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 324 people with gout who had visible uric acid crystal deposits under the skin (called tophi). Participants were split into three groups: one group took a lower dose of lesinurad (200 mg) combined with febuxostat, another took a higher dose of lesinurad (400 mg) combined with febuxostat, and a third group took a dummy pill (placebo) combined with febuxostat. All three groups therefore received febuxostat. The trial was measuring uric acid levels in the blood, changes to the tophi, and quality of life over 6 to 12 months. Not everyone finished the study — 79, 84, and 87 participants completed it in each of the three groups respectively. The reported data shows that by the six-month mark, the proportion of participants whose blood uric acid level fell below the target of 5.0 mg/dL (a standard measurement unit for uric acid) was 56.6% in the lower-dose lesinurad group, 76.1% in the higher-dose lesinurad group, and 46.8% in the placebo group. For the secondary outcomes measured at 12 months, the proportion of participants who had at least one tophus completely disappear was 25.5%, 30.3%, and 21.1% across the three groups respectively. When looking at either complete disappearance or a reduction of at least 50% in the size of at least one tophus, the reported proportions were 56.6%, 58.7%, and 50.5%. For quality of life, measured using a disability questionnaire (where a higher score means more disability), the proportion of participants who showed a meaningful improvement was 44.2%, 33.3%, and 52.5% across the three groups. 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, accept the risks, and are willing to sign a consent form before anything begins.
- You are willing to attend all required visits and follow the study schedule.
- You have been diagnosed with gout according to standard medical guidelines.
- If you are not currently taking an approved uric acid-lowering medication, your blood uric acid level is 8 mg/dL or higher.
- If you are already taking febuxostat or allopurinol at a medically appropriate dose, your blood uric acid level is 6.0 mg/dL or higher.
- You are able to take a gout flare prevention medication (either colchicine or an anti-inflammatory painkiller, with or without a stomach-protecting medicine).
- You have at least one measurable tophus (a hard lump caused by uric acid buildup) on your hand, wrist, foot, or ankle that is between 5 mm and 20 mm in size.
- Your body mass index (BMI) is below 45.
Who may not be able to join:
- You have a known allergy or sensitivity to the drug febuxostat.
- You have taken any uric acid-lowering medication for gout — other than allopurinol or febuxostat — within the past 8 weeks.
- You have previously been treated with a drug called pegloticase.
- You drink more than 14 alcoholic drinks per week (for example, more than 14 glasses of wine, beers, or shots).
- You have a history of, or suspected, drug misuse within the past 5 years.
- You have a history of muscle disease or a serious muscle breakdown condition (confirm with trial site).
- You currently need, or may need, medication that suppresses or alters your 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 or cervical conditions (confirm with trial site).
- You have had serious heart problems, a blood clot, or are currently taking blood-thinning medication within the past 12 months (confirm with trial site).
- You have high blood pressure that is not well controlled.
- Your kidneys are not functioning well enough, based on a specific blood test result (confirm with trial site).
- A specific muscle enzyme in your blood was found to be too high during the screening period (confirm with trial site).
- You have an active stomach ulcer that requires treatment.
- You have a history of a rare condition called xanthinuria, active liver disease, or poor liver function.
- You regularly take more than 325 mg of aspirin or aspirin-like medicines daily.
- You are taking certain medications used for seizures or mood conditions, specifically valpromide, progabide, or valproic acid.
- You have taken part in another clinical trial or received an experimental treatment within the past 8 weeks or more (depending on the medication).
- You have any other medical or psychological condition that the study doctor believes could put you at risk or prevent you from completing the study.
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
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Subjects With a Serum Urate (sUA) Level That is < 5.0 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.