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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02293460
• Date of registration: 13/11/2014
• Prospective Registration: Yes
• Primary sponsor: Laboratoire français de Fractionnement et de Biotechnologies
• Public title: Efficacy and Safety Study of I10E in Treatment of Patients With CIDP PRISM
• Scientific title: An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
• Date of first enrolment: May 2015
• Target sample size: 44
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02293460
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France, Italy, Morocco, Spain, Tunisia, Turkey, United Kingdom

Contacts

• Name: Eduardo NOBILE-ORAZIO, MD
• Affiliation: IRCCS Instituto Clinico Humanitas, Milano, Italy

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Intervention(s)

Drug: I10E

Primary Outcome(s)

Efficacy Endpoint: Responder Rate at End of Study [Time Frame: 24 weeks after first treament injection]

Secondary ID(s)

I10E-1302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02293460