Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
380 (estimated)
Sponsor
Atom Therapeutics Co., Ltd · Industry
Who this trial is looking for
This trial is looking for adults who have experienced multiple gout flares. Participants will take ABP-745 or standard treatment to see if it helps reduce pain and swelling during an acute gout flare.
Are You a Good Fit for This Trial?
Rules you outRheumatoid arthritisPsoriatic arthritisSeptic arthritisMultiple sclerosisAplastic anemiaHemophilia
You may be able to join if
I am between 18 and 70 years old.
I have a body mass index (BMI) between 18 and 40.
I have been diagnosed with gouty arthritis.
I have had 2 or more gout flares in the last year.
I have had an acute gout flare within the last 6 months.
I agree to keep my lifestyle stable during the study.
You may not be able to join if
I have taken oral prednisone of 10 mg or more in the last 24 hours.
I have used NSAIDs before starting the study drug.
I have taken colchicine or ABP-745 in the past 14 days.
I have participated in another clinical study in the past month.
I have taken certain medications like methotrexate or biologics in the past 30 days.
I have a current diagnosis of rheumatoid arthritis or similar diseases.
I am currently undergoing anticoagulation therapy.
I have had a significant disease like uncontrolled hypertension.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
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Eligibility Criteria
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.
…
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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