Last updated on February 2018

Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid


Brief description of study

This is an open label multicenter study to evaluate the safety and tolerability of multiple doses(3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase( SEL-037) and SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase (SEL-037) alone for a total of 5 treatment cycles in subjects with symptomatic gout and hyperuricemia. Additional subjects will be treated with multiple doses( 5 monthly IV infusions) of pegsiticase (SEL-037) alone.

Subjects will be monitored for safety endpoints through the 5th treatment cycle plus 30 days .Pharmacokinetic samples will drawn a pre-determined time points in addition to weekly serum uric acid levels.

Detailed Study Description

This is an open label multicenter study to evaluate the safety and tolerability of multiple doses(3 monthly IV infusions) of SEL-212( a combination of pegsiticase( SEL-037) and SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase (SEL-037) alone for a total of 5 treatment cycles in subjects with symptomatic gout and hyperuricemia. Additional subjects will be treated with multiple doses( 5 monthly IV infusions) of pegsiticase (SEL-037) alone.

Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming. All subjects will be monitored for safety and tolerability to drug throughout the study on a weekly schedule. Pharmacokinetic and pharmacodynamic parameters will at specific timepoints to monitor for continued efficacy. Pharmacodynamic parameters measured include uric acid levels and levels of ADAs.

The study duration per enrolled subject will be approximately 6 months including a 1 month screening period followed by 5 treatment cycles and an end of treatment visit which will occur 30 days after the last IV infusion .

Clinical Study Identifier: NCT02959918

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Earl E Sands, MD

Omega Research Consultants LLC
DeBary, FL United States
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