A Phase 3 Study of SEL-212 in Gout Patients Refractory to Conventional Therapy
Brief description of study
The main purpose of this study is to find out how well an experimental drug called SEL-212 can reduce uric acid levels and maintains reduced levels compared to a similar approved drug called Krystexxa®.This study is a randomized, open-label, parallel-arm study to compare the safety and efficacy profiles of SEL-212 to KRYSTEXXA. Approximately 150 patients will be randomized 1:1 at Baseline to receive treatment with SEL-212 or KRYSTEXXA for 6 months. Efficacy assessments, as measured by SUA levels, will be conducted at intervals that are appropriate to determine treatment effect differences, including at month 3 and month 6. Assessments of qualitative endpoints will be conducted on an assessor-blinded basis. Safety will be monitored throughout the study.
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