Phase 3
N=451
A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
Gout
Bottom Line
View on ClinicalTrials.gov: NCT05007392 ↗Enrolled (actual)
451
Serious AEs
1.6%
Results posted
Jul 2025
Primary outcome: Primary: Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF) — 38.1; 73.6 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dotinurad (Drug); Febuxostat (Drug); Dotinurad Matched Placebo (Other); Febuxostat Matched Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eisai Co., Ltd.
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF) |
38.1; 73.6 | <0.001 sig |
| SECONDARY Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF) |
50.5; 55.5 | — |
| SECONDARY Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 |
26.3; 27.6; 55.6; 62.7; 52.8; 56.9 | — |
| SECONDARY Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24 |
26.43; 27.43; 37.06; 39.10; 36.06; 38.62 | — |
| SECONDARY Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24 |
-2.60; -2.70; -3.62; -3.80; -3.52; -3.78 | — |
| SECONDARY Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24 |
9.65; 9.67; 7.07; 6.93; 6.01; 5.80 | — |
Summary
The primary purpose of the study is to confirm the efficacy of dotinurad 4 milligram (mg) to febuxostat 40 mg on the percentage of participants achieving a serum uric acid (SUA) level less than or equal to (<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 in Chinese participants with gout.
Eligibility Criteria
Inclusion Criteria
- Gout participant (with a history of gout attack or concurrent gouty tophi) with SUA level greater than (>) 7.0 mg/dL in the screening phase (within 14 days prior to randomization)
- Male or female participant with age greater than or equal to (>=) 18 years at the time of informed consent
- Provide written informed consent signed by the participant prior to entering the study or undergoing any study procedures, indicating that they understand the purpose and procedures required for the study and are willing to participate in the study
Exclusion Criteria
- Has gouty arthritis that has not resolved within 14 days prior to randomization
- Has secondary hyperuricemia
- Comorbidities with nephrolithiasis or clinical urinary calculi (example, haematuria, back pain)
- Evidence of clinically significant disease (example, cardiac disease: heart failure and angina unstable, respiratory, gastrointestinal, renal, or neurological disease: cerebral infarction) that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments
- Evidence of clinical significant hepatic disease: refer to Grade 2 in the "Seriousness Grading Criteria for Adverse Drug Reactions" or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 multiple (*) upper limit of normal (ULN) in the screening phase
- Estimated glomerular filtration rate (eGFR) of less than ( =180 millimetre of mercury (mmHg) or diastolic blood pressure of >=110 mmHg in the screening phase
- Hemoglobin A1c National Glycohemoglobin Standardization Program (NGSP) value of >=8.4 percent (%) in the screening phase
- Hypersensitivity to the study drugs (dotinurad or febuxostat) or their excipients, or all of urine alkalinizer (potassium citrate/sodium citrate hydrate compound preparations)
Data sourced from ClinicalTrials.gov (NCT05007392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.