Actively Recruiting
Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare
Led by Atom Therapeutics Co., Ltd · Updated on 2025-12-08
380
Participants Needed
38
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old, male or female
- Body mass index (BMI) between 18 and 40 kg/m2
- Medical history and current findings consistent with gouty arthritis diagnosis
- Experienced 2 or more gout flares in the 12 months before screening
- Onset of an acute gout flare within the last 6 months
- Stable doses of urate-lowering therapy before and during the treatment period
- Agreement to maintain a stable lifestyle including diet and exercise during the study period
You will not qualify if you...
- Use of oral prednisone 10 mg or higher, narcotics within 24 hours before first study drug dose, or glucocorticoid injection within 14 days before first dose
- Use of nonsteroidal anti-inflammatory drugs before first study drug dose at investigator's discretion
- Use of colchicine or ABP-745 within 14 days before first study drug dose
- Participation in any clinical study with investigational drugs within 1 month before and during the study
- Use of pegloticase, methotrexate, IL-1 blockers, TNF inhibitors, or other biologics within 30 days or 5 half-lives before first study drug dose
- Use of muscle relaxants, central stimulants, barbiturates within 30 days or 5 half-lives before first study drug dose
- Secondary gout caused by chemotherapy or transplant
- Current or past rheumatoid arthritis, psoriatic arthritis, infectious/septic arthritis, CPP crystal arthritis, acute polyarticular gout (4 or more joints), multiple sclerosis, demyelinating diseases, major chronic inflammatory or connective tissue diseases other than RA or PsA
- Prosthetic joint infection within 5 years or native joint infection within 1 year before screening
- Current anticoagulation therapy, thrombocytopenia, or bleeding disorders
- History of malignancy within 5 years except localized basal cell carcinoma
- Significant diseases including uncontrolled hypertension, congestive heart failure NYHA class III or above, uncontrolled diabetes with HbA1c over 8.5%
- Women of childbearing potential
- Only no or mild gout-related pain before first study drug dose
- Use of gout flare prophylaxis at randomization
- COVID-19 vaccination within 4 weeks before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
Onyx Clinical Research
Peoria, Arizona, United States, 61636
Actively Recruiting
2
Exinia Research
La Mesa, California, United States, 91942
Actively Recruiting
3
Evergreen Clinical Trial
Norcross, Georgia, United States, 30003
Not Yet Recruiting
4
Bioluminux Clinical Research
Naperville, Illinois, United States, 60540
Actively Recruiting
5
Exinia Research
Des Moines, Iowa, United States, 50308
Actively Recruiting
6
Northshore Research Associates
Alexandria, Louisiana, United States, 71303
Actively Recruiting
7
DelRicht Research
Baton Rouge, Louisiana, United States, 70769
Actively Recruiting
8
DelRicht Research
New Orleans, Louisiana, United States, 70115
Actively Recruiting
9
Interphase Clinical Trials
Lutherville, Maryland, United States, 21093
Actively Recruiting
10
DelRicht Research Gulfport
Gulfport, Mississippi, United States, 39501
Actively Recruiting
11
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States, 87176
Actively Recruiting
12
West Clinical Research
Morehead City, North Carolina, United States, 28557
Not Yet Recruiting
13
DelRicht Research
Tulsa, Oklahoma, United States, 74133
Actively Recruiting
14
Premier Family Physicians
Austin, Texas, United States, 78734
Not Yet Recruiting
15
Emeritus Sydney
Botany, New South Wales, Australia, 2019
Actively Recruiting
16
Canopy Clinical Research Northern Beaches
Brookvale, New South Wales, Australia, 2100
Actively Recruiting
17
Novatrials
Kotara, New South Wales, Australia, 2289
Actively Recruiting
18
Genesis Research Services
Newcastle, New South Wales, Australia, 2019
Actively Recruiting
19
Emeritus Melbourne
Camberwell, Victoria, Australia, 3124
Actively Recruiting
20
Canopy Clinical Research Altona North
North Altona, Victoria, Australia, 3025
Actively Recruiting
21
Peking University Third hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
22
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
23
The second affiliated hospital of guangxi medical university
Nanning, Guangxi, China, 530000
Actively Recruiting
24
Hebei Petro China Central Hospital
Langfang, Hebei, China, 065000
Actively Recruiting
25
Wuhan UHospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
26
Xiangtan Central Hospital
Xiangtan, Hunan, China, 411100
Actively Recruiting
27
Xiangya Hospital Zhuzhou Central South University
Zhuzhou, Hunan, China, 412000
Actively Recruiting
28
Huai'an First People's Hospital
Huai'an, Jiangsu, China, 223000
Actively Recruiting
29
Pingxiang People's Hospital
Pingxiang, Jiangxi, China, 337000
Actively Recruiting
30
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China, 277100
Actively Recruiting
31
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
32
Linfen Central hospital
Linfen, Shanxi, China, 041000
Actively Recruiting
33
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
34
Shaanxi Provincial People's Hospital
Xi’an, Shanxi, China, 710000
Actively Recruiting
35
Xi'an Daxing Hospital
Xi’an, Shanxi, China, 710000
Actively Recruiting
36
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
37
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
38
Wenzhou People's Hospital
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
U
Ullrich Schwertschlag, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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