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A study evaluating the efficacy and safety of secukinumab compared to a drug combination in patients with severe Takayasu arteritis.

Verified siteRegistered drugNo placebo
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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 individuals living with Takayasu Arteritis, a rare type of vasculitis, which is an inflammation of the blood vessels. The research aims to evaluate the effectiveness and safety of secukinumab compared to standard medical treatments in patients with severe forms of this condition. The study also considers the possibility of stopping the use of prednisone, a type of steroid medication, as part of achieving long-term health.

Participants may receive secukinumab or one of several other medications used as standard care, including infliximab, tocilizumab, or adalimumab. These treatments are administered through different methods, such as intravenous administration, which involves delivering medicine directly into a vein, or subcutaneous use, which is an injection into the fatty tissue just under the skin. During the study, health status is monitored to see if the disease enters a state of remission, meaning the symptoms and signs of the illness are significantly reduced or absent.

Over the course of the study, medical professionals will observe how patients respond to these different therapies over several months. Monitoring includes checking for changes in physical symptoms and using imaging tools such as magnetic resonance imaging or computed tomography to look at the blood vessels. The process tracks how well the medications work to control inflammation and whether patients can maintain their health without the continuous use of steroids.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment initiation

    After joining the study, one of several medications will be administered to treat takayasu arteritis, which is a condition involving inflammation of the large blood vessels.

    The test medication is secukinumab, which is given as a 300 mg injection under the skin.

    The comparator medications, which are standard treatments, may include infliximab administered through an intravenous line (a tube into a vein) at a dose of 5 mg/kg, tocilizumab administered via intravenous, subcutaneous, or intramuscular routes, or adalimumab given as a 40 mg injection under the skin.

  2. Step 2

    Monitoring and assessment

    During the first 6 months, disease activity is monitored to determine if remission—a state where the disease is inactive—is achieved while prednisone (a steroid medication) is discontinued.

    Remission is measured using a score based on symptoms like fever, weight loss, fatigue, joint pain, or changes in blood vessel signs such as pulse loss or new vascular lesions.

    Blood tests are used to check for inflammation markers, including erythrocyte sedimentation rate, C-reactive protein, and fibrinogen levels.

    imaging tests, such as ultrasound (Doppler), magnetic resonance angiography (MRA), computed tomography angiography (CTA), or positron emission tomography (PET), may be used to look for vessel wall thickening or new lesions.

  3. Step 3

    Long-term follow-up

    The study continues for up to 12 months to track the total amount of prednisone used and to monitor for any relapse or treatment failure.

    The frequency of adverse events (side effects) is recorded throughout this 12-month period.

    Physical health and vascular changes are assessed at the 3-month, 6-month, and 12-month marks.

Who can join the trial?

11 criteria

  • You must be 15 years of age or older and provide your written agreement to join the study.
  • You must be covered by the French national social security system, including those with AME (a specific medical assistance program in France).
  • You must use effective contraception (methods to prevent pregnancy) following the latest medical guidelines.
  • Women who can become pregnant must have a negative pregnancy test using blood or urine.
  • You must have a confirmed diagnosis of Takayasu Arteritis, which is a condition involving inflammation of the large blood vessels.
  • Your disease must be active, meaning you have had a score higher than 1 on the National Institutes of Health (NIH) scale (a tool used to measure how much disease activity is present) within the last 2 months.
  • Your disease must be classified as severe, meaning the condition either does not respond well to standard treatments, keeps coming back, or involves serious issues with your arteries (the tubes that carry blood through your body).
  • You must be able to take prednisone (a type of steroid medicine used to reduce inflammation) at a dose of 10 to 50 mg every day.
  • Your oral corticosteroid (steroid medicine taken by mouth) dose must have been the same for at least 2 weeks before starting the study medication.
  • You must not have any chronic active infections (long-lasting illnesses caused by germs).
  • If you have tested positive for tuberculosis (a serious bacterial infection that usually affects the lungs), you may only join if further medical tests prove the infection is not active.

Who cannot join the trial?

10 criteria

  • You are unable to follow the study rules or cannot provide informed consent, which is your formal agreement to participate after understanding all the details.
  • Your blood count, which measures the different types of cells in your blood, is abnormal. This includes having too few platelets (cells that help blood clot), neutropenia (a low level of certain white blood cells that fight infection), or haemoglobin (a protein in red blood cells that carries oxygen) levels below certain limits.
  • You are currently pregnant or breastfeeding.
  • You have a history of taking strong medicines that weaken your immune system (the body's defense against germs), or you have tested positive for HIV or Hepatitis B (a type of liver infection).
  • You have had an infection in the last 2 weeks that required intravenous antibiotics, which are medicines used to fight bacteria delivered directly into a vein.
  • You are allergic to or have a medical reason not to take Secukinumab, TNF inhibitors, tocilizumab, corticosteroids (steroid medicines), or medicines used to prevent tuberculosis (a serious bacterial infection).
  • You have received any live vaccines, which are versions of vaccines that use a weakened form of the germ, within the last 3 months.
  • You have had malignancy, which is another word for cancer, within the last 5 years, unless it was a specific type of skin cancer that has been properly treated.
  • You have severe renal impairment, meaning your kidneys (the organs that filter your blood) are not working well enough.
  • You have a history of significant liver disease or liver injury, shown by abnormal results in liver function tests, which are blood tests that measure specific proteins and substances like AST, ALT, alkaline phosphatase, or bilirubin produced by the liver.
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Investigated drugs

  • Secukinumab

    is the medication being tested in this study to see if it can help reduce symptoms and control the disease in patients with Takayasu arteritis.

  • Infliximab

    is a standard treatment used as a comparison to see how well the new medication works.

  • Tocilizumab

    is a standard treatment used as a comparison to evaluate the effectiveness of the test medication.

  • Adalimumab

    is a standard treatment used as a comparison to help determine if the new medication is more or less effective than current options.

What is already known about the treatment

  • Infliximab

    This medication is a specialized protein given directly into a vein through an intravenous infusion. It is widely used in medicine to treat various inflammatory diseases by targeting and blocking a specific protein in the body that triggers swelling and immune responses. By attaching itself to this protein, it prevents the immune system from attacking healthy tissues, helping to reduce inflammation. It belongs to a group of drugs known as tumor necrosis factor inhibitors.

  • Tocilizumab

    This medicine can be administered through an injection into a vein, under the skin, or into a muscle. It is a well-established treatment used for conditions where the immune system is overactive, such as certain types of arthritis. The drug works by blocking a specific signaling molecule that tells the body to produce inflammation. This medication is classified as an interleukin-6 receptor antagonist.

  • Secukinumab

    This medication is provided as a solution for injection under the skin using a pre-filled pen. It is currently being studied for its effectiveness in treating specific inflammatory conditions like Takayasu arteritis. The drug works at a molecular level by blocking a protein called interleukin-1A, which is a key messenger that causes inflammation in the body. It is categorized as an interleukin inhibitor.

  • Adalimumab

    This drug is administered via an injection under the skin. It is a commonly used treatment for several chronic inflammatory diseases to help manage symptoms and prevent tissue damage. It works by finding and neutralizing a specific protein that plays a major role in causing inflammation throughout the body. This medication is classified as a tumor necrosis factor inhibitor.

Investigated diseases

Takayasu arteritis - This condition involves inflammation of the walls of large arteries, particularly the aorta and its main branches. As the disease progresses, the inflammation can cause the artery walls to thicken, which may narrow the passage for blood flow. This narrowing can lead to reduced blood circulation to various parts of the body. In some cases, the inflammation can also weaken the artery walls, potentially leading to the formation of bulges called aneurysms. The disease can manifest through systemic symptoms like fever and fatigue, or through specific signs such as changes in blood pressure or pulse strength. Over time, it can result in visible changes to the structure of the blood vessels seen on medical imaging.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516215-24-00Protocol codeAPHP 240614Estimated enrolment52 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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