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Study of Secukinumab for Maintaining Remission in Patients with Non-Radiographic Axial Spondyloarthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial investigates the treatment of non-radiographic axial spondyloarthritis, a condition that causes inflammation and pain in the spine and pelvis. The study involves the use of secukinumab, an injection that helps reduce inflammation by targeting specific proteins in the immune system. The study will also involve a group of participants receiving a placebo for comparison.

The purpose of this clinical trial is to find out if continuous treatment with secukinumab is better than a placebo at preventing flare-ups in people who have already seen improvement from the treatment. Participants who have reached a state of remission, meaning their symptoms have improved significantly, will either continue with secukinumab or switch to a placebo to see how well the improvements last over time.

Participants will be randomly assigned to either continue receiving secukinumab or switch to a placebo in a process called "double-blind," meaning neither the participants nor the researchers know who is receiving which treatment. This helps ensure that the study results are unbiased. The study aims to maintain the positive effects of the treatment and observe how many participants remain flare-free over the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    Participants receive secukinumab or a placebo through subcutaneous injection. The dosage is 150 mg per 1 mL solution, administered using a pre-filled syringe.

    The goal is to achieve remission of non-radiographic axial spondyloarthritis, a condition characterized by inflammation of the spine and sacroiliac joints.

  2. Step 2

    Evaluation of remission

    Participants are assessed to determine if they have achieved remission. Remission is defined by the absence of significant symptoms and inflammation.

    This evaluation is crucial to decide if participants can proceed to the next phase of the trial.

  3. Step 3

    Randomized withdrawal-retreatment period

    Participants who achieve remission enter a double-blind, placebo-controlled phase. This means neither the participants nor the researchers know who receives the active drug or placebo.

    The objective is to evaluate if continuous treatment with secukinumab is more effective than placebo in preventing symptom flares.

  4. Step 4

    Monitoring and assessment

    Participants are monitored for flares, which are episodes of increased disease activity. The primary endpoint is the proportion of participants who remain flare-free at Week 120.

    Secondary assessments include the time to flare and the safety and tolerability of the treatment, evaluated through adverse events and changes in laboratory parameters and vital signs.

  5. Step 5

    Completion of trial

    The trial is estimated to end by June 19, 2030. Participants' data will contribute to understanding the long-term effectiveness and safety of secukinumab in maintaining remission.

Who can join the trial?

10 criteria

  • Participants must be male or non-pregnant, non-lactating female and at least 18 years old.
  • Must have a clinical diagnosis of a condition called axSpA (axial spondyloarthritis) and meet specific criteria:
    • Have had inflammatory back pain for at least 6 months.
    • The pain must have started before the age of 45.
    • Must show signs of sacroiliitis (inflammation in the lower back) on an MRI scan or have a positive HLA-B-27 test with at least two features of SpA (spondyloarthritis).
    • Must show objective signs of inflammation at the start of the study, which can be seen through:
      • An MRI scan showing inflammation in the sacroiliac joint.
      • Or a blood test showing hsCRP (a marker of inflammation) higher than normal.
      • Must have active axSpA, which means a score of 4 or more on a scale called BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) at the start of the study.
      • Must have spinal pain with a score of 4 or more on a specific question in the BASDAI at the start of the study.
      • Must have total back pain with a score of 40 or more on a scale called VAS (Visual Analogue Scale) at the start of the study.
      • Must have tried at least two different NSAIDs (non-steroidal anti-inflammatory drugs) at the highest recommended dose for at least 4 weeks before the study, without adequate relief, or had to stop due to side effects or other reasons.

Who cannot join the trial?

7 criteria

  • Participants with radiographic evidence of sacroiliitis, which is inflammation in the joints where the lower spine and pelvis connect. Specifically, they cannot have a grade 2 or higher on both sides, or grade 3 or higher on one side as assessed by a central reader.
  • Participants taking high potency opioid analgesics, which are strong pain-relieving medications like methadone, hydromorphone, or morphine.
  • Participants who have previously been treated with secukinumab or any other biologic drugs that directly target IL-17 or its receptor. This also includes other biologic treatments that alter the immune system, especially those targeting TNFα (tumor necrosis factor alpha), unless they stopped for reasons other than not working effectively.
  • Participants with a history of hypersensitivity, which is a severe allergic reaction, to the study drug or its excipients (inactive ingredients) or to drugs from similar chemical classes.
  • Participants with active ongoing inflammatory diseases other than non-radiographic axial spondyloarthritis (nr-axSpA) that could interfere with evaluating the benefits of the study drug. This includes conditions like uveitis, which is inflammation in the eye.
  • Participants with active inflammatory bowel disease, which is a condition involving chronic inflammation of the digestive tract.
  • Participants with a history of ongoing, chronic or recurrent infectious diseases, or evidence of having tuberculosis infection, which is a serious infectious disease affecting the lungs and sometimes other parts of the body.
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Investigated drugs

Secukinumab is a medication used in this clinical trial to help manage symptoms in people with non-radiographic axial spondyloarthritis. It works by targeting specific proteins in the body that cause inflammation, helping to reduce pain and swelling. The trial aims to see if continuing treatment with secukinumab can prevent the return of symptoms in patients who have already achieved remission.

What is already known about the treatment

Secukinumab – Secukinumab is administered as an injection under the skin. It is currently being studied in clinical trials for its effectiveness in treating non-radiographic axial spondyloarthritis, a type of inflammatory arthritis. The medication works by blocking a protein in the body called interleukin-17A, which plays a role in inflammation. Secukinumab is classified as a biologic medication, specifically a monoclonal antibody, and is used to reduce inflammation and improve symptoms in patients with certain autoimmune conditions.

Investigated diseases

Non-radiographic axial spondyloarthritis – This is a type of inflammatory arthritis that primarily affects the spine and the joints connecting the spine to the pelvis. Unlike other forms of spondyloarthritis, it does not show visible damage on standard X-rays, which can make it harder to diagnose. The disease often begins with pain and stiffness in the lower back and buttocks, especially in the morning or after periods of inactivity. Over time, the inflammation can lead to reduced flexibility and mobility in the spine. Symptoms may also include fatigue and, in some cases, inflammation in other parts of the body, such as the eyes or intestines. The progression of the disease can vary greatly among individuals, with some experiencing mild symptoms and others facing more severe challenges.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509320-17-00Protocol codeCAIN457I2401Estimated enrolment347 patientsSponsorNovartis Pharma AG

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