E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe plaque psoriasis |
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E.1.1.1 | Medical condition in easily understood language |
Plaque psoriasis appears as raised, red patches covered with silvery, scaly dead skin cells. |
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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 | 18.0 |
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 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
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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) |
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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 |
Pharmacogenetic analysis: a blood sample will be collected for pharmacogenetic analysis where local regulations allows.
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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 cyclosporine, methotrexate, or phototherapy)
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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.
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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) |
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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 100,
PASI 90,
PASI 75,
Static Physician's Global Assessment (sPGA),
Nail Psoriasis Severity Index (NAPSI),
Psoriasis Scalp Severity Index (PSSI),
Palmoplantar Psoriasis Severity Index (PPASI)
Body Surface Area (BSA) percentage involvement of psoriasis,
Additionally the following Patient Reported Outcome Measures:
Itch Numeric Rating Scale (NRS),
Dermatology Life Quality Index (DLQI),
Skin Pain Visual Analog Scale (VAS),
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) |
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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 | 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 | 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 |
Austria |
Belgium |
Brazil |
Canada |
France |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Spain |
Sweden |
Switzerland |
United Kingdom |
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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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End of Study is the date of the last visit or last scheduled procedure for the last active subject in the study.
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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 | 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 |