E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe active, chronic plaque psoriasis |
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E.1.1.1 | Medical condition in easily understood language |
Patches of raised red scaly skin |
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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 | 17.0 |
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 objective of the study is to evaluate the efficacy of secukinumab (300mg) treatment with respect to PASI 75 response rate after 16 weeks treatment, by assessing the percentage (%) of patients achieving PASI 75 after 16 weeks compared to baseline (defined as PASI status at Week 0). |
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E.2.2 | Secondary objectives of the trial |
1.To evaluate the efficacy of secukinumab (150mg) treatment with respect to PASI 75 response rate after 16 weeks treatment, by assessing the percentage (%) of patients achieving PASI 75 after 16 weeks compared to baseline (defined as PASI status at Week 0).
2.To evaluate the efficacy of secukinumab treatment with respect to PASI 75 response rate after 16 weeks treatment compared to baseline in the 3 key patient subgroups for both
•300mg secukinumab
•150mg secukinumab
3.To evaluate the efficacy of secukinumab (300mg and 150mg secukinumab) treatment with respect to PASI response rate compared to baseline:
•% of patients achieving PASI 90 after 16 wks
•% of patients achieving PASI 75 after 2, 4, 8, 12, 24, 48 and 72 wks
To evaluate the efficacy of secukinumab (300mg and 150mg secukinumab) treatment compared to baseline wrt:
•% of patients achieving PASI 50 after 2, 4, 8, 16, 12, 24, 48 and 72 wks
•% of patients achieving PASI 90 after 2, 4, 8, 12, 24, 48 and 72 wks |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Chronic plaque-type psoriasis diagnosed for at least 6 months prior to screening
- Moderate to severe disease severity at randomisation
•PASI ≥10 and
•DLQI >10
- Failed to respond to systemic therapies including ciclosporin, methotrexate and PUVA/Phototherapy (or is intolerant and/or has a contraindication to these)
- Previously treated with at least one anti-TNFα for moderate or severe psoriasis but is a primary or secondary non-responder. |
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E.4 | Principal exclusion criteria |
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis)
- Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium)
- Use of prohibited psoriasis or non-psoriasis treatments
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use 2 (two) effective forms of contraception during the study and for 16 weeks after stopping treatment.
- Men with a female partner of child bearing potential defined as all women physiologically capable of becoming pregnant unless they use 1 (one) effective form of contraception during the study and for 16 weeks after stopping treatment.
- Plans for administration of live vaccines during the study period or 6 weeks prior to initiation of study drug. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome variable is the PASI 75 response at 16 weeks: subjects achieving ≥ 75% improvement (reduction) in PASI score compared to baseline are defined as PASI 75 responders |
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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) |
The following key secondary variables will be analysed for 300mg and 150mg secukinumab by the same method as the primary variable.
•Percentage of patients achieving PASI 90 after 16 weeks
•Percentage of patients achieving PASI 75 after 2 weeks
•Percentage of patients achieving PASI 75 after 4 weeks
•Percentage of patients achieving PASI 75 after 8 weeks
•Percentage of patients achieving PASI 75 after 12 weeks
•Percentage of patients achieving PASI 75 after 24 weeks
•Percentage of patients achieving PASI 75 after 48 weeks
•Percentage of patients achieving PASI 75 after 72 weeks
PASI 50, PASI 75, PASI 90 response over time (2 - 72 weeks) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The following key secondary variables will be analysed for 300mg and 150mg secukinumab by the same method as the primary variable.
•Percentage of patients achieving PASI 90 after 16 weeks
•Percentage of patients achieving PASI 75 after 2 weeks
•Percentage of patients achieving PASI 75 after 4 weeks
•Percentage of patients achieving PASI 75 after 8 weeks
•Percentage of patients achieving PASI 75 after 12 weeks
•Percentage of patients achieving PASI 75 after 24 weeks
•Percentage of patients achieving PASI 75 after 48 weeks
•Percentage of patients achieving PASI 75 after 72 weeks
PASI 50, PASI 75, PASI 90 response over time (2 - 72 weeks) |
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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 | No |
E.6.11 | Pharmacogenomic | Yes |
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 | No |
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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |
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 |