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Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout

A Randomized, Open-Label, Multiple-Dose Phase II Study to Evaluate Efficacy and Safety of D-0120 Administered in Combination With Allopurinol in Subjects With Gout

NCT05665699•InventisBio Co., Ltd

View on ClinicalTrials.gov

Summary

D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response
•Subject has had at least 2 gout flares in the previous 12 months.
•Body Mass Index (BMI) between 18.0 and 45.0 kg/m2 (inclusive).
•Male and Female Subjects must agree to abstain or use effective contraception methods from the time of signing ICF and for the duration of study participation through 30 days after the last dose of study drug.
•Subjects must have adequate clinical laboratory and ECG results as assessed by the Principal Investigator

Exclusion Criteria

•Subjects with significant comorbidities, inadequate lab function, current (and within the past 5 years) diagnosis of cancer or any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
•Women who are pregnant or breastfeeding

Locations (19)

Study Center

Birmingham, Alabama, United States

Site Center

Plantation, Florida, United States

Study Center

Evergreen Park, Illinois, United States

Study Center

Brownsburg, Indiana, United States

Site Center

Louisville, Kentucky, United States

Study Center

Hickory, North Carolina, United States

Study Center

Rocky Mount, North Carolina, United States

Study Center

Salisbury, North Carolina, United States

Study Center

Wilmington, North Carolina, United States

Study Center

Winston-Salem, North Carolina, United States

Key Dates

Start Date

April 17, 2023

Primary Completion Date

July 31, 2025

Completion Date

December 30, 2025

Last Updated

May 8, 2025

Enrollment

ESTIMATED participants

Conditions

Gout

Interventions

D-0120

DRUG

Allopurinol

DRUG

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Gout

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout

Inclusion Criteria

Exclusion Criteria

A Study of Dotinurad Versus Allopurinol in Participants With Gout

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