Recruiting
Phase 2

ABP-745

Sponsor:

Atom Therapeutics Co., Ltd

Code:

NCT07145229

Conditions

Acute Gouty Arthritis

Gout Flare

Gout Flares

Acute Gout Flare

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

ABP-745 Dose A

ABP-745 Dose B

Colchicine

Placebo

Study Details

Brief 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.

Conditions

Acute Gouty Arthritis

Gout Flare

Gout Flares

Acute Gout Flare

Study ID

NCT07145229

Start date

Aug 26, 2025

Status verified date

Dec, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

380 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABP-745 Dose A

experimental: ABP-745 Dose B

active comparator: Colchicine

placebo comparator: Placebo

Interventions

ABP-745 Dose A

ABP-745 Dose A + Colchicine placebo - tablets (PO)

ABP-745 Dose B

ABP-745 Dose B + Colchicine placebo - tablets (PO)

Colchicine

ABP-745 placebo + Colchicine - tablets (PO)

Placebo

ABP-745 placebo + Colchicine placebo - tablets (PO)

Primary outcome measure

  • Change in Visual Analog Scale (VAS) pain score of the target joint [ Time Frame: 24 hours post the first dose of study drug ]

Central Contacts and Locations

Central contacts

Ullrich Schwertschlag, MD,PhD

1-978-257-1926ullrich.schwertschlag@atombp.com

Locations

Onyx Clinical Research

Recruiting

Peoria, Arizona, United States, 61636

Exinia Research

Recruiting

La Mesa, California, United States, 91942

Bioluminux Clinical Research

Recruiting

Naperville, Illinois, United States, 60540

Exinia Research

Recruiting

Des Moines, Iowa, United States, 50308

Northshore Research Associates

Recruiting

Alexandria, Louisiana, United States, 71303

DelRicht Research

Recruiting

Baton Rouge, Louisiana, United States, 70769

DelRicht Research

Recruiting

New Orleans, Louisiana, United States, 70115

Interphase Clinical Trials

Recruiting

Lutherville, Maryland, United States, 21093

DelRicht Research Gulfport

Recruiting

Gulfport, Mississippi, United States, 39501

Albuquerque Clinical Trials, Inc.

Recruiting

Albuquerque, New Mexico, United States, 87176

DelRicht Research

Recruiting

Tulsa, Oklahoma, United States, 74133

More Information

Sponsor

Atom Therapeutics Co., Ltd

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Keywords

  • Gout
  • Gout Flare
  • Colchicine
  • Acute gout flare
  • ABP-745

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Atom Therapeutics Co., Ltd on 2025-12-08.