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The European Union Clinical Trials Register allows you to search for protocol and results information on:

interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC

clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).

The EU Clinical Trials Register currently displays 44313 clinical trials with a EudraCT protocol, of which 7357 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).

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Clinical Trial Results:
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.

Summary
EudraCT number	2013-005558-31
Trial protocol	GB ES IT FR DE
Global end of trial date	28 Jul 2017

Results information
Results version number	v1(current)
This version publication date	14 Oct 2020
First version publication date	14 Oct 2020
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

I10E-1306

ISRCTN number

-

US NCT number

-

WHO universal trial number (UTN)

-

Sponsor organisation name

LFB Biotechnologies

Sponsor organisation address

3 Avenue des Tropiques, COURTABOEUF, France, 91930

Public contact

Global Clinical Development Leader, LFB BIOTECHNOLOGIES, +33 169 82 70 10,

Scientific contact

Global Clinical Development Leader, LFB BIOTECHNOLOGIES, +33 169 82 70 10,

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

18 Aug 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

28 Jul 2017

Global end of trial reached?

Yes

Global end of trial date

28 Jul 2017

Was the trial ended prematurely?

Yes

Main objective of the trial

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.

Protection of trial subjects

This study was conducted in compliance with good clinical practice (GCP) as described in the International Conference on Harmonisation (ICH) document “Guidance for Industry-E6 Good Clinical Practice: Consolidated Guidance” dated April 1996. These practices were consistent with the principles stated in the Declaration of Helsinki (October 2013 revised version). All other applicable regulations were followed.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

09 Nov 2015

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 3

Country: Number of subjects enrolled

Spain: 2

Country: Number of subjects enrolled

United Kingdom: 1

Country: Number of subjects enrolled

France: 2

Country: Number of subjects enrolled

Italy: 4

Country: Number of subjects enrolled

Tunisia: 6

Country: Number of subjects enrolled

Turkey: 1

Worldwide total number of subjects

19

EEA total number of subjects

12

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

15

From 65 to 84 years

4

85 years and over

0

Subject disposition

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Recruitment details

Between 09 November 2015 and 23 June 2017, 20 subjects from 14 sites signed an informed consent.

Screening details

-

Number of subjects started

20 ^[1]

Number of subjects completed

19

Reason: Number of subjects

screening failure: 1

Notes
[1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: 20 subjects signed an informed consent but only 19 subjects enrolled (1 screening failure).

Period 1 title

Treatment period (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Single arm

Arm description

Participation in the study was proposed to all subjects who completed and responded to treatment in PRISM study, satisfying in eligibility criteria and were willing to continue I10E at a reduced maintenance dose.

Arm type

Experimental

Investigational medicinal product name

IQYMUNE

Investigational medicinal product code

I10E

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Each subject was expected to receive 16 doses of I10E (study drug) at 0.5 g/kg over 1 to 2 days, every 3 weeks. Study drug was administered intravenously, with an infusion pump (B-Braun Infusomat Space).

Number of subjects in period 1	Single arm
Started	19
Completed	5
Not completed	14
Consent withdrawn by subject	1
Physician decision	1
early termination of the study by the sponsor	8
Lack of efficacy	4

Baseline characteristics

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Reporting group title

Treatment period

Reporting group description

-

Reporting group values	Treatment period	Total
Number of subjects	19	19
Age categorical
Units: Subjects
Adults (18-79 years)	19	19
Age continuous
Units: years
median (full range (min-max))	50.0 (24 to 79)	-
Gender categorical
Units: Subjects
Female	7	7
Male	12	12

End points

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Reporting group title

Single arm

Reporting group description

Participation in the study was proposed to all subjects who completed and responded to treatment in PRISM study, satisfying in eligibility criteria and were willing to continue I10E at a reduced maintenance dose.

Subject analysis set title

Total Treated set

Subject analysis set type

Safety analysis

Subject analysis set description

All subjects who received at least one infusion of I10E.

Primary: Responder rate

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End point title

Responder rate ^[1]

End point description

The responder rate at EOS visit based on the adjusted INCAT disability score was not analysed since the study was early terminated. Responders were defined as subjects 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.

End point type

Primary

End point timeframe

During treatment period the adjusted INCAT disability score was evaluated at week 0 (baseline), week 3, week 6, week 9, week 12, week 15, week 18, week 21, week 24, week 27, week 30, week 33, week 36, week 39, week 42, week 45, week 48 (End-of-Study).

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The responder rate at EOS visit based on the adjusted INCAT disability score was not analysed since the study was early terminated.

End point values	Single arm
Number of subjects analysed	0 ^[2]
Units: Subjects

Notes
[2] - study stopped prematurely

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Throughout the study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

Single arm

Reporting group description

Participation in the study was proposed to all subjects who completed and responded to treatment in PRISM study, satisfying in eligibility criteria and were willing to continue I10E at a reduced maintenance dose.

Serious adverse events	Single arm
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 19 (5.26%)
number of deaths (all causes)	0
number of deaths resulting from adverse events	0
Renal and urinary disorders
Urinary retention
subjects affected / exposed	1 / 19 (5.26%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Single arm
Total subjects affected by non serious adverse events
subjects affected / exposed	12 / 19 (63.16%)
Vascular disorders
Hypertension
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Hypotension
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
General disorders and administration site conditions
Fatigue
subjects affected / exposed	2 / 19 (10.53%)
occurrences all number	2
Chills
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Injection site erythema
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Injection site oedema
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Pain
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Pyrexia
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	2
Respiratory, thoracic and mediastinal disorders
Nasal congestion
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	4
Psychiatric disorders
Conversion disorder
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Insomnia
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Investigations
Blood pressure increased
subjects affected / exposed	2 / 19 (10.53%)
occurrences all number	2
Blood lactate dehydrogenase increased
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Injury, poisoning and procedural complications
Ligament sprain
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Post-traumatic pain
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Cardiac disorders
Palpitations
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Nervous system disorders
Headache
subjects affected / exposed	3 / 19 (15.79%)
occurrences all number	5
Migraine
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	2
Neuralgia
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Sciatica
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Ear and labyrinth disorders
Tinnitus
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Diarrhoea
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Duodenal ulcer
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Gastritis
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Hiatus hernia
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Vomiting
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Skin and subcutaneous tissue disorders
Dry skin
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Eczema nummular
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Erythema
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	3
Rash pruritic
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Musculoskeletal and connective tissue disorders
Pain in extremity
subjects affected / exposed	3 / 19 (15.79%)
occurrences all number	3
Arthralgia
subjects affected / exposed	2 / 19 (10.53%)
occurrences all number	3
Back pain
subjects affected / exposed	2 / 19 (10.53%)
occurrences all number	2
Neck pain
subjects affected / exposed	2 / 19 (10.53%)
occurrences all number	2
Muscle spasms
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Musculoskeletal pain
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Tendonitis
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Infections and infestations
Conjunctivitis
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Gastroenteritis viral
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Infected bite
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Influenza
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	2
Nasopharyngitis
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	2
Tooth abscess
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Upper respiratory tract infection
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	1
Urinary tract infection
subjects affected / exposed	1 / 19 (5.26%)
occurrences all number	2

More information

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Were there any global substantial amendments to the protocol? Yes

06 Jan 2016

Modification of some exclusion criteria - Removal of routine free bilirubin testing - Additional renal safety follow-up - Description of the patient population - Rules for follow-up of adverse events - Timing of safety monitoring (vital signs) - Update of IMP storage conditions. This amendment led to the protocol version 4.0 dated 06 January 2016.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
04 Jul 2017	This study was prematurely stopped because 4 subjects relapsed among 14 enrolled and treated subjects at the time of the early assessment of study results. An increase by ≥2 points in adjusted INCAT disability score compared to baseline was observed after administration of 2, 3, 6 or 7 courses of I10E at 0.5 g/kg every 3 weeks. LFB BIOTECHNOLOGIES judged that it was not acceptable to continue the study due to the magnitude of nonresponders at this lower dose corresponding to 50% decrease compared to the standard maintenance dose of 1.0 g/kg (every 3 weeks +/- 7 days) used in PRISM study. Subjects prematurely withdrawn from the study were to be managed at the discretion of the investigators.	-

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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