A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II
Status:
Recruiting
Trial end date:
2022-05-01
Target enrollment:
Participant gender:
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. Approximately 105 patients, stratified as to the presence or absence of tophi,
will be 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 (SEL-212/301 and SEL-212/302). Analysis of efficacy will be performed at Day 28 of
Treatment Period 6. Safety will be monitored throughout the study.