drugset / Trial / NCT02317562

Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302

NCT02317562

Phase 3 Terminated 19 enrolled LFB
NaSingle-groupOpen-labelTreatment

Summary

Primary objective: To assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP response after an initial 6-month treatment in PRISM study. (I10E-1302). Secondary objective: To assess the safety of I10E in this patient population.

Timeline

Start
2015-11
Primary completion
2017-07-28
Completion
2017-07-28

Drugs

EvaluationDrugModalityDoseRoute
Subject I10E Protein / enzyme biologic 0.5 g/kg