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 (NCT03600805) enrolled 83 people with giant cell arteritis — a condition involving inflammation of blood vessels, particularly in the head. Participants were divided into four groups: two groups received a placebo (inactive) injection alongside a steroid (prednisone) that was gradually reduced over either 52 weeks or 26 weeks, and two groups received the medicine sarilumab (at different doses — 150 mg or 200 mg, given every two weeks) alongside the 26-week steroid taper. The trial was primarily measuring how many people in each group achieved "sustained remission" — meaning their symptoms had settled, a blood marker of inflammation (C-reactive protein, or CRP) had returned to a normal level, and they had stayed that way without a flare-up or needing extra steroids — by Week 24 and Week 52. The reported data shows that, for the primary goal of sustained remission by Week 52, 30% of participants in the placebo with 52-week taper group, 0% in the placebo with 26-week taper group, 42.9% in the sarilumab 150 mg group, and 46.2% in the sarilumab 200 mg group met that measure. For sustained remission by Week 24, the reported figures were 39.3%, 7.1%, 42.9%, and 48.1% respectively. For the secondary measures, the reported data shows that by Week 12, the number of participants recorded as having achieved remission (in the full study population) was 16 out of 28 in the placebo/52-week taper group, 6 out of 14 in the placebo/26-week taper group, 9 out of 14 in the sarilumab 150 mg group, and 15 out of 27 in the sarilumab 200 mg group. The numbers of participants who did not experience a disease flare between Week 12 and Week 24 were also reported as 21, 7, 10, and 15 across the four groups respectively. It is worth noting that the groups were quite small, which limits how much can be read into these numbers. The reported data also shows that a notable proportion of participants in each group did not complete the full study. 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 37840134) ↗
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, Terminated
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) according to recognised medical classification standards
- Your GCA is either newly diagnosed or has not responded well to previous treatment
- You have had at least one symptom of GCA within the past 6 weeks before the study start date
- A specific blood test measuring inflammation (either ESR or CRP) showed elevated levels within 6 weeks of the study start date
- You are currently taking, or are able to take, a steroid called prednisone at a dose of 20–60 mg per day to treat active GCA
Who may not be able to join:
- You have received an organ transplant (except a cornea transplant that took place more than 3 months ago)
- You had a serious event affecting blood flow to your organs (unrelated to GCA) within the past 12 weeks
- You have recently used certain specific medications to treat GCA, including some immune-suppressing drugs, within specific time periods before the study start (confirm with trial site for exact medications and timeframes)
- You previously tried a type of medication called an IL-6 or IL-6 receptor blocker and it did not work, caused side effects, or you were advised not to take it
- You have used strong chemotherapy-type medications (such as cyclophosphamide) within the past 6 months
- You have used certain immune-suppressing medications (such as hydroxychloroquine, cyclosporine, or azathioprine) within the past 4 weeks (note: stable, low-dose methotrexate may be acceptable — confirm with trial site)
- You are also taking long-term steroid tablets for a condition other than GCA
- You received a very high dose of steroid injections for GCA within the past 8 weeks
- You are pregnant or breastfeeding
- You have active tuberculosis (TB) or untreated latent (inactive) TB
- You have a history of serious, hard-to-treat infections
- You currently have a fever linked to an infection, or a long-lasting or recurring infection requiring treatment
- You have diabetes that is not well controlled
- You have skin ulcers that have not healed or are still healing
- You received a live vaccine (such as the shingles or yellow fever vaccine) within the past 3 months
- You have tested positive for hepatitis B, hepatitis C, or HIV
- You have a history of shingles (herpes zoster) that has come back or been active
- You have had an infection in a joint or a joint replacement
- You have a current or past history of cancer of any kind
- You have had surgery in the past 4 weeks, or you have surgery planned during the study period
- You have a history of inflammatory bowel disease, severe diverticulitis, or a previous tear or hole in your digestive tract
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: Clinical Sciences & Operations, Sanofi
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
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Who Achieved Sustained Disease Remission at Week 52; Percentage of Participants Who Achieved Sustained Disease Remission at Week 24
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.