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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Groupe Hospitalier Du Sud Ile De France Melun France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre Hospitalier Blois Simone Veil Blois France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Cdupjn Hddrnimtxxn Uhqypdrxyevjh Ds Dyjps Dijon France
Anuwpuvysn Pfplcfxj Hwtaqdfi Dl Mtzccysxh Marseille France
Cjxgit Hpzprqsvfxs Ruhwvvyk Dczcrggwxmepci Angers France
Cfphxosa Smxlt Egvikns Toulouse France
Ivlpdthi dk Cteongyoqeet Hsivnuafwkr Umupikzwkxzfu dq Swxvd Eihzcoo (htncnuz Saint Priest En Jarez France
Hmvaehhd Uiifwinlsbbncm Snvipntqpk &nzvxzs Hjhdsjr dt Honpzcoicor STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
30.01.2026

Trial locations

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.

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 ID:
2024-516215-24-00
Protocol code:
APHP 240614
Trial Phase:
Therapeutic exploratory (Phase II)

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