A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Multicenter, Phase 2a Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 Monotherapy in Patients With Gout or Hyperuricemia

Conditions
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Gout, Hyperuricemia

Intervention / Treatment
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* Drug: ABP-671
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer. Subject with unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis within the last 12 months; or subjects currently receiving anticoagulants. Subject with QT interval corrected for heart rate according to Fridericia's formula > 470 msec (females) and > 450 msec (males) during the Screening Period, confirmed by a repeat assessment. Subject with uncontrolled hypertension Subject receiving chronic treatment with more than 325 mg aspirin per day. Subject that requires or may require systemic immunosuppressive or immunomodulatory treatment. Subject who received any investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to screening. Subject who is pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABP-671<br>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. | Drug: ABP-671<br>* ABP-671 Tablet<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percentage change in serum uric acid (sUA) levels |  | Baseline to the end of the 4-week Dose Evaluation Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean sUA |  | Baseline to the end of the 4-week Dose Evaluation Period | 
| Mean percentage change and change in mean sUA between cohorts |  | Baseline to the end of the 4-week Dose Evaluation Period | 
| Percentage of patients achieving sUA of < 6.0 mg/dL (0.357 mmol/L), < 5.0 mg/dL (0.297 mmol/L), and < 4.0 mg/dL (0.238 mmol/L) |  | Baseline to the end of the 4-week Dose Evaluation Period | 
| Change in mean sUA compared between BID and QD dosing |  | Baseline to the end of the 4-week Dose Evaluation Period |