Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Efficacy of upadacitinib plus short prednisolone tapering in adults with Giant Cell Arteritis

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Giant Cell Arteritis, a condition that causes inflammation of large blood vessels, often leading to headaches, vision problems, and jaw pain. Participants will receive the oral medication upadacitinib together with a short course of the steroid prednisolone, which will be reduced quickly (tapered) to the lowest effective amount. Some participants will receive an inactive tablet, called a placebo, so that the researchers can compare results. The purpose of the study is to determine whether this combination can keep the disease inactive for a long time.

People who join will take the study pills each day for several months and will have regular clinic visits where doctors check symptoms, blood tests, and sometimes imaging scans such as MRI to see how the blood vessels are doing. The dose of the steroid will be lowered faster than the usual schedule, and participants will be monitored for any return of symptoms (called a flare) or side effects. The study will follow each participant for about a year to see if the disease stays under control and to evaluate overall health and any problems caused by the medicines.

The research process

The trial runs in 11 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    After joining the study you will sign an informed consent form and answer several questionnaires about your health and symptoms.

    You will have blood tests and imaging examinations to document the current state of your disease.

    The study team will give you the medication packs you will need for the trial and explain how to take each tablet.

  2. Step 2

    Start of medication

    You will begin taking two types of oral tablets every day.

    upadacitinib 15 mg: one tablet taken once daily, continued for the whole study period.

    prednisolone (a steroid) tablets: the dose will follow a tapering schedule that starts with 20 mg daily.

  3. Step 3

    Prednisolone 20 mg daily (weeks 1‑12)

    For the first twelve weeks you will take one prednisolone tablet containing 20 mg each day.

    Continue to take upadacitinib 15 mg daily at the same time.

  4. Step 4

    Clinic visit week 12

    You will attend a study visit where blood samples, symptom questionnaires and a physical examination are performed.

    The investigators will check whether you have achieved remission and will confirm the next step of the steroid taper.

  5. Step 5

    Prednisolone 10 mg daily (weeks 13‑26)

    Starting after week 12 you will reduce the prednisolone dose to one tablet of 10 mg each day.

    Upadacitinib 15 mg daily is continued without change.

  6. Step 6

    Clinic visit week 26

    Another study visit will be scheduled to repeat blood tests, imaging if required, and questionnaires.

    The study team will assess disease activity and decide whether to continue the taper.

  7. Step 7

    Prednisolone 5 mg daily (weeks 27‑52)

    From week 27 you will further reduce the steroid to one tablet of 5 mg each day.

    Upadacitinib 15 mg daily remains unchanged.

  8. Step 8

    Clinic visit week 52

    A comprehensive evaluation will be performed, including blood work, imaging, and patient‑reported outcome questionnaires.

    The cumulative dose of prednisolone taken so far will be recorded.

  9. Step 9

    Prednisolone 1 mg daily (weeks 53‑78)

    If you remain in remission, the steroid dose will be lowered to one tablet of 1 mg each day for the next twenty‑six weeks.

    Upadacitinib 15 mg daily continues throughout this period.

  10. Step 10

    Clinic visit week 78 (final visit)

    The last study visit will include final blood tests, imaging, and questionnaires to evaluate long‑term remission and any side effects.

    The study medication will be stopped after this visit.

  11. Step 11

    Reporting disease flares or side effects

    At any time during the trial you should inform the study team if you notice a worsening of symptoms, new pain, vision changes, or any side effect such as infection, stomach problems, or unusual fatigue.

    These reports can be made by phone or during scheduled visits.

Who can join the trial?

8 criteria

  • You are 50 years old or older.
  • You agree in writing to take part in the study.
  • You have been newly diagnosed with or have a flare of Giant Cell Arteritis that a specialist doctor confirmed using scans (imaging) or a small tissue sample (biopsy).
  • You have not been taking more than a low dose of prednisolone (a steroid medicine) for more than a week before the screening visit. During the short screening period, a higher dose may be allowed as directed by the doctor.
  • You show signs of active disease, such as blood tests that indicate inflammation (a CRP level of at least 10 mg/L or an ESR of at least 50 mm/hr) and at least one symptom like a new or worsening headache, jaw pain while chewing, tongue burning, vision problems, feeling unwell, or scan evidence of blood‑vessel inflammation.
  • Your doctor believes your condition is stable enough to safely begin the planned reduction (taper) of steroid medication.
  • You are willing and able to take the study drug (upadacitinib) together with prednisolone or a placebo for the entire treatment period.
  • If you are a woman who can become pregnant, you must use reliable contraception during the study and for four weeks after the last dose, unless you cannot have children.

Who cannot join the trial?

29 criteria

  • People who cannot legally make decisions or do not understand what the study involves.
  • People who have taken upadacitinib before.
  • People who have other active inflammatory joint diseases, such as rheumatoid arthritis, except for polymyalgia rheumatica that can occur together with the study disease.
  • People who are currently using any other disease‑modifying medicines (called DMARDs) or have used them within the last three months.
  • People who have had a blood clot in a vein (called venous thromboembolism) or any condition that greatly increases the risk of clotting, other than the study disease.
  • People who have medical reasons that make taking upadacitinib or prednisolone unsafe, as listed in the drug information.
  • People who have had two or more episodes of shingles (called herpes zoster) or one severe, widespread episode of shingles.
  • People who have had a severe, widespread infection with herpes simplex (the virus that can cause cold sores or eczema herpeticum).
  • People who are infected with HIV (human immunodeficiency virus), confirmed by a positive blood test.
  • People with active tuberculosis (TB) confirmed by a recent CT scan, or who have a positive TB blood test and have not started preventive TB treatment.
  • People who have an active infection that needed treatment with IV (through a vein) antibiotics in the past 30 days, or oral or intramuscular (injected into a muscle) antibiotics in the past 14 days.
  • People with ongoing chronic infections or active viral infections that the doctor thinks make them unsuitable for the study.
  • People who test positive for hepatitis B surface antigen (HBsAg) or have detectable hepatitis C virus (HCV) RNA, indicating active hepatitis B or C infection.
  • People who have had a stroke, heart attack, heart stent, heart bypass surgery, or a blood clot in a vein within the past six months.
  • People who have had an organ transplant that requires ongoing medicines to suppress the immune system.
  • People who are allergic or very sensitive to any part of the study drugs or similar medicines.
  • People with a history of serious stomach or intestinal perforation (a hole in the wall), diverticulitis, or who the doctor thinks are at high risk for such a perforation.
  • People with conditions that could prevent the study drug from being absorbed properly, such as short bowel syndrome or gastric bypass surgery (but not those with a gastric band).
  • People who have had any cancer, except for skin cancers that are not melanoma or an early‑stage cervical cancer that was treated successfully.
  • People who have taken strong medicines that affect the liver enzyme system called CYP3A (either strong inhibitors or strong inducers) within the last 30 days.
  • People who have received a live vaccine that can replicate (such as certain measles or chickenpox vaccines) within 30 days before the first dose of upadacitinib, or who are expected to need such a vaccine during the study.
  • People who are currently participating in another clinical trial, or who took an investigational drug in another trial within 30 days before the last dose of that trial’s medication.
  • People whose recent lab tests show any of the following abnormal values: liver enzymes (AST or ALT) more than twice the normal limit, very low kidney function (GFR less than 30 mL/min/1.73 m²), very low white blood cell count, low neutrophils, low platelets, low lymphocytes, low hemoglobin (less than 9 g/dL), or very high creatine kinase (more than twice normal).
  • People who have a known problem with abusing medication, drugs, or alcohol within the past year, or who the doctor believes may not be able to follow the study safely.
  • People who are allergic or intolerant to upadacitinib, prednisolone, or any ingredient in these medicines.
  • Women who are pregnant or are breastfeeding.
  • Women who could become pregnant and are not willing or able to use a highly effective birth‑control method from the start of the study until at least 30 days after the last dose.
  • People who have other serious medical problems, or any condition that the doctor thinks would put them at risk, interfere with the study, or make the use of a drug class called Janus kinase inhibitors unsafe.
  • People who need ongoing oral or injectable steroids (glucocorticoids) for conditions other than the study disease, unless the last steroid dose was more than two months before screening.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Prednisolone

    is a short‑acting steroid taken by mouth that reduces inflammation and helps control the immune system. In this study it is used as the standard treatment for giant cell arteritis, and the trial is testing a faster tapering schedule to see if patients can stay in remission while reducing the steroid dose more quickly.

  • Upadacitinib

    is an oral medication that blocks a specific pathway (JAK) involved in inflammation. The trial is evaluating whether adding this drug to the shortened prednisolone taper can improve the chances of staying in remission without needing long‑term high‑dose steroids.

What is already known about the treatment

  • Prednisolone

    Prednisolone is taken as an oral tablet that you swallow; it is a well‑known glucocorticoid used for many years to treat inflammation and immune‑related conditions such as giant cell arteritis. It works by entering cells and attaching to glucocorticoid receptors, which then reduces the production of inflammatory chemicals. The drug is classified as a glucocorticoid and is widely listed in medical literature as a standard treatment for inflammatory diseases.

  • Upadacitinib

    Upadacitinib is also taken by mouth in tablet form and is a newer medicine approved for several autoimmune diseases while being studied for giant cell arteritis. It blocks a protein called Janus kinase 1, which stops certain signals that cause inflammation. This results in a reduction of inflammatory activity in the body. Upadacitinib belongs to the drug class known as Janus kinase (JAK) inhibitors.

Investigated diseases

Giant Cell Arteritis - Giant Cell Arteritis is an inflammatory condition that primarily affects the large and medium-sized arteries, especially those in the head such as the temporal arteries. The disease begins with swelling and irritation of the vessel wall, which can cause headache, scalp tenderness, and jaw pain. Over time the inflammation can thicken the arterial wall, narrowing the lumen and reducing blood flow. The process may spread to other arteries, including the aorta and its branches, leading to more widespread involvement. Symptoms can wax and wane, with periods of increased activity (flares) followed by quieter phases.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523199-22-00Protocol codeMED3-202401Estimated enrolment70 patientsSponsorRheinische Friedrich-Wilhelms-Universitaet Bonn

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.