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NCT07145229PHASE2Recruiting

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

Atom Therapeutics Co., Ltd

Start Date

8/26/2025

Completion Date

6/1/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to 70 years

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.

Interventions

DRUG

ABP-745 Dose A

DRUG

ABP-745 Dose B

DRUG

Colchicine

DRUG

Placebo

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Conditions

Acute Gouty ArthritisGout FlareGout FlaresAcute Gout Flare

Locations

Onyx Clinical Research

Peoria, Arizona 61636

United States

Exinia Research

La Mesa, California 91942

United States

Evergreen Clinical Trial

Norcross, Georgia 30003

United States

Bioluminux Clinical Research

Naperville, Illinois 60540

United States

Exinia Research

Des Moines, Iowa 50308

United States

Northshore Research Associates

Alexandria, Louisiana 71303

United States

DelRicht Research

Baton Rouge, Louisiana 70769

United States

DelRicht Research

New Orleans, Louisiana 70115

United States

Interphase Clinical Trials

Lutherville, Maryland 21093

United States

DelRicht Research Gulfport

Gulfport, Mississippi 39501

United States

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico 87176

United States

West Clinical Research

Morehead City, North Carolina 28557

United States

DelRicht Research

Tulsa, Oklahoma 74133

United States

Premier Family Physicians

Austin, Texas 78734

United States

Emeritus Sydney

Botany, New South Wales 2019

Australia

Canopy Clinical Research Northern Beaches

Brookvale, New South Wales 2100

Australia

Novatrials

Kotara, New South Wales 2289

Australia

Genesis Research Services

Newcastle, New South Wales 2019

Australia

Emeritus Melbourne

Camberwell, Victoria 3124

Australia

Canopy Clinical Research Altona North

North Altona, Victoria 3025

Australia

Peking University Third hospital

Beijing, Beijing Municipality 100000

China

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality 100000

China

The second affiliated hospital of guangxi medical university

Nanning, Guangxi 530000

China

Hebei Petro China Central Hospital

Langfang, Hebei 065000

China

Wuhan UHospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei 430000

China

Xiangtan Central Hospital

Xiangtan, Hunan 411100

China

Xiangya Hospital Zhuzhou Central South University

Zhuzhou, Hunan 412000

China

Huai'an First People's Hospital

Huai'an, Jiangsu 223000

China

Pingxiang People's Hospital

Pingxiang, Jiangxi 337000

China

Zaozhuang Municipal Hospital

Zaozhuang, Shandong 277100

China

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality 200040

China

Linfen Central hospital

Linfen, Shanxi 041000

China

Shanxi Bethune Hospital

Taiyuan, Shanxi 030000

China

Shaanxi Provincial People's Hospital

Xi’an, Shanxi 710000

China

Xi'an Daxing Hospital

Xi’an, Shanxi 710000

China

Chengdu Fifth People's Hospital

Chengdu, Sichuan 610000

China

Hangzhou First People's Hospital

Hangzhou, Zhejiang 310000

China

Wenzhou People's Hospital

Wenzhou, Zhejiang 325000

China