E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic lupus erythematosus |
Lupus eritematoso sistémico |
|
E.1.1.1 | Medical condition in easily understood language |
Systemic lupus erythematosus is a chronic autoimmune inflammatory disease which can present with a chronic disease course but has more often a relapsing-remitting disease course. |
Lupus eritematoso sistémico es una enfermedad inflamatoria autoinmune crónica que puede presentarse como una enfermedad crónica, pero tiene más a menudo un curso de enfermedad remitente-recidivante |
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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 | 21.1 |
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 |
|
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 |
Evaluate the long-term safety and tolerability of dapirolizumab pegol (DZP) treatment. |
Evaluar la seguridad y tolerabilidad a largo plazo del tratamiento con DZP |
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E.2.2 | Secondary objectives of the trial |
Evaluate the ability of dapirolizumab pegol (DZP) treatment: - to prevent relevant disease flares - to achieve and maintain the treat-to-target goal: low lupus disease activity state (LLDAS) - to maintain long-term clinical response |
Evaluar la capacidad del tratamiento con DZP: - Para prevenir exacerbaciones importantes de la enfermedad - Para lograr y mantener el objetivo del tratamiento: un LLDAS (Estado de baja actividad del lupus (low lupus disease activity state)) - Para mantener una respuesta clínica a largo plazo |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The participant could, in the opinion of the Investigator, benefit from long-term dapirolizumab pegol (DZP) treatment - The participant completed one of the placebo controlled (PBO-controlled) parent studies within 4 weeks prior to entry to this study |
- El participante podría, en opinión del investigador, beneficiarse del tratamiento a largo plazo con dapirolizumab pegol (DZP) - El participante completó uno de los estudios controlados con placebo (controlados con PBO) en el plazo de las 4 semanas anteriores a la entrada en este estudio |
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E.4 | Principal exclusion criteria |
- Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric systemic lupus erythematosus (SLE)) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study. This includes study participants with a life-threatening condition or ongoing malignancies at the start of the study. |
- El participante del estudio tiene alguna afección médica o psiquiátrica (incluidas las afecciones debidas al lupus eritematoso sistémico neuropsiquiátrico (SLE)) que, en opinión del investigador, podría poner en peligro o comprometería la capacidad del participante del estudio para participar en este estudio. Esto incluye a los participantes del estudio con una afección potencialmente mortal o neoplasias malignas en curso al comienzo del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Incidence of treatment-emergent adverse events (TEAEs) during the study 2. Incidence of serious treatment-emergent adverse events during the study 3. Incidence of treatment-emergent adverse events (TEAEs) leading to permanent dapirolizumab pegol discontinuation |
1. Incidencia de acontecimiento adverso surgido durante el tratamiento (TEAEs) durante el estudio 2. Incidencia de acontecimiento graves adverso surgido durante el tratamiento durante el estudio 3. Incidencia de acontecimiento adverso surgido durante el tratamiento (TEAEs) que resulten en la suspensión permanente de DZP |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1-3: From Baseline (Day 1) until Safety Follow-Up (up to Week 110) |
1-3: Desde basal (día 1) hasta seguimiento de seguridad (hasta la semana 110) |
|
E.5.2 | Secondary end point(s) |
1. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 24 2. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 52 3. Achievement of prevention of severe BILAG flares (severe BILAG flare-free) through Week 104 4. Achievement of LLDAS at >/= 50% of all visits 5. Achievement of BICLA response at Week 24 6. Achievement of BICLA response at Week 52 7. Achievement of BICLA response at Week 104 |
1. Logro de la prevención de exacerbaciones severas según BILAG (ausencia de exacerbaciones severas según BILAG) hasta la Semana 24 2. Logro de la prevención de exacerbaciones severas según BILAG (ausencia de exacerbaciones severas según BILAG) hasta la Semana 52 3. Logro de la prevención de exacerbaciones severas según BILAG (ausencia de exacerbaciones severas según BILAG) hasta la Semana 104 4. Logro de un LLDAS >/= 50% en todas las visitas 5. Mantenimiento de la respuesta según BICLA en la semana 24 6. Mantenimiento de la respuesta según BICLA en la semana 52 7. Mantenimiento de la respuesta según BICLA en la semana 104 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 5: Week 24 2, 6: Week 52 3, 7: Week 104 4: From Baseline (Day 1) until End of Treatment (Week 104) |
1, 5: Semana 24 2, 6: Semana 52 3, 7: Semana 104 4: Desde basal (día 1) hasta fin de tratamiento (Semana 104) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | 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 |
Tolerability, immunogenicity |
Tolerabilidad, inmunogenia |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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
| Yes |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
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 |
Chile |
Colombia |
Hong Kong |
Japan |
Korea, Republic of |
Mexico |
Peru |
Philippines |
Serbia |
Taiwan |
United States |
Austria |
Belgium |
Bulgaria |
Denmark |
France |
Germany |
Greece |
Hungary |
Italy |
Poland |
Portugal |
Romania |
Spain |
United Kingdom |
Czechia |
Argentina |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 7 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 5 |