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

Part of paid clinical trials in Peoria, Arizona.

Sponsor
Atom Therapeutics Co., Ltd
Study ID
NCT07145229
Phase
PHASE2
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ABP-745 Dose A — DRUG
    ABP-745 Dose A + Colchicine placebo - tablets (PO)
  • ABP-745 Dose B — DRUG
    ABP-745 Dose B + Colchicine placebo - tablets (PO)
  • Colchicine — DRUG
    ABP-745 placebo + Colchicine - tablets (PO)
  • Placebo — DRUG
    ABP-745 placebo + Colchicine placebo - tablets (PO)

Study Details

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.

Key Dates

Start date
Aug 26, 2025
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
380 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ABP-745 Dose A
  • Experimental: ABP-745 Dose B
  • Active Comparator: Colchicine
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in Visual Analog Scale (VAS) pain score of the target joint [ Time Frame: 24 hours post the first dose of study drug ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Onyx Clinical ResearchPeoriaArizona61636-
Exinia ResearchLa MesaCalifornia91942-
Evergreen Clinical TrialNorcrossGeorgia30003-
Bioluminux Clinical ResearchNapervilleIllinois60540-
Exinia ResearchDes MoinesIowa50308-
Northshore Research AssociatesAlexandriaLouisiana71303-
DelRicht ResearchBaton RougeLouisiana70769-
DelRicht ResearchNew OrleansLouisiana70115-
Interphase Clinical TrialsLuthervilleMaryland21093-
DelRicht Research GulfportGulfportMississippi39501-
Albuquerque Clinical Trials, Inc.AlbuquerqueNew Mexico87176-
West Clinical ResearchMorehead CityNorth Carolina28557-
DelRicht ResearchTulsaOklahoma74133-
Premier Family PhysiciansAustinTexas78734-

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