A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

Not Applicable

Recruiting

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

• Registration Number: NCT07089888
• 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 tophaceous 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: 2027-09
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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 76.
Dotinurad	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 up through Week 76.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24	Week 24

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants who Experience Complete Response (CR) or Partial Response (PR) of ≥1 Target Tophus at Week 76	Week 76
Percentage of Participants who Experience CR of ≥1 Target Tophus at Week 76	Week 76
Percentage of Participants with an sUA Level <4.0 mg/dL at Week 24	Week 24
Mean Rate of Gout Flares Requiring Treatment from Week 36 Through Week 76	Week 36 through Week 76
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 76	Week 24 and Week 36 through Week 76
Mean Change from Baseline in sUA at Week 24	Baseline and Week 24
Mean Percent Change from Baseline in the Sum of the Areas for all Target Tophi at Each Visit	Baseline to Week 80
Percentage of Participants who Do Not have a Gout Flare Requiring Treatment from Week 36 through Week 76	Week 36 through Week 76
Percentage of Participants with an sUA Level <5.0 mg/dL at Each Visit	Up to Week 80
Percentage of Participants with an sUA Level <4.0 mg/dL at Each Visit	Up to Week 80
Percentage of Participants with an sUA Level <3.0 mg/dL at Each Visit	Up to Week 80
Absolute Change from Baseline in sUA Levels at Each Visit	Baseline to Week 80
Percent Change from Baseline in sUA Levels at Each Visit	Baseline to Week 80
Percentage of Participants with a Gout Flare Requiring Treatment at Each Month Between Week 24 and the End of Study	Week 24 to Week 80
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)	Up to Week 80
Percentage of Participants with Serious Adverse Events (SAEs)	Up to Week 80

Trial Locations

Locations (1)

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