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Completed
NCT05665699
Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout
Conditions: Gout
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 80
Sponsor: InventisBio Co., Ltd
Location: Study Center Birmingham Alabama
Summary
D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05665699). StuddyBuddy aggregates publicly available trial information.