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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
241
Treatment Period 1: Open-label secukinumab 150 mg PFS s.c. at baseline, Weeks 1, 2, 3 and 4 followed by administration every four weeks up to Week 52.
Treatment Period 2: Double-blind placebo PFS s.c. every 4 weeks from Week 56 to Week 116.
Treatment Period 2: Double-blind secukinumab 150 mg PFS s.c. every 4 weeks from Week 56 to Week 116. Escape re-treatment (during Treatment Period 2): Open-label secukinumab 150 mg PFS s.c.
Novartis Investigative Site
Bruges, Belgium
Novartis Investigative Site
Genk, Belgium
Novartis Investigative Site
Ghent, Belgium
Novartis Investigative Site
Mons, Belgium
Novartis Investigative Site
Juiz de Fora, Minas Gerais, Brazil
Novartis Investigative Site
The proportion of participants remaining flare-free during Treatment Period 2
The primary efficacy endpoint is the proportion of participants in the randomized withdrawal population remaining flare-free at Week 120. A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP \> 3.5 at any visit during Treatment Period 2, starting at Week 60. Parameters used for ASDAS-CRP include: * Spinal pain (BASDAI question 2), * Patient's global assessment of disease activity, * Peripheral pain/swelling (BASDAI question 3), * Duration of morning stiffness (BASDAI question 6) * C-reactive protein (CRP) in mg/L
Time frame: Week 120
Time to flare during Treatment Period 2
A flare is defined as ASDAS-CRP ≥ 2.1 at 2 consecutive visits, or ASDAS-CRP \> 3.5 at any visit during Treatment Period 2, starting at Week 60.
Time frame: From Week 56 to Week 120
Number of participants with Adverse Events
Safety and tolerability demonstrated by assessing: \- Adverse events (AEs) and serious adverse events (SAEs)
Time frame: From Baseline to Week 128
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Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Barretos, São Paulo, Brazil
Novartis Investigative Site
Bogota, Cundinamarca, Colombia
Novartis Investigative Site
Bogota, Cundinamarca, Colombia
Novartis Investigative Site
Chía, Cundinamarca, Colombia
...and 55 more locations