E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic Arthritis |
artrite psoriasica |
|
E.1.1.1 | Medical condition in easily understood language |
Psoriatic Arthritis |
artrite psoriasica |
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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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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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 |
To evaluate the efficacy of brodalumab, (210 mg every 2 weeks (Q2W); and 140 mg Q2W) compared to placebo, in subjects with psoriatic arthritis, as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20 response at week 16. |
valutare l’efficacia di brodalumab (210 mg ogni 2 settimane [Q2W]; e 140 mg Q2W) rispetto al placebo in soggetti con artrite psoriasica valutata sulla base della percentuale di pazienti che alla settimana 16 raggiungono una risposta ACR20 secondo i criteri dell’American College of Rheumatology |
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E.2.2 | Secondary objectives of the trial |
Key Secondary Objectives:
To evaluate the efficacy of brodalumab compared to placebo on the following:
Psoriasis Area and Severity Index (PASI) 75 at week 16
Van der Heijde modified Total Sharp score (mTSS) at week 24 |
valutare l’efficacia di brodalumab rispetto al placebo sulla base dei parametri seguenti: indice PASI (Psoriasis Area and Severity Index) 75 alla settimana 16 e punteggio Van der Heijde-mTSS (Total Sharp Score modificato) alla settimana 24. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Brodalumab Pharmacokinetic Substudy Objective (optional): To characterize the pharmacokinetics of brodalumab
Biomarker development and pharmacogentic substudy (optional):
Objective: to collect samples for biomarker analysis; to investigate the effects of genetic variation in disease genes and drug target genes on psoriatic arthritis and/or subject response to brodalumab |
valutare l’efficacia di brodalumab rispetto al placebo sulla base dei parametri seguenti: indice PASI (Psoriasis Area and Severity Index) 75 alla settimana 16 e punteggio Van der Heijde-mTSS (Total Sharp Score modificato) alla settimana 24. |
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E.3 | Principal inclusion criteria |
- Subject has provided informed consent
- Subject is ≥ 18 years of age at time of screening
- Subject has had a diagnosis of psoriatic arthritis for at least 6 months and currently meets the CASPAR criteria
- Subject has ≥ 3 tender and ≥ 3 swollen joints
- Subject has a history of intolerance or inadequate response to NSAIDs and/or DMARDs for psoriatic arthritis |
il paziente ha fornito il consenso informato, il soggetto deve aver un’età di ≥ 18 anni al momento dello screening; il soggetto deve avere una diagnosi di artrite psoriasica da almeno 6 mesi e deve soddisfare i criteri |
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E.4 | Principal exclusion criteria |
Other Medical Conditions:
- Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the investigator to be clinically significant and uncontrolled.
- Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
Washouts or Other Treatments
- Subject has used commercially available or investigational biologic therapies for psoriasis and/or psoriatic arthritis as follows:
anti-tumor necrosis factor (TNF) therapy within 2 months prior to investigational product initiation
other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months prior to investigational product initiation
anti-IL17 or anti-IL12/IL23 biologic therapy, including brodalumab, secukinumab, ixekizumab, ustekinumab, briakinumab at any time
rituximab at any time
General
- Subject is currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) prior to screening.
- Other investigational procedures while participating in this study are excluded.
- Subject has known sensitivity to any of the products or components to be administered during dosing.
- Women of reproductive potential who are not willing to use an acceptable form of birth control during the study and for an additional 8 weeks after the last dose of study drug.
- Women who are lactating/breastfeeding or planning to breastfeed during the study and for an additional 8 weeks after the last dose of Amgen study drug.
|
Soggetti con patologie sistemiche (insufficienza renale, cardiaca, ipertensione, patologie
epatiche, diabete, anemia) consideratedallo sperimentatore significative dal punto di vista
clinico e non controllate; Il soggetto ha una qualsiasi condizione medica concomitante o un’anomalia all’ elettrocardiogramma (ECG) che, a giudizio dello sperimentatore, potrebbe rendere dannoso lo studio per il paziente; Soggetti che hanno fatto uso delle seguenti terapie per la psoriasi o l’artrite psoriasica in commercio o in fase di sperimentazione:
- terapia con anti-fattore di necrosi tumorale (TNF) nei 2 mesi precedenti la somministrazione del prodotto sperimentale
- altre terapie sperimentali o in commercio per la psoriasi o l’artrite psoriasica nei 3 mesi precedenti la somministrazione del prodotto sperimentale
- terapie biologiche anti-IL-17 o antiIL12/IL23, compreso brodalumab, secukinumab, ixekizumab, briakinumab in qualsiasi momento
- rituximax in qualsiasi momento
Soggetti attualmente arruolati in altri studi clinici con dispositivi medici o farmaci o per i quali non sono ancora scaduti 30 giorni dal termine della sperimentazione prima dello screening; Altre procedure di sperimentazione; Soggetti che hanno avuto episodi di sensibilizzazione ad uno dei prodotti o ai suoi componenti che verranno somministrati durante lo studio; Donne potenzialmente fertili che non sono disposte ad utilizzare un forma accettabile di controllo delle nascite durante lo studio e per ulteriori 8
settimane dopo l'ultima dose del farmaco in studio; Donne che stanno allattando o che intendono allattare durante lo studio e 18 settimane dopo l’ultima dose di farmaco sperimentale.
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E.5 End points |
E.5.1 | Primary end point(s) |
ACR20 response at week 16 |
una risposta ACR20 alla settimana 16 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Key secondary Endpoints:
PASI 75 at week 16
mTSS change from baseline at week 24 |
PASI 75 alla settimana 16
Variazione del punteggio mTSS rispetto al basale alla settimana 24
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
PASI 75 at week 16
mTSS change from baseline at week 24 |
PASI 75 alla settimana 16
Variazione del punteggio mTSS rispetto al basale alla settimana 24
|
|
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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
randomized, double-blind, placebo-controlled study with long term extension |
|
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 71 |
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 |
Belgium |
Canada |
France |
Greece |
Italy |
Netherlands |
Czech Republic |
Hungary |
Spain |
Mexico |
Poland |
Russian Federation |
Switzerland |
United Kingdom |
United States |
|
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
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
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 | 0 |