NCT02598596

Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Ampel BioSolutions, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of pegloticase on clinical outcome, as defined by an serum uric acid level \<6 mg/dL, in patients with chronic, refractory gout.

Detailed description

This is an exploratory open-label, multicenter study to evaluate the effectiveness of a 16-week high zone tolerance regimen of pegloticase on response to therapy (serum uric acid \<6 mg/dL) with this drug in adult hyperuricemic patients with gout refractory to conventional therapy. Eligible subjects will receive 1 of 3 different loading doses (8, 12, and 16 mg) on Study Day 1, and then receive 8 mg on Week 2 and 3, followed by 8 mg every 2 weeks through Week 17 for a total of 10 doses. Subjects will be monitored for efficacy and safety endpoints through Week 17. Subjects will also have blood drawn for pegloticase levels prior to each dose on Weeks 2, 3, 5, 7, 9, 11, 13,15, and 17. Following Study Week 17, subjects will have an option to continue dosing for an additional 8 weeks. A subset of subjects will participate in additional pharmacokinetic (PK) assessments. The study duration, per enrolled patient, will be approximately 26 weeks including a 2-week screening period, a 16-week treatment period (end of treatment \[EOT\] visit Week 17), and an optional 8-week dosing extension.

Conditions

• Gout

Interventions

Type	Name	Description
BIOLOGICAL	Pegloticase	Pegloticase, IV
DRUG	Azathioprine	Azathioprine (1.25 mg/kg, followed by 2.5 mg/kg) oral, daily

Timeline

• Start date: 2015-12-01
• Primary completion: 2020-04-13
• Completion: 2020-04-27
• First posted: 2015-11-06
• Last updated: 2021-10-11

Locations

11 sites across 1 country: United States