A randomized, parallel-group, double-blind, placebo-controlled, multicenter trial to investigate the efficacy and safety of subcutaneously administered secukinumab in patients with new-onset of giant cell arteritis (GCA) who are in clinical remission and eligible for treatment with glucocorticoidmonotherapy (GigAINt)
This study, called GigAINt, is looking at a new medicine called Cosentyx (also known as secukinumab) for adults with Giant Cell Arteritis (GCA). GCA is a condition that causes inflammation in blood vessels. The study is for people who have recently been diagnosed with GCA, are feeling better, and are currently taking steroid medicines. We want to find out if Cosentyx can help prevent GCA symptoms from returning and if it can help people reduce their steroid dose over time. We will compare Cosentyx to a 'dummy' medicine (placebo) to see if it's both effective and safe. This is a Phase III study, meaning it's a key step to see if the medicine can become widely available.
At a glance
What is this study about?
Giant Cell Arteritis (GCA) is a condition where the blood vessels, especially in the head and neck, become inflamed. This can cause headaches, changes in vision, and jaw pain. While steroid medicines often help people feel better, they can have side effects when taken for a long time. This study is for people with new GCA who are already feeling well with their current steroid treatment.
The main goal of this study is to see if a new medicine, Cosentyx, can help prevent GCA symptoms from coming back. We're also interested in whether participants who take Cosentyx can safely reduce their need for steroid medicines over time. By reducing steroids, we hope to lessen the side effects people might experience from long-term use. The study will compare Cosentyx to a 'dummy' treatment (placebo) to get a clear idea of how well it works and if it's safe.
This is a 'Phase III' study, which means it's one of the final stages of testing a new medicine before it might be approved for wider use. It's really important for understanding if Cosentyx could offer a new and better way to manage GCA, helping people stay well and potentially avoid some of the challenges of long-term steroid use.
Key takeaways
- This study evaluates Cosentyx for new GCA patients in remission.
- The goal is to prevent GCA flare-ups and reduce steroid dependence.
- It's a comparison between Cosentyx and a 'dummy' treatment (placebo).
- Participation involves regular clinic visits and health checks over a year.
- Both men and women, aged 18 and over, with recent GCA diagnosis can take part.
Who may be eligible?
This study is for adults aged 18 years and older. Both men and women can take part.
To be considered for the study, you must have been recently diagnosed with Giant Cell Arteritis (GCA). Importantly, you need to be in a period where your GCA symptoms are under control and you're feeling well thanks to your current steroid medication.
The research team will have specific medical criteria to ensure the study is safe and suitable for you. They will check your medical history and current health to confirm if you meet all the requirements.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been recently diagnosed with Giant Cell Arteritis (GCA)?
- Are your GCA symptoms currently under control?
- Are you currently receiving steroid treatment for your GCA?
What does participation involve?
If you decide to take part in this study, you will either receive the new medicine, Cosentyx, or a placebo (a dummy medicine that looks like Cosentyx but contains no active drug). You will not know which treatment you are receiving, and neither will your study doctor – this is called 'double-blind'. Both treatments are given as an injection under the skin using a pre-filled syringe.
Over the course of the study, you will have regular visits to the clinic. At these visits, the study team will monitor your GCA symptoms, check your overall health, and keep track of your steroid dosage. They will ask you about your pain levels and your general well-being. We will also perform routine safety checks, including blood tests, to make sure the treatment is safe for you. The study aims to follow participants for a period of 52 weeks (about a year) to see the long-term effects of the treatment.
Potential risks and benefits
Locations (1)
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Common questions
What is Giant Cell Arteritis (GCA)?
GCA is a condition that causes swelling and inflammation in the blood vessels, often in the head and neck, leading to symptoms like headaches and vision problems.
What is Cosentyx?
Cosentyx is a medicine being tested in this study to see if it can help prevent GCA symptoms from returning and allow people to reduce their steroid use.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks like the real treatment but does not contain any active drug. It helps researchers compare the effects of the actual medicine.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know which treatment you are receiving. This is called 'double-blind' and helps ensure the study results are fair and unbiased.
How is the study medicine given?
The study medicine (Cosentyx or placebo) is given as an injection under the skin, using a pre-filled syringe.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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