The trial is taking place at:
B

Bioclinical Research Alliance | Miami, FL

Veeva-enabled site

Extension Study of ABP-671 in Participants With Gout

A

Atom Bioscience

Status and phase

Invitation-only
Phase 3
Phase 2

Conditions

Gout

Treatments

Drug: ABP-671
Drug: Allopurinol

Study type

Interventional

Funder types

Industry

Identifiers

NCT06276556
ABP-671-302

Details and patient eligibility

About

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).

Enrollment

580 estimated patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

580 participants in 2 patient groups

ABP-671
Experimental group
Treatment:
Drug: ABP-671
Allopurinol
Active Comparator group
Treatment:
Drug: Allopurinol

Trial contacts and locations

54

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Data sourced from clinicaltrials.gov

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