A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with giant cell arteritis (GCA) (GCAptAIN)
This research study, called GCAptAIN, is looking into a new treatment for giant cell arteritis (GCA). It's a condition where blood vessels become inflamed. The study is testing a medicine called secukinumab at two different doses (150mg and 300mg). Some participants will receive secukinumab, while others will get a placebo (a dummy medicine with no active ingredients). Everyone in the study will also be on a reducing dose of steroids (prednisone). We want to find out if secukinumab is safe and effective at helping people with GCA stay in remission (meaning their symptoms are under control) for a full year, and if it can help them reduce their steroid use.
At a glance
What is this study about?
Giant cell arteritis (GCA) is a condition that causes inflammation in your blood vessels, usually in your head and neck. This can lead to headaches, jaw pain, vision problems, and other serious issues.
Currently, steroids like prednisone are the main treatment for GCA. While they effectively control the inflammation, long-term use can have many side effects. This study is exploring a new medicine called secukinumab, which works in a different way to reduce inflammation. The hope is that secukinumab could help people with GCA stay well and potentially reduce their reliance on steroids.
This study will compare secukinumab with a placebo (a dummy medicine) to understand its effects better. Importantly, all participants will also be taking steroids, but they will gradually reduce their dose over time, guided by their doctors. This approach is designed to see if secukinumab, when added to the usual steroid treatment, can help more people stay in remission and improve their quality of life. The study design ensures we can confidently assess if secukinumab is a helpful and safe addition to current GCA treatment.
Key takeaways
- This study is for adults with giant cell arteritis (GCA).
- It's testing a new medicine called secukinumab alongside steroid treatment.
- The goal is to see if secukinumab helps patients stay well and reduce steroid use.
- Some participants will receive secukinumab, others a placebo (dummy medicine).
- Participation involves regular clinic visits and close medical supervision for about one year.
Who may be eligible?
To join this study, you need to be at least 18 years old. Both men and women can take part. The study is specifically for people who have been diagnosed with giant cell arteritis (GCA).
There will be other specific medical requirements that your doctors will check. These are in place to make sure the study is safe for you and that the results are clear and accurate. For example, your doctors will need to make sure your GCA is active but stable enough for you to safely participate.
It's important to discuss your full medical history with the study team. They will be able to tell you if this study is a good fit for you, based on all the detailed criteria.
- Are you 18 years old or older?
- Have you been diagnosed with giant cell arteritis (GCA)?
- Are you able to attend regular appointments for one year?
- Are you willing to take study medication (injection) and a reducing dose of steroids?
- Have you discussed this study with your GCA specialist?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be randomly assigned to receive either secukinumab (at one of two doses) or a placebo (a dummy medicine). You won't know which one you're getting, and neither will your study doctor. Everyone will also be on a planned schedule to reduce their steroid medicine (prednisone) over time.
Throughout the study, you'll have regular visits to the clinic for check-ups, blood tests, and to receive your study medication, which will be given as an injection under the skin. Your health and symptoms will be closely monitored for 52 weeks (about one year) to see how you're responding. There will also be follow-up appointments after this main treatment period to ensure your continued well-being.
Potential risks and benefits
Locations (17)
- —Estonia
- —Sweden
- —Hungary
- —Finland
- —France
- —Norway
- —Greece
- —Czechia
- —Portugal
- —Italy
- —Poland
- —Belgium
+5 more sites — see the official record for the full list.
Common questions
What is giant cell arteritis (GCA)?
GCA is a condition where large blood vessels, often in your head, become inflamed. It can cause headaches, jaw pain, and vision problems.
What is secukinumab?
Secukinumab is a medicine that helps reduce inflammation in the body. This study is testing if it can help people with GCA.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real thing but contains no active ingredients. It helps researchers understand if the new drug is truly working.
How long will the study last?
The main treatment and monitoring period for this study is 52 weeks, which is about one year, with further follow-up after that.
Can I still take my regular steroid medicine?
Yes, everyone in this study will be taking a steroid medicine (prednisone) and will follow a plan to gradually reduce their dose.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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