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

Completed · Phase 2

Conditions studied: Gout

In brief

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

Key facts

Study ID

NCT05665699

Run by

InventisBio Co., Ltd

People needed

80

Starts

2023-04-17

Expected to finish

2025-12-30

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Study Center — Scottdale, Pennsylvania, United States
• Study Center — Bristol, Tennessee, United States
• Site Center — Hendersonville, Tennessee, United States
• Study Center — Knoxville, Tennessee, United States
• Site Center — Fort Worth, Texas, United States
• Site Center — The Woodlands, Texas, United States
• Site Center — Richmond, Virginia, United States
• Site Center — Bellevue, Washington, United States
• Study Center — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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