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

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509320-17-00

Acronym

CAIN457I2401

Enrollment

244

Registered

2024-05-17

Start date

2023-03-28

Completion date

Unknown

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-radiographic axial spondyloarthritis

Brief summary

The proportion of participants remaining flare-free at Week 120

Detailed description

Time to flare during Treatment Period 2, Safety and tolerability demonstrated by assessing: • Adverse events (AEs) and serious adverse events (SAEs) (incidence, severity, and relationship with study drug) • Clinically significant changes in laboratory parameters and vital signs

Interventions

DRUGPlacebo to AIN457 150 mg/1 mL Solution for injection in pre-filled syringe

DRUGSECUKINUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportion of participants remaining flare-free at Week 120	—

Secondary

Measure	Time frame
Time to flare during Treatment Period 2, Safety and tolerability demonstrated by assessing: • Adverse events (AEs) and serious adverse events (SAEs) (incidence, severity, and relationship with study drug) • Clinically significant changes in laboratory parameters and vital signs	—

Countries

Belgium, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026