Study to Evaluate the Safety and Effectiveness of ABP-745 Compared to Colchicine and Placebo in Adults with an Acute Gout Flare

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ABP-745 in people experiencing an acute gout flare. This Phase 2, randomized, double-blind, international, multicenter study compares ABP-745 to standard colchicine treatment and placebo. The goal is to see how well ABP-745 reduces pain and swelling during a gout flare, with the main measure being the pain score after treatment. Participants will be randomly assigned to one of four groups two different doses of ABP-745 with a colchicine placebo, standard colchicine treatment with an ABP-745 placebo, or a placebo for both drugs. All treatments are given as tablets by mouth. The study will monitor participants from the first dose through up to 14 days to assess pain changes and any side effects. During the study, participants will have their pain measured using a visual analog scale at various times, including 24 hours and up to 8 days after the first dose. Researchers will also track any treatment-related adverse events for up to two weeks. Participants must maintain stable lifestyle habits and medication doses during the study. The total study duration and follow-up include safety assessments to understand the effects and tolerability of the treatments.

Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare