Efficacy and Safety Study of I10E in Treatment of Patients With CIDP

NCT02293460 | Completed Phase 3 Results

• 1 other identifier: I10E-1302
• Study Type: interventional
• Target: 44
• Locations: 5 countries
• Sites: 28

Brief Summary

Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. Secondary objective: To assess the safety of I10E in patients with CIDP.

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

  Responders were defined as patients with a decrease ≥1 point in the adjusted INCAT disability score compared to baseline. Adjusted INCAT disability score can vary from 0 (normal) to 9 (maximal disability). If a patient was treated with a not-allowed treatment during the study period, then all adjusted INCAT disability score measured after the intake of these not-allowed treatments were censored. If the score at EoS visit was missing, then the Last Observation Carried Forward (LOCF) approach was applied to replace this missing value.

  24 weeks after first treament injection

Study Arms (1)

I10E Arm

EXPERIMENTAL

Drug: I10E

Interventions

I10E DRUG

Patients who meet all eligibility criteria will receive one dose of IMP at 2g/kg over 2-5 days followed by 7 doses of IMP at 1g/kg over 1-2 day(s), every 3 weeks. Duration of treatment period: 21 weeks +/- 7 days.

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
• Definite or probable CIDP according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) guidelines 2010 clinical and neurophysiological criteria Pure motor CIDP, provided that a diagnosis of multifocal motor neuropathy has been ruled out CIDP associated with monoclonal gammopathy of undetermined significance (MGUS), provided that anti-MAG antibodies titer is lower than the used technique's negativity threshold (1000 BTU for Bühlmann ELISA technique) Lewis-Sumner syndrome
• Score of at least 2 on the adjusted INCAT disability scale
• Patient who either :
• has never been previously treated with Ig (Ig-naive patient) Or
• was previously treated with Ig but is in clinical relapse following treatment withdrawal. In the latter case, the last Ig course shall have been administered no less than 3 months prior to screening

You may not qualify if:

• History of IgA deficiency, unless the absence of anti-IgA antibodies has been documented
• History of cardiac insufficiency (New York Heart Association \[NYHA\] III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension
• History of venous thrombo-embolic disease, myocardial infarction or, cerebrovascular accident
• Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologic 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 in 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, amyloid, 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 corticotherapy within the last 3 months prior to screening, with oral or systemic corticosteroids 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-alfa, interferon-beta1a, anti-CD20, alemtuzumab, aziathioprine, etanercept, mycophenolate mofetil, methotrexate and haemopoetic stem cell transplantation)
• Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening
• Administration of another investigational product within the last month prior to screening

Sponsors & Collaborators

• Laboratoire français de Fractionnement et de Biotechnologies: lead

Study Sites (33)

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

Hôpital Pontchaillou

Rennes, 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 - Istituto Clinico Humanitas

Milan, Italy

Location

IRRCS Istituto Nazionale Neurologico Besta

Milan, Italy

Location

Ospedale San Raffaele IRCCS

Milan, Italy

Location

Azienda Ospedaliere Universitaria di Padova

Padua, Italy

Location

Università Cattolica del Sacro Cuore

Roma, Italy

Location

Azienda Ospedaliere Universitaria san Giovanni

Torino, Italy

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Quiron Madrid

Madrid, 28223, 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

Hôpital Razi, La Manouba

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 UniversityCerrahpasa Medical School Neurology

Istanbul, Turkey (Türkiye)

Location

Marmara Universitesi Egitim Ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye)

Location

St Georges

London, SW17OQT, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

University Hospital of North Straffordshire

Stratford-upon-Avon, 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

Results Point of Contact

• Title: Clinical trial information desk
• Organization: LFB Biotechnologies

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: November 13, 2014
• First Posted: November 18, 2014
• Study Start: May 1, 2015
• Primary Completion: September 29, 2017
• Study Completion: September 29, 2017
• Last Updated: January 27, 2021
• Results First Posted: March 9, 2020

Record last verified: 2021-01

Locations

FR (7); IT (7); ES (6); TU (5); GB (3)