Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03725202) enrolled 429 adults with giant cell arteritis (GCA) — an inflammatory condition affecting blood vessels, particularly in the head. Participants were randomly divided into three groups: 112 received a placebo (dummy pill) alongside a 52-week course of corticosteroids (a type of steroid medicine used to reduce inflammation); 107 received a lower dose (7.5 mg) of a drug called upadacitinib alongside a shorter 26-week corticosteroid course; and 210 received a higher dose (15 mg) of upadacitinib alongside the same shorter corticosteroid course. The trial's main goal was to measure how many participants reached "sustained remission" — meaning no signs or symptoms of GCA from Week 12 through to Week 52, while sticking to their steroid-tapering schedule. The reported data shows that for the primary goal of sustained remission at Week 52, 29.0% of the placebo group reached this point, compared with 41.1% in the 7.5 mg upadacitinib group and 46.4% in the 15 mg upadacitinib group. For a stricter measure called "sustained complete remission" (which also required blood inflammation markers to return to normal), the reported figures were 16.1%, 26.2%, and 37.1% respectively. When looking at who was in complete remission specifically at Week 52, the reported percentages were 19.6% (placebo), 43.0% (7.5 mg), and 50.2% (15 mg). The reported data also shows that 55.6% of participants in the placebo group experienced at least one disease flare (a return of symptoms serious enough to need more steroids) during the 52 weeks, compared with 41.3% in the 7.5 mg group and 34.3% in the 15 mg group. The median time to a first flare in the placebo group was reported as 323 days; this figure was not reported for either upadacitinib group. The total amount of corticosteroids taken over 52 weeks was reported as approximately 2,882 mg in the placebo group, 1,905 mg in the 7.5 mg group, and 1,615 mg in the 15 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 40174237) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Vasculitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with giant cell arteritis (GCA), confirmed by blood tests showing high inflammation levels, plus symptoms of GCA or a related condition called polymyalgia rheumatica, AND confirmed by a biopsy or a scan (such as ultrasound, MRI, CT, or PET).
- Your GCA is currently active — either newly diagnosed or has come back — and this started within the last 8 weeks before the study begins.
- You have taken at least 40 mg of prednisone (or a similar steroid) at some point before the study starts, and are currently taking at least 20 mg of prednisone (or equivalent) daily.
- Your GCA is considered stable enough by your doctor to safely follow the study's planned steroid-reduction schedule.
- If you are female, you are either past menopause, have had a permanent surgical procedure to prevent pregnancy, or agree to use at least one approved method of birth control throughout the study.
Who may not be able to join:
- You have previously taken any medication belonging to a class of drugs called JAK inhibitors.
- You have taken an IL-6 inhibitor (a type of immune-suppressing drug) within the last 4 weeks before the study starts, or you have taken one in the past but your GCA got worse while you were on it.
- You have recently used certain immune-suppressing medications, including: anakinra (within 1 week), methotrexate, hydroxychloroquine, cyclosporine, azathioprine, or mycophenolate (within 4 weeks), steroids taken by mouth for reasons other than GCA or steroids given by injection/IV (within 4 weeks), leflunomide within 8 weeks (unless a specific clearing process was followed), or strong immune-suppressing drugs like cyclophosphamide within the last 6 months.
- You have a current or past history of certain infections, including herpes zoster (shingles), herpes simplex, HIV, active tuberculosis, ongoing or recurring serious infections, or active hepatitis B or C.
- You are female and are currently pregnant, breastfeeding, or planning to become pregnant during the study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: ABBVIE INC., AbbVie
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Achieving Sustained Remission at Week 52
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.