Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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, also known as pegadricase) 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 participants with symptomatic gout and hyperuricemia. Additional participants 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 participants 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 participant 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 . ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02959918
Study type Interventional
Source Selecta Biosciences, Inc.
Contact
Status Completed
Phase Phase 2
Start date October 2016
Completion date January 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05434858 - Imagery as Biomarker of Gout N/A
Completed NCT04060173 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 Phase 1
Recruiting NCT05504083 - Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients Phase 2
Completed NCT04966325 - Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects Early Phase 1
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT00995618 - Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia Phase 2
Completed NCT00288158 - Primary Prevention of Hypertension in Obese Adolescents Phase 2
Terminated NCT04987294 - Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease Phase 2
Completed NCT04236219 - ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers Phase 1
Completed NCT06189404 - Effect of Tigulixostat on the Pharmacokinetics of Theophylline Phase 1
Recruiting NCT05586958 - Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients Phase 3
Recruiting NCT06084585 - The Efficacy of Amway Uric Acid Lowering Product on Hyperuricemia N/A
Recruiting NCT06056570 - Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia Phase 1/Phase 2
Not yet recruiting NCT04586803 - Study on the Bioavailability of Three Different Prescription Processes of SHR4640 Tablets in Healthy Volunteers Phase 1
Not yet recruiting NCT02944214 - Compare the Renal Protective Effects of Febuxostat and Benzbromarone in CKD Chinese Patients N/A
Completed NCT02557126 - Study of URC102 to Assess the Safety and Efficacy in Gout Patients Phase 2
Active, not recruiting NCT01021241 - Safety and Efficacy Study of Intravenous Uricase-PEG 20 Phase 1
Completed NCT00756964 - Lowering Serum Uric Acid to Prevent Acute Kidney Injury Phase 2
Terminated NCT00607152 - Rasburicase (Fasturtec) Registration Trial Phase 3
Completed NCT03906006 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects Phase 1