Last updated on July 2019

A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA in Gout Patients Refractory to Conventional Therapy

Brief description of study

This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA. Patients will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA for 6 months. Efficacy assessments, as measured by serum uric acid (SUA) levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.

Detailed Study Description

This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA. Patients will be randomized 1:1 to receive treatment with SEL-212 [a combination of pegadricase (SEL-037) and ImmTOR (SEL-110)] or KRYSTEXXA for 6 months.

Study patients in the SEL-212 arm will receive study drug every 28 days for a total of up to 6 infusions of SEL-212. Study patients in the KRYSTEXXA arm will receive study drug according to the manufacturer's prescribing information, i.e., every 14 days for a total of up to 12 infusions of KRYSTEXXA.

Efficacy assessments, as measured by SUA levels, will be conducted at intervals that are appropriate to determine treatment effect differences. Safety will be monitored throughout the study.