A Study of Dotinurad Versus Allopurinol in Participants With Gout

Not Applicable

Recruiting

• Conditions: Gout
• Interventions: Drug: Allopurinol; Drug: Dotinurad

• Registration Number: NCT07089875
• Lead Sponsor: Crystalys Therapeutics

Brief Summary

The primary objective of this study is 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-22
• Study First Posted: 2025-07-28
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Last Update Submitted: 2025-08-11
• Last Update Posted: 2025-08-13
• Primary Completion: 2027-08
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
2. Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year.
3. Had at least 2 gout flares in the 12 months prior to Screening (reported by the participant or documented in the participant's medical records).
4. 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 and remain on their dosing regimen until Day 1.
5. sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
6. 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.
7. 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.

Exclusion Criteria

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 nonsteroidal anti-inflammatory drugs.
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, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening.
6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allopurinol	Allopurinol	Participants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 64.
Dotinurad 2 mg Maintenance	Dotinurad	Participants will discontinue their allopurinol and start dotinurad 1 mg QD for first 4 weeks (Weeks 1-4) and then dotinurad 2 mg QD through Week 64.
Dotinurad 4 mg Maintenance	Dotinurad	Participants will discontinue their allopurinol and start dotinurad 1 mg QD for first 4 weeks (Weeks 1-4), dotinurad 2 mg QD for the next 8 weeks (Weeks 5-12), and dotinurad 4 mg QD thereafter through Week 64.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24	Week 24

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24 Inclusive	Weeks 16, 20 and 24
Mean Rate of Gout Flares Requiring Treatment From Week 36 Through Week 64	Week 36 through Week 64
Percentage of Participants With an sUA level <5.0 mg/dL at Week 24 and no Gout Flares Requiring Treatment From Week 36 Through Week 64	Week 24 and Week 36 through Week 64
Mean Change From Baseline in sUA at Week 24	Baseline and Week 24
Percentage of Participants who do not Have a Gout Flare Requiring Treatment From Week 24 Through Week 64	Week 24 through Week 64
Percentage of Participants With an sUA Level <6.0 mg/dL at Each Visit	Up to Week 68
Percentage of Participants With an sUA Level <5.0 mg/dL at Each Visit	Up to Week 68
Percentage of Participants With an sUA Level <4.0 mg/dL at Each Visit	Up to Week 68
Absolute Change from Baseline in sUA Levels at Each Visit	Baseline to Week 68
Percent Change from Baseline in sUA Levels at Each Visit	Baseline to Week 68
Percentage of Participants With a Gout Flare Requiring Treatment at Each Month Between Week 24 and the end of Study	Week 24 to Week 68
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	Day 1 through Week 68
Percentage of Participants With Serious Adverse Events (SAEs)	Day 1 through Week 68

Trial Locations

Locations (1)

Pioneer Research Solutions; 🇺🇸 Houston, Texas, United States