NCT07145229 · Atom Therapeutics Co., Ltd
Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare
What this study is about
A randomly assigned, where neither patients nor doctors know which treatment is given, international conducted at multiple hospitals, colchicine and compared against an inactive treatment study to evaluate the effectiveness and safety of ABP-745 in subjects with acute gout.
View original scientific description
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.
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)
Primary outcome measures
Change in Visual Analog Scale (VAS) pain score of the target joint
Time frame: 24 hours post the first dose of study drug
Change from baseline in 0-100 mm VAS pain score of the target joint
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects are eligible for the study if they meet all of the following Inclusion Criteria:
- Age 18-70 years old (inclusive), male or female.
- Body mass index (BMI)18-40 kg/m2 (inclusive).
- Medical history and current findings consistent with diagnosis of gouty arthritis.
- Subjects must have experienced 2 or more gout flares within 12 months prior to screening.
- Onset of an acute gout flare, within 6 months
- Patients receiving ULT agents (such as allopurinol, febuxostat, probenecid, etc.) must be on stable doses of these drugs prior to first dose of study drug (and remain on the same dose throughout the Treatment Period).
- Subjects agree to maintain a stable lifestyle (such as diet and exercise) during the study period. Key
Exclusion criteria
- Subjects are excluded from the study if one or more of the following criteria are met:
- Administration of oral prednisone ≥ 10 mg or equivalent doses of other glucocorticoids, or use of narcotics, within 24 hour
Where
- Peoria, Arizona
- La Mesa, California
- Norcross, Georgia
- Naperville, Illinois
- Des Moines, Iowa
- Alexandria, Louisiana
- Baton Rouge, Louisiana
- New Orleans, Louisiana
- Lutherville, Maryland
- Gulfport, Mississippi
- Albuquerque, New Mexico
- Morehead City, North Carolina
And 2 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 8, 2025 · Source of record for eligibility and locations