| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Moderate to severe plaque psoriasis |
| Psoriasi a placche da moderata a severa |
|
| E.1.1.1 | Medical condition in easily understood language |
| Plaque psoriasis appears as raised, red patches covered with silvery, scaly dead skin cells |
Psoriasi a placche che appaiono sollevate, rosse coperte
da chiazze argentee |
|
| 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 | 10071117 |
| E.1.2 | Term | Plaque psoriasis |
| E.1.2 | System Organ Class | 100000004858 |
|
| 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 primary objectives of this study are to
assess whether 80 mg
ixekizumab every 2-week (Q2W) is:
1. noninferior to ustekinumab at Week 12 in the treatment of patients
with moderate to severe psoriasis, as measured by proportion of
patients achieving Psoriasis Area and Severity Index (PASI) 90, and then
2. superior to ustekinumab at Week 12 in the treatment of patients with
moderate-to-severe plaque psoriasis, as measured by proportion of
patients achieving PASI 90 |
Gli obiettivi primari di questo studio sono di valutare se 80mg di ixekizumab ogni 2 settimane (Q2W)
sono:
•noninferiori ad ustekinumab in 12settimane nel trattamento dei pazienti con psoriasi a placche da moderata a grave, come
misurato da una porzione di pazienti che hanno raggiunto il 90% di miglioramento nell’indice PASI, PASI90 (Psoriasis Area and
Severity Index), e quindi
•superiorità ad ustekinumab in 12settimane nel trattamento dei pazienti con psoriasi a placche da moderata a grave, come
misurato da una porzione di pazienti che hanno raggiunto PASI 90 |
|
| E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are
to assess whether ixekizumab
is superior to ustekinumab at the study visits in the treatment of
patients with moderate-to-severe plaque psoriasis as measured by:
-proportion of patients achieving a ≥75% improvement in PASI (PASI
75), a ≥90% improvement in PASI (PASI 90), and a 100% improvement
of PASI (PASI 100) from baseline
-proportion of patients with an static Physician Global Assessment
(sPGA) (0,1) with at least a 2-point improvement from baseline
-proportion of patients achieving an sPGA (0) (remission)
-proportion of patients achieving dermatology-specific quality of life
index (DLQI) (0,1)
-proportion of patients reaching Itch Numeric Rating Scale (NRS)
responder definition (decrease of 4 points in the Itch NRS in patients
with baseline score ≥4 points)
-change from baseline in Itch NRS
-change from baseline Skin Pain visual analog scale (VAS) |
Gli obiettivi secondari chiave di questo studio sono di comparare i seguenti risultati di efficacia e
sicurezza misurati tra ixekizumab (Q2W) ed ustekinumab alla 12 settimana:
•proporzione di pazienti che hanno raggiunto un miglioramento ≥75% nell’indice PASI rispetto alla baseline (PASI 75)
•proporzione di pazienti che hanno raggiunto un miglioramento del 100% nell’indice PASI rispetto alla baseline (PASI 100)
•proporzione binaria di pazienti che hanno raggiunto sPGA di 0 [remissione]
•proporzione di pazienti con un static Physician Global Assessment (sPGA) (0,1) con almeno un migliroamento di 2 punti rispetto al
basale
•proporzione di pazienti che hanno raggiunto l’indice dermatology-specific quality of life (DLQI) (0,1)
•proporzione di pazienti che hanno raggiunto la scala Itch Numeric Rating Scale (NRS) (diminuzione di 4 punti nei pazienti con Itch
NRS che alla baseline hanno un punteggio ≥4 punti)
•cambiamenti rispetto alla baseline nella scala Itch NRS
•cambiamenti ri |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Are at least 18 years of age
-Have had moderate to severe plaque psoriasis for at least 6 months
-Have had a failure, contraindication, or intolerability to at least 1 systemic therapy (including yclosporine, methotrexate, or
phototherapy |
-essere maggiorenni
-avere la psoriasi a placche, da moderata a severa, per almeno 6 mesi
-avere avuto almeno un fallimento, una controindicazione un'intollerabilità ad almeno una terapia sistemica (inclusa ciclosporina,
metrotrexato o foroterapia) |
|
| E.4 | Principal exclusion criteria |
Have forms of psoriasis other than plaque psoriasis.
-Have recently received certain treatments for their psoriasis (in
particular within the last 4 weeks but the restriction can go up to 12
months for some treatments).
-Have received ustekinumab.
-Have already been treated with ixekizumab or another drug with a
similar mode of action.
-Have received excessive sun exposure or have used tanning booths
within 4 weeks prior to receiving treatment in this study or expect to do
so during the study.
-Have recently received a live vaccine (within 12 weeks prior to
receiving treatment in this study) or plan to do so during the study.
-Have had a vaccination with Bacillus Calmette-Guerin (BCG) within the
past year.
-Have an active or recent infection.
-Have active or dormant tuberculosis.
-Have a compromised immune system.
-Have another disease which is not currently under control, including
heart disease, uncontrolled arterial hypertension, mental illness, and
other diseases.
Have either a current diagnosis or a recent history of malignant disease.
-Have allergies to certain treatments or latex.
-Are pregnant or breastfeeding. |
avere ricevuto di recente alcuni trattamenti per la psoriasi (in particolare entro le ultime 4settimane, ma le restrizioni possono
arrivare anche 12 mesi per alcuni trattamenti)
-avere ricevuto ustekizumab
-essere stati già trattai con ixekizumab o un altro farmaco con la stessa modalità di azione
-avere avuto una eccessiva esposizione al sole o avere usato lampade solari entro le 4 settimane precedenti al ricevimento del
trattamento in questo studio
-avere ricevuto di recente un vaccino vivo (entro 12 settimane prima) o si prevede di farlo nel corso di questo studio
-avere avuto una vaccinazione con Calmette-Guerin baccillo entro l'anno precedente
-avere una infezione attiva o recente
-avere una tubercolosi attiva o non attiva
-avere un sistema immunitario compromesso
-avere un'altra malattia che non è attualmente sotto controllo, incluse malattie cardiache, ipertensione arteriosa incontrollata,
malattie mentali ed altre
-avere una diagnosi attuale od un anamnesi di malattia maligna
-avere allergie ad alcuni trattamento o al latex
-essere incinta o in allattamento |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Psoriasis Area and Severity Index (PASI) 90
response (at least a (≥)90% improvement in PASI score from baseline) |
risposta all'Indice PASI 90 (almeno maggiore di 90% del miglioramento nel punteggio a partire dalla
baseline) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
Itch Numeric Rating Scale (NRS),
Dermatology Life Quality Index (DLQI),
Skin Pain Visual Analog Scale (VAS),
XML File Identifier: 3ROCXhQs6ORbkT2GC+PkgwX4msY=
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Hospital Anxiety and Depression Scale (HADS),
Short Form (36-item) Health Survey,
Patient's Global Assessment of Disease Severity,
Work Productivity Activity Impairment questionnaire – Psoriasis (WPAI),
and
European Quality of Life – 5 Dimensions 5 Level + Bolt On (EQ 5D 5L) |
Itch Numeric Rating Scale (NRS),
Dermatology Life Quality Index (DLQI),
Skin Pain Visual Analog Scale (VAS),
XML File Identifier: 3ROCXhQs6ORbkT2GC+PkgwX4msY=
Page 20/31
Hospital Anxiety and Depression Scale (HADS),
Short Form (36-item) Health Survey,
Patient's Global Assessment of Disease Severity,
Work Productivity Activity Impairment questionnaire – Psoriasis (WPAI),
and
European Quality of Life – 5 Dimensions 5 Level + Bolt On (EQ 5D 5L) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| 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 | No |
| E.6.7 | Pharmacodynamic | No |
| 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) | 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 | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 47 |
| 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 |
|
| 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
|
End of Study is the date of the last visit or last scheduled procedure for
the last active subject in the study |
| Data dell'ultima visita o dell'ultima procedura prevista per l'ultimo paziente attivo nella sperimentazione |
|
| 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 | 10 |
| E.8.9.1 | In the Member State concerned days | 4 |
| 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 | 10 |
| E.8.9.2 | In all countries concerned by the trial days | 4 |
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