Gout, Hyperuricemia
Conditions
Brief 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.
Interventions
DRUGABP-671
ABP-671 Tablet
DRUGPlacebo
Placebo
Sponsors
Atom Therapeutics Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage change in serum uric acid (sUA) levels | Baseline to the end of the 4-week Dose Evaluation Period |
Secondary
| Measure | 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 |
Countries
Australia
Outcome results
None listed