Back to resultsA Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia
Primary Purpose
Gout, Hyperuricemia
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
ABP-671
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gout
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.
Sites / Locations
- Paratus - Canberra Clinic
- Paratus - Central Coast Clinic
- Peninsula Private Hospital
- Emeritus Research - Melbourne
- Paratus - Western Sydney Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ABP-671
Placebo
Arm Description
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.
Outcomes
Primary Outcome Measures
Mean percentage change in serum uric acid (sUA) levels
Secondary Outcome Measures
Change in mean sUA
Mean percentage change and change in mean sUA between cohorts
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)
Change in mean sUA compared between BID and QD dosing
Full Information
NCT ID
NCT04638543
First Posted
November 16, 2020
Last Updated
April 10, 2023
Sponsor
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04638543
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 27, 2020 (Actual)
Primary Completion Date
October 26, 2021 (Actual)
Study Completion Date
October 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Hyperuricemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABP-671
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ABP-671
Intervention Description
ABP-671 Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Mean percentage change in serum uric acid (sUA) levels
Time Frame
Baseline to the end of the 4-week Dose Evaluation Period
Secondary Outcome Measure Information:
Title
Change in mean sUA
Time Frame
Baseline to the end of the 4-week Dose Evaluation Period
Title
Mean percentage change and change in mean sUA between cohorts
Time Frame
Baseline to the end of the 4-week Dose Evaluation Period
Title
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)
Time Frame
Baseline to the end of the 4-week Dose Evaluation Period
Title
Change in mean sUA compared between BID and QD dosing
Time Frame
Baseline to the end of the 4-week Dose Evaluation Period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Paratus - Canberra Clinic
City
Canberra
Country
Australia
Facility Name
Paratus - Central Coast Clinic
City
Kanwal
Country
Australia
Facility Name
Peninsula Private Hospital
City
Kippa-Ring
Country
Australia
Facility Name
Emeritus Research - Melbourne
City
Melbourne
Country
Australia
Facility Name
Paratus - Western Sydney Clinic
City
Sydney
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia
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