New gout drug aims to beat pain faster than standard treatment

NCT ID NCT07145229

Symptom relief Sponsor: Atom Therapeutics Co., Ltd Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 2 trial tests an experimental drug called ABP-745 against colchicine (a standard gout medicine) and a placebo in 380 adults with acute gout flares. The goal is to see if ABP-745 reduces pain and swelling better than current options. Participants will take tablets and report their pain levels over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: ABP-745 (an experimental drug) and colchicine (standard gout medication)
What this could lead to: If successful, ABP-745 could offer a new option for quickly reducing pain and swelling during an acute gout flare.
What could go wrong: This is an early Phase 2 trial with only 380 participants, so results may not apply to everyone. The drug may not work better than existing treatments or could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 380 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

gout

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute gout flare Acute gouty arthritis Gout flare Gout flares

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

38 sites in 3 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Albuquerque Clinical Trials, Inc.
RECRUITING

Albuquerque, New Mexico, 87176, United States
Bioluminux Clinical Research
RECRUITING

Naperville, Illinois, 60540, United States
Canopy Clinical Research Altona North
RECRUITING

North Altona, Victoria, 3025, Australia
Canopy Clinical Research Northern Beaches
RECRUITING

Brookvale, New South Wales, 2100, Australia
Chengdu Fifth People's Hospital
RECRUITING

Chengdu, Sichuan, 610000, China
DelRicht Research
RECRUITING

Baton Rouge, Louisiana, 70769, United States
DelRicht Research
RECRUITING

New Orleans, Louisiana, 70115, United States
DelRicht Research
RECRUITING

Tulsa, Oklahoma, 74133, United States
DelRicht Research Gulfport
RECRUITING

Gulfport, Mississippi, 39501, United States
Emeritus Melbourne
RECRUITING

Camberwell, Victoria, 3124, Australia
Emeritus Sydney
RECRUITING

Botany, New South Wales, 2019, Australia
Evergreen Clinical Trial
NOT_YET_RECRUITING

Norcross, Georgia, 30003, United States
Exinia Research
RECRUITING

La Mesa, California, 91942, United States
Exinia Research
RECRUITING

Des Moines, Iowa, 50308, United States
Genesis Research Services
RECRUITING

Newcastle, New South Wales, 2019, Australia
Hangzhou First People's Hospital
RECRUITING

Hangzhou, Zhejiang, 310000, China
Hebei Petro China Central Hospital
RECRUITING

Langfang, Hebei, 065000, China
Huai'an First People's Hospital
RECRUITING

Huai'an, Jiangsu, 223000, China
Huashan Hospital, Fudan University
RECRUITING

Shanghai, Shanghai Municipality, 200040, China
Interphase Clinical Trials
RECRUITING

Lutherville, Maryland, 21093, United States
Linfen Central hospital
RECRUITING

Linfen, Shanxi, 041000, China
Northshore Research Associates
RECRUITING

Alexandria, Louisiana, 71303, United States
Novatrials
RECRUITING

Kotara, New South Wales, 2289, Australia
Onyx Clinical Research
RECRUITING

Peoria, Arizona, 61636, United States
Peking University Third hospital
RECRUITING

Beijing, Beijing Municipality, 100000, China
Pingxiang People's Hospital
RECRUITING

Pingxiang, Jiangxi, 337000, China
Premier Family Physicians
NOT_YET_RECRUITING

Austin, Texas, 78734, United States
Shaanxi Provincial People's Hospital
RECRUITING

Xi’an, Shanxi, 710000, China
Shanxi Bethune Hospital
RECRUITING

Taiyuan, Shanxi, 030000, China
The second affiliated hospital of guangxi medical university
RECRUITING

Nanning, Guangxi, 530000, China
Wenzhou People's Hospital
RECRUITING

Wenzhou, Zhejiang, 325000, China
West Clinical Research
NOT_YET_RECRUITING

Morehead City, North Carolina, 28557, United States
Wuhan UHospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING

Wuhan, Hubei, 430000, China
Xi'an Daxing Hospital
RECRUITING

Xi’an, Shanxi, 710000, China
Xiangtan Central Hospital
RECRUITING

Xiangtan, Hunan, 411100, China
Xiangya Hospital Zhuzhou Central South University
RECRUITING

Zhuzhou, Hunan, 412000, China
Xuanwu Hospital Capital Medical University
RECRUITING

Beijing, Beijing Municipality, 100000, China
Zaozhuang Municipal Hospital
RECRUITING

Zaozhuang, Shandong, 277100, China

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