πŸ›οΈ Verified NIH Record β€’ Updated 2026-08-20

A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission (NCT05622708)

πŸ”΅ Active, Not Recruiting Phase4 πŸ’Š Investigational Drug / Biologic Sponsor: Novartis Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (8 items).

Location: Novartis Investigative Site β€” Genk, Belgium

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Participants with radiographic evidence for sacroiliitis, grade β‰₯ 2 bilaterally or grade β‰₯ 3 unilaterally (radiological criterion according to the modified New York diagnostic criteria for AS) as assessed by central reader.
  • Participants taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine).
  • Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor or previous treatment with immunomodulatory biologic agents including those targeting TNFΞ± (tumor necrosis factor Ξ±) (unless participants discontinued the treatment with TNFΞ± inhibitor due to a reason other than efficacy \[primary or secondary lack of efficacy, inadequate response\] and only after appropriate wash-out period prior to baseline was observed).
  • History of hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes.
  • Active ongoing inflammatory diseases other than nr-axSpA that might confound the evaluation of the benefit of secukinumab therapy, including uveitis.
  • Active inflammatory bowel disease.
  • History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection.

πŸ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

πŸ“ All Participating Trial Locations (62 Sites)

  • Novartis Investigative Site β€” Genk, Belgium
  • Novartis Investigative Site β€” Bruges,
  • Novartis Investigative Site β€” Ghent,
  • Novartis Investigative Site β€” Mons,
  • Novartis Investigative Site β€” Juiz de Fora, Minas Gerais
  • Novartis Investigative Site β€” Porto Alegre, Rio Grande do Sul
  • Novartis Investigative Site β€” Barretos, SΓ£o Paulo
  • Novartis Investigative Site β€” Bogota, Cundinamarca
  • Novartis Investigative Site β€” Bogota, Cundinamarca
  • Novartis Investigative Site β€” ChΓ­a, Cundinamarca
  • Novartis Investigative Site β€” Bucaramanga, Santander Department
  • Novartis Investigative Site β€” Prague,
  • Novartis Investigative Site β€” Prague,
  • Novartis Investigative Site β€” Prague,
  • Novartis Investigative Site β€” UherskΓ© HradiΕ‘tΔ›,
  • Novartis Investigative Site β€” Chambray-lΓ¨s-Tours,
  • Novartis Investigative Site β€” Le Mans,
  • Novartis Investigative Site β€” Nice,
  • Novartis Investigative Site β€” Paris,
  • Novartis Investigative Site β€” Bad Doberan,
  • Novartis Investigative Site β€” Berlin,
  • Novartis Investigative Site β€” Berlin,
  • Novartis Investigative Site β€” Hamburg,
  • Novartis Investigative Site β€” Herne,
  • Novartis Investigative Site β€” Ratingen,

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
πŸ›οΈ View Official NIH Record β†—