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 | 21.0 |
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 i.v. secukinumab at Week 16 is superior to placebo in subjects with active psoriatic arthritis (PsA) based on the proportion of patients achieving an American College of Rheumatology 50 (ACR50) response. |
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E.2.2 | Secondary objectives of the trial |
-To demonstrate that the efficacy of i.v. secukinumab at Week 16 is superior to placebo based on: the proportion of subjects achieving: 1- an ACR20 response 2- minimal disease activity (MDA) 5/7 3- a PASI90 response in the group of subjects who have >=3% skin involvement with psoriasis. the improvement from baseline for the: 4- PASDAS 5- HAQ-DI 6- SF36-PCS 7- FACIT-fatigue 8- mNAPSI the proportion of subjects with resolution of: 9- dactylitis by the Leeds Dactylitis Index in the subset of subjects who have dactylitis at baseline 10- enthesitis by the Leeds Enthesitis Index in the subset of subjects who have enthesitis at baseline 11- Overall safety and tolerability of secukinumab compared to placebo as assessed by vital signs, clinical laboratory values and adverse events monitoring |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Diagnosed with PsA by CASPAR criteria with symptoms for at least 6 months and moderate to severe PsA having at least 3 tender joints out of 8 and at least 3 swollen joints out of 76 - Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis - Inadequate response to NSDAIDs Other protocol-defined inclusion criteria may apply |
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E.4 | Principal exclusion criteria |
- Pregnancy or lactation - Ongoing infectious or malignant process on a chest X-ray or MRI - Previous exposure to IL-17 or IL-17R targeting therapies - Previous exposure to any biological immunomodulating agent excluding TNF antagonists Other protocol-defined exclusion criteria may apply |
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E.5 End points |
E.5.1 | Primary end point(s) |
American College of Rheumatology 50 (ACR50) response |
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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) |
1- an ACR20 response 2- minimal disease activity (MDA) 5/7 3- a PASI90 response in the group of subjects who have >=3% skin involvement with psoriasis. 4- PASDAS 5- HAQ-DI 6- SF36-PCS 7- FACIT-fatigue 8- mNAPSI 9- dactylitis by the Leeds Dactylitis Index in the subset of subjects who have dactylitis at baseline 10- enthesitis by the Leeds Enthesitis Index in the subset of subjects who have enthesitis at baseline 11- Overall safety and tolerability of secukinumab compared to placebo as assessed by vital signs, clinical laboratory values and adverse events monitoring |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 to 4: 16 weeks 4 to 8: Baseline to Week 16 9 and 10: 16 weeks 11: 60 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 | 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 |
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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 | 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 | 17 |
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 |
Brazil |
Colombia |
Guatemala |
India |
Malaysia |
Philippines |
Russian Federation |
South Africa |
Thailand |
Turkey |
United States |
Bulgaria |
Poland |
Czechia |
Greece |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 26 |
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 | 6 |