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 — DRUGABP-745 Dose A + Colchicine placebo - tablets (PO)
- ABP-745 Dose B — DRUGABP-745 Dose B + Colchicine placebo - tablets (PO)
- Colchicine — DRUGABP-745 placebo + Colchicine - tablets (PO)
- Placebo — DRUGABP-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
- Ullrich Schwertschlag, MD,PhD1-978-257-1926
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Onyx Clinical Research | Peoria | Arizona | 61636 | - |
| Exinia Research | La Mesa | California | 91942 | - |
| Evergreen Clinical Trial | Norcross | Georgia | 30003 | - |
| Bioluminux Clinical Research | Naperville | Illinois | 60540 | - |
| Exinia Research | Des Moines | Iowa | 50308 | - |
| Northshore Research Associates | Alexandria | Louisiana | 71303 | - |
| DelRicht Research | Baton Rouge | Louisiana | 70769 | - |
| DelRicht Research | New Orleans | Louisiana | 70115 | - |
| Interphase Clinical Trials | Lutherville | Maryland | 21093 | - |
| DelRicht Research Gulfport | Gulfport | Mississippi | 39501 | - |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87176 | - |
| West Clinical Research | Morehead City | North Carolina | 28557 | - |
| DelRicht Research | Tulsa | Oklahoma | 74133 | - |
| Premier Family Physicians | Austin | Texas | 78734 | - |
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