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

• Register: EUCTR
• Last refreshed on: 19 February 2018
• Main ID: EUCTR2013-005557-73-IT
• Date of registration: 27/08/2014
• Prospective Registration: Yes
• Primary sponsor: LFB BIOTECHNOLOGIES
• Public title: An international study on efficacy and safety of I10E in CIDP patients
• Scientific title: An international, multicentre, efficacy and safety study of I10E in initial and maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy - PRISM
• Date of first enrolment: 30/09/2014
• Target sample size: 42
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005557-73
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: Single arm; If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clinical trial information desk
• Affiliation: LFB BIOTECHNOLOGIES

• Name: Clinical trial information desk
• Affiliation: LFB BIOTECHNOLOGIES

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 :
a) has never been previously treated with Ig (Ig-naive 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, 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 or nephrotic syndrome characterised by proteinuria =3.5 g/24hours, serum protein levels <60 g/L and serum albumin levels <30 g/L.
12. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet in Renal Disease (MDRD) calculation.
13. Serum levels of alanine aminotransferase (AST) or aspartate aminotransferase (ALT), >2 times upper limit of normal range.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 17.0 Level: PT Classification code 10057645 Term: Chronic inflammatory demyelinating polyradiculoneuropathy System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: human normal immunoglobulin for intravenous administration
Product Code: I10E
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Current Sponsor code: I10E
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: The secondary objective is to assess the safety of I10E in patients with CIDP.
Exploratory objectives:
To assess a potential relationship between total serum IgG trough levels, biomarkers levels and clinical changes - as assessed by neurological scales - in patients with CIDP.
To assess a potential relationship between ultrasonography (US) coupled to neurophysiology analysis of nerves and clinical changes - as assessed by neurological scales - in patients with CIDP (ancillary study in Italy).

Main Objective: The primary objective of this study is to assess the efficacy of I10E in improving the disability of patients with CIDP.

Primary end point(s): Responder rate at EOS visit.
Responders are defined as patients with a decrease =1 point in the
adjusted INCAT score between baseline and the EOS visit.

Timepoint(s) of evaluation of this end point: at baseline and the End Of Study visit.

Secondary Outcome(s)

Secondary end point(s): - Responder rate at 12 weeks.
- Time to response.
- Percentage of patients at 12 weeks and EOS visit with no change in
CIDP treatment.
- Changes from baseline to 12 weeks and EOS visit in the following
scores:
• Adjusted INCAT score;
• Grip strength with the Martin vigorimeter in both hands;
• Rasch-built Overall Disability Scale (R-ODS);
• Patient and Investigator Clinical Global Impression (CGI);
• Medical Research Council (MRC) 12 muscles sum score (0 to 5) and Rasch-modified MRC (0 to 3).

Timepoint(s) of evaluation of this end point: Baseline, at 12 weeks and End of study visit

Secondary ID(s)

I10E-1302

2013-005557-73-GB

Source(s) of Monetary Support

LFB BIOTECHNOLOGIES