AuthorisedTherapeutic exploratory (Phase II)Interventional

BOSICART - Bosentan in the treatment of Giant Cell Arteritis

The BOSICART study is testing a new medicine called Bosentan for people with Giant Cell Arteritis, a condition that causes inflammation in blood vessels. The main goal is to see if Bosentan can help patients avoid their condition flaring up again (a relapse) and allow them to reduce their steroid medication (like Prednisone or Prednisolone) more easily. Steroids are a common treatment but can have side effects. Doctors want to find out if Bosentan, when added to current treatments, can improve patients' quality of life, prevent further problems like new blockages, and reduce the long-term need for high doses of steroids. This is an early stage study, looking for promising results.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

11 Aug 2025

Newly diagnosed or relapsing Giant-cell arteritis

What is this study about?

Giant Cell Arteritis (often shortened to GCA) is a condition where the medium to large arteries, usually in your head and neck, become inflamed. This can cause headaches, scalp tenderness, jaw pain, and even lead to serious problems like blindness or stroke if not treated quickly. The usual treatment involves strong steroid medications, often Prednisone or Prednisolone, which work well to control the inflammation.

However, taking steroids for a long time or at high doses can have many side effects, such as weight gain, bone thinning, and mood changes. Because of this, doctors are always looking for ways to reduce the amount of steroids a person needs to take while still keeping their GCA under control. This study, called BOSICART, is investigating whether a new medication, Bosentan, can help achieve this. Bosentan works differently from steroids and researchers hope it could allow patients to take less steroid medication over time.

The main aim of the study is to see if patients taking Bosentan, alongside their usual treatment, can stay free from flares of their GCA and reduce their steroid dose more successfully over a year, compared to those not taking Bosentan. The study will also look at how Bosentan affects the risk of new problems and how it influences patients' quality of life. This is an important step in finding better ways to manage GCA and improve the lives of those affected.

Key takeaways

Exploring if Bosentan can help manage Giant Cell Arteritis.
Aims to reduce the need for high doses of steroid medication.
Could improve quality of life for people with GCA.
An early study to see if the treatment shows promise.
Participation involves regular check-ups over about a year.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. You might be able to take part if you have recently been diagnosed with Giant Cell Arteritis or if your Giant Cell Arteritis has come back after being stable for a while.

The medical team will carefully check your health and medical history to make sure the study is safe and right for you. There might be some specific health details or other medications you're taking that would mean you can't join, but the doctors will discuss all of this with you.

If you are interested, your doctor can provide more detailed information and help you understand if you meet the specific requirements for this research.

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.

Are you 18 years old or older?
Have you recently been diagnosed with Giant Cell Arteritis?
Has your Giant Cell Arteritis recently come back (relapsed)?
Are you comfortable attending regular clinic visits for about a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new medicine (Bosentan) or a placebo (a dummy pill with no active medicine), alongside your standard Prednisone or Prednisolone treatment. The doctors will try to gradually reduce your steroid dose over time, following a specific plan.

You would have regular visits to the hospital or clinic over a period of about one year. During these visits, the medical team would check your health, conduct blood tests, and ask you questions about how you are feeling and any symptoms you might have. You would also fill out questionnaires about your quality of life at certain times during the study. After the first year, they might continue to check on your health for a second year.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn’t widely available, which could potentially help manage your Giant Cell Arteritis more effectively and perhaps reduce your need for steroids. However, as with any medication, there’s a possibility of side effects from Bosentan, some of which might not be fully known yet. The medical team will closely monitor you for any problems and explain any risks they are aware of before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your 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 Giant Cell Arteritis?

It's a condition where blood vessels, usually in the head and neck, become inflamed.

What is Bosentan?

It's a medication being tested to see if it can help treat GCA and reduce steroid use.

What does a 'relapse' mean in this study?

It means your GCA symptoms have returned or worsened, despite treatment.

Will I still get my usual steroid treatment?

Yes, you will receive either Bosentan or a placebo alongside your standard Prednisone/Prednisolone.

How long will the study last for me?

You will be actively involved for about one year, with some follow-up checks possibly extending to two years.