NCT07145229

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Atom Therapeutics Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Gouty Arthritis
• Gout Flare
• Gout Flares
• Acute Gout Flare

Interventions

Type	Name	Description
DRUG	ABP-745 Dose A	ABP-745 Dose A + Colchicine placebo - tablets (PO)
DRUG	ABP-745 Dose B	ABP-745 Dose B + Colchicine placebo - tablets (PO)
DRUG	Colchicine	ABP-745 placebo + Colchicine - tablets (PO)
DRUG	Placebo	ABP-745 placebo + Colchicine placebo - tablets (PO)

Timeline

• Start date: 2025-08-26
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-08-28
• Last updated: 2025-12-08

Locations

38 sites across 3 countries: United States, Australia, China

Regulatory

• FDA-regulated drug study