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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
This is a randomized, parallel‐arm, multicenter study to compare the safety and efficacy profiles of SEL‐212 and KRYSTEXXA®. Participants 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 participants in the SEL‐212 arm will receive study drug every 28 days for a total of up to 6 infusions of SEL‐212. Study participants 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.
Epistemonikos ID: a88bbb865793af4c3b5a9fb39a7c8403efc55e09
First added on: May 22, 2024