Chronic Inflammatory Demyelinating PolyradiculoneuropathyPhase 3PRISMNCT02293460

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

A Phase 3 study testing I10E in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Laboratoire français de Fractionnement et de Biotechnologies at 33 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. 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: 44 participants
Where: 33 sitesin 6 countries
Study dates: May 2015to 29 Sep 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
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
Score of at least 2 on the adjusted INCAT disability scale
Patient who either :
has never been previously treated with Ig (Ig-naive patient) Or
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

Who cannot join

History of IgA deficiency, unless the absence of anti-IgA antibodies has been documented
History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension
History of venous thrombo-embolic disease, myocardial infarction or, cerebrovascular accident
Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologic malignancy with monoclonal gammopathy
Body mass Index (BMI) ≥40 kg/m²
Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet in Renal Disease (MDRD) calculation

Show all 13Show fewer

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
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 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
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)
Plasma exchange, blood products or derivatives administered within the last 3 months prior to screening
Administration of another investigational product within the last month prior to screening

Trial locations and contacts

33 sites in 6 countries.

Country

City, postcode or hospital

33 sites in 6 countries

France7 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
Hôpital Pontchaillou
Rennes
CHU de saint Etienne - Hôpital nord
Saint-Etienne
Hôpital de Hautepierre
Strasbourg

Other trials in France

Italy7 sites

IRRCS Azienda Ospedaliera Universitaria
Genova
IRCCS - Istituto Clinico Humanitas
Milan
IRRCS Istituto Nazionale Neurologico Besta
Milan
Ospedale San Raffaele IRCCS
Milan
Azienda Ospedaliere Universitaria di Padova
Padova
Università Cattolica del Sacro Cuore
Roma
Azienda Ospedaliere Universitaria san Giovanni
Torino

Other trials in Italy

Spain6 sites

Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Quiron Madrid
Madrid, 28223
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

Hôpital Razi, La Manouba
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 UniversityCerrahpasa Medical School Neurology
Istanbul
Marmara Universitesi Egitim Ve Arastirma Hastanesi
Istanbul

Other trials in Turkey (Türkiye)

United Kingdom3 sites

St Georges
London, SW17OQT
Southampton General Hospital
Southampton
University Hospital of North Straffordshire
Stratford-upon-Avon

Other trials in United Kingdom

About this study

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

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.

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 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.

Study groups in NCT02293460
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
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.
Measured: 24 weeks after first treament injection

Timeline

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

May 201529 Sep 2017

First posted18 Nov 2014 (estimated)
Study startMay 2015
Primary completion29 Sep 2017
Study completion29 Sep 2017

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: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02293460
Sponsor's protocol ID: I10E-1302
Acronym: PRISM
Status last verified: Jan 2021
First submitted: 13 Nov 2014
Last updated: 27 Jan 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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All Chronic Inflammatory Demyelinating Polyradiculoneuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
ClinicalTrials.gov ID: NCT02293460
Acronym / sponsor ID: PRISM / I10E-1302
Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Keywords: Peripheral neuropathy, Disimmune disease, Neurology Chronic disease, Rare disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Laboratoire français de Fractionnement et de BiotechnologiesIndustry (pharma, biotech, devices)
Study start: May 2015
Primary completion: 29 Sep 2017 (actual)
Study completion: 29 Sep 2017 (actual)
First posted: 18 Nov 2014 (estimated)
Results: Posted 9 Mar 2020

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 in improving the disability of patients with CIDP.

Secondary objective:

To assess the safety of I10E in patients with CIDP.

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 (6 listed)

Male or female patient aged 18 years or more
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
Score of at least 2 on the adjusted INCAT disability scale
Patient who either :

Key exclusion criteria (13 listed)

History of IgA deficiency, unless the absence of anti-IgA antibodies has been documented
History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension
History of venous thrombo-embolic disease, myocardial infarction or, cerebrovascular accident
Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologic malignancy with monoclonal gammopathy
Body mass Index (BMI) ≥40 kg/m²

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 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.	Drug	I10E Arm

Primary outcome

Efficacy Endpoint: Responder Rate at End of Study
Time frame: 24 weeks after first treament injection
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.

Results and safety

Results posted to the registry on 9 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm	43	37

Primary outcome: Efficacy Endpoint: Responder Rate at End of Study

Time frame: 24 weeks after first treament injection. Count of participants. Unit: Participants

Measure	Full Analysis Set n = 42
Value	32

Full Analysis Set: Responder rate: 76.2 (95% CI 60.5 to 87.9), p <0.0001, exact binomial Clopper-Pearson

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 (week 24 after inclusion).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total Treated Set	7 of 43 (16.3%)	39 of 43 (90.7%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 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

33 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 33 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in France, Italy, 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 9 Mar 2020). 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 (time frame: 24 weeks after first treament injection). 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 NCT02293460.

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 27 Jan 2021.