A Study of Dotinurad Versus Allopurinol in Participants With Gout

Conditions

• Gout

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Allopurinol — DRUG
  Over-encapsulated tablets containing active drug substance administered orally (PO).
• Dotinurad — DRUG
  Over-encapsulated tablets containing active drug substance administered PO.

Study Details

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.

Key Dates

Start date

Aug 1, 2025

Status verified

Jun 2026

Primary completion

Nov 29, 2027

Completion

Nov 29, 2027

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Allopurinol
  Participants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 64.
• Experimental: Dotinurad 2 mg Maintenance
  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.
• Experimental: Dotinurad 4 mg Maintenance
  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 Measure

Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24 [ Time Frame: Week 24 ]

Central Contacts

• Clinical Trial Lead
  (858) 356-4740
  [email protected]

Locations (80)

Find similar trials in Birmingham, AL

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