E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Plaque Psoriasis |
Psoriasi a Placche |
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E.1.1.1 | Medical condition in easily understood language |
Plaque Psoriasis |
Psoriasi a Placche |
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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 | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
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 main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy. |
L’obiettivo di questo studio è quello di valutare l’efficacia e la sicurezza di risankizumab rispetto a secukinumab per il trattamento di soggetti adulti affetti da psoriasi a placche di grado da moderato a grave idonei a ricevere la terapia sistemica.
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Non applicabile |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug: • Serum aspartate transaminase (AST) < 2 × ULN; • Serum alanine transaminase (ALT) < 2 × ULN; • Serum direct bilirubin = 2.0 mg/dL; except for subjects with isolated elevation of indirect bilirubin relating to a confirmed diagnosis of Gilbert syndrome; • Total white blood cell (WBC) count > 3,000/µL; • Absolute neutrophil count (ANC) > 1,500/µL; • Platelet count > 100,000/µL; • Hemoglobin > 8 g/dL. 2. Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the Baseline Visit; 3. Subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis • Subject has = 10% BSA psoriasis involvement, sPGA score of = 3, and PASI = 12 at Screening and Baseline Visit; 4. Subject must be a candidate for systemic therapy as assessed by the investigator; 5. Subject must be an acceptable candidate to receive secukinumab according to the local label for this compound. |
1. Valori di laboratorio che soddisfano i seguenti criteri durante il periodo di screening, prima della prima dose del medicinale sperimentale: • Valori sierici di aspartato aminotransferasi (AST) < 2 × ULN ; • Valori sierici di alanina aminotransferasi (ALT) < 2 × ULN; • Valori sierici di bilirubina diretta = 2,0 mg/dL; ad eccezione dei soggetti con innalzamenti isolati dei valori di bilirubina indiretta associati a una diagnosi confermata di sindrome di Gilbert; • Conta totale dei globuli bianchi (WBC) > 3.000/µL; • Conta assoluta dei neutrofili (ANC) > 1.500/µL; • Conta delle piastrine > 100.000/µL; • Emoglobina > 8 g/dL. 2. Diagnosi di psoriasi a placche cronica, con o senza artrite psoriasica, da almeno 6 mesi prima della visita di Baseline; 3. Soggetto affetto da psoriasi a placche cronica e stabile, di grado da moderato a grave, con o senza artrite psoriasica • Soggetto con = 10% BSA interessata dalla psoriasi, punteggio sPGA = 3, e punteggio PASI = 12 alle visite di Screening e Baseline; 4. Il soggetto deve essere idoneo a ricevere la terapia sistemica, in base alla valutazione dello sperimentatore; 5. Il soggetto deve essere idoneo a ricevere secukinumab secondo quanto riportato nella scheda tecnica locale di questo medicinale
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E.4 | Principal exclusion criteria |
1. No history of:
• Erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis;
• Active skin disease other than psoriasis that could interfere with the assessment of psoriasis;
• Chronic infections including HIV, viral hepatitis (hepatitis B, hepatitis C), and/ or active tuberculosis. Subjects with a positive QuantiFERON®-TB /PPD test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines. The patient will not be eligible for randomization if latent tuberculosis is present and is untreated as per local guidelines.
Active systemic infection during the last 2 weeks prior to Baseline Visit (exception: common cold) prior to Baseline Visit, as assessed by the investigator;
2. No history of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix;
3. No previous exposure to risankizumab;
4. No previous exposure to secukinumab;
5. Subject must not have been treated with any investigational drug within 30 days or 5 half lives of the drug (whichever is longer) prior to the first dose of study drug or currently be enrolled in another clinical study. |
Nessuna storia di: • Psoriasi eritrodermica, psoriasi pustolosa generalizzata o localizzata, psoriasi indotta oppure esacerbata da farmaci, o psoriasi guttata di nuova insorgenza; • Patologia cutanea in fase attiva diversa dalla psoriasi, tale da poter interferire con la valutazione della psoriasi; • Infezioni croniche fra cui HIV, epatite virale (epatite B, epatite C), e/o tubercolosi attiva. I soggetti con risultato positivo al test QuantiFERON®-TB /PPD potranno partecipare allo studio qualora venga accertato in maniera definitiva, mediante ulteriori esami diagnostici (in accordo alla pratica locale/linee guida locali) che il soggetto non presenta evidenza di tubercolosi in fase attiva. Qualora si determini la presenza di tubercolosi latente, dovrà essere avviato e mantenuto il trattamento previsto dalle linee guida nazionali. In presenza di tubercolosi latente, il paziente non sarà eleggibile alla randomizzazione in assenza del trattamento previsto dalle linee guida locali. Infezione sistemica attiva nel corso delle ultime 2 settimane precedenti la visita di Baseline (eccezione: raffreddore) prior to Baseline Visit , in base alla valutazione del medico sperimentatore; 2. Nessuna storia documentata di neoplasia maligna attiva o sospetta, oppure storia di qualsiasi neoplasia maligna negli ultimi 5 anni, ad eccezione del carcinoma cutaneo non melanoma (NMSC) oppure del carcinoma localizzato in situ della cervice uterina trattati con successo; 3. Nessuna esposizione pregressa a risankizumab; 4. Nessuna esposizione pregressa a secukinumab; 5. Il soggetto non deve aver ricevuto trattamento con qualsiasi medicinale sperimentale nei 30 giorni o per un periodo equivalente a 5 emivite del medicinale (quale dei due periodi sia più lungo) prima della prima dose del medicinale sperimentale, e non deve essere attualmente arruolato in un altro studio clinico.
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E.5 End points |
E.5.1 | Primary end point(s) |
The 2 primary endpoints are: • Proportion of subjects achieving a PASI 90 response at Week 52; superiority of risankizumab vs. secukinumab. • Proportion of subjects achieving a PASI 90 response at Week 16; noninferiority of risankizumab vs. secukinumab with non-inferiority margin of 12%. |
I due endpoint primari sono: - Percentuale di soggetti che ottengono la risposta PASI 90 (Psoriasis Area Severity Index ) alla Settimana 52; superiorità di risankizumab vs secukinumab. - Percentuale di soggetti che ottengono la risposta PASI 90 alla Settimana 16; non inferiorità di risankizumab vs secukinumab con un margine di non inferiorità pari al 12%.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 52, Week 16
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Settimana 52, Settimana 16 |
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E.5.2 | Secondary end point(s) |
The multiplicity-controlled key secondary endpoints are: • Proportion of subjects achieving a PASI 100 response at Week 52; superiority of risankizumab vs. secukinumab; • Proportion of subjects achieving an sPGA 0 or 1 at Week 52; superiority of risankizumab vs. secukinumab; • Proportion of subjects achieving a PASI 75 response at Week 52; superiority of risankizumab vs. secukinumab. Other efficacy endpoints include change and percent change from baseline in PASI and body surface area (BSA) as well as multiple levels of PASI and sPGA responses at all visits.
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I molteplici e controllati endpoint chiave secondari sono: - Percentuale di soggetti che ottengono la risposta PASI 100 alla Settimana 52; superiorità di risankizumab vs secukinumab; - Percentuale di soggetti che ottengono un punteggio alla valutazione globale statica del medico (static physician global assessment, sPGA) pari a 0 oppure 1 alla Settimana 52; superiorità di risankizumab vs secukinumab; - Percentuale di soggetti che ottengono la risposta PASI 75 alla Settimana 52; superiorità di risankizumab vs secukinumab. Gli altri endpoint di efficacia includono variazione e variazione percentuale rispetto al baseline del punteggio PASI e dell’area di superficie corporea (BSA) oltre che livelli multipli di risposta PASI e sPGA a tutte le visite.
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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 | No |
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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 38 |
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 |
Australia |
Canada |
France |
Germany |
Italy |
Netherlands |
Poland |
Spain |
United Kingdom |
United States |
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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
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The end-of-study is defined as the date of the last subject's last visit (Week 52/Final or Early Termination Visit) |
LSLV (Settimana 52/Final or Early Termination Visit) |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |