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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare (NCT07145229) is a Phase 2 interventional studying Acute Gouty Arthritis and Gout Flare, sponsored by Atom Therapeutics Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Acute Gouty Arthritis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 380 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Key Who May Qualify: Subjects are eligible for the study if they meet all of the following Who May Qualify: - 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 Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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)

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Onyx Clinical Research
Peoria, Arizona, United States
Exinia Research
La Mesa, California, United States
Evergreen Clinical Trial
Norcross, Georgia, United States
Bioluminux Clinical Research
Naperville, Illinois, United States
Exinia Research
Des Moines, Iowa, United States
Northshore Research Associates
Alexandria, Louisiana, United States
DelRicht Research
Baton Rouge, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Interphase Clinical Trials
Lutherville, Maryland, United States
DelRicht Research Gulfport
Gulfport, Mississippi, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
West Clinical Research
Morehead City, North Carolina, United States
DelRicht Research
Tulsa, Oklahoma, United States
Premier Family Physicians
Austin, Texas, United States
Emeritus Sydney
Botany, New South Wales, Australia
Canopy Clinical Research Northern Beaches
Brookvale, New South Wales, Australia
Novatrials
Kotara, New South Wales, Australia
Genesis Research Services
Newcastle, New South Wales, Australia
Emeritus Melbourne
Camberwell, Victoria, Australia
Canopy Clinical Research Altona North
North Altona, Victoria, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07145229), the sponsor (Atom Therapeutics Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07145229 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07145229?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07145229?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07145229. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07145229. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.