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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04638543




Registration number
NCT04638543
Ethics application status
Date submitted
16/11/2020
Date registered
20/11/2020
Date last updated
12/04/2023

Titles & IDs
Public title
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia
Scientific 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
Secondary ID [1] 0 0
ABP-671-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Hyperuricemia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABP-671
Treatment: Drugs - Placebo

Experimental: ABP-671 - 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.

Placebo comparator: Placebo -


Treatment: Drugs: ABP-671
ABP-671 Tablet

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean percentage change in serum uric acid (sUA) levels
Timepoint [1] 0 0
Baseline to the end of the 4-week Dose Evaluation Period
Secondary outcome [1] 0 0
Change in mean sUA
Timepoint [1] 0 0
Baseline to the end of the 4-week Dose Evaluation Period
Secondary outcome [2] 0 0
Mean percentage change and change in mean sUA between cohorts
Timepoint [2] 0 0
Baseline to the end of the 4-week Dose Evaluation Period
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
Baseline to the end of the 4-week Dose Evaluation Period
Secondary outcome [4] 0 0
Change in mean sUA compared between BID and QD dosing
Timepoint [4] 0 0
Baseline to the end of the 4-week Dose Evaluation Period

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/10/2021
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Paratus - Canberra Clinic - Canberra
Recruitment hospital [2] 0 0
Paratus - Central Coast Clinic - Kanwal
Recruitment hospital [3] 0 0
Peninsula Private Hospital - Kippa-Ring
Recruitment hospital [4] 0 0
Emeritus Research - Melbourne - Melbourne
Recruitment hospital [5] 0 0
Paratus - Western Sydney Clinic - Sydney
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Kanwal
Recruitment postcode(s) [3] 0 0
- Kippa-Ring
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04638543
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04638543