AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Randomized, Double-Blind, Phase II Investigator Initiated Trial of Upadacitinib and Short Glucocorticoid Tapering in Giant Cell Arteritis

Giant cell arteritis (GCA) causes inflammation in blood vessels, particularly around the head and neck. This can lead to severe headaches, jaw pain, and vision problems. Currently, strong steroid tablets like prednisolone are the main treatment. While steroids work well, taking them for a long time often causes unpleasant side effects. This clinical trial is testing a newer medicine called upadacitinib alongside steroids. Researchers want to find out if upadacitinib allows patients to lower their steroid dose more quickly while keeping the illness in remission (under control). Participants take study tablets and have regular check-ups over 52 to 78 weeks. Doctors will track symptoms, use imaging scans to check vessel health, and watch for any flare-ups. The goal is to provide a safer, more effective long-term treatment option for adults living with GCA.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Enrolment target

Start

02 Oct 2026

Giant Cell Arteritis

What is this study about?

Giant cell arteritis, often called GCA, is an inflammatory condition that affects medium and large blood vessels, most commonly the arteries around the temples and neck. When these vessels swell, blood cannot flow as easily. This can trigger sudden, severe headaches, tenderness in the scalp, pain while chewing, and in serious cases, changes to your sight or even permanent vision loss.

The standard treatment for GCA is a course of steroid tablets, usually prednisolone. Steroids are very good at calming inflammation quickly, but staying on them for months or years can lead to unwanted health problems. These can include brittle bones, high blood sugar, weight gain, and a higher risk of picking up common infections. Because of this, doctors are eager to find treatments that help control GCA without relying on high doses of steroids for long periods.

This trial investigates whether adding a medicine called upadacitinib can help. Upadacitinib works by calming specific signals in your immune system that cause swelling. The researchers hope that patients taking upadacitinib can gradually lower their steroid dose much faster than usual, while still keeping their GCA safely under control and preventing painful flare-ups.

Key takeaways

Tests whether upadacitinib helps giant cell arteritis patients reduce steroid use safely.
Open to adults aged 18 and older diagnosed with giant cell arteritis.
Study lasts between 52 and 78 weeks and includes regular clinic visits and scans.
Aims to lower the risk of long-term steroid side effects while keeping symptoms away.
Participation is entirely voluntary, with close medical supervision throughout.

Who may be eligible?

This trial is open to adults aged 18 and older who have been diagnosed with giant cell arteritis. Both men and women can join.

Doctors will review your medical history and current symptoms to confirm whether you have active GCA that requires treatment. They will also check what medications you are taking, particularly whether you need or are already using steroid tablets like prednisolone.

To keep everyone safe, you may not be able to join if you have certain other serious health issues, such as active severe infections, or if taking upadacitinib is not considered safe for you. Your study doctor will carry out health checks to make sure the trial is suitable.

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.

I am aged 18 or older.
I have been diagnosed with giant cell arteritis (GCA).
I have symptoms such as temple headaches, jaw pain, or vision changes related to GCA.
I am currently taking, or need to start taking, steroid tablets (such as prednisolone).
I am able and willing to attend regular hospital check-ups and undergo scans for up to 18 months.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts between one and one and a half years (around 52 to 78 weeks). During this time, you will take daily tablets, which include the trial medicine upadacitinib and a planned, reducing dose of steroid tablets (prednisolone). Some participants may receive dummy tablets (placebos) at certain points to ensure the results are completely fair and unbiased.

You will need to attend regular clinic appointments so the medical team can closely monitor your health. These visits will involve physical examinations, blood tests, and discussions about how you are feeling. Doctors will also check the health of your blood vessels using non-invasive imaging, such as ultrasound scans, eye scans, and occasionally other body scans like MRI or PET scans. If you experience any symptom flare-ups, your care team will adjust your treatment promptly.

Potential risks and benefits

The main potential benefit of joining is that the trial medicine may help keep your GCA in check while allowing you to cut down on steroids more quickly. You will also receive very close, expert medical attention throughout the study. However, there are risks to consider. All medicines can cause side effects; upadacitinib can affect how your immune system fights off germs, potentially increasing your risk of minor or chest infections. You will also need to spend time attending clinic visits and scans. Taking part is completely voluntary, and you are free to leave the trial at any time without it affecting your normal NHS 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
Germany

Common questions

What is giant cell arteritis?

It is a condition where large blood vessels, especially those in the head, become inflamed. It causes symptoms like severe headaches, scalp pain, jaw stiffness, and vision problems.

Why do doctors want to reduce steroid use?

Steroids work very well to calm swelling quickly, but taking them over many months can cause side effects like weight gain, bone thinning, and raised blood sugar.

What is upadacitinib?

It is a tablet that calms inflammation by blocking specific proteins in your immune system that cause swelling in your blood vessels.

Do I have to pay to take part in this trial?

No, clinical trial medicines, tests, and extra clinic appointments are provided free of charge, and travel expenses are often reimbursed.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point. Deciding to withdraw will never affect your regular medical treatment or relationship with your healthcare team.