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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open Label Phase II Multiple Dose Safety, Pharmacokinetic and Pharmacodynamics Study of SEL-212 Followed by Open Label Administration of SEL-037 in Subjects With Symptomatic Gout and Elevated Blood

Brief 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 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 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 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 .


Sponsor: Selecta Biosciences, Inc.

Current Primary Outcome: Safety and tolerability of multiple intravenous infusions of SEL-212 as assessed by the frequency of drug related adverse events, graded by severity [ Time Frame: Five monthly infusions ]

To determine the safety and tolerability of 3 monthly infusions of SEL-212 followed by 2 monthly infusions of SEL-037 (pegsiticase) as assessed by frequency of drug related adverse events, graded by severity


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetics (PK) of SEL-037 (pegsiticase) after multiple monthly IV infusions with or without SEL-110 [ Time Frame: 5 months ]
    Measurement of the pharmacokinetics of SEL-037, with or without SEL-110, for 30 days after multiple monthly IV infusions by area under the blood concentration versus time curve (AUC)
  • Pharmacodynamics (PD) (ability to reduce circulating uric acid) of SEL-037 after multiple monthly IV infusions with or without SEL-110 [ Time Frame: 5 months ]
    Measurement of the pharmacodynamics (ability to reduce circulating uric acid) of SEL-037 after multiple monthly infusions with or without SEL-110 by measurement of blood uric acid levels for 30 days post infusion
  • Immunogenicity of SEL-037 after multiple monthly IV infusions with our without SEL-110 [ Time Frame: 5 months ]
    Immunogenicity of SEL-037 after multiple monthly IV infusions with or without SEL-110 by measurement of anti-drug antibody levels over 30 days post each infusion
  • The pharmacokinetics (PK) of rapamycin after multiple IV infusions of SEL-110 with multiple IV infusions of SEL-037. [ Time Frame: 5 months ]
    To determine the pharmacokinetics of rapamycin after multiple I V infusions of SEl-212 by area under the blood concentration versus time curve (AUC)


Original Secondary Outcome: Same as current

Information By: Selecta Biosciences, Inc.

Dates:
Date Received: November 6, 2016
Date Started: October 2016
Date Completion: October 2017
Last Updated: November 8, 2016
Last Verified: November 2016