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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

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.

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.

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)

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