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

NCT02317562 | Terminated Phase 3 Results

• 1 other identifier: I10E-1306
• Study Type: interventional
• Target: 19
• Locations: 5 countries
• Sites: 25

Brief 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

Keywords

Peripheral neuropathy; Disimmune disease; Neurology chronic disease; Rare disease

Outcome Measures

Primary Outcomes (1)

• 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  Since the study was prematurely terminated and an important number of subjects early withdrawn, the responder rate is biased and consequently not interpretable.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)

Study Arms (1)

I10E Arm

EXPERIMENTAL

Drug: I10E

Interventions

I10E DRUG

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

I10E Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient aged 18 years or more.
• 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.
• Covered by national healthcare insurance system as required by local regulations.
• Written informed consent obtained prior to any study-related procedures.

You may not qualify if:

• History of severe allergic reaction or serious adverse reaction to any Ig.
• Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
• History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
• History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
• Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
• Body mass index (BMI) ≥40 kg/m².
• Glomerular filtration rate \<80 mL/min/1.73m² measured according to the Modified Diet Renal Disease (MDRD) calculation.
• 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.
• Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception.
• 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.
• 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.
• 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.
• Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening.
• Anticipated poor compliance of patient with study procedures.

Sponsors & Collaborators

• Laboratoire français de Fractionnement et de Biotechnologies: lead

Study Sites (30)

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, France

Location

Hôpital général du CHU de Dijon

Dijon, France

Location

CHU de Nice - Hôpital l'Archet

Nice, France

Location

CHU paris - Hôpital Pitié salpétrière

Paris, France

Location

CHU de Saint Etienne - Hôpital Nord

Saint-Etienne, France

Location

Hôpital de Hautepierre

Strasbourg, France

Location

IRRCS Azienda Ospedaliera Universitaria

Genova, Italy

Location

IRCCS Instituto Clinico Humanitas

Milan, Italy

Location

IRRCS Istutito Nazionale Neurologico Besta

Milan, Italy

Location

Ospedale San Raffaele IRCCS

Milan, Italy

Location

Azienda Ospedaliera Universitaria di Padova

Padua, Italy

Location

Università Cattolica del sacro Cuore

Roma, Italy

Location

Azienda Ospedaliera Universitaria san Giovanni

Torino, Italy

Location

Hospital de la santa creu i Sant Pau

Barcelona, Spain

Location

Hospital General Universitario Gregorio

Madrid, Spain

Location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

Hospital Universitario i Politècnico La Fe

Valencia, Spain

Location

Tunisia Hôpital Razi

Manouba, Tunisia

Location

Hôpital Fattouma Bourguiba

Monastir, Tunisia

Location

Hôpital Habib Bourguiba

Sfax, Tunisia

Location

Hôpital Sahloul

Sousse, Tunisia

Location

Hôpital Militaire de Tunis

Tunis, Tunisia

Location

Ankara university medical school Neurology

Ankara, Turkey (Türkiye)

Location

Hacettepe University medical School Neurology

Ankara, Turkey (Türkiye)

Location

Uludag University Medical School Neurology

Bursa, Turkey (Türkiye)

Location

istanbul University Cerrahpasa Medical School Neurology

Istanbul, Turkey (Türkiye)

Location

Marmara Universitesi Egitim Ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye)

Location

Southhampton general Hospital

Southhampton, United Kingdom

Location

University Hospital of North Straffordshire

Straffordshire, United Kingdom

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Peripheral Nervous System Diseases; Rare Diseases

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was prematurely stopped because 4 subjects relapsed among 14 enrolled and treated subjects at the time of the early assessment of study results. LFB BIOTECHNOLOGIES judged that it was not acceptable to continue the study.

Results Point of Contact

• Title: Clinical Information Desk
• Organization: LFB

supportqcm@lfb.fr

0033169827010

Study Officials

• Eduardo NOBILE-ORAZIO, MD

  IRCCS Instituto Clinico Humanitas, Milano, Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 16, 2014
• Study Start: November 1, 2015
• Primary Completion: July 28, 2017
• Study Completion: July 28, 2017
• Last Updated: April 20, 2021
• Results First Posted: April 20, 2021

Record last verified: 2021-04

Locations

ES (5); IT (7); TU (5); GB (2); FR (6)