Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare
NCT ID: NCT07145229
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
380 participants
INTERVENTIONAL
2025-08-26
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ABP-745 Dose A
ABP-745 Dose A
ABP-745 Dose A + Colchicine placebo - tablets (PO)
ABP-745 Dose B
ABP-745 Dose B
ABP-745 Dose B + Colchicine placebo - tablets (PO)
Colchicine
Colchicine
ABP-745 placebo + Colchicine - tablets (PO)
Placebo
Placebo
ABP-745 placebo + Colchicine placebo - tablets (PO)
Interventions
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ABP-745 Dose A
ABP-745 Dose A + Colchicine placebo - tablets (PO)
ABP-745 Dose B
ABP-745 Dose B + Colchicine placebo - tablets (PO)
Colchicine
ABP-745 placebo + Colchicine - tablets (PO)
Placebo
ABP-745 placebo + Colchicine placebo - tablets (PO)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Atom Therapeutics Co., Ltd
INDUSTRY
Responsible Party
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Locations
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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
Peking University Third hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
The second affiliated hospital of guangxi medical university
Nanning, Guangxi, China
Hebei Petro China Central Hospital
Langfang, Hebei, China
Wuhan UHospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangtan Central Hospital
Xiangtan, Hunan, China
Xiangya Hospital Zhuzhou Central South University
Zhuzhou, Hunan, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Linfen Central hospital
Linfen, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Shaanxi Provincial People's Hospital
Xi’an, Shanxi, China
Xi'an Daxing Hospital
Xi’an, Shanxi, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Wenzhou People's Hospital
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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ABP-745-201
Identifier Type: -
Identifier Source: org_study_id
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