A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients with Hyperuricemia
This research study is looking into a new treatment called Tigulixostat for people in the UK who have gout and high levels of uric acid in their blood. Gout is a type of arthritis that can cause sudden, severe attacks of pain, swelling, redness, and tenderness in your joints. High uric acid is often the cause of gout. The study aims to find out how well Tigulixostat works to lower uric acid compared to a commonly used gout medicine, Allopurinol, and a placebo (a dummy pill with no active medicine). It also checks if Tigulixostat is safe. Participants will be split into groups, receiving either Tigulixostat, Allopurinol, or a placebo, and sometimes other standard gout treatments like Colchicine or Naproxen will be used to manage gout flares.
At a glance
What is this study about?
This study is a Phase 3 clinical trial, which means it's one of the final steps in testing a new medicine before it can be made available to everyone. It's designed for people who have gout and also have high levels of uric acid in their blood. High uric acid is a key factor in causing gout, so lowering it is important for managing the condition.
The main goal is to see if the new medicine, Tigulixostat, can effectively lower uric acid levels in the blood and keep them low over several months. Specifically, it's looking to see if patients taking Tigulixostat can maintain their uric acid levels below a certain target for a sustained period. This is compared against a standard treatment, Allopurinol, and a placebo, which helps researchers understand the true effect of the new medicine.
Beyond simply lowering uric acid, the study also tracks other important aspects. Researchers will monitor how often participants experience gout flare-ups, whether existing gout 'tophi' (lumps of uric acid crystals under the skin) improve, and crucially, they will carefully record any side effects or health problems that occur. This thorough approach helps ensure the new medicine is not only effective but also safe for people living with gout.
Key takeaways
- This study tests a new gout medicine, Tigulixostat, against standard treatment and a placebo.
- It aims to see if Tigulixostat can effectively lower uric acid and is safe.
- Participation involves regular checks and blood tests over several months.
- The study is for adults with gout and high uric acid levels.
- You won't know which treatment you're receiving, which is normal for this type of research.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Crucially, you must have been diagnosed with gout and currently have higher than normal levels of uric acid in your blood. This is important because the new medicine being tested aims to lower uric acid.
There might be other health conditions or medicines you're taking that could prevent you from joining. This is to make sure the study is safe for you and that the results are clear. The study team will discuss all these details with you.
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 diagnosed with gout?
- Do you currently have high levels of uric acid in your blood?
- Are you able to attend regular study appointments?
What does participation involve?
If you decide to take part, you'll be randomly assigned to one of several groups. You could receive the new medicine (Tigulixostat), a standard gout medicine (Allopurinol), or a placebo (a dummy pill without active medicine). Neither you nor your study doctor will know which treatment you are receiving, which helps ensure the study results are unbiased.
Throughout the study, you'll have regular hospital visits for check-ups. These visits will involve blood tests to measure your uric acid levels and other general health markers. The study team will also monitor your vital signs, like blood pressure, and conduct physical examinations. You may be given other medicines like Colchicine or Naproxen to help manage any gout flare-ups you might have during the study. The total duration of the study, including all follow-up, will be well over a year.
Potential risks and benefits
Locations (9)
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedPoland
- —UnverifiedCzechia
- —UnverifiedBelgium
- —UnverifiedLithuania
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedBulgaria
Common questions
What is hyperuricemia?
Hyperuricemia means you have higher than normal levels of uric acid in your blood. This is a common cause of gout.
What is a placebo?
A placebo is a 'dummy' pill or treatment that looks exactly like the real medicine but contains no active drug. It helps researchers understand if the real medicine is truly effective.
What does 'double-blind' mean?
Double-blind means neither you nor your study doctor will know which treatment you are receiving (the new medicine, current medicine, or placebo). This helps to prevent bias.
How long will the study last?
The main part of the study where your uric acid levels are closely monitored is for 6 months, but overall participation including follow-up will be longer, potentially over a year.
Will I still get treatment for gout flares during the study?
Yes, you may receive standard treatments like Colchicine or Naproxen to help manage any gout flares you experience during the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.