Acute Gouty ArthritisPhase 2NCT07145229
Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare
A Phase 2 study testing ABP-745 Dose A, ABP-745 Dose B and Colchicine in people with Acute Gouty Arthritis and Gout Flare, run by Atom Therapeutics Co., Ltd at 38 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Gouty Arthritis, Gout Flare, Gout Flares
- What is being tested?
- ABP-745 Dose A, ABP-745 Dose B and Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 38 sitesin 3 countries
- Study dates
- 26 Aug 2025to Jun 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
38 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
38 sites in 3 countries
China18 sites, 18 recruiting
- Recruiting
Peking University Third hospital
Beijing, Beijing Municipality, 100000
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100000
- Recruiting
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 610000
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310000
- Recruiting
Huai'an First People's Hospital
Huai'an, Jiangsu, 223000
- Recruiting
Hebei Petro China Central Hospital
Langfang, Hebei, 065000
- Recruiting
Linfen Central hospital
Linfen, Shanxi, 041000
- Recruiting
The second affiliated hospital of guangxi medical university
Nanning, Guangxi, 530000
- Recruiting
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000
- Recruiting
Wenzhou People's Hospital
Wenzhou, Zhejiang, 325000
- Recruiting
Wuhan UHospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
- Recruiting
Shaanxi Provincial People's Hospital
Xi’an, Shanxi, 710000
- Recruiting
Xi'an Daxing Hospital
Xi’an, Shanxi, 710000
- Recruiting
Xiangtan Central Hospital
Xiangtan, Hunan, 411100
- Recruiting
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, 277100
- Recruiting
Xiangya Hospital Zhuzhou Central South University
Zhuzhou, Hunan, 412000
United States14 sites, 14 recruiting
- Recruiting
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87176
- Recruiting
Northshore Research Associates
Alexandria, Louisiana, 71303
- Not yet recruiting
Premier Family Physicians
Austin, Texas, 78734
- Recruiting
DelRicht Research
Baton Rouge, Louisiana, 70769
- Recruiting
Exinia Research
Des Moines, Iowa, 50308
- Recruiting
DelRicht Research Gulfport
Gulfport, Mississippi, 39501
- Recruiting
Exinia Research
La Mesa, California, 91942
- Recruiting
Interphase Clinical Trials
Lutherville, Maryland, 21093
- Not yet recruiting
West Clinical Research
Morehead City, North Carolina, 28557
- Recruiting
Bioluminux Clinical Research
Naperville, Illinois, 60540
- Recruiting
DelRicht Research
New Orleans, Louisiana, 70115
- Not yet recruiting
Evergreen Clinical Trial
Norcross, Georgia, 30003
- Recruiting
Onyx Clinical Research
Peoria, Arizona, 61636
- Recruiting
DelRicht Research
Tulsa, Oklahoma, 74133
Australia6 sites, 6 recruiting
- Recruiting
Emeritus Sydney
Botany, New South Wales, 2019
- Recruiting
Canopy Clinical Research Northern Beaches
Brookvale, New South Wales, 2100
- Recruiting
Emeritus Melbourne
Camberwell, Victoria, 3124
- Recruiting
Novatrials
Kotara, New South Wales, 2289
- Recruiting
Genesis Research Services
Newcastle, New South Wales, 2019
- Recruiting
Canopy Clinical Research Altona North
North Altona, Victoria, 3025
About this study
Official title: 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
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
- Acute Gouty Arthritis, Gout Flare, Gout Flares, Acute Gout Flare
- Being tested
- ABP-745 Dose A, ABP-745 Dose B, Colchicine, Placebo
- Keywords
- Gout, Gout Flare, Colchicine, Acute gout flare, ABP-745
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP-745 Dose ADrug
ABP-745 Dose A + Colchicine placebo - tablets (PO)
ABP-745 Dose BDrug
ABP-745 Dose B + Colchicine placebo - tablets (PO)
ColchicineDrug
ABP-745 placebo + Colchicine - tablets (PO)
PlaceboDrug
ABP-745 placebo + Colchicine placebo - tablets (PO)
| Study group | Role | What they receive |
|---|---|---|
| ABP-745 Dose A | Experimental | Not described Receives: Drug: ABP-745 Dose A |
| ABP-745 Dose B | Experimental | Not described Receives: Drug: ABP-745 Dose B |
| Colchicine | Active comparator | Not described Receives: Drug: Colchicine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) pain score of the target joint
Change from baseline in 0-100 mm VAS pain score of the target joint
Measured: 24 hours post the first dose of study drug
Secondary outcomes (2)
Change and percentage change from baseline in VAS pain score of the target joint
Measured: 2-8 days post the first dose of study drug
Incidence of treatment-emergent adverse events (Safety and Tolerability)
TEAEs and SAEs, and clinically significant changes in physical examination, vital signs, safety laboratory tests, and 12-lead ECG.
Measured: up to 14 days post the first dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start26 Aug 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gouty ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atom Therapeutics Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145229
- Sponsor's protocol ID
- ABP-745-201
- Status last verified
- Dec 2025
- First submitted
- 13 Aug 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided