Extension Study of ABP-671 in Participants With Gout
- Registration Number
- NCT06276556
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 580
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Allopurinol Allopurinol - ABP-671 ABP-671 -
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (Safety and Tolerability) Week 26 Incidence of treatment-emergent adverse events (TEAEs), including AEs of special interest (AESIs), serious AEs (SAEs), and AEs leading to study treatment discontinuation
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L) Week 26
- Secondary Outcome Measures
Name Time Method Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L) Week 26
Trial Locations
- Locations (54)
Alliance for Multispecialty Research
🇺🇸Tempe, Arizona, United States
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
Scroll for more (44 remaining)Alliance for Multispecialty Research🇺🇸Tempe, Arizona, United States