Extension Study of ABP-671 in Participants With Gout

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Gout

In brief

The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3).

Key facts

Study ID

NCT06276556

Run by

Atom Therapeutics Co., Ltd

People needed

43

Starts

2024-04-22

Expected to finish

2024-09-05

Last updated by the study team

2025-07-16

Who can join

Age: 19 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have completed the double-blind Treatment Period in Study ABP-671-301 (Part 1 or Part 2) and are actively receiving and tolerating the study drug up to the Week 28 visit in Study ABP-671-301

You may not qualify if…

• Has a new medical or psychological condition that, in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the participant, interfere with the participant's ability to comply with the protocol requirements to complete the Extension Study, or potentially compromise the results or interpretation of the Extension Study.
• Is planning to become pregnant or breastfeed during the study or within ≤30 days after the last dose of the study drug.
• Is intolerant or unwilling to take colchicine or naproxen.

Where it is running

• Tucson Neuroscience Research, LLC — Tucson, Arizona, United States
• Anaheim Clinical Trials (Cenexel ACT) — Anaheim, California, United States
• Center for Clinical Trials of Sacramento — Sacramento, California, United States
• Access Research Institute — Brooksville, Florida, United States
• Nature Coast Clinical Reasearch — Crystal River, Florida, United States
• JY Research Institute Inc. — Cutler Bay, Florida, United States
• Accel Clinical Research Site — DeLand, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• A & D Doctor Center — Miami, Florida, United States
• Bioclinical Research Alliance — Miami, Florida, United States
• Cordova Research Institute — Miami, Florida, United States
• Century Research LLC — Miami, Florida, United States
• ITB Research — Miami, Florida, United States
• Combined Research Orlando Phase I-IV — Orlando, Florida, United States
• New Horizons Research — Palmetto Bay, Florida, United States
• Advanced Clinical Research of Atlanta — Atlanta, Georgia, United States
• Centricity Research — Columbus, Georgia, United States
• Alliance for Multispecialty Research, LLC. — Newton, Kansas, United States
• DelRicht Research — New Orleans, Louisiana, United States
• AMR — New Orleans, Louisiana, United States
• Annapolis Internal Medicine/CCT Research — Annapolis, Maryland, United States
• DelRicht Research of Gulfport — Gulfport, Mississippi, United States
• Quality Clinical Research, Inc — Omaha, Nebraska, United States
• Santa Rosa Medical Center — Las Vegas, Nevada, United States
• Alliance for Multispecialty Research — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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