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ABP-745 for treating acute gout flares

A Randomized, Double-blind, Multicenter, Colchicine and Placebo-controlled Study to Evaluate the Efficacy and Safety of ABP-745 in Subjects With an Acute Gout Flare

PHASE2 · Atom Therapeutics Co., Ltd · NCT07145229

This trial will test whether ABP-745 reduces pain and swelling better than colchicine or placebo in adults having an acute gout flare.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment380 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAtom Therapeutics Co., Ltd (industry)
Drugs / interventionschemotherapy, methotrexate, prednisone
Locations38 sites (Peoria, Arizona and 37 other locations)
Trial IDNCT07145229 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, randomized, double-blind, multicenter trial comparing two doses of ABP-745 with standard colchicine and placebo in adults experiencing an acute gout flare. Participants are randomly assigned to ABP-745 Dose A, ABP-745 Dose B, colchicine, or placebo and followed for pain and swelling outcomes. The primary outcome is pain score after treatment, with safety and tolerability also monitored. Eligible participants are adults 18–70 years with a history consistent with gout and at least two flares in the past 12 months.

Who should consider this trial

Good fit: Adults aged 18–70 with physician-diagnosed gout who have had two or more flares in the past year and who can attend one of the study sites may be eligible.

Not a fit: Patients who recently used higher-dose glucocorticoids or narcotics, those outside the age or BMI ranges, or those without recurrent flares are unlikely to qualify or gain benefit from this trial.

Why it matters

Potential benefit: If successful, ABP-745 could offer faster or greater relief of pain and swelling than current colchicine treatment for acute gout flares.

How similar studies have performed: Colchicine is an established acute gout treatment, while ABP-745 is investigational and there are limited published data on its effectiveness compared with established therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key 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 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.

Where this trial is running

Peoria, Arizona and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Acute Gouty Arthritis, Gout Flare, Gout Flares, Acute Gout Flare, Gout, Colchicine, Acute gout flare, ABP-745

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.