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

NCT02317562 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-04-20

Study results available
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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.

Conditions

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions

DRUG

I10E

Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.

Sponsors & Collaborators

  • Laboratoire français de Fractionnement et de Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Eduardo NOBILE-ORAZIO, MD · IRCCS Instituto Clinico Humanitas, Milano, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-07-28
Completion
2017-07-28

Countries

  • France
  • Italy
  • Spain
  • Tunisia
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02317562 on ClinicalTrials.gov