AuthorisedTherapeutic exploratory (Phase II)Interventional

STARS - Prospective, bayesian, randomized, controlled, open-label, parallel-group, phase II interventional study evaluating efficacy and safety of secukinumab versus standard of care in active severe Takayasu patients

The STARS study is a clinical trial investigating a new treatment for Takayasu arteritis, a rare condition where blood vessels become inflamed. This study, known as STARS, aims to find out if a medicine called secukinumab (also known as Cosentyx) is more effective and safer than currently used treatments for people with severe Takayasu arteritis. Researchers will compare secukinumab to other common medicines like infliximab, adalimumab, and tocilizumab. The main goal is to see if secukinumab can help patients achieve remission, meaning their disease symptoms are well-controlled and they can stop taking steroids like prednisone, within six months. They will also be looking at how well patients stay in remission and if there are any side effects over a year.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

26 Feb 2026

TAkayasu ARteritiS

What is this study about?

This research study, called STARS, is exploring new ways to treat Takayasu arteritis. This is a rare condition that causes inflammation in your body's largest blood vessels, which can lead to various health problems. At the moment, doctors treat Takayasu arteritis with different medicines that help reduce inflammation. However, these treatments don't always work for everyone, or they might have side effects.

In this study, doctors want to see if a specific new medicine, called secukinumab (you might know it as Cosentyx), can be a better option. It works by targeting a specific part of your immune system that causes inflammation. The study will compare secukinumab to some of the treatments your doctor might normally prescribe, such as infliximab, adalimumab, and tocilizumab. It's an important step to find more effective and safer ways to manage this condition.

The main goal is to see if secukinumab helps patients get their disease under control, which doctors call 'remission.' This means that the signs of active inflammation are greatly reduced. Specifically, they're hoping that people taking secukinumab will reach remission within six months and be able to stop taking prednisone, a steroid medicine often used for inflammation. They'll closely watch for changes in symptoms, blood tests, and scans to understand how well the different treatments are working and if they are safe.

Key takeaways

The STARS study is testing a new medicine (secukinumab/Cosentyx) for severe Takayasu arteritis.
It compares the new medicine to standard treatments like infliximab, adalimumab, and tocilizumab.
The main goal is to see if patients achieve remission and can stop taking prednisone within six months.
Detailed patient monitoring, including blood tests and scans, will be carried out over 12 months.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults who have severe Takayasu arteritis and are currently experiencing active symptoms. This means you would need to be 18 years old or older to take part.

To be considered for the study, your doctor would check specific signs of active disease. This includes things like ongoing fever, weight loss, or tiredness that can't be explained by other conditions. They would also look for new problems with your blood vessels, such as new pains, changes in your pulse, or differences in blood pressure between your arms.

Your blood test results, like levels of C-reactive protein (CRP), and scans of your blood vessels would also be checked to confirm that your disease is active enough to be included in the study. The medical team will review all these details carefully to ensure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I 18 years old or older?
Have I been diagnosed with Takayasu arteritis?
Do I have ongoing, active symptoms of the disease, like unexplained fever, tiredness, or new pains?
Are my blood tests showing signs of inflammation?
Have recent scans shown changes in my blood vessels related to my condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the STARS study, you’ll be given either secukinumab or one of the standard treatments for Takayasu arteritis. You won't know which one you are receiving. The study involves regular visits to the clinic over a period of 12 months. During these visits, the medical team will monitor your health closely.

This will include thorough check-ups, blood tests to measure inflammation, and scans of your blood vessels. They will also ask you about any symptoms you're having and how you're feeling. The aim is to see how your condition responds to the treatment and to keep a close eye on any potential side effects. The total duration of active treatment and follow-up for the main goals of the study will be for 12 months.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as receiving close medical monitoring and access to a newer treatment that might be more effective for your Takayasu arteritis. However, like all medicines, the treatments in this study can have side effects, and there's no guarantee that the new medicine will work for you. The research team will explain all known potential risks in detail before you decide to join. Remember, taking part is completely your choice, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is Takayasu arteritis?

It's a rare condition that causes inflammation in the large blood vessels, particularly the aorta and its branches, which can lead to narrowing or blockages.

What is secukinumab (Cosentyx)?

It's a medicine that targets a specific protein involved in inflammation, aiming to reduce the activity of the immune system in conditions like Takayasu arteritis.

What does 'remission' mean in this study?

Remission means your Takayasu arteritis symptoms are under control, and the signs of active inflammation are significantly reduced, possibly allowing you to stop taking steroids.

Will I know which treatment I'm getting?

No, this is a 'blinded' study, meaning neither you nor your doctor will know if you're receiving secukinumab or one of the standard treatments, to ensure fair results.

How long does the study last?

The main part of the study where your treatment and health are closely monitored will last for 12 months.