Chronic Inflammatory Demyelinating PolyradiculoneuropathyPhase 3PRISM2NCT02317562

Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302

A Phase 3 study testing I10E in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Laboratoire français de Fractionnement et de Biotechnologies at 30 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Primary objective: 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. (I10E-1302). Secondary objective: To assess the safety of I10E in this patient population. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
What is being tested?: I10E
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 30 sitesin 6 countries
Study dates: Nov 2015to 28 Jul 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patient aged 18 years or more.
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.
Covered by national healthcare insurance system as required by local regulations.
Written informed consent obtained prior to any study-related procedures.

Who cannot join

History of severe allergic reaction or serious adverse reaction to any Ig.
Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
Body mass index (BMI) ≥40 kg/m².

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Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet Renal Disease (MDRD) calculation.
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.
Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception.
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.
Increasing dosage or introduction of a systemic corticosteroids therapy within the last 3 months prior to screening, at a dose higher than 10 mg daily prednisolone or equivalent. Topical corticosteroids are permitted.
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.
Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening.
Anticipated poor compliance of patient with study procedures.

Trial locations and contacts

30 sites in 6 countries.

Country

City, postcode or hospital

30 sites in 6 countries

Italy7 sites

IRRCS Azienda Ospedaliera Universitaria
Genova
IRCCS Instituto Clinico Humanitas
Milan
IRRCS Istutito Nazionale Neurologico Besta
Milan
Ospedale San Raffaele IRCCS
Milan
Azienda Ospedaliera Universitaria di Padova
Padova
Università Cattolica del sacro Cuore
Roma
Azienda Ospedaliera Universitaria san Giovanni
Torino

Other trials in Italy

France6 sites

CHU de Bordeaux - Hôpital Pellegrin
Bordeaux
Hôpital général du CHU de Dijon
Dijon
CHU de Nice - Hôpital l'Archet
Nice
CHU paris - Hôpital Pitié salpétrière
Paris
CHU de Saint Etienne - Hôpital Nord
Saint-Etienne
Hôpital de Hautepierre
Strasbourg

Other trials in France

Spain5 sites

Hospital de la santa creu i Sant Pau
Barcelona
Hospital General Universitario Gregorio
Madrid
Hospital Clinico Universitario de Santiago
Santiago de Compostela
Hospital Universitario Virgen del Rocio
Seville
Hospital Universitario i Politècnico La Fe
Valencia

Other trials in Spain

Tunisia5 sites

Tunisia Hôpital Razi
Manouba
Hôpital Fattouma Bourguiba
Monastir
Hôpital Habib Bourguiba
Sfax
Hôpital Sahloul
Sousse
Hôpital Militaire de Tunis
Tunis

Other trials in Tunisia

Turkey (Türkiye)5 sites

Ankara university medical school Neurology
Ankara
Hacettepe University medical School Neurology
Ankara
Uludag University Medical School Neurology
Bursa
istanbul University Cerrahpasa Medical School Neurology
Istanbul
Marmara Universitesi Egitim Ve Arastirma Hastanesi
Istanbul

Other trials in Turkey (Türkiye)

United Kingdom2 sites

Southhampton general Hospital
Southhampton
University Hospital of North Straffordshire
Straffordshire

Other trials in United Kingdom

About this study

Official title: 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"

Primary objective:

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. (I10E-1302).

Secondary objective:

To assess the safety of I10E in this patient population.

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Being tested: I10E
Keywords: Peripheral neuropathy, Disimmune disease, Neurology chronic disease, Rare disease
Medical subject headings: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Peripheral Nervous System Diseases, Rare Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

I10EDrug
Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.

Study groups in NCT02317562
Study group	Role	What they receive
I10E Arm	Experimental	Not described Receives: Drug: I10E

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit
Since the study was prematurely terminated and an important number of subjects early withdrawn, the responder rate is biased and consequently not interpretable.
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.
Measured: week 48 (End-of-Study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201528 Jul 2017

First posted16 Dec 2014 (estimated)
Study startNov 2015
Primary completion28 Jul 2017
Study completion28 Jul 2017

Why it stopped: Sponsor's decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Inflammatory Demyelinating PolyradiculoneuropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02317562
Sponsor's protocol ID: I10E-1306
Acronym: PRISM2
Status last verified: Apr 2021
First submitted: 11 Dec 2014
Last updated: 20 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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"
ClinicalTrials.gov ID: NCT02317562
Acronym / sponsor ID: PRISM2 / I10E-1306
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Keywords: Peripheral neuropathy, Disimmune disease, Neurology chronic disease, Rare disease
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor's decision
Enrolment: 19 participants (actual)
Lead sponsor: Laboratoire français de Fractionnement et de BiotechnologiesIndustry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: 28 Jul 2017 (actual)
Study completion: 28 Jul 2017 (actual)
First posted: 16 Dec 2014 (estimated)
Results: Posted 20 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary objective:

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. (I10E-1302).

Secondary objective:

To assess the safety of I10E in this patient population.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
I10E Arm	Experimental	Drug: I10E

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female patient aged 18 years or more.
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.
Covered by national healthcare insurance system as required by local regulations.
Written informed consent obtained prior to any study-related procedures.

Key exclusion criteria (14 listed)

History of severe allergic reaction or serious adverse reaction to any Ig.
Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
I10EPatients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.	Drug	I10E Arm

Primary outcome

Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit
Time frame: week 48 (End-of-Study)
Since the study was prematurely terminated and an important number of subjects early withdrawn, the responder rate is biased and consequently not interpretable. 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.

Results and safety

Results posted to the registry on 20 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
I10E Arm	19	5

Primary outcome: Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit

Time frame: week 48 (End-of-Study). Count of participants. Unit: Participants

Measure	I10E Arm n = 19
Value	15

Population analysed: Study prematurely stopped due to sponsor decision based on the relapse rate.

Adverse events

Time frame: The safety was assessed by recording all AEs occurring during the study, i.e. after signature of the informed consent and until the end of the study recorded. (up to 48 weeks after inclusion).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
I10E Arm	1 of 19 (5.3%)	12 of 19 (63.2%)	0 of 19

Limitations and caveats (from the sponsor): 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. LFB BIOTECHNOLOGIES judged that it was not acceptable to continue the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eduardo NOBILE-ORAZIO, MD principal investigator

IRCCS Instituto Clinico Humanitas, Milano, Italy

30 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing I10E in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Laboratoire français de Fractionnement et de Biotechnologies at 30 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Italy, France, Spain, Tunisia, Turkey (Türkiye) and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Endpoint : Responder Rate at End of Study (EOS) Visit (time frame: week 48 (End-of-Study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02317562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.