An international study on efficacy and safety of I10E in CIDP patients

Phase 1

• Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP); MedDRA version: 19.0Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-005557-73-DE
• Lead Sponsor: FB BIOTECHNOLOGIES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-08
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

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 :
a)has never been previously treated with Ig (Ig-naïve patient)
OR
b) 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.
5. Covered by national healthcare insurance system as required by
local regulations.
6. Written informed consent obtained prior to any study-related
procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. History of severe allergic reaction or serious adverse reaction
to any immunoglobulin (Ig).
2. Clinically documented lack of response to previous Ig
treatment.
3. History of IgA deficiency (IgA = 70 mg/L), unless the absence of anti-IgA antibodies has been documented.
4. Known hypersensitivity to human Ig or to any of the
excipients of I10E (glycine and polysorbate 80).
5. History of cardiac insufficiency (New York Heart
Association [NYHA] III/IV), uncontrolled cardiac
arrhythmia, unstable ischemic heart disease, or uncontrolled
hypertension.
6. History of venous thrombo-embolic disease, myocardial
infarction or, cerebrovascular accident.
7. Risk factor for blood hyperviscosity such as
cryoglobulinemia or haematologic malignancy with
monoclonal gammopathy.
8. History of personal or familial congenital thrombophilia or
acquired thrombophilia.
9. Factors contributing to venous stasis such as long-term bed
confinement.
10. Body Mass Index (BMI) = 40 kg/m².
11. Protein-losing enteropathy characterised by serum protein levels < 60 g/L and serum albumin levels < 30 g/L.
12. History of kidney transplantation, nephrotic syndrome (defined as proteinuria > 3.5 g per 24 hours accompanied by hypoalbuminemia and edema), or any acute or chronic kidney disease that in the opinion of the investigator and/or nephrologist would preclude the use of I10E and/or interfere with the assessment of the safety and efficacy of I10E.
AND/OR
*Chronic kidney disease (CKD) for more than 3 months as documented by at least one of the following:
*glomerular filtration rate (GFR) < 60 mL/min/1.73m2 measured according to the Modified Diet in Renal Disease (MDRD) formula
AND/OR
*urine protein reagent strip: = 2 crosses
AND/OR
*urine protein reagent strip: one cross with one of the following:
*albumin excretion rate (AER) > 300 mg/24 hours or protein excretion rate (PER) > 500 mg/24 hours (24h-urine collection)
OR
*albumin to creatinine ratio (ACR) >30 mg/mmol or protein to creatinine ratio (PCR) > 50 mg/mmol (spot urine sample).
13. Serum levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times upper limit of normal (ULN) range.
14.Any other ongoing disesase that may cause chronic peripheral neuropathy, such as toxin exposure, dietary deficienct, 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, Waldenstrom's macroglobulinaemia, amyloidosis, and hereditary neuropathy.
15.Woman with positive results on a urine pregnancy test or breastfeeding women or women of childbearing potential without an effective contraception.
Effective contraceptives are injectable, patch or oral combined oestron progestative or progestative contraceptives, Cooper T or levonorgest releasing intra-uterine devices, depot intramuscular medroxyprogesterone, subcutaneous progestative contraceptive implants, condoms or occlusive caps (diaphragm or cervical/vault caps) with spermicide, true abstinence (when this is in line with the preferred and usual lifestyle of the patient).
16.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.
17.Increasing dosage or introduction of a systemic corticoids therapy , or corticosteroids therapy at a dose

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified