A Phase 4 interventional study of Secukinumab and Placebo in Non-radiographic Axial Spondyloarthritis, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 62 sites in 18 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment
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:
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.
Clinical diagnosis of axSpA AND according to ASAS axSpA criteria:
Exclusion Criteria:
Open-label Secukinumab PFS (prefilled syringe) labeled as AIN457 150mg/1mL
Drug: Secukinumab
Double-blind Secukinumab and Placebo PFS labeled as AIN457 150mg/1mL/Placebo
Drug: Placebo · Drug: Secukinumab
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.
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
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Non-Radiographic Axial Spondyloarthritis→
Novartis Pharmaceuticals