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Study of secukinumab and prednisone combination therapy for patients with giant cell arteritis (GCA): Evaluation of treatment effectiveness and safety

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What is this trial about?

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

This study focuses on patients with Giant Cell Arteritis (GCA), a condition that causes inflammation of blood vessels, typically affecting people over 50 years of age. The study tests two medications: secukinumab, which is given as an injection under the skin, and prednisone, which is taken as tablets by mouth. The purpose is to determine if secukinumab combined with a shorter prednisone treatment course works better than using a longer prednisone treatment with placebo in treating GCA.

During the study, participants will receive either secukinumab injections (150 mg or 300 mg) or placebo injections under the skin. All participants will also take prednisone tablets, but the duration of prednisone treatment will vary between groups. One group will take prednisone for 26 weeks while another will take it for 52 weeks. The total study duration is planned for approximately 52 weeks.

Throughout the study, doctors will monitor participants to see if their GCA symptoms improve and stay under control. They will also track how much prednisone each participant needs and watch for any side effects from the treatments. The study will measure various aspects of participants' health, including their energy levels, overall well-being, and any treatment-related health issues.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive either secukinumab (150mg or 300mg) or a placebo through an injection under the skin (subcutaneous injection)

    You will also receive prednisone (a steroid medication) taken by mouth, starting at a dose between 20-60mg daily

    The initial phase begins after completing all required medical tests and examinations

  2. Step 2

    Treatment continuation

    The treatment continues for 52 weeks (one year)

    If you receive secukinumab, your prednisone dose will be gradually reduced over 26 weeks

    If you receive placebo, your prednisone dose will be gradually reduced over 52 weeks

    Regular blood tests will monitor your ESR (a blood test measuring inflammation) and CRP (a protein indicating inflammation levels)

  3. Step 3

    Monitoring and assessments

    Your health status will be regularly evaluated throughout the study

    Physical examinations and laboratory tests will be performed to monitor your condition

    You will complete questionnaires about your fatigue levels and quality of life

    Any side effects or health changes will be recorded and monitored

  4. Step 4

    Final evaluation

    At week 52, final assessments will be conducted to evaluate the treatment's effectiveness

    The total amount of prednisone taken during the study will be calculated

    Your overall health status, including any side effects from the medications, will be evaluated

    The study team will assess whether your giant cell arteritis (GCA) is in remission (reduced or absent symptoms)

Who can join the trial?

12 criteria

  • Must sign an informed consent before participating in the study
  • Must be able to communicate with the study doctor and follow study requirements
  • Must be at least 50 years old (men and non-pregnant, non-breastfeeding women)
  • Must have a diagnosis of Giant cell arteritis (GCA) with:
    • Disease starting at age 50 or older
    • Clear symptoms like new headaches, tender scalp, vision problems, jaw pain while chewing, or shoulder/hip pain with morning stiffness
    • Positive biopsy or imaging tests (ultrasound, MRI, CT, or PET-CT) showing blood vessel inflammation
    • Must have active disease within 6 weeks before study start, shown by:
      • Active symptoms of GCA
      • High levels of inflammation in blood tests (ESR ≥ 30 mm/hr or CRP ≥ 10 mg/L)
      • Must have either:
        • Newly diagnosed GCA (within 6 weeks before study start)
        • Relapsing GCA (diagnosed more than 6 weeks ago with symptoms returning after initial treatment)
        • Must be able to safely take prednisone (a steroid medication) at doses between 20-60 mg daily
        • If taking methotrexate (MTX), must be on a stable dose (up to 25 mg/week) for at least 4 weeks before study start and taking folic acid

Who cannot join the trial?

15 criteria

  • Active or chronic infection, including tuberculosis, HIV, or hepatitis B/C
  • History of cancer within the past 5 years (except for successfully treated skin cancers)
  • Pregnant women or women planning pregnancy during the study period
  • Breastfeeding mothers
  • Severe heart conditions or uncontrolled high blood pressure
  • History of severe allergic reactions to medications
  • Current treatment with other biological medications
  • Severe kidney or liver problems
  • Mental health conditions that could interfere with study participation
  • Use of live vaccines within 6 weeks before starting the study
  • Previous participation in this specific clinical trial
  • Alcohol or drug abuse within the past 6 months
  • Any condition that, in the investigator's opinion, makes the patient unsuitable for the study
  • Unable to follow study procedures or attend scheduled visits
  • Treatment with other investigational drugs within 30 days before starting the study
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Investigated drugs

  • Secukinumab

    is a medication that works by targeting and blocking a protein in the body that causes inflammation. It is given as an injection under the skin (subcutaneously) and is used to treat giant cell arteritis, which is a condition that causes inflammation in blood vessels. This medication helps reduce inflammation and manage symptoms of the disease.

  • Glucocorticoids

    are a type of steroid medications that help reduce inflammation throughout the body. In this trial, they are used in a gradually decreasing dose (called a taper regimen) alongside the main treatment. Glucocorticoids are commonly used to treat inflammatory conditions and help control symptoms while other treatments begin to work.

What is already known about the treatment

  • Secukinumab

    A human monoclonal antibody administered through subcutaneous injection that works by targeting and blocking interleukin-17A, a protein involved in inflammation. This medication is currently being investigated in clinical trials for the treatment of Giant Cell Arteritis (GCA), a serious inflammatory blood vessel disease, in combination with glucocorticoid therapy. Secukinumab belongs to the class of biological disease-modifying antirheumatic drugs (bDMARDs) and is already approved for treating several autoimmune conditions, with its potential new application in GCA aimed at maintaining disease remission while reducing the need for long-term steroid use.

  • Glucocorticoids

    A class of steroid medications that are used as a standard treatment for Giant Cell Arteritis, administered orally in a tapering dose schedule. These medications work by suppressing the immune system and reducing inflammation throughout the body, helping to control symptoms and prevent complications of GCA. Glucocorticoids are powerful anti-inflammatory drugs that act by binding to specific receptors in cells, influencing the production of various inflammatory mediators and immune system responses.

Investigated diseases

Giant cell arteritis - A chronic inflammatory condition that affects large and medium-sized blood vessels, particularly those in the head, neck, and arms. The disease causes inflammation of the arteries' lining, which leads to swelling and thickening of arterial walls. This condition typically develops gradually and commonly affects the temporal arteries running along the temples. The inflammation can cause symptoms such as persistent headaches, scalp tenderness, jaw pain during chewing, and general fatigue. Giant cell arteritis most frequently occurs in adults over 50 years of age, with women being affected more commonly than men.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510744-31-00Protocol codeCAIN457R12301Estimated enrolment406 patientsSponsorNovartis Pharma AG

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