Study Description
This study will establish whether prolonged chronic dosing with secukinumab is needed in
participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved
remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score -
C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP < 1.3).
Maintenance of remission on continued secukinumab treatment will be evaluated compared to
placebo using a randomized withdrawal design. The primary outcome measure for this study
is the proportion of participants remaining flare-free at Week 120. This study will establish whether prolonged chronic dosing with secukinumab is needed in
participants with nr-axSpA who have achieved remission. Remission is defined as
Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive
Disease (ID) response Inactive Disease (ID) response (ASDAS-CRP < 1.3). The maintenance
of remission on continued secukinumab treatment will be evaluated compared to placebo
using a randomized withdrawal design. The primary outcome measure for this study is the
proportion of participants remaining flare-free at Week 120.
Study treatment will be as follows:
- Open-label Secukinumab PFS (prefilled syringe) will be labeled as AIN457 150mg/1mL
- Double-blind Secukinumab and Placebo PFS will be labeled as AIN457
150mg/1mL/Placebo.
Study duration will be up to 128 weeks from Baseline.
The treatment duration will be up to 120 weeks with last treatment administration at Week
116.
In the Treatment Period 1 participant will attend a site visit approximately 1 month
after Baseline and approximately every 12 weeks thereafter. In the Treatment Period 2
participant will attend site visits approximately every 4 weeks.
Interventions
Placebo
Secukinumab
Eligibility Criteria
Inclusion Criteria:
- Male or non-pregnant, non-lactating female participants at least 18 years of age
- Clinical diagnosis of axSpA AND according to ASAS axSpA criteria:
1. Inflammatory back pain for at least 6 months
2. Onset before 45 years of age
3. Sacroiliitis on MRI (magnetic resonance imaging) (as assessed by central
reader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features
- Objective signs of inflammation at screening, evident by either MRI with Sacroiliac
Joint inflammation (as assessed by central reader) AND / OR hsCRP > ULN (as defined
by the central lab)
- Active axSpA as assessed by total BASDAI ≥ 4 cm (0-10 cm) at baseline.
- Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline.
- Total back pain as measured by VAS (visual analog scale) ≥ 40 mm (0-100 mm) at
baseline.
- Participants should have been on at least 2 different NSAIDs (non-steroidal
anti-inflammatory drugs) at the highest recommended dose for at least 4 weeks in
total prior to baseline with an inadequate response or failure to respond, or less
if therapy had to be withdrawn due to intolerance, toxicity or contraindications.
Exclusion Criteria:
- Participants with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or
grade ≥ 3 unilaterally (radiological criterion according to the modified New York
diagnostic criteria for AS) as assessed by central reader.
- Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone,
morphine).
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17
or IL-17 receptor or previous treatment with immunomodulatory biologic agents
including those targeting TNFα (tumor necrosis factor α) (unless participants
discontinued the treatment with TNFα inhibitor due to a reason other than efficacy
[primary or secondary lack of efficacy, inadequate response] and only after
appropriate wash-out period prior to baseline was observed).
- History of hypersensitivity to the study drug or its excipients or to drugs of
similar chemical classes.
- Active ongoing inflammatory diseases other than nr-axSpA that might confound the
evaluation of the benefit of secukinumab therapy, including uveitis.
- Active inflammatory bowel disease.
- History of ongoing, chronic or recurrent infectious disease or evidence of
tuberculosis infection.
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