Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout
Gout
About this trial
This is an interventional treatment trial for Gout
Eligibility Criteria
Inclusion Criteria: Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response Subject has reported at least 2 gout flares in the previous 12 months. Body Mass Index (BMI) between 18.0 and 40.0 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
Sites / Locations
- Study CenterRecruiting
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- DallasRecruiting
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Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort A
Cohort B
week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol
week 1: D-0120 low dose in combination with Allopurinol week 2: D-0120 increased dose in combination with Allopurinol week 3-12: D-0120 high dose in combination with Allopurinol