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Phase 3 Study of Dotinurad vs Allopurinol in Participants With Gout
EU CTIS ID: 2024-520206-19-00
What this study is testing
To evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Provide written informed consent and any authorizations required by local law.
- 2. Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
- 3. Diagnosis of gout based on 2015 ACR-EULAR criteria for at least 1 year.
- 4. Had at least 2 gout flares in the 12 months prior to Screening
- 5. Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment) up to 600 mg/day for at least 3 months prior to Screening.
- 6. sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
You likely can't join if
- 1. History of or presence of kidney stones within 1 year prior to Screening.
- 2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
- 3. Hypersensitivity or intolerance to dotinurad or to colchicine AND NSAIDs.
- 4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse
- 5. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.
- 6. Participants with unstable long-term conditions, such as diabetes, high cholesterol, hypertension, asthma, etc.
See the full eligibility criteria
- 1. Provide written informed consent and any authorizations required by local law.
- 2. Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
- 3. Diagnosis of gout based on 2015 ACR-EULAR criteria for at least 1 year.
- 4. Had at least 2 gout flares in the 12 months prior to Screening
- 5. Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment) up to 600 mg/day for at least 3 months prior to Screening.
- 6. sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
- 7. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.
- 8. Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of study drug.
- 1. History of or presence of kidney stones within 1 year prior to Screening.
- 2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
- 3. Hypersensitivity or intolerance to dotinurad or to colchicine AND NSAIDs.
- 4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse
- 5. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.
- 6. Participants with unstable long-term conditions, such as diabetes, high cholesterol, hypertension, asthma, etc.
- 7. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or study compliance or may confound interpretation of study results.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.