At a glance
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A Randomized Double-Blind, Placebo-Controlled Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
In Brief
A Phase 3 clinical trial evaluating SEL-212 low-dose, SEL-212 high-dose, and 1 other intervention for Chronic Gout. Completed, enrolled 112 participants across 40 sites.
Detailed Summary
This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo. 112 and 153 patients, stratified as to the presence or absence of tophi, were randomized in a 1:1:1 allocation ratio prior to Baseline to receive treatment with one of two dose levels of SEL-212 or placebo every 28 days for approximately 6 months in each trial respectively (SEL-212/301 and SEL-212/302). Analysis of primary and key efficacy was performed at Day 28 of Treatment Period 6. Safety was monitored throughout the study.
Study Details
Timeline
Interventions
IV infusion of SEL-212 low-dose every 28 days for a total of up to 12 infusions
IV infusion of SEL-212 high-dose every 28 days for a total of up to 12 infusions
IV infusion of Normal Saline every 28 days for a total of up to 12 infusions