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 enrolled 161 people across five treatment groups in its first phase (Part A, lasting 52 weeks). Participants were testing a medicine called sirukumab (SIR) — given by injection under the skin at different doses and schedules — compared to a placebo (dummy injection), with all groups also taking a steroid called prednisone for varying lengths of time. The trial was studying giant cell arteritis (GCA), an inflammatory condition affecting blood vessels. The main thing being measured was how many people reached and stayed in "sustained remission" — meaning their symptoms had cleared, their blood markers of inflammation had returned to normal, they had completed their prednisone course, and had not needed any extra treatment — all the way to week 52. Participants who achieved that sustained remission could then continue into a second phase (Part B, lasting a further 104 weeks). The reported data shows that very small numbers of participants reached the primary goal of sustained remission at week 52. In the group receiving sirukumab 100 mg every two weeks combined with six months of prednisone, 3 out of 42 participants met this definition. In the sirukumab 100 mg every two weeks with three months of prednisone group, 2 out of 39 did so. In the sirukumab 50 mg every four weeks with six months of prednisone group, 1 out of 26 did. In both placebo groups — one with six months of prednisone (27 participants) and one with 12 months of prednisone (27 participants) — zero participants met the sustained remission definition. For the secondary outcomes, the reported data for time to first disease flare was listed as "not available" across all groups in both parts of the trial, and Part B results were largely not reported due to the very small numbers who progressed to that phase. 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 32844378) ↗
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 are 50 years of age or older
- You have been diagnosed with Giant Cell Arteritis (GCA), confirmed by specific blood test results showing signs of inflammation (confirm with trial site for exact values)
- You have had at least one key symptom of GCA, such as head or scalp pain, jaw pain, or shoulder/hip aching and stiffness (symptoms of a related condition called polymyalgia rheumatica)
- Your diagnosis was confirmed by either a biopsy of the artery near your temple, or by a scan or imaging test showing inflammation in large blood vessels
- Your GCA is currently active (causing symptoms and raised inflammation levels in blood tests) within 6 weeks of starting the trial
- You are currently taking, or able to take, prednisone (a steroid) at a dose of 20–60 mg per day for GCA
- Your doctor believes your condition is stable enough for you to safely follow a gradual steroid dose-reduction plan during the trial
- If you are a woman who could become pregnant, you are using an acceptable form of contraception
- You have been tested and do not have active or hidden tuberculosis (TB)
Who may not be able to join:
- You are currently pregnant or breastfeeding
- You have had major surgery in the past 12 weeks, or have major surgery planned that could affect your participation in the trial
- You have received an organ transplant (except a cornea transplant more than 3 months ago)
- You have recently used certain medications that affect the immune system, including some biologics, chemotherapy drugs, or specific treatments like tocilizumab, rituximab, methotrexate, or abatacept — the time restrictions vary by medication (confirm with trial site for details)
- You have received high-dose intravenous steroids (methylprednisolone above 100 mg/day) within the past 8 weeks
- You have a history of serious allergic reactions to antibody-based medicines or similar treatments
- You have another serious illness that your doctor believes would make trial participation unsafe
- You have had a major event such as a heart attack or stroke (unrelated to GCA) within the past 12 weeks
- You have a heart condition involving abnormal heart rhythm, including a specific electrical abnormality on a heart tracing (ECG), a personal or family history of certain inherited heart rhythm problems, or a history of second or third degree heart block (confirm with trial site)
- You currently have significant liver disease that could interfere with the trial
- You have a history of, or currently have, bowel conditions such as diverticulitis, inflammatory bowel disease, or other gut problems that could increase the risk of a bowel perforation
- You have a history of, or currently have, a nerve or brain condition such as multiple sclerosis or optic neuritis (inflammation of the optic nerve)
- You currently have an active infection, a history of frequent infections, or have been hospitalised for an infection in the past 60 days, or have recently used antibiotic or antifungal medicines
- You have a condition that weakens your immune system, or another autoimmune disease
- You have HIV, hepatitis B, or hepatitis C
- You have received a live vaccine (virus or bacterial) within the past 3 months
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: GSK Clinical Trials, GlaxoSmithKline
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
Part A: Number of Participants in 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.