> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-efficacy-of-abp-745-in-participants-with-an-acute-a0736100-e686-483d-83fe-f5eb87f4144c > Record changed: 2026-10-13 # Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare NCT07145229 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) Participants 380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) Lead sponsor Atom Therapeutics Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) Start date 2025-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) Number of sites 38 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Short title** Safety and Efficacy of ABP-745 in Participants With an Acute Gout Flare Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) ## Dates **Completion date** 2026-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **First posted** 2025-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Registry last updated** 2025-12-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Primary completion date** 2026-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Start date** 2025-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) ## Size and sites **Participants** 380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Planned participants** 380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Number of sites** 38 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Lead sponsor** Atom Therapeutics Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) ## Identifiers **Registry ID** NCT07145229 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **ClinicalTrials.gov ID** NCT07145229 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) ## Outcomes ### Primary outcomes 1. Change in Visual Analog Scale (VAS) pain score of the target joint Timeframe: 24 hours post the first dose of study drug Change from baseline in 0-100 mm VAS pain score of the target joint ### Secondary outcomes 1. Change and percentage change from baseline in VAS pain score of the target joint Timeframe: 2-8 days post the first dose of study drug 2. Incidence of treatment-emergent adverse events (Safety and Tolerability) Timeframe: up to 14 days post the first dose of study drug TEAEs and SAEs, and clinically significant changes in physical examination, vital signs, safety laboratory tests, and 12-lead ECG. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 70 Years **Healthy volunteers** No 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) ## Sites - Onyx Clinical ResearchPeoria, United StatesRecruiting - Exinia ResearchLa Mesa, United StatesRecruiting - Evergreen Clinical TrialNorcross, United StatesNot yet recruiting - Bioluminux Clinical ResearchNaperville, United StatesRecruiting - Exinia ResearchDes Moines, United StatesRecruiting - Northshore Research AssociatesAlexandria, United StatesRecruiting - DelRicht ResearchBaton Rouge, United StatesRecruiting - DelRicht ResearchNew Orleans, United StatesRecruiting - Interphase Clinical TrialsLutherville, United StatesRecruiting - DelRicht Research GulfportGulfport, United StatesRecruiting - Albuquerque Clinical Trials, Inc.Albuquerque, United StatesRecruiting - West Clinical ResearchMorehead City, United StatesNot yet recruiting - DelRicht ResearchTulsa, United StatesRecruiting - Premier Family PhysiciansAustin, United StatesNot yet recruiting - Emeritus SydneyBotany, AustraliaRecruiting - Canopy Clinical Research Northern BeachesBrookvale, AustraliaRecruiting - NovatrialsKotara, AustraliaRecruiting - Genesis Research ServicesNewcastle, AustraliaRecruiting - Emeritus MelbourneCamberwell, AustraliaRecruiting - Canopy Clinical Research Altona NorthNorth Altona, AustraliaRecruiting - Peking University Third hospitalBeijing, ChinaRecruiting - Xuanwu Hospital Capital Medical UniversityBeijing, ChinaRecruiting - The second affiliated hospital of guangxi medical universityNanning, ChinaRecruiting - Hebei Petro China Central HospitalLangfang, ChinaRecruiting - Wuhan UHospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaRecruiting And 13 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07145229) ## Related records ### Drugs (2) - [Colchicine](https://trialight.com/data/asset/colchicine-ae804b3e-3263-453f-abb3-ae1e813f2ccf.md) - [Xelafaslatide](https://trialight.com/data/asset/xelafaslatide-acaa45ff-a64e-4124-8a4b-a43b2a5ddf5a.md) ### Lead sponsors (1) - [Atom Therapeutics Co., Ltd](https://trialight.com/data/company/atom-therapeutics-co-ltd-b7d33683-77a8-4d9a-9bb7-39730876d67c.md) ### Conditions (1) - [Gout](https://trialight.com/data/condition/gout-b61aaf55-4a3b-56d9-966a-ca77100d2fc5.md) ### Targets (15) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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