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 |
|
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 |
|
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., with or without loading regimen, at Week 16 is superior to placebo based on proportion of subjects achieving American College of Rheumatology 20 (ACR20) response in subjects with active PsA. |
|
E.2.2 | Secondary objectives of the trial |
-To demonstrate: •The improvement on secukinumab 150 mg, with or without loading, at Week 16 is superior to placebo for: •the disease activity assessed by the changes in Disease Activity Score for 28 joints (DAS28-CRP) (utilizing hsCRP) relative to baseline, • medical outcome short form health survey physical component score (SF-36-PCS) relative to baseline. •The efficacy of secukinumab 150 mg, with or without loading, at Week 16 is superior to placebo based on the proportion of subjects with at least 3% BSA with psoriasis achieving Psoriatic Area and Severity Index 75 (PASI75) response. -The efficacy of secukinumab 150 mg, with or without loading: •At Week 16 is superior to placebo based on the proportion of subjects achieving an ACR50 response. •At Week 4 is superior to placebo based on the proportion of subjects achieving an ACR20 response. -Overall safety and tolerability of secukinumab. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria 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 protocoldefined inclusion criteria do apply |
|
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 TNFα. •Previous treatment with any cell-depleting therapies •Other protocol-defined exclusion criteria do apply |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of American College of Rheumatology 20 (ACR20) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-Disease Activity Score for 28 joints (DAS28-CRP) utilizing hsCRP (a) -Psoriatic Area and Severity Index 75 (PASI75) (a) -Short Form Health Survey Physical Component Score (SF-36-PCS) (a) -American College of Rheumatology 50 (ACR50) (a) -Assessment of American College of Rheumatology 20 (ACR20) (b) -Overall safety and tolerability (c) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
(a) 16 weeks (b) 4 weeks (c) 112 weeks |
|
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 | 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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 46 |
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 |
Belgium |
Bulgaria |
Canada |
Czech Republic |
France |
Germany |
Italy |
Poland |
Russian Federation |
Sweden |
United Kingdom |
United States |
|
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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |