E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Psoriasis looks like red, raised scaly areas of the skin |
|
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 | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
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 |
To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52. |
|
E.2.2 | Secondary objectives of the trial |
To demonstrate in the patient pool of PASI 75 responders who do not reach a PASI 90 response at Week 24 that secukinumab 300 mg s.c. administered at a shorter dosing interval is superior to secukinumab 300 mg s.c. administered every 4 weeks at Week 52 based on the PASI 90 response rate.
Evaluate the proportion of PASI 50, PASI 75, PASI 100 and Novartis Investigator’s Global Assessment modified 2011 (IGA mod 2011) 0/1
responder rates at Week 52.
Evaluate the course of mean PASI over time from Week 24 to Week 52.
Evaluate the effect of different maintenance treatment frequencies on patient reported outcomes (PROs): Dermatology Life Quality Index (DLQI©), EuroQOL 5-Dimension Health Questionnaire (EQ-5D©), Work Productivity and Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), and the patient’s assessment of pain, itching and scaling. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Chronic plaque-type psoriasis diagnosed for at least 6 months
prior to Screening and candidate for systemic therapy.
2. Moderate to severe psoriasis at Baseline as evidenced by:
• PASI ≥ 10 and
• IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and
• BSA affected by plaque-type psoriasis of ≥ 10%.
Other protocol-defined inclusion criteria may apply |
|
E.4 | Principal exclusion criteria |
1. History of exposure to any biologic drug taken for the treatment of chronic plaque psoriasis or any other indication including but not limited to anti-tumor necrosis factor (TNF) alpha, anti-interleukin (IL)12/23, or any anti-IL-17A or IL-17A receptor (IL 17AR) antibody.
2. History of hypersensitivity to any of the study drugs or to drugs of
similar chemical classes including latex-hypersensitivity.
3. Forms of psoriasis other than chronic plaque-type (eg, pustular,
erythrodermic and guttate psoriasis).
4. Drug-induced psoriasis (ie, new onset or current exacerbation
from beta-blockers, calcium channel inhibitors or lithium).
5. Ongoing use of prohibited psoriasis treatments (eg, topical or systemic corticosteroids, ultraviolet (UV) therapy).
6. Ongoing use of other non-psoriasis prohibited treatments.
Washout periods detailed in the protocol have to be adhered to.
All other prior non-psoriasis concomitant treatments must be at a stable dose as detailed in the protocol before initiation of study
drug.
7. Pregnant or nursing (lactating) women, where pregnancy is
defined as the state of a female after conception and until the
termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).
8. Women of child-bearing potential, defined as all women
physiologically capable of becoming pregnant, unless they are using effective methods of contraception during entire study or longer if required by locally approved prescribing information (e.g. in EU 20 weeks).
9. Active ongoing inflammatory diseases other than psoriasis that
might confound the evaluation of the benefit of secukinumab
therapy.
10. Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions) which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
Other protocol-defined exclusion criteria may apply. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Psoriasis Area and Severity Index 90 response rate |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1) Psoriasis Area and Severity Index 90 response rate
2) Psoriasis Area and Severity Index 50 response rate
3) Psoriasis Area and Severity Index 75 response rate
4) Psoriasis Area and Severity Index 100 response rate
5) Investigator's Global Assessment modified 2011 0/1 responder rates
6) mean Psoriasis Area and Severity Index
7) Dermatology Life Quality Index
(DLQI©)
8) EuroQOL 5-Dimension Health Questionnaire (EQ-5D©)
9) Work Productivity and Activity Impairment Questionnaire-Psoriasis
(WPAI-PSO)
10) patient’s assessment of pain, itching and
scaling. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) week 52
2) week 52
3) week 52
4) week 52
5) week 52
6) From week 24 to Week 52
7) week 52
8) week 52
9) week 52
10) week 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
300 mg dose of secukinumab every 4 weeks |
|
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 275 |
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 |
Bulgaria |
Croatia |
Czech Republic |
Denmark |
Finland |
France |
Germany |
Greece |
Hungary |
Ireland |
Israel |
Italy |
Latvia |
Lithuania |
Netherlands |
Norway |
Poland |
Portugal |
Romania |
Russian Federation |
Serbia |
Slovakia |
Spain |
Sweden |
Switzerland |
United Kingdom |
|
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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
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 | 4 |