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Evaluating the need for ongoing treatment with secukinumab in patients with non-radiographic axial spondyloarthritis who are in 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

Phase 4 Interventional Novartis · NCT05622708

This study is testing if people with non-radiographic axial spondyloarthritis who are in remission still need to keep taking secukinumab or if they can stop treatment without having a flare-up.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment340 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionssecukinumab
Locations84 sites (Brugge and 83 other locations)
Trial IDNCT05622708 on ClinicalTrials.gov

What this trial studies

This study aims to determine whether patients with non-radiographic axial spondyloarthritis (nr-axSpA) who have achieved remission require continued treatment with secukinumab. Participants will be randomly assigned to receive either secukinumab or a placebo to assess the maintenance of remission over a period of 120 weeks. The primary outcome will be the proportion of participants who remain flare-free at Week 120, measured using the Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP). The study will involve regular site visits for monitoring and assessment throughout the treatment duration.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a clinical diagnosis of axSpA who have achieved remission as defined by specific inflammatory markers.

Not a fit: Patients who have not achieved remission or those with other forms of spondyloarthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help determine the necessity of ongoing secukinumab treatment, potentially reducing unnecessary medication exposure for patients in remission.

How similar studies have performed: Other studies have shown promising results with secukinumab in treating axial spondyloarthritis, but this specific approach to maintenance therapy in remission is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Male or non-pregnant, non-lactating female participants at least 18 years of age
* Clinical diagnosis of axSpA AND according to ASAS axSpA criteria:

  1. Inflammatory back pain for at least 6 months
  2. Onset before 45 years of age
  3. Sacroiliitis on MRI (magnetic resonance imaging) (as assessed by central reader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features
* Objective signs of inflammation at screening, evident by either MRI with Sacroiliac Joint inflammation (as assessed by central reader) AND / OR hsCRP \> ULN (as defined by the central lab)
* Active axSpA as assessed by total BASDAI ≥ 4 cm (0-10 cm) at baseline.
* Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline.
* Total back pain as measured by VAS (visual analog scale) ≥ 40 mm (0-100 mm) at baseline.
* Participants should have been on at least 2 different NSAIDs (non-steroidal anti-inflammatory drugs) at the highest recommended dose for at least 4 weeks in total prior to baseline with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications.

Exclusion Criteria:

* Participants with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 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 TNFα (tumor necrosis factor α) (unless participants discontinued the treatment with TNFα 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.

Where this trial is running

Brugge and 83 other locations

+34 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-radiographic Axial Spondyloarthritisnr-AxSpanon-radiographic axial SpondyloarthritisSecukinumabremissionwithdrawalinflammatory back painsacroiliitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.