Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAtom Therapeutics Co., Ltd
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ABP-745 Dose A
- ABP-745 Dose B
- Colchicine
- Placebo
Treatment groups
380 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov