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 |
Bechterev syndrome, Marie-Strümpell disease |
|
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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10002556 |
E.1.2 | Term | Ankylosing spondylitis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 at least one dose of secukinumab
(75mg s.c. or 150mg s.c.) at Week 16 is superior to placebo in patients
with active AS based on the proportion of patients achieving an ASAS 20
(Assessment of Spondyloarthritis International Society criteria)
response. |
|
E.2.2 | Secondary objectives of the trial |
1. To demonstrate the efficacy of at least one dose of secukinumab
(75mg s.c. or 150mg s.c.) at Week 16 is superior to placebo in patients
with active AS based on:
-the proportion of patients achieving an ASAS 40 response
-the change from baseline of hsCRP
-the proportion of patients achieving an ASAS 5/6 response
-the change from baseline in total Bath Ankylosing Spondylitis Disease
Asctivity (BASDAI)
-the change from baseline in SF-36 PCS
-the change from baseline in Ankylosing Spondylitis Quality of Life
(ASQoL)
-the proportion of patients achiveing an ASAS partial remission
2. The overall safety and tolerability of secukinumab (75mg s.c. or
150mg s.c.) compared to placebo as assessed by vital signs, clinical
laboratory values, and adverse events monitoring. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or non-pregnant, non-lactating female patients at least 18 years of age
• Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
• Patients should have been on NSAIDs with an inadequate response
• Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose
• Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response
Other protocol-defined inclusion criteria may apply.
|
|
E.4 | Principal exclusion criteria |
• Chest X-ray with evidence of ongoing infectious or malignant process
• Patients with total ankylosis of the spine
• Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
• Previous treatment with any cell-depleting therapies
Other protocol-defined exclusion criteria may apply. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1) ASAS 40 response
2) Serum hsCRP
3) ASAS 5/6 response
4) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
5) Physical function component of the short-form health survey (SF-36
PCS)
6) Ankylosing Spondylitis Quality of Life questionnaire (ASQoL)
7) ASAS partial remission
8) Overall safety and tolerability |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
English 16 Weeks (1, 2, 3, 4, 5, 6, 7)
104 weeks (8) |
|
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 | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
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 |
Belgium |
Bulgaria |
Canada |
France |
Italy |
Netherlands |
Germany |
Mexico |
Peru |
Russian Federation |
Taiwan |
Turkey |
United Kingdom |
United States |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |