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 involved two groups of participants who were each taking a combination of two medicines — febuxostat (80 mg) plus either a lower dose (200 mg) or a higher dose (400 mg) of lesinurad. A total of 97 people started in the lower-dose group and 99 in the higher-dose group. The trial was measuring uric acid levels in the blood (uric acid is a substance that builds up in people with gout) and whether lumps under the skin caused by uric acid build-up, called tophi, fully disappeared over the course of the study period. The reported data shows that, among participants still being tracked at the 12-month extension point, 77.8% of those in the lower-dose combination group and 82.5% of those in the higher-dose combination group had blood uric acid levels below 5.0 mg/dL — the target level the trial was measuring against. For the second measure, looking only at participants who had at least one tophus (uric acid lump) at the start of the study, the reported data shows that 54.3% in the lower-dose group and 61.0% in the higher-dose group had at least one of those lumps completely resolve by the 12-month extension point. It is worth noting that a notable number of participants did not complete the study — 40 in the lower-dose group and 48 in the higher-dose group — and the figures above reflect only those who remained in the study at that time. 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 ↗
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 Gout Trial, Completed
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 must be able to understand what the study involves and the risks, and be willing to sign a consent form before anything begins.
- You must have completed the full 12-month treatment period in a previous related study (Study RDEA594-304) and have been actively taking and tolerating the study medications (either lesinurad or a placebo, along with febuxostat 80 mg) at your final visit in that study.
- You can be male or female; however, if you are a woman who could become pregnant, you must agree to use an effective non-hormonal form of birth control throughout the study and for at least 14 days after taking your last dose of the study medication.
Who may not be able to join:
- You may not be eligible if you have any physical or mental health condition that the study doctor believes could put you at unnecessary risk or make it difficult for you to follow the study's requirements or complete the study (confirm with trial site).
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: Nihar Bhakta, MD, Ardea Biosciences, Inc.
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 With an sUA Level That is < 5.0 mg/dL
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.