Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302 (PRISM2)

International, Multicentre, Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM Study I10E-1302"

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
• Intervention / Treatment: Drug: I10E

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux - Hôpital Pellegrin
  • Dijon, France
    • Hôpital général du CHU de Dijon
  • Nice, France
    • CHU de Nice - Hopital L'Archet
  • Paris, France
    • CHU Paris - Hôpital Pitié Salpétrière
  • Saint Etienne, France
    • CHU de Saint Etienne - Hôpital Nord
  • Strasbourg, France
    • Hopital de Hautepierre
• Italy
  • Genova, Italy
    • IRRCS Azienda Ospedaliera Universitaria
  • Milano, Italy
    • Ospedale San Raffaele IRCCS
  • Milano, Italy
    • IRCCS Instituto Clinico Humanitas
  • Milano, Italy
    • IRRCS Istutito Nazionale Neurologico Besta
  • Padova, Italy
    • Azienda Ospedaliera Universitaria di Padova
  • Roma, Italy
    • Università Cattolica del Sacro Cuore
  • Torino, Italy
    • Azienda Ospedaliera Universitaria san Giovanni
• Spain
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau
  • Madrid, Spain
    • Hospital General Universitario Gregorio
  • Santiago de Compostela, Spain
    • Hospital Clinico Universitario de Santiago
  • Seville, Spain
    • Hospital Universitario Virgen del Rocío
  • Valencia, Spain
    • Hospital Universitario i Politècnico La Fe
• Tunisia
  • La Manouba, Tunisia
    • Tunisia Hôpital Razi
  • Monastir, Tunisia
    • Hôpital Fattouma Bourguiba
  • Sfax, Tunisia
    • Hôpital Habib Bourguiba
  • Sousse, Tunisia
    • Hôpital Sahloul
  • Tunis, Tunisia
    • Hopital Militaire de Tunis
• Turkey
  • Ankara, Turkey
    • Ankara university medical school Neurology
  • Ankara, Turkey
    • Hacettepe University medical School Neurology
  • Bursa, Turkey
    • Uludag University Medical School Neurology
  • Istanbul, Turkey
    • Marmara Universitesi Egitim Ve Arastirma Hastanesi
  • Istanbul, Turkey
    • istanbul University Cerrahpasa Medical School Neurology
• United Kingdom
  • Southhampton, United Kingdom
    • Southhampton General Hospital
  • Straffordshire, United Kingdom
    • University Hospital of North Straffordshire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patient aged 18 years or more.
2. Responder patient who have completed the last visit of PRISM I10E-1302 study defined as a patient with a decrease ≥1 point in the adjusted INCAT disability score between baseline and the end-of-study (EOS) visit of PRISM I10E-1302 study.
3. Covered by national healthcare insurance system as required by local regulations.
4. Written informed consent obtained prior to any study-related procedures.

Exclusion Criteria:

1. History of severe allergic reaction or serious adverse reaction to any Ig.
2. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
3. History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
4. History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
5. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
6. Body mass index (BMI) ≥40 kg/m².
7. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet Renal Disease (MDRD) calculation.
8. Any other ongoing disease that may cause chronic peripheral neuropathy, such as toxin exposure, dietary deficiency, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus erythematosus or other connective tissue diseases, infection with HIV, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Lyme disease, multiple myeloma, Waldenström's macroglobulinaemia, amyloidosis, and hereditary neuropathy.
9. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception.
10. Any other serious medical condition that would interfere with the clinical assessment of CIDP or use of I10E or prevent the patient from complying with the protocol requirements.
11. Increasing dosage or introduction of a systemic corticosteroids therapy within the last 3 months prior to screening, at a dose higher than 10 mg daily prednisolone or equivalent. Topical corticosteroids are permitted.
12. Treatment within 12 months prior to screening with immunomodulatory or immunosuppressant agents (including but not limited to cyclophosphamide, cyclosporine, interferon-α, interferon-β1a, anti-CD20, alemtuzumab, aziathioprine, etanercept, mycophenolate mofetil and methotrexate) or haemopoetic stem cell transplantation.
13. Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening.
14. Anticipated poor compliance of patient with study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: I10E Arm	Drug: I10E; Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit	Since the study was prematurely terminated and an important number of subjects early withdrawn, the responder rate is biased and consequently not interpretable. Responders were defined as subjects with either: No change or decrease in the adjusted INCAT disability score and without any change in CIDP treatment between baseline and EOS visit. OR An increase by 1 point in the adjusted INCAT disability score without requirement of any change in CIDP treatment between baseline and EOS visit.	week 48 (End-of-Study)

Collaborators and Investigators

• Sponsor: Laboratoire français de Fractionnement et de Biotechnologies
• Investigators: Principal Investigator: Eduardo NOBILE-ORAZIO, MD, IRCCS Instituto Clinico Humanitas, Milano, Italy

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): July 28, 2017
• Study Completion (Actual): July 28, 2017

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 16, 2014

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Peripheral neuropathy; Rare disease; Disimmune disease; Neurology chronic disease
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies; Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
• Other Study ID Numbers: I10E-1306