E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe chronic plaque psoriasis |
Psoriasi a placche da moderata a grave |
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E.1.1.1 | Medical condition in easily understood language |
Psoriasis is a skin condition that causes red, raised scaly patches on the skin |
La psoriasi è una condizione della pella che causa rossore, chiazze squamose in rilievo/rialzate sulla pelle |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050577 |
E.1.2 | Term | Psoriatic plaque |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
Efficacy of Anti-IL-17 MAb in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI at 12 weeks |
Valutare l'efficacia di Anti-IL-17 MAb alla Settimana 12 nel trattamento dei pazienti con psoriasi a placche da moderata a grave, misurata in base ai parametri sPGA (static Physician Global Assessment) e PASI (Psoriasis Area and Severity Index) |
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E.2.2 | Secondary objectives of the trial |
•Efficacy of Anti-IL-17 MAb in subjects with moderate to severe chronic plaque psoriasis based on sPGA and PASI over12 and 60 weeks •Quality of life assessments based on patient reported outcomes over 12 and 60 weeks |
Valutare l'efficacia di Anti-IL-17 MAb nel trattamento dei pazienti con psoriasi a placche da moderata a grave, misurata in base ai parametri sPGA e PASI oltre 12 e 60 settimane.-Valutazioni della qualità della vita misurata in base ai risultati segnalati dai pazienti oltre 12 e 60 settimane. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Have active plaque psoriasis covering at least 10% body surface area and a PASI score of 12 •Candidate for phototherapy and/or systemic therapy •Have a sPGA score of at least 3 |
•Presentano psoriasi a placche attiva su almeno il 10% dell’area di superficie corporea e un punteggio PASI di 12; •Candidati alla fototerapia e/o alla terapia sistemica; •Presentano un punteggio sPGA di almeno 3; |
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E.4 | Principal exclusion criteria |
•Have pustular, erythrodermic, and/or guttate forms of psoriasis •Have a history of drug-induced psoriasis •Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline •Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept <60 days; golimumab <90 days; ustekinumab <8 months; rituximab or efalizumab <12 months; or any other biologic agent <5half-lives prior to baseline •Have received systemic psoriasis therapy (such as psoralen and ultraviolet A [PUVA] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization (exception: class 6 [mild, such as desonide] or 7 [least potent, such as hydrocortisone] topical steroids will be permitted for use limited to the face, axilla, and/or genitalia) •Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study •Have ever received natalizumab or other agents that target alpha-4- integrin •Have participated in any study with IL-17 antagonist including LY2439821 •Have another serious disorder or illness •Have suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months •Have a history of uncontrolled high blood pressure •Have clinical laboratory test results at entry that are outside the normal reference range •Are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug •Are a woman who is lactating or breast feeding •Are a woman and could become pregnant during this study, you must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study •Are a post menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months •Are a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test to see if you can participate •Are a male, you must agree to reduce the risk of your female partner becoming pregnant during the study |
•Presentano forme pustolose, eritrodermiche e/o guttate di psoriasi; •Hanno una storia di psoriasi indotta da farmaci; •Hanno avuto un’esacerbazione clinicamente significativa di psoriasi nelle 12 settimane precedenti il basale; •Utilizzo concomitante o recente di qualsiasi agente biologico entro i seguenti periodi di washout: etanercept <28 giorni; infliximab, adalimumab o alefacept <60 giorni; golimumab <90 giorni; ustekinumab <8 mesi; rituximab o efalizumab <12 mesi; o qualsiasi altro agente biologico <5 emivite prima del basale; •Hanno ricevuto terapie sistemiche per la psoriasi (come fototerapia con psoralene e radiazione UVA [PUVA], ciclosporina, corticosteroidi, metotrexato, retinoidi orali, micofenolato mofetile, tioguanina, idrossiurea, sirolimus, azatioprina) o fototerapia (comprese radiazioni UVB o auto-trattamento con solarium) nelle 4 settimane precedenti; oppure hanno ricevuto un trattamento topico per la psoriasi nelle 2 settimane precedenti la randomizzazione (eccezione: sarà consentito l’uso di steroidi topici di classe 6 [lievi, come desonide] o 7 [i meno potenti, come idrocortisone] limitatamente al viso, alle ascelle e/o ai genitali) •Non possono evitare un’esposizione solare eccessiva o l’uso di docce abbronzanti per almeno 4 settimane prima del basale e durante lo studio •Hanno ricevuto natalizumab o altri agenti che hanno come bersaglio l’alfa-4-integrina •Hanno partecipato a qualsiasi studio con antagonista dell’IL-17 comprendente LY2439821 •Soffrono di un altro grave disturbo o malattia •Hanno sviluppato una grave infezione batterica (per esempio, polmonite e cellulite) negli ultimi 3 mesi •Hanno una storia di ipertensione arteriosa non controllata •All’arruolamento presentano esiti degli esami clinici di laboratorio al di fuori dei normali valori di riferimento •Stanno partecipando a un altro studio clinico riguardante un farmaco sperimentale o ne sono stati ritirati negli ultimi 30 giorni •Soggetti di sesso femminile in fase di allattamento •I soggetti di sesso femminile che potrebbero sviluppare una gravidanza durante lo studio dovranno consultare il medico dello studio riguardo ai metodi contraccettivi da adottare per evitare una gravidanza durante lo studio •I soggetti di sesso femminile in post-menopausa devono avere almeno 45 anni e non avere più cicli mestruali da 12 mesi •I soggetti di sesso femminile di età compresa tra 40 e 45 anni che risultano negativi al test di gravidanza e non hanno più cicli mestruali da soli 12 mesi dovranno sottoporsi a ulteriori esami del sangue per verificare se possano partecipare •I soggetti di sesso maschile dovranno acconsentire a ridurre il rischio che le rispettive partner sviluppino una gravidanza durante lo studio |
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E.5 End points |
E.5.1 | Primary end point(s) |
Static Physician Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI) |
scala sPGA (static Physician Global Assessment)e punteggio PASI (Psoriasis Area and Severity Index) |
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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) |
•PASI and sPGA •Quality of life assessments |
PASI e sPGA)- Valutazioni della qualità della vita |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At Week 12 and Week 60 |
Alla settimana 12 e settimana 60 |
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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 | Yes |
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 | 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 | 3 |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 59 |
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 |
Japan |
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
|
End of study is the date of the last visit or last scheduled procedure for the last active subject in the study. |
Il termine dello studio è la data dell'ultima visita o dell'ultima procedura programmata per l'ultimo paziente attivo nello studio. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 67 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 67 |
E.8.9.2 | In all countries concerned by the trial days | 0 |