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 (NCT03827018) looked at a medicine called mavrilimumab for people with a condition called giant cell arteritis (GCA), which is an inflammation of blood vessels. A total of 70 people took part — 42 received mavrilimumab and 28 received a placebo (a dummy treatment with no active ingredient). The main thing the trial was measuring was how long it took for participants' symptoms to flare up again over a 26-week period. Participants also followed a steroid-tapering schedule during the study. The reported data shows that for the primary measure — time to flare — the mavrilimumab group did not reach a median time to flare during the 26 weeks (meaning fewer than half of that group had a flare by the end of the study period), while the placebo group reached a median of about 25 weeks before a flare occurred. For one of the secondary measures, the reported data shows that approximately 83% of people in the mavrilimumab group completed the 26 weeks without a flare, compared with approximately 50% in the placebo group. For two blood markers linked to inflammation — ESR and CRP — the mavrilimumab group took longer to show elevated readings than the placebo group, though the exact median times for CRP and for signs/symptoms in the mavrilimumab group were not reached within the study period and so were not reported as a specific number. The reported data also shows that the total cumulative dose of corticosteroids (a type of steroid medicine) taken over 26 weeks was approximately 2,074 mg in the mavrilimumab group and approximately 2,403 mg in the placebo group, though the reasons for this difference are not explained in the submitted data. 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 35264321) ↗
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 2 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) that is either newly diagnosed or has come back or not responded to previous treatment.
- Your blood tests show signs of inflammation — specifically, a high erythrocyte sedimentation rate (above 30 mm/hour) or elevated C-reactive protein (1 mg/dL or above).
- Your GCA symptoms are under control (in remission) by the time the study officially begins (Day 0).
- If you are a woman, you are either past menopause, have had a permanent sterilisation procedure (such as removal of the uterus, ovaries, or fallopian tubes, or tubal ligation), have a partner who has had a vasectomy, or — if you could become pregnant — you are not currently pregnant or breastfeeding and agree to use a highly effective form of contraception.
- If you are a man and are sexually active with a partner who could become pregnant, you have had a vasectomy or agree to use a highly effective form of contraception.
Who may not be able to join:
- You have received a transplanted organ (except a corneal transplant carried out more than 3 months before joining the study).
- You are currently taking part in another clinical trial that involves a treatment intervention.
- You have taken a non-biological experimental drug within roughly the past 4 weeks or longer, depending on the specific drug (confirm with trial site).
- You have received certain immune-system-targeting biological therapies within the past 8 weeks to 12 months, depending on the type of therapy (confirm with trial site).
- You have been treated with a strong type of chemotherapy drug called an alkylating agent within the past 12 weeks.
- You have received steroid injections (into a muscle, joint, or vein) within the past 4 weeks.
- You have received a live or live-attenuated vaccine (such as shingles or yellow fever vaccine) within 4 weeks before the study start date.
- You have taken certain immune-suppressing medications — including hydroxychloroquine, cyclosporine A, azathioprine, cyclophosphamide, or mycophenolate mofetil — within the past 4 weeks.
- You are pregnant, planning to become pregnant, or are currently breastfeeding.
- You have a known allergy or bad reaction to the study drug (mavrilimumab), the placebo, any other biological therapy, or prednisone or its ingredients.
- You have tested positive (or had two unclear results) on a QuantiFERON test, which screens for tuberculosis (TB).
- You have had a significant active infection, an infection that required a hospital stay or intravenous antibiotics in the past 12 weeks, or a serious opportunistic infection within the past 6 months.
- You have a chronic active hepatitis B infection.
- You are considered at high risk of infection, or you have an infected joint replacement still in your body, leg ulcers, a permanent urinary catheter, or ongoing or repeated chest infections.
- You have had a cancer diagnosis in the last 10 years — except for certain treated and cured skin cancers or early-stage cervical cancer.
- You have a respiratory (lung or breathing) condition that is not well controlled.
- You have a history of ongoing or repeated respiratory tract infections.
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: John Paolini, M.D., Kiniksa Pharmaceuticals, Ltd.
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
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Time to Flare by Week 26
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.