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

NCT05622708 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Non-radiographic Axial Spondyloarthritis

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-28
Primary Completion
2028-04-19
Completion
2028-06-13

Countries

  • Belgium
  • Brazil
  • Colombia
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • Philippines
  • Poland
  • Romania
  • Thailand
  • Turkey (Türkiye)
  • Vietnam

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05622708 on ClinicalTrials.gov