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

Phase 3

Completed

• Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
• Interventions: Drug: I10E

• Registration Number: NCT02293460
• Lead Sponsor: Laboratoire français de Fractionnement et de Biotechnologies

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-18
• Study Start: 2015-05
• Primary Completion: 2017-09-29
• Study Completion: 2017-09-29
• Results First Submitted: 2019-12-30
• Results First Submitted QC: 2020-02-24
• Results First Posted: 2020-03-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I10E Arm	I10E	-

Primary Outcome Measures

Name	Time	Method
Efficacy Endpoint: Responder Rate at End of Study	24 weeks after first treament injection	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.

Trial Locations

Locations (33)

Hôpital Pontchaillou; 🇫🇷 Rennes, France

Hôpital général du CHU de Dijon; 🇫🇷 Dijon, France

CHU Paris - Hôpital Pitié salpétrière; 🇫🇷 Paris, France

Azienda Ospedaliere Universitaria di Padova; 🇮🇹 Padova, Italy

Hôpital Fattouma Bourguiba; 🇹🇳 Monastir, Tunisia

Hôpital militaire de Tunis; 🇹🇳 Tunis, Tunisia

CHU de Bordeaux - Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

CHU de Nice - Hôpital l'Archet; 🇫🇷 Nice, France

CHU de saint Etienne - Hôpital nord; 🇫🇷 Saint Etienne, France

Ospedale San Raffaele IRCCS; 🇮🇹 Milano, Italy

IRRCS Azienda Ospedaliera Universitaria; 🇮🇹 Genova, Italy

IRCCS - Istituto Clinico Humanitas; 🇮🇹 Milano, Italy

IRRCS Istituto Nazionale Neurologico Besta; 🇮🇹 Milano, Italy

Azienda Ospedaliere Universitaria san Giovanni; 🇮🇹 Torino, Italy

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen del Rocio; 🇪🇸 Seville, Spain

Università Cattolica del Sacro Cuore; 🇮🇹 Roma, Italy

Hospital clinico Universitario de Santiago; 🇪🇸 Santiago de Compostela, Spain

Hospital General Universitario Gregorio; 🇪🇸 Madrid, Spain

Hospital Universitario i Politècnico La Fe; 🇪🇸 Valencia, Spain

Hôpital Razi, La Manouba; 🇹🇳 Manouba, Tunisia

Hôpital habib Bourguiba; 🇹🇳 Sfax, Tunisia

Hôpital Sahloul; 🇹🇳 Sousse, Tunisia

Ankara University medical School Neurology; 🇹🇷 Ankara, Turkey

Uludag University Medical School Neurology; 🇹🇷 Bursa, Turkey

Hacettepe University Medical School Neurology; 🇹🇷 Ankara, Turkey

Marmara Universitesi Egitim Ve Arastirma Hastanesi; 🇹🇷 Istanbul, Turkey

Istanbul UniversityCerrahpasa Medical School Neurology; 🇹🇷 Istanbul, Turkey

St Georges; 🇬🇧 London, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

University Hospital of North Straffordshire; 🇬🇧 Stratford-upon-Avon, United Kingdom

Hospital Quiron Madrid; 🇪🇸 Madrid, Spain