Clinical Trials Register

Summary
EudraCT Number:	2013-005558-31
Sponsor's Protocol Code Number:	I10E-1306
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2016-07-08
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Germany - PEI

A.2

EudraCT number

2013-005558-31

A.3

Full title of the trial

International, multicentre, efficacy and safety study of I10E in the
maintenance treatment of patients with Chronic Inflammatory
Demyelinating Polyradiculoneuropathy: Extension of PRISM study
I10E-1302

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Exstension of the international study on efficacy and safety of I10E in CIDP patients

A.3.2

Name or abbreviated title of the trial where available

PRISM 2

A.4.1

Sponsor's protocol code number

I10E-1306

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	LFB BIOTECHNOLOGIES
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	LFB BIOTECHNOLOGIES
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	LFB BIOTECHNOLOGIES
B.5.2	Functional name of contact point	Clinical trial information desk
B.5.3	Address:
B.5.3.1	Street Address	3, avenue des Tropiques, BP 40305 – LES ULIS
B.5.3.2	Town/ city	COURTABOEUF CEDEX
B.5.3.3	Post code	91958
B.5.3.4	Country	France
B.5.4	Telephone number	+33169 82 70 10
B.5.5	Fax number	+33169 82 72 72
B.5.6	E-mail	neuharte@lfb.fr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	IQYMUNE
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratoire Français du Fractionnement et des Biotechnologies
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Human normal 10% immunoglobulin for intravenous administrationn
D.3.2	Product code	I10
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HUMAN NORMAL IMMUNOGLOBULIN (IV)
D.3.9.2	Current sponsor code	I10
D.3.9.3	Other descriptive name	HUMAN NORMAL IMMUNOGLOBULIN (IV)
D.3.9.4	EV Substance Code	SUB12041MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	Yes
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

E.1.1.1

Medical condition in easily understood language

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is
an acquired paralytic illness affecting peripheral nerves and caused by a
demyelinating process.

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10057645
E.1.2	Term	Chronic inflammatory demyelinating polyradiculoneuropathy
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

The study is descriptive. The primary objective is to assess the efficacy of I10E administered at a reduced maintenance dose in sustaining CIDP response after an initial 6-month treatment in PRISM study.

E.2.2

Secondary objectives of the trial

The secondary objective is to assess the safety of I10E in this patient population.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female patient aged 18 years or more.
2. Responder patient who have completed the last visit of PRISM I10E-1302 study defined as a patient with a decrease ≥1 point in the adjusted INCAT disability score between baseline and the end-of-study (EOS) visit of PRISM I10E-1302 study.
3. Covered by national healthcare insurance system as required
by local regulations.
4. Written informed consent obtained prior to any study-related
procedures.

E.4

Principal exclusion criteria

Based on follow-up and results of analyses performed in PRISM
I10E-1302 study, a patient may be eligible in PRISM 2 I10E-1306
study if none of the following criteria is met:
Based on follow-up and results of analyses performed in PRISM
I10E-1302 study, a patient may be eligible in PRISM 2 I10E-1306
study if none of the following criteria is met:
1. History of severe allergic reaction or serious adverse reaction to
any Ig.
2. Known hypersensitivity to human Ig or to any of the excipients
of I10E (glycine and polysorbate 80).
3. History of cardiac insufficiency (New York Heart Association
(NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable
ischemic heart disease, or uncontrolled hypertension.
4. History of venous thromboembolic disease, myocardial
infarction or cerebrovascular accident.
5. Risk factor for blood hyperviscosity such as cryoglobulinemia
or haematological malignancy with monoclonal gammopathy.
6. History of personal or familial congenital thrombophilia or
acquired thrombophilia.
7. Factors contributing to venous stasis such as long-term bed
confinement.
8. Body Mass Index (BMI) ≥40 kg/m².
9. Protein-losing enteropathy characterised by serum protein
levels <60 g/L and serum albumin levels <30 g/L.
10. 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:
o albumin excretion rate (AER) >300 mg/24 hours
or protein excretion rate (PER) >500 mg/24 hours
(24h-urine collection)
OR
o albumin to creatinine ratio (ACR) >30 mg/mmol
or protein to creatinine ratio (PCR) >50 mg/mmol
(spot urine sample).
11. Serum levels of alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) >2 times upper limit of normal (ULN)
range.
12. 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, amyloidosis, and hereditary neuropathy.
13. Woman with positive results on a urine pregnancy test or
breastfeeding woman or woman of childbearing potential
without an effective contraception.
Effective contraceptives are injectable, patch or oral combined
oestro-progestative or progestative contraceptives, Copper 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).
14. 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.
15. Increasing dosage or introduction of a systemic corticosteroids
therapy, or corticosteroids therapy at a dose higher than 10 mg
per day prednisolone, or equivalent within the last 3 months
prior to screening (in I10E-1302 Clinical Study). Topical
corticosteroids are permitted.
16. Treatment within 12 months prior to screening with
immunomodulatory or immunosuppressant agents (including
but not limited to cyclophosphamide, cyclosporine,
interferon-α, interferon-β1a, anti-CD20, alemtuzumab,
aziathioprine, etanercept, mycophenolate mofetil and
methotrexate) or haemopoetic stem cell transplantation.
17. Plasma exchange, blood products or derivatives administered
within the last 3 months prior to screening.
18. Drug or alcohol abuse.
19. Anticipated poor compliance of patient with study procedures.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint will be the responder rate at EOS
visit.
Responders are defined as patients with either:
- No change or decrease in the adjusted INCAT disability score and without any change in CIDP treatment between baseline and EOS visit.
or
- An increase by 1 point in the adjusted INCAT disability score without requirement of any change in CIDP treatment between baseline and EOS visit.

E.5.1.1

Timepoint(s) of evaluation of this end point

At the inclusion (baseline), end of study visit

E.5.2

Secondary end point(s)

Main secondary efficacy endpoints:
− Change from baseline to 24 weeks (Visit V9) and EOS visit in the adjusted INCAT disability score.
− Responder rate at 24 weeks (visit V9).
− Time to relapse.
− Change from baseline to 24 weeks (Visit V9) and EOS visit in the following scores:
▪ Grip strength with the Martin Vigorimeter in both hands;
▪ Rasch-built Overall Disability Scale (R-ODS);
▪ Medical Research Council (MRC) 12 muscles sum score
(0 to 5) and Rasch-modified MRC (0 to 3).
Other secondary endpoints:
- Percentage of patients at 24 weeks (Visit V9) and EOS visit with no requirement of change in CIDP treatment from baseline.
- Change from baseline to 24 weeks (Visit V9) and EOS visit in Patient and Investigator Clinical Global Impression (CGI).

E.5.2.1

Timepoint(s) of evaluation of this end point

At the inclusion, at week 24 and at the end of study visit

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Exploratory objectives:
• To assess a potential relationship between serum total IgG trough
levels, biomarkers levels and clinical response, 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
response, as assessed by neurological scales, in patients with CIDP
(ancillary study in Italy only).

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

single arm

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

France

Germany

Italy

Poland

Spain

Tunisia

Turkey

United Kingdom

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

At the last visit patients will be switched to the normal standard of care for the condition.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-07-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-08-10

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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