Firsekibart as a Prophylactic Treatment for Acute Gout Flare in Participants Initiating Urate-Lowering Therapy: A Phase 2, Randomized, Open-Label, Multicenter, Active-Controlled Trial.

ABSTRACT:

Objective

To evaluate the efficacy and safety of firsekibart versus colchicine for prophylaxis against acute gout flares in participants initiating urate-lowering therapy (ULT).

Methods

In this randomized, multicenter, open-label, active-controlled, phase 2 trial, participants were randomized (1:1:1) to receive a single subcutaneous injection of firsekibart 100 mg or 200 mg or oral colchicine 0.5 mg/day for 12 weeks. ULT was initiated at baseline or within 1 week before screening. The primary endpoint was the mean number of acute gout flares per participant over 12 weeks.

Results

A total of 162 participants received firsekibart 100 mg (n = 55), 200 mg (n = 52), or colchicine (n = 55). Baseline characteristics were comparable between groups. No flares were observed in

SUBMITTER: Yu Y 

PROVIDER: S-EPMC12592937 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature