Dotinurad for Gout
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called dotinurad to evaluate its effectiveness in lowering uric acid levels in individuals with tophaceous gout, a condition that causes painful lumps called tophi to form around joints. The study compares dotinurad to allopurinol, a common gout medication. Participants will either continue with allopurinol or switch to different doses of dotinurad over several weeks. Suitable candidates have had gout for at least a year and have visible tophi on their hands, wrists, feet, or ankles. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that dotinurad is safe and well-tolerated in people with gout. Research indicates that no serious side effects occurred at any dose. During the studies, no major health issues were linked to dotinurad use. Participants did not report any new safety concerns, suggesting it is generally safe. So far, the treatment appears manageable for most people, with no reports of serious problems.12345
Why do researchers think this study treatment might be promising for gout?
Dotinurad is unique because it offers a different approach to managing gout compared to standard treatments like allopurinol. While most gout medications lower uric acid levels by inhibiting production, dotinurad works by enhancing the kidney's ability to remove uric acid from the body. This new mechanism of action could potentially lead to better control of uric acid levels and fewer side effects. Researchers are excited about dotinurad as it might provide an effective alternative for patients who do not respond well to current options.
What evidence suggests that this trial's treatments could be effective for gout?
In this trial, participants will receive either Dotinurad or Allopurinol. Previous studies have shown that Dotinurad significantly lowers uric acid levels in individuals with high uric acid and gout. Dotinurad blocks a specific protein in the kidneys, reducing the amount of uric acid reabsorbed into the body. In one study, 55.5% of patients taking Dotinurad reached a healthy uric acid level within 12 weeks. Research indicates that Dotinurad is as effective as other gout medications at lowering uric acid, supporting its potential to manage gout symptoms effectively.12367
Are You a Good Fit for This Trial?
Adults aged 18-75 with tophaceous gout, meeting specific criteria for the disease's duration and severity. They must have at least one measurable tophus on hands/wrists or feet/ankles and a serum uric acid level of ≥5.0 mg/dL. Participants should agree to abstain from sex or use contraception, and women must not be pregnant or breastfeeding.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either dotinurad or allopurinol. Dotinurad is administered at 1 mg QD for the first 4 weeks, 2 mg QD for the next 8 weeks, and 4 mg QD thereafter up through Week 76. Allopurinol is administered at the same dose once a day through Week 76.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Allopurinol
- Dotinurad
Find a Clinic Near You
Who Is Running the Clinical Trial?
Crystalys Therapeutics
Lead Sponsor