Study of ABP-745 for Acute Gout Flares
This study is testing a new drug called ABP-745 to see if it can help reduce pain and swelling during an acute gout flare (a sudden, severe attack of gout). Researchers want to compare ABP-745 to standard colchicine treatment and a placebo (an inactive substance). You might be able to join if you are 18 to 70 years old, have a body mass index (BMI) between 18 and 40, and have had at least two gout flares in the past year. The main goal is to see how much your pain improves after 24 hours of taking the study drug.
- Study design
- This is a randomized, double-blind study involving 380 participants across multiple international locations. Participants will receive either ABP-745 (at one of two doses), colchicine, or a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures pain at 24 hours after the first dose of the study drug.
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NCT07145229
Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare
Recruiting
PHASE2Ages 18–70InterventionalTreatmentAtom Therapeutics Co., Ltd
~380 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:ABP-745 Dose AABP-745 Dose BColchicinePlacebo
At a glance
Recruiting sites
35 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Visual Analog Scale (VAS) pain score of the target joint
Measured over 24 hours post the first dose of study drug
Conditions
Where it's being run
38 sites across 26 statesNew South Wales4
Shanxi4
Louisiana3
Victoria2
Beijing Municipality2
Hunan2
Zhejiang2
Arizona1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
Administration of oral prednisone ≥ 10 mg or equivalent doses of other glucocorticoids, or use of narcotics, within 24 hours prior to first dose of study drug, or intramuscular, intravenous, or intra-articular injection of any glucocorticoid within 14 days prior to first dose of study drug.
Use of Nonsteroidal Anti-inflammatory Drugs (NSAIDs) prior to first dose dose of study drug, at the investigator's discretion.
Administration of colchicine or ABP-745 within 14 days prior to first dose of study drug.
Subjects took any investigational drug in any clinical study within 1 month prior to first dose of study drug and throughout the study period.
Administration of pegloticase, or methotrexate, or any biologic IL-1 blocker, TNF inhibitor, or other biological agent within 30 days prior to first dose of study drug or within 5 half-lives of the study drug prior to the first dose of study drug, whichever is longer.
Administration of muscle relaxants, central stimulants, barbiturates, etc. within 30 days prior to first dose of study drug or within 5 half-lives of the drug prior to the first dose of study drug, whichever is longer.
Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout).
Subjects with a current diagnosis or history of rheumatoid arthritis, psoriatic arthritis, evidence or suspicion of infectious/septic arthritis, calcium pyrophosphate (CPP) crystal arthritis, acute polyarticular gout (4 or more joints), multiple sclerosis or any other demyelinating disease, or; major chronic inflammatory disease or connective tissue disease other than RA or psoriatic arthritis (PsA), including but not limited to fibromyalgia or systemic lupus erythematosus (with the exception of secondary Sjögrens syndrome, etc.); with arthritis due to any cause other than gout that may confound any study assessments per Investigator discretion or Prosthetic joint infection within 5 years of screening, or native joint infection within 1 year of screening
Current anticoagulation therapy, thrombocytopenia, or diseases with a risk of thrombocytopenia, such as aplastic anemia, hypersplenism, or known hemorrhagic diseases like idiopathic thrombocytopenic purpura or hemophilia.
History of malignancy within 5 years prior to screening, excluding localized cancers such as basal cell carcinoma.
Presence of significant diseases, including but not limited to: uncontrolled hypertension (systolic blood pressure ≥160 or diastolic blood pressure ≥100 mmHg), congestive heart failure (New York Heart Association \[NYHA\] class III or above), uncontrolled type 1 or 2 diabetes mellitus (hemoglobin A1c \[HbA1c\] \>8.5%). Inclusion will be determined by the Investigator based on the subject's specific condition.
Women of childbearing potential as defined by Appendix 2.
Experienced only no or mild gout-related pain prior to first dose of study drug.
Use of gout flare prophylaxis (e.g., colchicine, NSAIDs, prednisone/methylprednisolone) at the time of randomization based on conversation with subject and self-reported.
Corona Virus Disease (COVID) vaccination in the 4 weeks prior to randomization.
What this trial measures
- Change in Visual Analog Scale (VAS) pain score of the target joint24 hours post the first dose of study drug
Change from baseline in 0-100 mm VAS pain score of the target joint