Extension Study of ABP-671 in Participants With Gout

Phase 2

Terminated

• Conditions: Gout

• Registration Number: NCT06276556
• Lead Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-2-12
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Inclusion Criteria:<br><br> - Must have completed the double-blind Treatment Period in Study ABP-671-301 (Part 1<br> or Part 2) and are actively receiving and tolerating the study drug up to the Week<br> 28 visit in Study ABP-671-301<br><br>Exclusion Criteria:<br><br> - Has a new medical or psychological condition that, in the opinion of the<br> Investigator and/or Medical Monitor, might create undue risk to the participant,<br> interfere with the participant's ability to comply with the protocol requirements to<br> complete the Extension Study, or potentially compromise the results or<br> interpretation of the Extension Study.<br><br> - Is planning to become pregnant or breastfeed during the study or within =30 days<br> after the last dose of the study drug.<br><br> - Is intolerant or unwilling to take colchicine or naproxen.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants who achieve serum uric acid (sUA) levels <6.0 mg/dL (<0.360 mmol/L);Incidence of treatment-emergent adverse events (Safety and Tolerability)

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who achieve sUA levels <5.0 mg/dL (<0.300 mmol/L)