Clinical trial • Phase II • Immunology | Rare Disease
IMEROPRUBART for Chronic inflammatory demyelinating polyneuropathy (CIDP)
Phase II trial of IMEROPRUBART for Chronic inflammatory demyelinating polyneuropathy (CIDP).
Overview
- Trial Therapeutic Area
- Immunology | Rare Disease
- Trial Disease
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 07-07-2025
- First CTIS Authorization Date
- 28-10-2025
Trial design
Randomised, placebo is identical to imp but with no active substance (placebo-controlled). Phase II trial in Slovenia, Estonia, Belgium and others.
- Randomised
- Yes
- Comparator
- Placebo is identical to IMP but with no active substance (placebo-controlled).
- Target Sample Size
- 92
- Trial Duration For Participant
- 532
Eligibility
Recruits 92 No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be ≥18 years and provide informed consent (ICF). No assent procedures for minors are applicable..
- Pregnancy Exclusion
- Are breastfeeding or pregnant as determined by a positive serum pregnancy test at the Screening Visit or urine human chorionic gonadotropin test at the Baseline Visit (Day 1).
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Participants must be ≥18 years and provide informed consent (ICF). No assent procedures for minors are applicable.
Inclusion criteria
- {"criterion_text":"- Are ≥ 18 years of age at the time of signing the informed consent form (ICF)."}
- {"criterion_text":"- Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) Guideline on Diagnosis and Treatment of CIDP."}
- {"criterion_text":"- Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNS guideline on diagnosis and treatment of CIDP."}
- {"criterion_text":"- Are currently on, and have been receiving, chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (intravenous immunoglobulin [IVIg] or subcutaneous immunoglobulin [SCIg]) ± low dose oral corticosteroids, for at least 3 months for the treatment of CIDP at the time of the Screening Visit."}
Exclusion criteria
- {"criterion_text":"- Have current or prior history of IgM paraproteinemia with or without antimyelin-associated-glycoprotein antibodies."}
- {"criterion_text":"- Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN/PNS guideline on diagnosis and treatment of CIDP."}
- {"criterion_text":"- Have polyneuropathy with etiology other than CIDP including but not limited to: • Multifocal motor neuropathy • Hereditary demyelinating neuropathy • Polyneuropathy, organomegaly, endocrinopathy, or monoclonal protein and skin change syndromes • Lumbosacral radiculoplexus neuropathy • Systemic illnesses, including vitamin deficiency syndromes and paraneoplastic neuropathies • Drug- or toxin-induced"}
- {"criterion_text":"- Have diabetes mellitus (DM) and meets any of the following criteria: • Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study. • In the opinion of the Investigator, there is evidence of poorly controlled DM immediately preceding the diagnosis of CIDP. • In the opinion of the Investigator, there is evidence of poorly controlled DM at Screening."}
- {"criterion_text":"- Have a history of myelopathy or evidence of central demyelination."}
- {"criterion_text":"- Are breastfeeding or pregnant as determined by a positive serum pregnancy test at the Screening Visit or urine human chorionic gonadotropin test at the Baseline Visit (Day 1)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The proportion of participants remaining Relapse-free by Week 24.","definition_or_measurement_approach":"Relapse-free status by Week 24 assessed by aINCAT score (main objective: preventing Relapse as assessed by aINCAT)."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline to Week 24 in I-RODS.","definition_or_measurement_approach":"Change from baseline to Week 24 measured by I-RODS instrument."}
- {"endpoint_text":"- Change from baseline to Week 24 in Mean Grip Strength in the dominant hand.","definition_or_measurement_approach":"Change from baseline to Week 24 in mean grip strength of dominant hand (measurement using vigorimeter / grip strength device)."}
- {"endpoint_text":"- Change from baseline to Week 24 in MRC-SS.","definition_or_measurement_approach":"Change from baseline to Week 24 measured by MRC sum score (MRC-SS)."}
- {"endpoint_text":"- Change from baseline to Week 24 in aINCAT score.","definition_or_measurement_approach":"Change from baseline to Week 24 measured by adjusted INCAT (aINCAT) score."}
Recruitment
- Registry Or Advocacy Recruitment
- True, Advocacy Group (no specific advocacy organisation name provided in documents; multiple 'Advocacy Group' recruitment materials referenced).
- Digital Remote Recruitment
- True, digital/remote methods include banner ads, social media posts, web postings, and advocacy group email/newsletter materials (country-specific versions referenced).
- Planned Sample Size
- 92
- Recruitment Window Months
- 55
- Consent Approach
- Consent provided by the participant (participants must be ≥18 years). Informed Consent Forms (L1_SIS and ICF_Main and related ICF documents) are provided; multiple language versions available (examples in files: EN, DE, FR, NL, IT, ES, HU, PL, PT, RO, SI, SK, BG, GR, EE, FI, NO, IE). No assent for minors (minors excluded). Specific pregnancy-related consent/information materials are also provided where applicable.
Methods
- Advocacy group channels (banner ads, emails, newsletter text, web postings) — country-specific versions provided (e.g., files labelled with country codes such as SI, EE, BE, RO, HU, IT, etc.).
- Printed materials: Brochure, Flyer, Poster — country-specific language versions.
- Digital channels: Social media and web posts — country-specific versions.
- Healthcare professional outreach: 'Dr to Patient' letters aimed at clinicians to refer patients.
- Site-based recruitment materials: Patient visit guides and posters/flyers distributed at sites.
- Multimedia: Injection training videos and instructions for use.
- Home Health / Site support: Home Health Care services listed among third parties (e.g., Illingworth Research Group Limited indicated for Home Health Care).
- Patient reimbursement/travel support (Greenphire listed for patient reimbursement / travel).
Geography
- Total Number Of Sites
- 66
- Total Number Of Participants
- 79
Slovenia
- Earliest CTIS Part Ii Submission Date
- 01-10-2025
- Latest Decision Or Authorization Date
- 29-10-2025
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- University Medical Center Ljubljana
- Department Name
- Institute of Clinical Neurophysiology
- Contact Person Name
- Blaz Koritnik
- Contact Person Email
- blaz.koritnik@kclj.si
Estonia
- Earliest CTIS Part Ii Submission Date
- 15-10-2025
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 16
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Clinic4U OÜ
- Contact Person Name
- Katrin Gross-Paju
- Contact Person Email
- katrin.gross-paju@astrakliinik.ee
Belgium
- Earliest CTIS Part Ii Submission Date
- 10-10-2025
- Latest Decision Or Authorization Date
- 13-11-2025
- Processing Time Days
- 34
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- UZ Leuven
- Department Name
- Neurology
- Contact Person Name
- Kristl Claeys
- Contact Person Email
- kristl.claeys@uzleuven.be
Romania
- Earliest CTIS Part Ii Submission Date
- 02-10-2025
- Latest Decision Or Authorization Date
- 13-11-2025
- Processing Time Days
- 42
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Institutul Clinic Fundeni
- Department Name
- Neurologie I
- Contact Person Name
- Adriana Dulamea
- Contact Person Email
- adrianadulamea@gmail.com
- Site Name
- Brainaxy Clinic S.R.L.
- Department Name
- Spitalizare de zi
- Contact Person Name
- Any Axelerad
- Contact Person Email
- docuaxi@yahoo.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 14-10-2025
- Latest Decision Or Authorization Date
- 29-10-2025
- Processing Time Days
- 15
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Kistarcsai Flor Ferenc Korhaz
- Department Name
- Neurológia és Stroke Osztály
- Contact Person Name
- Gyula Panczel
- Contact Person Email
- panczel.gyula@florhosp.hu
- Site Name
- Clinexpert Kft.
- Contact Person Name
- Ferenc Fazekas
- Contact Person Email
- dr.f.fazekas@gmail.com
- Site Name
- University Of Pecs
- Department Name
- Klinikai Központ, Neurológiai Klinika
- Contact Person Name
- Endre Pál
- Contact Person Email
- pal.endre@pte.hu
Italy
- Earliest CTIS Part Ii Submission Date
- 13-10-2025
- Latest Decision Or Authorization Date
- 28-10-2025
- Processing Time Days
- 15
- Number Of Sites
- 11
- Number Of Participants
- 8
Sites
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- UO Neurologia
- Contact Person Name
- Gabrielle Siciliano
- Contact Person Email
- gabrielesiciliano.studi@ao-pisa.toscana.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Neurologia
- Contact Person Name
- Marco Luigetti
- Contact Person Email
- marco.luigetti@policlinicogemelli.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Human Neuroscience Health
- Contact Person Name
- Maurizio Inghilleri
- Contact Person Email
- Maurizio.inghilleri@uniroma1.it
- Site Name
- Fondazione Istituto Neurologico Nazionale Casimiro Mondino
- Department Name
- UO Neuroncologia
- Contact Person Name
- Elisa Vegezzi
- Contact Person Email
- elisa.vegezzi@mondino.it
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- SC Neurologia 3 - Neuralgologia
- Contact Person Name
- Eleonora Dalla Bella
- Contact Person Email
- eleonora.dallabella@istituto-besta.it
- Site Name
- Azienda Unita Sanitaria Locale Di Bologna
- Department Name
- UOC Clinical Neurologica
- Contact Person Name
- Vincenzo Angelo Donadio
- Contact Person Email
- vincenzo.donadio@unibo.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Neurologia
- Contact Person Name
- Barbara Frigeni
- Contact Person Email
- bfrigeni@asst-pg23.it
- Site Name
- Centro Clinico Nemo
- Department Name
- Centro Clinico Nemo - Brescia
- Contact Person Name
- Massimiliano Filosto
- Contact Person Email
- massimiliano.filosto@unibs.it
- Site Name
- Azienda Ospedaliero-Universitaria Senese
- Department Name
- UOC Neurologia
- Contact Person Name
- Federica Ginanneschi
- Contact Person Email
- federica.ginanneschi@unisi.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- UO Neurologia
- Contact Person Name
- Stefano Previtali
- Contact Person Email
- previtali.stefano@hsr.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- SSD Malattie Neuromuscolari Rare
- Contact Person Name
- Francesca Magri
- Contact Person Email
- francesca.magri@policlinico.mi.it
Austria
- Earliest CTIS Part Ii Submission Date
- 14-10-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 20
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Neurology
- Contact Person Name
- Jakob Rath
- Contact Person Email
- jakob.rath@meduniwien.ac.at
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 13-10-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 21
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
- Department Name
- Clinic of Neurodegenerative and Peripheral Nerve Disorders
- Contact Person Name
- Ivan Milanov
- Contact Person Email
- ubalnp@yahoo.com
- Site Name
- Medical Center Academica 2008 EOOD
- Contact Person Name
- Plamen Tsvetanov
- Contact Person Email
- tzvetanovmd@mail.bg
- Site Name
- University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
- Department Name
- Clinic of neurological diseases
- Contact Person Name
- Mariya Dimitrova
- Contact Person Email
- dr.m.i.dimitrova@gmail.com
- Site Name
- Diagnostics And Consultation Center Convex Ltd.
- Contact Person Name
- Sashka Zhelyazkova
- Contact Person Email
- doc_sashka@abv.bg
- Site Name
- Military Medical Academy
- Department Name
- Clinic of neurological diseases
- Contact Person Name
- Vanya Deneva
- Contact Person Email
- vania_den@yahoo.com
Germany
- Earliest CTIS Part Ii Submission Date
- 01-08-2025
- Latest Decision Or Authorization Date
- 29-10-2025
- Processing Time Days
- 88
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Charite Research Organisation GmbH
- Department Name
- NeuroCure Clinical Research Center – NCRC Klinik fur Neurologie
- Contact Person Name
- Frauke Stascheit
- Contact Person Email
- frauke.stascheit@charite.de
- Site Name
- Katholisches Klinikum Bochum gGmbH
- Department Name
- Neurologische Universitätsklink - St. Josef Hospital
- Contact Person Name
- Kalliopi Pitarokoili
- Contact Person Email
- kalliopi.pitarokoili@rub.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Johannes Dorst
- Contact Person Email
- johannes.dorst@uni-ulm.de
- Site Name
- Klinikum Wuerzburg Mitte gGmbH
- Department Name
- Klinik für Neurologie und Neurologische Frührehabilitation
- Contact Person Name
- Mathias Maürer
- Contact Person Email
- mathias.maeurer@kwm-klinikum.de
Denmark
- Earliest CTIS Part Ii Submission Date
- 10-10-2025
- Latest Decision Or Authorization Date
- 28-10-2025
- Processing Time Days
- 18
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of neurology
- Contact Person Name
- Tina Dysgaard
- Contact Person Email
- tina.dysgaard@regionh.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of neurology
- Contact Person Name
- Soren Sindrup
- Contact Person Email
- soeren.sindrup@rsyd.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 16-10-2025
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 15
- Number Of Sites
- 7
- Number Of Participants
- 4
Sites
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Neurology
- Contact Person Name
- Eduardo Agüera Morales
- Contact Person Email
- neuroensayos@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Contact Person Name
- Raùl Juntas Morales
- Contact Person Email
- raul.juntas@vallhebron.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neurology
- Contact Person Name
- María Teresa Sevilla Mantecón
- Contact Person Email
- sevilla_ter@gva.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Neuroloy
- Contact Person Name
- Luis Antonio Querol Gutiérrez
- Contact Person Email
- lquerol@santpau.cat
- Site Name
- Hospital Universitario Basurto
- Department Name
- Neurology
- Contact Person Name
- Solange Kapetanovic Garcia
- Contact Person Email
- solange.kapetanovicgarcia@osakidetza.eus
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Neurology
- Contact Person Name
- Tania Garcia Sobrino
- Contact Person Email
- tania.garcia.sobrino@sergas.es
- Site Name
- Hospital Universitario Y Politecnico La Fe - (additional site entry in list)
- Department Name
- Neurology
Finland
- Earliest CTIS Part Ii Submission Date
- 30-09-2025
- Latest Decision Or Authorization Date
- 29-10-2025
- Processing Time Days
- 29
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Turku University Hospital
- Department Name
- Neurology
- Contact Person Name
- Manu Turku
- Contact Person Email
- manu.jokela@tyks.fi
Greece
- Earliest CTIS Part Ii Submission Date
- 26-09-2025
- Latest Decision Or Authorization Date
- 30-10-2025
- Processing Time Days
- 34
- Number Of Sites
- 7
- Number Of Participants
- 4
Sites
- Site Name
- Eginitio Hospital
- Department Name
- 1st Neurology Department
- Contact Person Name
- Leonidas Stefanis
- Contact Person Email
- lstefanis@bioacademy.gr
- Site Name
- University General Hospital Of Ioannina
- Department Name
- Neurology clinic
- Contact Person Name
- Spyridon Konitsiotis
- Contact Person Email
- skonitso@gmail.com
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Neurology Department
- Contact Person Name
- Panayiotis Mitsias
- Contact Person Email
- p.mitsias@gmail.com
- Site Name
- University General Hospital Of Alexandroupoli
- Department Name
- University Department of Neurology
- Contact Person Name
- Aikaterini Terzoudi
- Contact Person Email
- katerzoudi@hotmail.com
- Site Name
- General University Hospital Of Patras
- Department Name
- Neurology Department, Neuromuscular Unit
- Contact Person Name
- Elisabeth Chroni
- Contact Person Email
- echroni@yahoo.com
- Site Name
- University General Hospital Attikon
- Department Name
- Second Department of Neurology - National and Kapodistrian University of Athens
- Contact Person Name
- Georgios Tsivgoulis
- Contact Person Email
- tsivgoulisgiorg@yahoo.gr
- Site Name
- General University Hospital Of Larissa
- Department Name
- Neurology Department
- Contact Person Name
- Efthimios Dardiotis
- Contact Person Email
- ebsdar@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 10-10-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 24
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Neurology
- Contact Person Name
- Ludo Van der Pol
- Contact Person Email
- w.l.vanderpol@umcutrecht.nl
Portugal
- Earliest CTIS Part Ii Submission Date
- 29-08-2025
- Latest Decision Or Authorization Date
- 28-10-2025
- Processing Time Days
- 60
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Unidade Local De Saude De Matosinhos E.P.E.
- Department Name
- Serviço de Neurologia
- Contact Person Name
- Sandra Moreira
- Contact Person Email
- sandramanuela.moreira@ulsm.min-saude.pt
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Department Name
- Serviço de Neurologia
- Contact Person Name
- Henrique Moniz Costa
- Contact Person Email
- henrique.costa@ulsge.min-saude.pt
- Site Name
- Unidade Local De Saude De Almada-Seixal E.P.E.
- Department Name
- Serviço de Neurologia
- Contact Person Name
- Pedro Pereira
- Contact Person Email
- pedro.m.pereira@hgo.min-saude.pt
Poland
- Earliest CTIS Part Ii Submission Date
- 16-10-2025
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 15
- Number Of Sites
- 11
- Number Of Participants
- 5
Sites
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Oddzial Kliniczny Neurologii
- Contact Person Name
- Agnieszka Slowik
- Contact Person Email
- neurologiabk@su.krakow.pl
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Oddział Neurologiczny z Pododdziałem Udarowym i z Pododdziałem Rehabilitacji Neurologicznej
- Contact Person Name
- Agnieszka Kulaga
- Contact Person Email
- kulaga_a@poczta.onet.pl
- Site Name
- Clinical Research Center Sp. z o.o. Medic-R sp.k.
- Department Name
- Neurology
- Contact Person Name
- Artur Druzdz
- Contact Person Email
- artur.druzdz@cr-center.pl
- Site Name
- Neurologia Śląska Centrum Medyczne
- Contact Person Name
- Marek Smilowski
- Contact Person Email
- marek.smilowski2@gmail.com
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o.
- Department Name
- MICS Centrum Medyczne Bydgoszcz
- Contact Person Name
- Lukasz Rzepinski
- Contact Person Email
- luk.rzepinski@gmail.com
- Site Name
- Centrum Medyczne Hope Clinic
- Department Name
- Neurology
- Contact Person Name
- Sebastian Szklener
- Contact Person Email
- sebastianszklener@gmail.com
- Site Name
- Clinirem Sp. z o.o. (Bydgoszcz)
- Contact Person Name
- Urszula Chyrchel-Paszkiewicz
- Contact Person Email
- pgluchyrchel@gmail.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Contact Person Name
- Mariusz Kwarciany
- Contact Person Email
- mariusz.kwarciany@gumed.edu.pl
- Site Name
- Clinirem Sp. z o.o. (Wielicka 42)
- Contact Person Name
- Urszula Chyrchel-Paszkiewicz
- Contact Person Email
- pgluchyrchel@gmail.com
- Site Name
- Medicover Integrated Clinical Services Sp. z o.o. (Bydgoszcz secondary)
- Contact Person Name
- Lukasz Rzepinski
- Contact Person Email
- luk.rzepinski@gmail.com
- Site Name
- Additional Polish investigational site (listed)
- Department Name
- Pending / N/A
- Contact Person Name
- Pending
- Contact Person Email
- Pending@pending
Slovakia
- Earliest CTIS Part Ii Submission Date
- 26-09-2025
- Latest Decision Or Authorization Date
- 29-10-2025
- Processing Time Days
- 33
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Univerzitna Nemocnica Martin
- Department Name
- Neurologická klinika
- Contact Person Name
- Monika Turcanova Koprusakova
- Contact Person Email
- koprusakova@gmail.com
- Site Name
- Penta Hospitals SK a.s.
- Department Name
- Neurologické oddelenie
- Contact Person Name
- Erika Zacharova
- Contact Person Email
- erika.zacharova@pentahospitals.sk
- Site Name
- Fakultna Nemocnica S Poliklinikou J. A. Reimana Presov
- Department Name
- Neurologické oddelenie
- Contact Person Name
- Anna Cvengrošová
- Contact Person Email
- annacvengrosova@gmail.com
Norway
- Earliest CTIS Part Ii Submission Date
- 13-10-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Division of Clinical Neuroscience
- Contact Person Name
- Angelina Maniaol
- Contact Person Email
- angman@ous-hf.no
Ireland
- Earliest CTIS Part Ii Submission Date
- 09-10-2025
- Latest Decision Or Authorization Date
- 31-10-2025
- Processing Time Days
- 22
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- University Hospital Waterford
- Department Name
- Neurology
- Contact Person Name
- Orla Tuohy
- Contact Person Email
- orla.tuohy@hse.ie
Sponsor
Primary sponsor
- Full Name
- Immunovant Sciences GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- PPD Global Ltd.
- Responsibilities
- Multiple operational roles (codes listed for clinical operations, monitoring, lab, etc.); contact: pprovalsgr.sm@thermofisher.com
- Name
- Syneos Health Inc.
- Responsibilities
- IDMC and other clinical operations support; contact: donna.davison@syneoshealth.com
- Name
- Marken LLP
- Responsibilities
- Logistics / distribution support (roles indicated by sponsor duties)
- Name
- Medidata Solutions Inc.
- Responsibilities
- eClinical platform / data capture (codes present)
- Name
- Suvoda LLC
- Responsibilities
- eTMF / eClinical systems (codes present)
- Name
- Longboat Clinical Limited
- Responsibilities
- Site technology solutions; prescreening logs and site training
Third parties
- {"country":"Netherlands","full_name":"CliniChain B.V.","duties_or_roles":"Equipment: Vigorimeters","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Catalent Cts (Edinburgh) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Duties codes listed (multiple responsibilities); explicit value fields: none","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"Home Health Care","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement / Travel","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Quipment","duties_or_roles":"Medical and study equipment","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Emsere B.V.","duties_or_roles":"Laboratory equipment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eclinical Solutions LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"Multiple roles (codes present); explicit value fields: none","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cogstate Inc.","duties_or_roles":"Rater training","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Voisin Consulting Life Sciences","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"IDMC","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"eCOA / ePRO","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"PPD Global Limited (Granta Park, Great Abington)","duties_or_roles":"Multiple roles including central trial activities (codes listed)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"Patient recruitment","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Site Technology Solutions: Prescreening logs, Visit planning tool, Site training","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"Central Lab","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"","full_name":"Additional third parties listed (various)","duties_or_roles":"","organisation_type":""}
Investigational products
- Investigational Product Name
- IMVT-1402
- Active Substance
- IMEROPRUBART
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Maximum Dose
- 600 mg (max daily dose amount as listed)
- Investigational Product Name
- Placebo is identical to IMP but with no active substance.
- Modality
- Other
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- EMPASIPRUBART for Chronic inflammatory demyelinating polyneuropathy (CIDP)
- RITUXIMAB for Chronic inflammatory demyelinating polyneuropathy (CIDP)
- RILIPRUBART for Chronic inflammatory demyelinating polyneuropathy (CIDP)
- TIBULIZUMAB for Systemic sclerosis | Systemic sclerosis-associated interstitial lung disease
- tabelecleucel for Epstein-Barr virus-associated primary immunodeficiency lymphoproliferative disease (PID LPD) | Epstein-Barr virus-associated post-transplant lymphoproliferative disorder (PTLD) | Epstein-Barr virus-associated sarcoma (including leiomyosarcoma) | Epstein-Barr virus-associated CNS post-transplant lymphoproliferative disorder