolerability of intravenous (iv) dapirolizumab pegol (DZP). |
- Evaluar la eficacia de los regímenes de dosis individuales de dapirolizumab pegol (DZP) por vía intravenosa (iv) en la semana 24. - Evaluar la seguridad y tolerabilidad de dapirolizumab pegol (DZP) por vía intravenosa (iv). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Clinical diagnosis of SLE confirmed by the SLICC Classification Criteria for SLE . 2.The subject has at least 1 of the following: Anti-dsDNA antibodies confirmed by the central laboratory OR Low complement (ie, either low C3, or low C4, or both) confirmed by the central laboratory OR ANA titer of >=1:80 confirmed by the central laboratory at in combination with at least 1 of the following: 1.Historical positivity for anti-dsDNA or 2.Positivity for anti-ENA confirmed by the central laboratory 3.The subject has moderate to severe SLE disease activity |
1. LES diagnosticado por un médico y confirmado por los criterios de clasificación de SLICC para LES. 2. El sujeto tiene al menos 1 de los siguientes: Anticuerpos anti-ADNdc confirmados por el laboratorio central O BIEN Bajo complemento (es decir, bajo C3, bajo C4 o ambos) confirmado por el laboratorio central O BIEN Valoración de ANA >= 1:80 confirmada por el laboratorio central en combinación con al menos 1 de los siguientes: 1.Positividad histórica para anti-ADNdc o bien 2.Positividad para anti-ENA confirmada por el laboratorio central. 3. El sujeto presenta una actividad entre moderada y severa de LES. |
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E.4 | Principal exclusion criteria |
1.Subject has a mixed connective tissue disease, scleroderma, and/or overlap syndromes of SLE. 2.Subjects with severe neuropsychiatric SLE or other neurological symptoms that in the opinion of the Investigator, would prevent the subject from completing protocol required procedures and assessments. 3.Subject has new or worsening Class III or IV lupus nephritis. 4.Subject has chronic kidney failure stage 3b. 5.Subject has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T cell deficiencies, or human T cell lymphotropic virus 1 infection at any time prior to or during the study. 6.Subject has clinically significant active or latent infection, for example, but not limited to, chronic viral hepatitis B or C. 7.Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection are excluded. 8.Subjects who have received live/live attenuated vaccines within 6 weeks prior to the first study drug infusion (Visit 2) or who plan to receive these vaccines during the study or 12 weeks after the final dose of study drug . 9.Subjects with a history of thromboembolic events within 12 months of Screening. 10.Subject has used protocol defined prohibited medications. |
1. Sujetos con una enfermedad mixta del tejido conectivo, escleroderma o síndromes solapados de LES. 2. Sujetos con LES neuropsiquiátrico grave u otros síntomas neurológicos que, en opinión del investigador, podrían impedir que completaran los procedimientos y evaluaciones requeridos por el protocolo. 3. Sujetos con nefritis lúpica de clase III o IV nueva o debida a un empeoramiento. 4. Sujetos con insuficiencia renal crónica de fase 3b. 5. Sujetos con evidencias de infección por el virus de inmunodeficiencia humana (VIH), agammaglobulinemia, deficiencia de células T o infección por el virus linfotrópico humano de células T de tipo 1 en cualquier momento anterior al estudio o durante el mismo. 6. Sujetos con una infección activa o latente clínicamente significativa, por ejemplo, aunque sin limitarse a ello, hepatitis B o C viral crónica. 7. Sujetos con infección por tuberculosis (TB) conocida, con alto riesgo de contraer la infección por TB o con una infección por TB latente (LTB) quedan excluidos. 8. Sujetos que hayan recibido vacunas vivas/vivas atenuadas en las 6 semanas anteriores a la primera infusión del fármaco del estudio (visita 2) o que planeen recibir estas vacunas durante el estudio o en las 12 semanas posteriores a la dosis final del fármaco del estudio. 9. Sujetos con antecedentes de episodios tromboembólicos en los 12 meses anteriores a la selección. 10. Sujetos que hayan usado los medicamentos prohibidos indicados en el protocolo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
•Percentage of subjects with BICLA response across 3 doses of dapirolizumab pegol (DZP) and placebo (PBO) at Week 24. |
•Porcentaje de sujetos con respuesta de la BICLA de las 3 dosis de dapirolizumab pegol (DZP) y placebo (PBO) en la semana 24. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The percentage of subjects with BICLA response in the individual dose groups at Week 24. |
El porcentaje de sujetos con respuesta de la BICLA de los regímenes de dosis individuales en la semana 24 . |
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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 | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Patient reported outcomes. |
Resultados comunicados de los pacientes. |
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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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 33 |
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 |
Bulgaria |
Chile |
Colombia |
Germany |
Hungary |
Mexico |
Peru |
Poland |
Romania |
Russian Federation |
Spain |
Ukraine |
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 the study is defined as the date of the last visit of the last subject in the study. |
El fin del ensayo se define como la fecha de la última visita del último paciente del ensayo. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |