A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or … (NCT04638543) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia
Australia60 participantsStarted 2020-11-27
Plain-language summary
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics study of 6 different dose regimens of ABP-671 compared with placebo. The study will consist of three sequential groups with escalating total daily ABP-671 doses. Each group is further divided into two dose cohorts with either QD or BID dosing. Each dose group will have 3 stages following screening: Run-in, Dose Evaluation, and Follow-up.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.
* Subject meets the diagnosis of gout as per the American College of Rheumatism/ European League Against Rheumatism (EULAR) Gout Classification Criteria or diagnosis of hyperuricemia.
* Subject has an sUA level ≥ 7.0 mg/dL at baseline.
* Subject must be willing to discontinue any other UA-lowering medication (e.g., allopurinol, febuxostat, and probenecid) and take gout prophylaxis medication during the study.
* Body mass index (BMI) ≤ 40 kg/m2.
Exclusion Criteria:
* Subject with a documented history of rheumatoid arthritis or other autoimmune disease.
* Subject with any clinically significant hepatic, cardiovascular, renal, neoplastic, psychiatric illness, or hematological disorders such as polycythemia vera, sickle cell disease, or myelodysplastic disorder.
* Subject with a history of alcohol or drug abuse within the past 1 year prior to screening, or current evidence of substance dependence or abuse.
* Subject with a positive test for active hepatitis B, hepatitis C infection or human immunodeficiency virus (HIV) infection.
* Subject with active liver disease, or hepatic dysfunction.
* Subject with an inadequate renal function with estimated serum creatinine \> 1.5 mg/dL (\> 0.133 mmol/L) or creatinine clearance \< 60 mL/min (by Cockcroft-Gault formula).
* Subject with a history of malignancy…
What they're measuring
1
Mean percentage change in serum uric acid (sUA) levels
Timeframe: Baseline to the end of the 4-week Dose Evaluation Period