drugset / Trial / NCT01001923

Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis Pain

NCT01001923 ↗

Phase 2 Terminated 15 enrolled Regeneron Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with chronic pancreatitis. Secondary objectives were: * to assess the safety and tolerability of REGN475/SAR164877 in patients with chronic pancreatitis pain; * to characterize the pharmacokinetic, pharmacodynamic, and immunogenicity profiles of REGN475/SAR164877 in this population; * to measure the change in the total daily dose of rescue medications required.

Timeline

Start
2009-12
Primary completion
2011-01
Completion
2011-01

Outcome

Outcome not reported

Stopped (Enrollment): “Business decision due to low subject recruitment and enrollment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Fasinumab Monoclonal antibody — Intravenous

Indications

No indication recorded.