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
Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
⁃ 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.
Locations
United States
Arizona
Onyx Clinical Research
RECRUITING
Peoria
California
Exinia Research
RECRUITING
La Mesa
Georgia
Evergreen Clinical Trial
NOT_YET_RECRUITING
Norcross
Iowa
Exinia Research
RECRUITING
Des Moines
Illinois
Bioluminux Clinical Research
RECRUITING
Naperville
Louisiana
Northshore Research Associates
RECRUITING
Alexandria
DelRicht Research
RECRUITING
Baton Rouge
DelRicht Research
RECRUITING
New Orleans
Maryland
Interphase Clinical Trials
RECRUITING
Lutherville
Mississippi
DelRicht Research Gulfport
RECRUITING
Gulfport
North Carolina
West Clinical Research
NOT_YET_RECRUITING
Morehead City
New Mexico
Albuquerque Clinical Trials, Inc.
RECRUITING
Albuquerque
Oklahoma
DelRicht Research
RECRUITING
Tulsa
Texas
Premier Family Physicians
NOT_YET_RECRUITING
Austin
Other Locations
Australia
Emeritus Sydney
RECRUITING
Botany
Canopy Clinical Research Northern Beaches
RECRUITING
Brookvale
Emeritus Melbourne
RECRUITING
Camberwell
Novatrials
RECRUITING
Kotara
Genesis Research Services
RECRUITING
Newcastle
Canopy Clinical Research Altona North
RECRUITING
North Altona
China
Peking University Third hospital
RECRUITING
Beijing
Xuanwu Hospital Capital Medical University
RECRUITING
Beijing
Chengdu Fifth People's Hospital
RECRUITING
Chengdu
Hangzhou First People's Hospital
RECRUITING
Hangzhou
Huai'an First People's Hospital
RECRUITING
Huai'an
Hebei Petro China Central Hospital
RECRUITING
Langfang
Linfen Central hospital
RECRUITING
Linfen
The second affiliated hospital of guangxi medical university
RECRUITING
Nanning
Pingxiang People's Hospital
RECRUITING
Pingxiang
Huashan Hospital, Fudan University
RECRUITING
Shanghai
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Wenzhou People's Hospital
RECRUITING
Wenzhou
Wuhan UHospital, Tongji Medical College, Huazhong University of Science and Technology