|E.1 Medical condition or disease under investigation
|Medical condition(s) being investigated
|Medical condition in easily understood language
|Diseases [C] - Musculoskeletal Diseases [C05]
|E.1.2 Medical condition or disease under investigation
|System Organ Class
|10028395 - Musculoskeletal and connective tissue disorders
|Condition being studied is a rare disease
|E.2 Objective of the trial
|Main objective of the trial
|To demonstrate the proportion of subjects on secukinumab ( 150 mg s.c. or 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c.).
|Secondary objectives of the trial
|-To demonstrate the change from baseline in mSASSS in subjects on AIN457 (150mg sc or 300mg sc) is superior to GP2017 at W104
-To demonstrate the proportion of subjects with a syndesmophyte at baseline with no new syndesmophytes at W104 on AIN457 (150mg sc or 300mg sc) is superior to GP2017
-To evaluate the Berlin SI joint edema score in subjects on AIN457 (150mg sc and 300mg sc) at W104 versus GP2017 (in a subset of subjects at selected sites)
-To evaluate the ASspiMRI-a Berlin modification score in subjects on AIN457 (150mg sc or 300mg sc) at W104 versus GP2017 (in a subset of subjects at selected sites)
-To evaluate ASAS20 response, ASAS40 response, ASAS partial remission and ASDAS inactive disease in subjects on AIn457 150mg sc compared to AIN457 300mg sc at W104
-Overall safety and tolerability of AIN457
|Trial contains a sub-study
|Principal inclusion criteria
|- Male or non-pregnant, non-nursing female patients at least 18 years of age.
- Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/non biologic DMARD therapy.
- Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10.
- Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10).
- Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm).
- hsCRP ≥ 5mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray.
Other protocol-defined inclusion criteria may apply,
|Principal exclusion criteria
|- Patients with total ankylosis of the spine.
- Pregnant or nursing (lactating) women.
- Evidence of ongoing infectious or malignant process.
- Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFα.
- Subjects taking high potency opioid analgesics.
- Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents.
Other protocol-defined exclusion criteria may apply,
|E.5 End points
|Primary end point(s)
|No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) for 150 mg sc or 300 mg sc secukinumab versus GP2017)
|Timepoint(s) of evaluation of this end point
|Secondary end point(s)
|- Change from baseline in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS).
- No new syndesmophyte as measured by mSASSS.
- Assessment of SpondyloArthritis International Society 20 (ASAS20).
- ASAS 40.
- ASAS partial remission.
- Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease.
- Berlin sacroiliac (SI) joint edema score.
- Ankylosing Spondylitis Spine Magnetic Resonance Imaging - activity (ASspiMRI-a) Berlin modification score.
|Timepoint(s) of evaluation of this end point
|E.6 and E.7 Scope of the trial
|Scope of the trial
|Trial type and phase
|Human pharmacology (Phase I)
|First administration to humans
|Other trial type description
|Therapeutic exploratory (Phase II)
|Therapeutic confirmatory (Phase III)
|Therapeutic use (Phase IV)
|E.8 Design of the trial
|Other trial design description
|Pts know if they receive PR1 or PR2;but they don`t know the dose of PR1 (150 or 300mg) they receive
| Comparator of controlled trial
|Other medicinal product(s)
|Number of treatment arms in the trial
The trial involves single site in the Member State concerned
| The trial involves multiple sites in the Member State concerned
|Number of sites anticipated in Member State concerned
|The trial involves multiple Member States
|Number of sites anticipated in the EEA
|E.8.6 Trial involving sites outside the EEA
|Trial being conducted both within and outside the EEA
|Trial being conducted completely outside of the EEA
|If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
|Korea, Republic of
|Trial has a data monitoring committee
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
|In the Member State concerned years
|In the Member State concerned months
|In the Member State concerned days
|In all countries concerned by the trial years
|In all countries concerned by the trial months
|In all countries concerned by the trial days