Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 14 of 14

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)	Last 3 Visits (up to 52 weeks)	Analysis was performed on the intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL.	Percentage of subjects	NUMBER
SECONDARY	Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit	Week 28	Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.	Percentage of subjects	NUMBER
SECONDARY	Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit	Week 52	Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.	Percentage of subjects	NUMBER
SECONDARY	Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit	Final Visit (up to 52 weeks)	Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.	Percentage of subjects	NUMBER
SECONDARY	Percent Change From Baseline in Serum Urate Levels at Week 28.	Baseline and Week 28	Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.	percent change from baseline	MEAN
SECONDARY	Percent Change From Baseline in Serum Urate Levels at Week 52.	Baseline and Week 52	Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.	percent change from baseline	MEAN
SECONDARY	Percent Change From Baseline in Serum Urate Levels at Final Visit	Baseline and Final Visit (up to 52 weeks)	Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.	percent change from baseline	MEAN
SECONDARY	Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.	Baseline and Week 28	Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.	percent change from baseline	MEDIAN
SECONDARY	Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.	Baseline and Week 52	Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.	percent change from baseline	MEDIAN
SECONDARY	Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.	Baseline and Final Visit (up to 52 weeks)	Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.	percent change from baseline	MEDIAN
SECONDARY	Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.	Baseline and Week 28	Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.	number of tophi	MEDIAN
SECONDARY	Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.	Baseline and Week 52	Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.	number of tophi	MEDIAN
SECONDARY	Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.	Baseline and Final Visit (up to 52 weeks)	Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.	number of tophi	MEDIAN
SECONDARY	Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.	Weeks 8 through 52	Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 52.	percentage of subjects	NUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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