Clinical trial NCT04638543: A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Hyperuricemia
Lead sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean percentage change in serum uric acid (sUA) levels
timeFrame: Baseline to the end of the 4-week Dose Evaluation Period
Secondary outcomes:
measure: Change in mean sUA
timeFrame: Baseline to the end of the 4-week Dose Evaluation Period
measure: Mean percentage change and change in mean sUA between cohorts
timeFrame: Baseline to the end of the 4-week Dose Evaluation Period
measure: 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)
timeFrame: Baseline to the end of the 4-week Dose Evaluation Period
measure: Change in mean sUA compared between BID and QD dosing
timeFrame: Baseline to the end of the 4-week Dose Evaluation Period
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Paratus - Canberra Clinic
city: Kanwal
country: Australia
facility: Paratus - Central Coast Clinic
city: Kippa-Ring
country: Australia
facility: Peninsula Private Hospital
city: Melbourne
country: Australia
facility: Emeritus Research - Melbourne
city: Sydney
country: Australia
facility: Paratus - Western Sydney Clinic
Study officials:
References: