E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe chronic plaque-type psoriasis |
psoriasi cronica a placche di grado moderato e severo |
|
E.1.1.1 | Medical condition in easily understood language |
Psoriasis looks like red, raised scaly areas of skin |
La psoriasi si presenta come aree cutanee squamose rosse e sollevate |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
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 | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
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 | 10037153 |
E.1.2 | Term | Psoriasis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous 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 |
To compare efficacy, safety and tolerability of secukinumab 300 mg every 2 weeks to secukinumab 300 mg every 4 weeks in subjects with moderate to severe chronic plaque-type psoriasis and body weight of 90 kg or higher, and to explore the option of exposure escalation for those subjects who do not achieve the therapeutic goal at the dose regimen of 300 mg every 4 weeks. |
Dimostrare l’efficacia di secukinumab 300 mg ogni 2 settimane in confronto alla somministrazione di secukinumab 300 mg ogni 4 settimane, in termini di risposta PASI 90 alla settimana 16. |
|
E.2.2 | Secondary objectives of the trial |
To demonstrate the efficacy of secukinumab 300 mg every 2 weeks in comparison to secukinumab 300 mg every 4 weeks with respect to Investigator's Global Assessment (IGA) mod 2011 0 or 1 response at Week 16.
To investigate the clinical safety and tolerability of secukinumab 300 mg every 2 weeks in comparison to 300 mg every 4 weeks. |
Dimostrare l’efficacia di secukinumab 300 mg ogni 2 settimane in confronto alla somministrazione di secukinumab 300 mg ogni 4 settimane, in termini di risposta IGA 0/1 (Investigator’s Global assessment mod. 2011) alla settimana 16. Valutare la sicurezza e la tollerabilità di secukinumab 300 mg ogni 2 settimane in confronto alla somministrazione di secukinumab 300 mg ogni 4 settimane durante le 52 settimane di trattamento |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent must be obtained before any assessment is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations.
2. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study.
3. Men or women at least 18 years of age at time of screening.
4. Body weight of =90 kg at the time of randomization.
5. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
6. Moderate to severe psoriasis as defined at randomization by:
• Psoriasis Area and Severity Index (PASI) score of 12 or greater, and
• IGA mod 2011 score of 3 or greater (based on a static scale of 0 – 4), and
• Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
7. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by
• topical treatment and/or,
• phototherapy and/or,
• previous systemic therapy. |
1. Soggetti che abbiano fornito il proprio consenso informato scritto prima di ogni esame e/o valutazione. 2. Soggetti capaci di comprendere e comunicare con lo sperimentatore, e che siano in grado di eseguire tutte le procedure e le visite previste dallo studio. 3. Uomini o donne di almeno 18 anni di età compiuti al momento dello screening. 4. Peso corporeo = 90 kg al momento della randomizzazione. 5. Psoriasi cronica a placche presente da almeno 6 mesi e diagnosticata prima della randomizzazione. 6. Psoriasi cronica di grado da moderato a severo al momento della randomizzazione definita da: • Punteggio PASI =12 e • Body Surface Area (BSA) =10% e • Punteggio IGA mod 2011 =3 7. Pazienti candidabili alla terapia sistemica, definiti come affetti da psoriasi non adeguatamente controllata da: • trattamenti topici e/o • fototerapia e/o • precedente terapia sistemica |
|
E.4 | Principal exclusion criteria |
1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or Randomization. 2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to as per protocol Table 5-1. Subjects not willing to limit UV light exposure (e.g., sunbathing and / or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. 3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting interleukin (IL-17) or the IL-17 receptor. 4. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 4 weeks until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations. 5. Pregnant or nursing (lactating) women 6. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen’s disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). 7. History of hypersensitivity to any of the study drug constituents.
|
• Forme di psoriasi diverse da quella cronica a placche (es. psoriasi pustolosa, eritrodermica e guttata) allo screening o alla randomizzazione. • Utilizzo in corso di studio di trattamenti proibiti dal protocollo. I periodi di wash-out necessari e dettagliati nel protocollo devono essere rispettati (cfr. Tab. 5-1 del protocollo). Il rifiuto da parte del soggetto di non voler limitare l’esposizione alla luce UV durante lo studio (per esempio prendere il sole e/o l'uso di dispositivi abbronzanti) è considerato un criterio di non eleggibilità. Nota: l’utilizzo di vaccini vivi in concomitanza con lo studio o nelle 6 settimane precedenti la randomizzazione non è permesso. • Precedente trattamento con secukinumab (AIN457) o con altri farmaci biotecnologici che hanno come target diretto l’IL-17 o il suo recettore (IL-17R). • Utilizzo di qualsiasi altro farmaco sperimentale al momento dell’arruolamento o nelle 4 settimane precedenti, o nel periodo pari a 5 emivite dall’entrata in studio. • Donne in gravidanza accertata o in allattamento. • Condizioni cliniche (incluse ma non limitate a quelle di tipo metabolico, ematologico, renale, epatico, polmonare, neurologico, endocrino, cardiaco, infettivo o gastrointestinale) che, secondo giudizio dello sperimentatore, compromettono significativamente il sistema immunitario del paziente e/o mettono il paziente ad un livello di rischio inaccettabile per ricevere una terapia immunomodulante. Patologie concomitanti gravi progressive o non controllate che, secondo giudizio dello sperimentatore, rendono il paziente non adatto allo studio o ne aumentano il rischio. Qualunque condizione medica o psichiatrica che, secondo giudizio dello sperimentatore, possa precludere al partecipante di aderire al protocollo o completare lo studio in accordo al protocollo. • Pazienti con una funzionalità renale gravemente ridotta (VFG stimato inferiore a 29 ml/min/1.73m2). • Infezioni sistemiche attive (escluso il raffreddore comune) nelle ultime 2 settimane che precedono il basale e qualunque infezione che ricorra su base regolare. • Storia di patologia infettiva in atto, cronica o ricorrente o evidenza di tubercolosi definita da un Quantiferon TB-Gold test (QFT), allo Screening, positivo o con esito inderminato. • Evidenza in anamnesi pregressa o concomitante di infezione da virus dell’immunodeficienza umano (HIV), evidenza di epatite B o epatite C prima della randomizzazione. • Anamnesi di malattie linfoproliferative o di qualsiasi neoplasia maligna nota o storia nota negli ultimi 5 anni di patologia neoplastica maligna trattata o non trattata, indipendentemente dalla presenza o meno di recidiva locale o metastasi (ad eccezione dei seguenti casi: malattia cutanea di Bowen, o carcinoma delle cellule basali o cheratosi attinica, trattati e con evidenza di mancata recidiva nelle precedenti 12 settimane; carcinoma in situ della cervice o poliposi benigna del colon sottoposta a rimozione chirurgica). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
IGA mod 2011 0 or 1 response
Clinical safety and tolerability ; IGA mod 2011 0 or 1 response Clinical safety and tolerability |
GA mod 2011 0 or 1 response
Clinical safety and tolerability; IGA mod 2011 0 or 1 response Sicurezza e tollerabilità clinica |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 16
Week 52; Week 16 Week 52 |
Week 16
Week 52; Settimana 16 Settimana 52 |
|
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 | 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 | 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 | 17 |
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 |
Canada |
Russian Federation |
United States |
Germany |
Hungary |
Italy |
|
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
|
|
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 | 7 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |