A Randomized, Double-blind, Multicenter, Colchicine and Placebo-controlled Study to Evaluate the Efficacy and Safety of ABP-745 in Subjects With an Acute Gout Flare
A randomized, double-blind, international multicenter, colchicine and placebo-controlled study to evaluate the efficacy and safety of ABP-745 in subjects with acute gout. Efficacy of ABP-745 in reducing pain and swelling compared with standard colchicine treatment and placebo will be evaluated in participants with acute gout. The primary efficacy measurement will be pain score after treatment.
⁃ Subjects are eligible for the study if they meet all of the following Inclusion Criteria:
• Age 18-70 years old (inclusive), male or female.
• Body mass index (BMI)18-40 kg/m2 (inclusive).
• Medical history and current findings consistent with diagnosis of gouty arthritis.
• Subjects must have experienced 2 or more gout flares within 12 months prior to screening.
• Onset of an acute gout flare, within 6 months
• Patients receiving ULT agents (such as allopurinol, febuxostat, probenecid, etc.) must be on stable doses of these drugs prior to first dose of study drug (and remain on the same dose throughout the Treatment Period).
• Subjects agree to maintain a stable lifestyle (such as diet and exercise) during the study period.