NCT05622708

A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

A Multicenter Study of Secukinumab, With a Randomized Double-blind, Placebo-controlled Withdrawal-retreatment Period, to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Non-radiographic Axial Spondyloarthritis

Interventions

Type	Name	Description
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.
DRUG	Placebo	Treatment Period 2: Double-blind placebo PFS s.c. every 4 weeks from Week 56 to Week 116.
DRUG	Secukinumab	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.

Timeline

• Start date: 2023-03-28
• Primary completion: 2028-04-19
• Completion: 2028-06-13
• First posted: 2022-11-21
• Last updated: 2026-03-11

Locations

63 sites across 18 countries: Belgium, Brazil, Colombia, Czechia, France, Germany, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, Philippines, Poland, Romania, Thailand, Turkey (Türkiye), Vietnam