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 610 people with gout across three groups: 204 took lesinurad 200 mg combined with allopurinol, 200 took lesinurad 400 mg combined with allopurinol, and 206 took a placebo (inactive treatment) combined with allopurinol. The trial was mainly measuring how many people in each group had their blood uric acid level drop below a certain target (6.0 mg/dL — a level considered important in gout management) by the six-month mark. It also looked at gout flare-ups and the shrinking of tophi (lumps that can form under the skin in some people with gout) over 12 months. The reported data shows that by month six, 55.4% of people in the lesinurad 200 mg plus allopurinol group, and 66.5% of people in the lesinurad 400 mg plus allopurinol group, had uric acid levels below the target, compared with 23.3% in the placebo plus allopurinol group. For gout flares requiring treatment during months six to twelve, the reported average number of flares per person was 0.7 in the 200 mg group, 0.8 in the 400 mg group, and 0.9 in the placebo group. Regarding tophi, among participants who had at least one measurable tophus at the start of the trial, 31.4% in the 200 mg group, 27.6% in the 400 mg group, and 33.3% in the placebo group had at least one tophus fully resolve by month 12. 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 35835008) ↗
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 are able to understand what the study involves, are aware of the risks, and are willing to sign a consent form before anything begins.
- You have been diagnosed with gout according to standard medical guidelines.
- You have been taking allopurinol (and only allopurinol) as your gout medication for at least 8 weeks before screening, at a steady dose of at least 300 mg per day (or at least 200 mg per day if you have moderate kidney problems).
- You are able to take a gout flare prevention medication, such as colchicine or an anti-inflammatory painkiller (NSAID), possibly alongside a stomach-protecting medication.
- Your uric acid level in the blood was at or above a certain level at two separate check-in points during screening (confirm exact values with trial site).
- You have had at least 2 gout flares in the past 12 months.
- Your body mass index (BMI) is below 45 (a measure of body weight relative to height).
Who may not be able to join:
- You have a known allergy or sensitivity to allopurinol.
- You have been taking any other gout-lowering medication (other than allopurinol) within the 8 weeks before screening.
- You are pregnant or currently breastfeeding.
- You drink more than 14 alcoholic drinks per week (for example, more than 14 glasses of wine, beers, or shots).
- You have had a history or suspicion of drug abuse within the past 5 years.
- You currently need, or may need, medications that suppress or alter the immune system.
- You have a known or suspected HIV infection.
- You have tested positive for an active hepatitis B or hepatitis C infection.
- You have been diagnosed with cancer in the past 5 years, with some exceptions such as certain treated skin cancers or treated early-stage cervical conditions (confirm with trial site).
- In the past 12 months, you have had unstable chest pain (angina), a severe heart failure diagnosis, a heart attack, a stroke, or a blood clot in a vein — or you are currently taking blood-thinning medication.
- You have high blood pressure that is not well controlled by treatment.
- Your kidneys are not functioning well enough, based on a specific measurement of kidney filtration rate (confirm with trial site).
- You have active stomach ulcer disease that requires treatment.
- You have a history of a condition called xanthinuria, or you have active liver disease or poor liver function.
- You regularly take more than 325 mg of aspirin or aspirin-like medication (salicylates) per day.
- You are currently taking valpromide, progabide, or valproic acid (certain medications used for conditions such as epilepsy).
- You have taken part in another clinical trial or received an experimental treatment within the past 8 weeks or longer (depending on the medication used).
- You have any other medical or mental health condition that could put you at risk or make it difficult to fully participate in 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: Chris Storgard, 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
9 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6.
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.