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

NCT ID: NCT02293460

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-09-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I10E Arm

Group Type: EXPERIMENTAL

I10E

Intervention Type: 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.

Interventions

I10E

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female patient aged 18 years or more

2. 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

3. Score of at least 2 on the adjusted INCAT disability scale

4. Patient who either :

1. has never been previously treated with Ig (Ig-naive patient) Or

2. 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

Exclusion Criteria

1. History of IgA deficiency, unless the absence of anti-IgA antibodies has been documented

2. History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension

3. History of venous thrombo-embolic disease, myocardial infarction or, cerebrovascular accident

4. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologic malignancy with monoclonal gammopathy

5. Body mass Index (BMI) ≥40 kg/m²

6. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet in Renal Disease (MDRD) calculation

7. 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

8. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception.

9. 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

10. 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

11. 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)

12. Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening

13. Administration of another investigational product within the last month prior to screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoire français de Fractionnement et de Biotechnologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo NOBILE-ORAZIO, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Instituto Clinico Humanitas, Milano, Italy

Locations

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, , France

Hôpital général du CHU de Dijon

Dijon, , France

CHU de Nice - Hôpital l'Archet

Nice, , France

CHU Paris - Hôpital Pitié salpétrière

Paris, , France

Hôpital Pontchaillou

Rennes, , France

CHU de saint Etienne - Hôpital nord

Saint-Etienne, , France

Hôpital de Hautepierre

Strasbourg, , France

IRRCS Azienda Ospedaliera Universitaria

Genova, , Italy

IRCCS - Istituto Clinico Humanitas

Milan, , Italy

IRRCS Istituto Nazionale Neurologico Besta

Milan, , Italy

Ospedale San Raffaele IRCCS

Milan, , Italy

Azienda Ospedaliere Universitaria di Padova

Padua, , Italy

Università Cattolica del Sacro Cuore

Roma, , Italy

Azienda Ospedaliere Universitaria san Giovanni

Torino, , Italy

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Quiron Madrid

Madrid, , Spain

Hospital General Universitario Gregorio

Madrid, , Spain

Hospital clinico Universitario de Santiago

Santiago de Compostela, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Universitario i Politècnico La Fe

Valencia, , Spain

Hôpital Razi, La Manouba

Manouba, , Tunisia

Hôpital Fattouma Bourguiba

Monastir, , Tunisia

Hôpital habib Bourguiba

Sfax, , Tunisia

Hôpital Sahloul

Sousse, , Tunisia

Hôpital militaire de Tunis

Tunis, , Tunisia

Ankara University medical School Neurology

Ankara, , Turkey (Türkiye)

Hacettepe University Medical School Neurology

Ankara, , Turkey (Türkiye)

Uludag University Medical School Neurology

Bursa, , Turkey (Türkiye)

Istanbul UniversityCerrahpasa Medical School Neurology

Istanbul, , Turkey (Türkiye)

Marmara Universitesi Egitim Ve Arastirma Hastanesi

Istanbul, , Turkey (Türkiye)

St Georges

London, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

University Hospital of North Straffordshire

Stratford-upon-Avon, , United Kingdom

Countries

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

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

I10E-1302

Identifier Type: -

Identifier Source: org_study_id