E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
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 | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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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 |
To demonstrate that the efficacy of secukinumab 150 mg s.c. or 300 mg s.c., at Week 24 is superior to placebo based on proportion of subjects achieving American College of Rheumatology 20 (ACR20) response in subjects with active PsA |
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E.2.2 | Secondary objectives of the trial |
•Efficacy of secukinumab 150mg or 300mg at Wk 24 is superior to pbo based on proportion of subjects achieving an ACR50 response
•Improvement on secukinumab 150mg or 300mg at Wk 24 is superior to pbo for disease activity assessed by the changes in DAS28-CRP relative to bsl
•Efficacy of secukinumab 150mg or 300mg at Wk 24 is superior to pbo based on proportion of subjects achieving PASI75 response
•Improvement from bsl on secukinumab 150mg or 300mg is superior to pbo at Wk 24 for SF-36-PCS
•Efficacy of secukinumab 150mg or 300mg at Wk 24 is superior to pbo based on proportion of subjects achieving PASI90 response
•Improvement from baseline on secukinumab 150mg or 300mg is superior to pbo at Wk 24 for HAQ-DI score
•Efficacy of secukinumab 150mg or 300mg at Wk 24 is superior to pbo based on proportion of subjects with:
-dactylitis in the subset of subjects who have dactylitis at bsl
-enthesitis in the subset of subjects who have enthesitis at bsl
•Overall safety & tolerability |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASification crietria for Psoriatic ARthritis (CASPAR) criteria
- Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative
- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis
- Inadequate control of symptoms with NSAID
Other protocol-definied inclusion criteria may apply |
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E.4 | Principal exclusion criteria |
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process.
- Subjects taking high potency opioid analgesics
- Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor.
- Ongoing use of prohibited psoriasis treatments/medications
- Subjects who have ever received biologic immunomodulating agents except for those targeting TNF-alpha.
- Previous treatment with any cell-depleting therapies
Other protocol-definied exclusion criteria may apply |
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E.5 End points |
E.5.1 | Primary end point(s) |
American College of Rheumatology 20 (ACR20) response in subjects treated with secukinumab versus placebo |
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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) |
•American College of Rheumatology 50 (ACR50) response in subjects treated with secukinumab versus placebo (a)
•Disease Activity Score for 28 joints (DAS28-CRP) (utilizing hsCRP) relative to baseline, assessed in subjects treated with secukinumab versus placebo (a)
•Psoriatic Area and Severity Index 75 (PASI75) response in subjects treated with secukinumab versus placebo (a)
•Physical function component of the short-form health survey (SF-36-PCS), relative to baseline, in subjects treated with secukinumab versus placebo (a)
•Psoriatic Area and Severity Index 90 (PASI90) response in subjects treated with secukinumab versus placebo (a)
•Health Assessment Questionnaire – Disability Index (HAQ-DI score), relative to baseline, in subjects treated with secukinumab versus placebo (a)
•Presence of Dactylitis, in subjects treated with secukinumab versus placebo (a)
•Presence of Enthesitis, in subjects treated with secukinumab versus placebo (a)
•Overall safety and tolerability (b) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- 24 weeks (a)
- 3 years (b) |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Serum biomarkers related to targeted pathway |
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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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 |
Australia |
Bulgaria |
Canada |
Czech Republic |
Germany |
Italy |
Netherlands |
Russian Federation |
Spain |
Switzerland |
United Kingdom |
United States |
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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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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 | 11 |
E.8.9.1 | In the Member State concerned days | |
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 | 11 |