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

Summary

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 participants will be treated with multiple doses ( 5 monthly IV infusions) of pegsiticase (SEL-037) alone. Participants will be monitored for safety endpoints through the 5th treatment cycle plus 30 days .Pharmacokinetic samples will be drawn at pre-determined time points in addition to weekly serum uric acid levels.

Timeline

Start

2016-10

Primary completion

2018-12

Completion

2019-01

Publications

• Kivitz A, DeHaan W, Azeem R, Park J, Rhodes S, Inshaw J, Leung SS, Nicolaou S, Johnston L, Kishimoto TK, Traber PG, Sands E, Choi H. Phase 2 Dose-Finding Study in Patients with Gout Using SEL-212, a Novel PEGylated Uricase (SEL-037) Combined with Tolerogenic Nanoparticles (SEL-110). Rheumatol Ther. 2023 Aug;10(4):825-847. doi: 10.1007/s40744-023-00546-0. Epub 2023 Apr 17.

Drugs

Indications