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

Chronic Inflammatory Demyelinating Polyradiculoneuropathy Clinical Trial

— PRISM  

Official title:

An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293460
• Other study ID #: I10E-1302
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: September 29, 2017

Study information

• Verified date: January 2021
• Source: Laboratoire français de Fractionnement et de Biotechnologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 29, 2017
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy
• Polyradiculoneuropathy
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	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
Italy	IRRCS Azienda Ospedaliera Universitaria	Genova
Italy	IRCCS - Istituto Clinico Humanitas	Milano
Italy	IRRCS Istituto Nazionale Neurologico Besta	Milano
Italy	Ospedale San Raffaele IRCCS	Milano
Italy	Azienda Ospedaliere Universitaria di Padova	Padova
Italy	Università Cattolica del Sacro Cuore	Roma
Italy	Azienda Ospedaliere Universitaria san Giovanni	Torino
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital General Universitario Gregorio	Madrid
Spain	Hospital Quiron Madrid	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
Tunisia	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
Turkey	Ankara University medical School Neurology	Ankara
Turkey	Hacettepe University Medical School Neurology	Ankara
Turkey	Uludag University Medical School Neurology	Bursa
Turkey	Istanbul UniversityCerrahpasa Medical School Neurology	Istanbul
Turkey	Marmara Universitesi Egitim Ve Arastirma Hastanesi	Istanbul
United Kingdom	St Georges	London
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	University Hospital of North Straffordshire	Stratford-upon-Avon

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire français de Fractionnement et de Biotechnologies

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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