a study of secukinumab to evaluate maintenance of response in participants with non-radiographic axial spondyloarthritis who achieved remission

Conditions: Non-radiographic Axial Spondyloarthritis

Summary: 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.

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.

Keywords: nr-axspa non-radiographic axial spondyloarthritis secukinumab remission withdrawal inflammatory back pain sacroiliitis ain457