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

NCT07145229 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2025-12-08

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Atom Therapeutics Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2026-05-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145229 on ClinicalTrials.gov