Pharmaceutical company assesses the drug ABP-671 in patients with Gout or Hyperuricemia
Photo by Joey Csunyo
Jiangsu Atom Bioscience and Pharmaceutical Co. is recruiting patients for the clinical trial of A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia.
This is a 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.
The study starts in November 2020. The indicative completion of the clinical trial will be expected in July 2021.
The list of locations in Australia:
Paratus - Canberra Clinic, Canberra
Paratus - Central Coast Clinic, Kanwal
Emeritus Research – Melbourne, Melbourne
Paratus - Western Sydney Clinic, Sydney
Among the criteria that allow participation, the following are indicated:
- Participant meets the diagnosis of gout as per the American College of Rheumatism/ European League Against Rheumatism (EULAR) Gout Classification Criteria or diagnosis of hyperuricemia.
- Participant has an sUA level ≥ 7.0 mg/dL at baseline.
- Participant 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.
Mean percentage change in serum uric acid (sUA) levels is primary outcome measure.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04638543
