E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe chronic plaque-type psoriasis |
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E.1.1.1 | Medical condition in easily understood language |
Psoriasis looks like red, raised scaly areas of the 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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis over 12 weeks based on PASI and IGA |
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E.2.2 | Secondary objectives of the trial |
- Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis over 52 weeks based on PASI and IGA
- Clinical safety and tolerability of secukinumab over 12 and 52 weeks
- Quality of life assessments based on patient reported outcomes over 12 and 52 weeks
- To demonstrate the superiority of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis with respect to psoriasis-related itching, pain and scaling as measured by the Psoriasis Diary at Week 12 compared to placebo |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects with chronic, plaque-type psoriasis for at least 6 months
- Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area
- Must be inadequately controlled by prior treatments (topicals, phototherapy, and/or systemic therapies)
Other protocol-defined inclusion criteria may apply. |
|
E.4 | Principal exclusion criteria |
- Current forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermic and guttate psoriasis)
- Drug induced psoriasis
- Use of other psoriasis treatments during the study
- Prior use of secukinumab or any other drug that targets IL-17 or the IL-17 receptor
- Pregnant or lactating women; women who do not agree to use contraception during the study and for 16 weeks after stopping treatment
- Significant medical problems such as uncontrolled high blood pressure, congestive heart failure, or a condition that significantly immunocompromises the subject.
- History of an ongoing, chronic or recurrent infection or evidence of untreated tuberculosis
Other protocol-defined exclusion criteria may apply.
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 and IGA
- Clinical safety and tolerability of secukinumab
- Patient reported outcomes |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Respectively:
- 52 weeks
- 12 and 52 weeks
- 12 and 52 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 | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 |
Argentina |
Canada |
Colombia |
Israel |
Japan |
Mexico |
Panama |
Peru |
Russian Federation |
Taiwan |
United States |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |