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

NCT04638543 | Completed Phase 2

• 1 other identifier: ABP-671-201
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Gout; Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• Mean percentage change in serum uric acid (sUA) levels

  Baseline to the end of the 4-week Dose Evaluation Period

Secondary Outcomes (4)

• 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

Study Arms (2)

ABP-671

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ABP-671 DRUG

ABP-671 Tablet

ABP-671

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atom Therapeutics Co., Ltd: lead

Study Sites (5)

Paratus - Canberra Clinic

Canberra, Australia

Location

Paratus - Central Coast Clinic

Kanwal, Australia

Location

Peninsula Private Hospital

Kippa-Ring, Australia

Location

Emeritus Research - Melbourne

Melbourne, Australia

Location

Paratus - Western Sydney Clinic

Sydney, Australia

Location

MeSH Terms

Conditions

Gout; Hyperuricemia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: November 27, 2020
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

AU (5)