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
1 other identifier
interventional
380
3 countries
38
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2025
Shorter than P25 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2025
CompletedStudy Start
First participant enrolled
August 26, 2025
CompletedFirst Posted
Study publicly available on registry
August 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedDecember 8, 2025
December 1, 2025
8 months
August 13, 2025
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Visual Analog Scale (VAS) pain score of the target joint
Change from baseline in 0-100 mm VAS pain score of the target joint
24 hours post the first dose of study drug
Secondary Outcomes (2)
Change and percentage change from baseline in VAS pain score of the target joint
2-8 days post the first dose of study drug
Incidence of treatment-emergent adverse events (Safety and Tolerability)
up to 14 days post the first dose of study drug
Study Arms (4)
ABP-745 Dose A
EXPERIMENTALABP-745 Dose B
EXPERIMENTALColchicine
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2025
First Posted
August 28, 2025
Study Start
August 26, 2025
Primary Completion
May 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
December 8, 2025
Record last verified: 2025-12