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

Conditions

• Non-radiographic Axial Spondyloarthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Mar 28, 2023

Status verified

May 2026

Primary completion

Feb 8, 2028

Completion

Apr 4, 2028

Study Design

Enrollment

240 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Period 1
  Open-label Secukinumab PFS (prefilled syringe) labeled as AIN457 150mg/1mL
• Experimental: Treatment Period 2
  Double-blind Secukinumab and Placebo PFS labeled as AIN457 150mg/1mL/Placebo

Primary Outcome Measure

The proportion of participants remaining flare-free during Treatment Period 2 [ Time Frame: Week 120 ]