E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic lupus erythematosus |
Lupus eritematoso sistemico |
|
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. |
Il lupus eritematoso sistemico è una malattia cronica infiammatoria autoimmune che può avere un decorso di malattia cronica, ma che ha più spesso un decorso di malattia recidivante-remittente. |
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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. |
Valutare la sicurezza a lungo termine e la tollerabilità del trattamento con dapirolizumab pegol (DZP). |
|
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 |
Valutare la capacità del trattamento con dapirolizumab pegol (DZP): - prevenire rilevanti riacutizzazioni di malattia - raggiungere e mantenere l'obiettivo treat-to-target: basso stato di attività della malattia da lupus (LLDAS) - mantenere la risposta clinica a lungo termine |
|
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 |
- Il partecipante potrebbe, secondo lo sperimentatore, trarre beneficio dal trattamento a lungo termine con dapirolizumab pegol (DZP) - Il partecipante ha completato uno degli studi collegati controllati con placebo (PBO- controlled) entro le 4 settimane precedenti l'ingresso in questo studio |
|
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. |
- Il partecipante allo studio ha qualsiasi condizione medica o psichiatrica (comprese le condizioni dovute al lupus eritematoso sistemico neuropsichiatrico (LES)) che, a giudizio dello sperimentatore, potrebbe mettere a repentaglio o compromettere la capacità del partecipante allo studio di partecipare a questo studio. Ciò include i partecipanti allo studio con una condizione pericolosa per la vita o tumori maligni in corso all'inizio dello studio. |
|
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. Incidenza degli eventi avversi emergenti dal trattamento (TEAE) durante lo studio 2. Incidenza di eventi avversi gravi emergenti dal trattamento durante lo studio 3. Incidenza di eventi avversi emergenti dal trattamento (TEAE) che portano all'interruzione permanente di dapirolizumab pegol |
|
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: Dal basale (giorno 1) fino al follow-up di sicurezza (fino alla settimana 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. Raggiungimento della prevenzione di gravi riacutizzazioni BILAG (senza riacutizzazioni gravi BILAG) fino alla settimana 24 2. Raggiungimento della prevenzione di gravi riacutizzazioni BILAG (senza riacutizzazioni gravi BILAG) fino alla settimana 52 3. Raggiungimento della prevenzione di gravi riacutizzazioni BILAG (senza riacutizzazioni gravi BILAG) fino alla settimana 104 4. Raggiungimento di LLDAS a >=50% di tutte le visite 5. Raggiungimento della risposta BICLA alla settimana 24 6. Raggiungimento della risposta BICLA alla settimana 52 7. Raggiungimento della risposta BICLA alla settimana 104 |
|
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: Settimana 24 2, 6: Settimana 52 3, 7: Settimana 104 4: Dal basale (giorno 1) fino alla fine del trattamento (settimana 104) |
|
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 |
Tollerabilità, immunogenicità |
|
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 | No |
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.8.2.4 | 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 | 2 |
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 | Information not present in EudraCT |
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 |
Australia |
Canada |
Chile |
Colombia |
Hong Kong |
Japan |
Korea, Republic of |
Mexico |
Peru |
Philippines |
Taiwan |
United States |
Austria |
France |
Poland |
Bulgaria |
Romania |
Spain |
Czechia |
Germany |
Greece |
Italy |
Belgium |
Denmark |
Hungary |
Portugal |
United Kingdom |
Serbia |
|
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 | 3 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
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 |