Clinical trial • Phase IV • Immunology | Endocrinology
IMEROPRUBART for Graves' Disease
Phase IV trial of IMEROPRUBART for Graves' Disease. None/Not specified-controlled. 244 participants.
Overview
- Trial Therapeutic Area
- Immunology | Endocrinology
- Trial Disease
- Graves' Disease
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 20-01-2026
- First CTIS Authorization Date
- 05-05-2026
Trial design
None/Not specified-controlled Phase IV trial in Belgium, Bulgaria, Czechia and others.
- Comparator
- None/Not specified
- Target Sample Size
- 244
- Trial Duration For Participant
- 364
Eligibility
Recruits 244 No vulnerable populations selected (isVulnerablePopulationSelected=false)..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected=false).
Inclusion criteria
- {"criterion_text":"- Participants who completed Study IMVT-1402-2502 or Study IMVT-1402-2503."}
Exclusion criteria
- {"criterion_text":"- Have permanently discontinued IMP during the treatment period in the feeder study or have met study stopping criteria at any point up until the end of participation in the feeder study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percentage of Group A Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time Frame: At Week 52]","definition_or_measurement_approach":"Assessed as the percentage of Group A participants who remain euthyroid, off anti-thyroid drugs (ATD), and off IMVT-1402 at Week 52."}
Secondary endpoints
- {"endpoint_text":"- Percentage of Group A Participants who are euthyroid and off ATD [Time Frame: At Week 26]","definition_or_measurement_approach":"Assessed as the percentage of Group A participants who are euthyroid and not taking ATD at Week 26."}
- {"endpoint_text":"- Percentage of Group A Participants who are euthyroid and off ATD [Time Frame: Up to Week 52]","definition_or_measurement_approach":"Assessed as the percentage of Group A participants who are euthyroid and off ATD up to Week 52."}
- {"endpoint_text":"- Percentage of Group A Participants who are euthyroid, off ATD, and off IMVT-1402 [Time Frame: Up to Week 52]","definition_or_measurement_approach":"Assessed as the percentage of Group A participants who are euthyroid, off ATD, and off IMVT-1402 up to Week 52."}
- {"endpoint_text":"- Time to earliest date of euthyroidism, off ATD, and off IMVT-1402 to the earliest date of confirmed relapse in Group A Participants [Time Frame: Up to Week 52]","definition_or_measurement_approach":"Time-to-event measured from earliest date of euthyroidism (off ATD and off IMVT-1402) to earliest date of confirmed relapse in Group A, up to Week 52."}
- {"endpoint_text":"- Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time Frame: Up to Week 52]","definition_or_measurement_approach":"Assessed as the percentage of Group B participants who remain euthyroid, off ATD, and off IMVT-1402 up to Week 52."}
- {"endpoint_text":"- Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time Frame: At Week 52]","definition_or_measurement_approach":"Assessed as the percentage of Group B participants who remain euthyroid, off ATD, and off IMVT-1402 at Week 52."}
- {"endpoint_text":"- Time from Week 0 to the earliest date of confirmed relapse in Group B Participants [Time Frame: Up to Week 52]","definition_or_measurement_approach":"Time-to-event from Week 0 to earliest confirmed relapse in Group B, up to Week 52."}
- {"endpoint_text":"- Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time Frame: Up to Week 52]","definition_or_measurement_approach":"Assessed as the percentage of Group C participants who remain euthyroid, off ATD, and off IMVT-1402 up to Week 52."}
- {"endpoint_text":"- Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time Frame: At Week 52]","definition_or_measurement_approach":"Assessed as the percentage of Group C participants who remain euthyroid, off ATD, and off IMVT-1402 at Week 52."}
- {"endpoint_text":"- Time From Week 0 to the earliest date of confirmed relapse in Group C Participants [Time Frame: Up to Week 52]","definition_or_measurement_approach":"Time-to-event from Week 0 to earliest confirmed relapse in Group C, up to Week 52."}
- {"endpoint_text":"- Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb [Time Frame: At Week 26]","definition_or_measurement_approach":"Assessed as the percentage of Group A participants who are euthyroid, off ATD, and TRAb-seronegative at Week 26."}
- {"endpoint_text":"- Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb [Time Frame: Up to Week 52]","definition_or_measurement_approach":"Assessed as the percentage of Group A participants who are euthyroid, off ATD, and TRAb-seronegative up to Week 52."}
Recruitment
- Planned Sample Size
- 244
- Recruitment Window Months
- 46
- Consent Approach
- Informed consent obtained from participants. Multiple country- and language-specific informed consent (SIS/ICF) documents are provided (examples: EN, BG, DE, FR, NL, ES, IT, HU, LV, PL, EL, CZ) and there are template ICFs for pregnant partners, caregivers and scouts; no separate assent process is described in the available records.
Geography
- Total Number Of Sites
- 93
- Total Number Of Participants
- 128
Belgium
- Earliest CTIS Part Ii Submission Date
- 10-04-2026
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 26
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Hopital Erasme
- Department Name
- Division of Endocrinology
- Contact Person Name
- Aglaia Kyrilli
- Contact Person Email
- aglaia.kyrilli@hubruxelles.be
- Site Name
- AZ ST-JAN Brugge A.V.
- Department Name
- Internal Medicine / Endocrinology
- Contact Person Name
- Annick Van den Bruel
- Contact Person Email
- annick.VandenBruel@azsintjan.be
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 10-04-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 31
- Number Of Sites
- 14
- Number Of Participants
- 17
Sites
- Site Name
- Medcenter Nova Clinic Ltd.
- Contact Person Name
- Gergana Marinova
- Contact Person Email
- gergana_tosheva@abv.bg
- Site Name
- Alexandrovska University Hospital
- Department Name
- Clinic of Endocrinology and Metabolic Diseases
- Contact Person Name
- Zdravko Kamenov
- Contact Person Email
- zkamenov@hotmail.com
- Site Name
- Diagnostic Consultative Center Equita OOD
- Contact Person Name
- Neli Klyuchkova
- Contact Person Email
- klychkova@gmail.com
- Site Name
- University Multiprofile Hospital For Active Treatment Sofiamed OOD
- Department Name
- Clinic of Endocrinology and Metabolic Diseases
- Contact Person Name
- Anna-Maria Borissova Ivanova
- Contact Person Email
- anmarbor@abv.bg
- Site Name
- Medical Centre Pratia Clinic EOOD
- Contact Person Name
- Artin Magardichyan
- Contact Person Email
- dr.artin.magardichiyan@gmail.com
- Site Name
- University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
- Department Name
- Third Clinic of Endocrinology and Metabolic Diseases
- Contact Person Name
- Roussanka Kovatcheva
- Contact Person Email
- roussanka_kov@yahoo.com
- Site Name
- Medical Center Viva Phoenix OOD
- Contact Person Name
- Kaloyan Velkov
- Contact Person Email
- kaloyanvelkov@gmail.com
- Site Name
- Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
- Department Name
- Department of Endocrinology and Metabolic Diseases
- Contact Person Name
- Farah Ghassan
- Contact Person Email
- gasan_farah@mail.bg
- Site Name
- Medical Center Smolyan Klinikal Research Ltd.
- Contact Person Name
- Emiliya Apostolova
- Contact Person Email
- vitamed@abv.bg
- Site Name
- Medical Center Berbatov Ltd.
- Contact Person Name
- Dimitar Berbatov
- Contact Person Email
- dr.berbatov@gmail.com
- Site Name
- Kalimat Medical Center Ltd.
- Contact Person Name
- Mariana Yoncheva-Mihaylova
- Contact Person Email
- mdyoncheva@gmail.com
- Site Name
- Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
- Department Name
- Department of Endocrinology and Metabolic Diseases
- Contact Person Name
- Ivaylo Lefterov
- Contact Person Email
- ilefterov@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Pulmed Ltd.
- Department Name
- Department of Endocrinology and Metabolic Diseases at Clinic of Internal Diseases
- Contact Person Name
- Mitkov Mitko
- Contact Person Email
- mitko_mitkov@yahoo.com
- Site Name
- University Multiprofile Hospital For Active Treatment Kaspela EOOD
- Department Name
- Clinic of Endocrinology and Metabolic Diseases
- Contact Person Name
- Boyan Nonchev
- Contact Person Email
- nonchev_md@abv.bg
Czechia
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 92
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Edumed s.r.o.
- Contact Person Name
- Alicia Veselá
- Contact Person Email
- alica.vesela@edu-med.cz
- Site Name
- Milan Kvapil s.r.o.
- Department Name
- Diabetologická ambulance
- Contact Person Name
- František Loos
- Contact Person Email
- frankyloos@gmail.com
- Site Name
- Endokrinologie Klanovice s.r.o.
- Contact Person Name
- Markéta Weichetová
- Contact Person Email
- m.weichetova@post.cz
- Site Name
- ResTrial s.r.o.
- Department Name
- Klinika ResTrial
- Contact Person Name
- Emília Malicherová
- Contact Person Email
- emilia.malicherova@restrial.com
Germany
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 98
- Number Of Sites
- 5
- Number Of Participants
- 9
Sites
- Site Name
- Medicover Medizin gGmbH
- Department Name
- Medizinische Klinik und Poliklinik IV
- Contact Person Name
- Guenter Stalla
- Contact Person Email
- Guenter.Stalla@medicover.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Medizinische Klinik II, Gastroenterologie, Hepatologie, Infektiologie and Endokrinologie
- Contact Person Name
- Jochen Seufert
- Contact Person Email
- Jochen.seufert@uniklinik-freiburg.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Department of Medicine III, Devision of Endocrinology, Diabetes and Bone diseases
- Contact Person Name
- Lorenz Hofbauer
- Contact Person Email
- lorenz.hofbauer@uniklinikum-dresden.de
- Site Name
- HELIOS Kliniken Schwerin GmbH
- Department Name
- Internal Medecine, Endocrinology, Diabetology
- Contact Person Name
- Urs Lichtenauer
- Contact Person Email
- urs.lichtenauer@helios-gesundheit.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Medizinische Klinik I, Endokrinologie
- Contact Person Name
- Ulrich Dischinger
- Contact Person Email
- dischinger_u@ukw.de
Greece
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 94
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- General Hospital Of Athens Alexandra
- Department Name
- Endocrine Department and Diabetological Center
- Contact Person Name
- Vasiliki Vasileiou
- Contact Person Email
- vasvasendo@gmail.com
- Site Name
- Evaggelismos Hospital
- Department Name
- Department of Endocrinology "D.IKKOS"
- Contact Person Name
- Marinella Tzanela
- Contact Person Email
- endo.evangelismos@gmail.com
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- Department of Endocrinology, Diabetes & Metabolism
- Contact Person Name
- Fotini Adamidou
- Contact Person Email
- fotini.adamidou@gmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- 1st department of internal medecine, Endocrinology Unit
- Contact Person Name
- Anna Angelousi
- Contact Person Email
- a.angelousi@gmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 17-03-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 55
- Number Of Sites
- 6
- Number Of Participants
- 18
Sites
- Site Name
- University Of Debrecen
- Department Name
- Internal Medicine Clinic, Endocrinology
- Contact Person Name
- Miklos Bodor
- Contact Person Email
- bodor.miklos@med.unideb.hu
- Site Name
- Obudai Egeszseguegyi Centrum Kft.
- Contact Person Name
- István Páll
- Contact Person Email
- istvan.pall@oec.hu
- Site Name
- Semmelweis University
- Department Name
- Department of Internal Medicine and Oncology
- Contact Person Name
- István Takacs
- Contact Person Email
- takacs.istvan@semmelweis.hu
- Site Name
- Trial Pharma Kft.
- Department Name
- Endocrinology
- Contact Person Name
- Tivadar Banyai
- Contact Person Email
- banyai.tivadar@bmkk.eu
- Site Name
- University Of Pecs
- Department Name
- Clinical Center, 1st Department of Internal Medicine, Department of Endocrinology and Metabolism
- Contact Person Name
- Emese Mezosi
- Contact Person Email
- mezosi.emese@pte.hu
- Site Name
- University Of Szeged
- Department Name
- Clinical Center, Internal Medicine Clinic, Endocrinology
- Contact Person Name
- Zsuzsanna Valkusz
- Contact Person Email
- valkusz.zsuzsanna@med.u-szeged.hu
Italy
- Earliest CTIS Part Ii Submission Date
- 14-04-2026
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 22
- Number Of Sites
- 22
- Number Of Participants
- 16
Sites
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- DIPARTIMENTO DI SANITA' PUBBLICA
- Contact Person Name
- Domenico Salvatore
- Contact Person Email
- domsalva@unina.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Endocrinology Department
- Contact Person Name
- Andrea Giustina
- Contact Person Email
- Giustina.andrea@hsr.it
- Site Name
- Azienda Sanitaria Universitaria Friuli Centrale
- Department Name
- Oncology Area Department
- Contact Person Name
- Jacopo Manso
- Contact Person Email
- Jacopo.manso@asfuc.sanita.fvg.it
- Site Name
- Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
- Department Name
- SC Endocrinologia
- Contact Person Name
- Maria Laura Piera Tanda
- Contact Person Email
- marialaura.tanda@uninsubria.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- Medicine and Surgery
- Contact Person Name
- Efisio Puxeddu
- Contact Person Email
- efisio.puxeddu@unipg.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- SC Malattie Endocrine-Diabetologia
- Contact Person Name
- Silvia Ippolito
- Contact Person Email
- sippolito@asst-pg23.it
- Site Name
- Istituti Clinici Scientifici Maugeri S.p.A.
- Department Name
- Unit of Endocrinology and Metabolic Diseases
- Contact Person Name
- Mario Rotondi
- Contact Person Email
- Mario.rotondi@icsmaugeri.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Unit of Endocrinology
- Contact Person Name
- Mario Salvi
- Contact Person Email
- mario@mariosalvinet.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- UOC Medicina Specialistica Endocrino-Metabolica
- Contact Person Name
- Salvatore Monti
- Contact Person Email
- salvatore.monti@uniroma1.it
- Site Name
- Azienda Unita' Sanitaria Locale Toscana Nord Ovest
- Department Name
- U.O. Aziendale di Endocrinologia
- Contact Person Name
- Daniele Barbaro
- Contact Person Email
- endocrinologia.livorno@uslnordovest.toscana
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Dipartimento di Medicinina Generale e Specilistica
- Contact Person Name
- Gianluca Aimaretti
- Contact Person Email
- Gianluca.aimaretti@unito.it
- Site Name
- Azienda Ospedaliero-Universitaria Senese
- Department Name
- Medical Sciences
- Contact Person Name
- Maria Grazia Castagna
- Contact Person Email
- mariagrazia.castagna@unisi.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- UO Endocrinologia II
- Contact Person Name
- Michele Marino
- Contact Person Email
- michele.marino@med.unipi.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Department of Experimental Medicine, Sapienza University of Rome
- Contact Person Name
- Elisa Giannetta
- Contact Person Email
- Elisa.giannetta@uniroma1.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Cagliari
- Department Name
- U.O Endocrinologia
- Contact Person Name
- Giulia Lanzolla
- Contact Person Email
- giulia.lanzolla@unica.it
- Site Name
- Istituto Auxologico Italiano
- Department Name
- Endocrinologia e Malattie del Metabolismo
- Contact Person Name
- Luca Persani
- Contact Person Email
- luca.persani@unimi.it
- Site Name
- Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
- Department Name
- UoC endocrinologia
- Contact Person Name
- Francesco Scavuzzo
- Contact Person Email
- Francesco.scavuzzo@aocardarelli.it
- Site Name
- Azienda Ospedaliera Santa Croce E Carle
- Department Name
- Endocrinology
- Contact Person Name
- Federico Arecco
- Contact Person Email
- arecco.f@ospedale.cuneo.it
- Site Name
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Department Name
- UOC Malattie Endocrine, del ricambio e della nutrizione
- Contact Person Name
- Giorgio Arnaldi
- Contact Person Email
- giorgio.arnaldi@policlinico.pa.it
- Site Name
- Universita Humanitas
- Department Name
- Department of Biomedical Sciences
- Contact Person Name
- Andrea Gerardo Antonio Lania
- Contact Person Email
- Andrea.lania@humanitas.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Endocrinologia
- Contact Person Name
- Andrea Pontecorvi
- Contact Person Email
- Alfredo.pontecorvi@unicatt.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- U.O.C. Endocrinologia e prevenzione e cura del diabete
- Contact Person Name
- Uberto Pagotto
- Contact Person Email
- uberto.pagotto@unibo.it
Latvia
- Earliest CTIS Part Ii Submission Date
- 13-04-2026
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 23
- Number Of Sites
- 6
- Number Of Participants
- 7
Sites
- Site Name
- Daces Teterovskas arsta prakse endokrinologija SIA
- Contact Person Name
- Dace Teterovska
- Contact Person Email
- dace.fonds@inbox.lv
- Site Name
- Riga East University Hospital
- Department Name
- Clinical Centre "Bikernieki", Ophthalmology clinic
- Contact Person Name
- Kristine Baumane
- Contact Person Email
- baumanek@ml.lv
- Site Name
- Veselibas un socialas aprupes klinika APS SIA
- Department Name
- Endocrinology
- Contact Person Name
- Lelde Krüzmane
- Contact Person Email
- lelde.kruzmane@gmail.com
- Site Name
- Ziemelkurzemes regionala slimnica SIA
- Department Name
- Ophthalmology
- Contact Person Name
- Kaspars Ozols
- Contact Person Email
- mr.kaspars.ozols@gmail.com
- Site Name
- Pauls Stradins Clinical University Hospital
- Department Name
- Center of Endrocrinology
- Contact Person Name
- Kristine Geldnere
- Contact Person Email
- kristineab@inbox.lv
- Site Name
- Siguldas Slimnica
- Department Name
- Outpatient Department
- Contact Person Name
- Renate Helda
- Contact Person Email
- slimnica@siguldasslimnica.lv
Spain
- Earliest CTIS Part Ii Submission Date
- 26-02-2026
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 70
- Number Of Sites
- 8
- Number Of Participants
- 13
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Nutrition and endocrinology
- Contact Person Name
- Mireia Mora
- Contact Person Email
- mporta@clinic.cat
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Endocrinology
- Contact Person Name
- Federico Vázquez
- Contact Person Email
- fvasquezs.germanstrias@gencat.cat
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Endocrinology
- Contact Person Name
- Monica Marazuela
- Contact Person Email
- Monica.marazuela@salud.madrid.org
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Servicio de Endocrinología, Metabolismo y Nutrición
- Contact Person Name
- Maria del Carmen MONTAÑEZ ZORRILLA
- Contact Person Email
- mariacarmen.montanez@salud.madrid.org
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Endocrinology
- Contact Person Name
- Martin López de la Torre Casares
- Contact Person Email
- martinendocrino@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Endocrinology and Nutrition
- Contact Person Name
- Alejandra Planas Vilaseca
- Contact Person Email
- alejandraplanas04@gmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Ophtalmology
- Contact Person Name
- Antonio Garrido
- Contact Person Email
- gaherfamily@hotmail.com
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Endocrinology
- Contact Person Name
- Maria Angeles Galvez Moreno
- Contact Person Email
- Mariaa.galvez.sspa@juntadeandalucia.es
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-04-2026
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 21
- Number Of Sites
- 4
- Number Of Participants
- 2
Sites
- Site Name
- Ikazia Ziekenhuis
- Department Name
- Internal medicine
- Contact Person Name
- Carolien Beukhof
- Contact Person Email
- c.beukhof@ikazia.nl
- Site Name
- Albert Schweitzer Ziekenhuis
- Contact Person Name
- Simone Cornelia Christina Hartong
- Contact Person Email
- s.c.c.hartong@asz.nl
- Site Name
- Maasstad Ziekenhuis Stichting
- Department Name
- Internal Medicine
- Contact Person Name
- Charlotte van Noord
- Contact Person Email
- noordc@maasstadziekenhuis.nl
- Site Name
- Sint Franciscus Vlietland Groep Stichting
- Department Name
- Internal Medicine
- Contact Person Name
- Kim Van Der Weerd
- Contact Person Email
- k.weerd@franciscus.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 10-04-2026
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 28
- Number Of Sites
- 18
- Number Of Participants
- 32
Sites
- Site Name
- Centrum Medyczne Hope Clinic Sebastian Szklener
- Contact Person Name
- Marcin Lewicki
- Contact Person Email
- lewicki-marcin@wp.pl
- Site Name
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Centrum Diabetologiczne Kliniki Chorób Wewnętrznych, Endokrynologii i Diabetologii
- Contact Person Name
- Edward Franek
- Contact Person Email
- edward.franek@pimmswia.gov.pl
- Site Name
- Clinical Best Solutions Sp. z o.o. S.K.
- Contact Person Name
- Jolanta Patro-Malysza
- Contact Person Email
- jolapatro@wp.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Endokrynologii i Chorób Wewnętrznych
- Contact Person Name
- Marek Bolanowski
- Contact Person Email
- marek.bolanowski@umw.edu.pl
- Site Name
- Med Polonia Sp. z o.o.
- Department Name
- Dział badań klinicznych
- Contact Person Name
- Grzegorz Konieczny
- Contact Person Email
- gkonieczny78@gmail.com
- Site Name
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
- Department Name
- Etyka Ośrodek Badań Klinicznych
- Contact Person Name
- Wojciech Matuszewski
- Contact Person Email
- wojciechmatuszewski@etykaosrodek.pl
- Site Name
- Diab Serwis Popenda Sp. j.
- Contact Person Name
- Grażyna Popenda
- Contact Person Email
- grazyna.popenda.diabserwis@gmail.com
- Site Name
- Ośrodek Medyczny “Osteomed”
- Contact Person Name
- Mirosław Szlachcic
- Contact Person Email
- m.szlachcic@medistica.com.pl
- Site Name
- Eb Group Sp. z o.o.
- Department Name
- Centrum Zdrowia MDM
- Contact Person Name
- Tomasz Bednarczuk
- Contact Person Email
- tomasz.bednarczuk@wum.edu.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Zakład Medycyny Nuklearnej i Endokrynologii Onkologicznej Centrum Wsparcia Badań Klinicznych
- Contact Person Name
- Barbara Jarząb
- Contact Person Email
- barbara.jarzab@io.gliwice.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Klinika Endokrynologii, Diabetologii i Chorób Wewnętrznych
- Contact Person Name
- Katarzyna Siewko
- Contact Person Email
- katarzyna.siewko@umb.edu.pl
- Site Name
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
- Department Name
- Klinika Endokrynologii
- Contact Person Name
- Aldona Kowalska
- Contact Person Email
- aldona.kowalska@onkol.kielce.pl
- Site Name
- Trialmed Sp. z o.o.
- Department Name
- Clinical Trials
- Contact Person Name
- Iwona Kaczor-Zboj
- Contact Person Email
- ikz@trialmed.pl
- Site Name
- Centrum Medyczne Intercor Sp. z o.o.
- Contact Person Name
- Roman Junik
- Contact Person Email
- intercor@farmepo.com
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Oddział Kliniczny Endokrynologii, Endokrynologii Onkologicznej, Med Nuklearnej i Chorób Wewnętrznych
- Contact Person Name
- Grzegorz Sokolowski
- Contact Person Email
- Grzegsok@gmail.com
- Site Name
- Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
- Department Name
- Poradnia Internistyczn
- Contact Person Name
- Marek Ruchala
- Contact Person Email
- mruchala@ump.edu.pl
- Site Name
- Clinicly Sp. z o.o.
- Department Name
- Centrum Medyczne Clinicly
- Contact Person Name
- Agata Bronisz
- Contact Person Email
- agata.bronisz.opole@gmail.com
- Site Name
- Reumed Sp. z o.o.
- Department Name
- Poradnia endokrynologicz na i diabetologiczna
- Contact Person Name
- Agnieszka Zwolak
- Contact Person Email
- zwolakag@wp.pl
Sponsor
Primary sponsor
- Full Name
- Immunovant Sciences GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- code 1; code 15: Equipment, Translations, Print Services; code 2; code 5; (also listed with code 4 in another entry)
- Name
- PRA Hellas CRO A.E.
- Responsibilities
- code 1
- Name
- Pharmaceutical Research Associates Group B.V.
- Responsibilities
- code 4
- Name
- Syneos Health Clinique Inc.
- Responsibilities
- code 4
- Name
- Scout Clinical
- Responsibilities
- code 15: Patient reimbursement services
Third parties
- {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code 1; code 15: Equipment, Translations, Print Services; code 2; code 5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Avantor Inc.","duties_or_roles":"code 15: Long-term storage","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code 15: Packaging, Labelling and Distribution","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited (duplicate entry)","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eclinical Solutions LLC","duties_or_roles":"code 6","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH (Weil Am Rhein)","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH (Rheinfelden)","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"code 15: Patient reimbursement services","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"France","full_name":"Voisin Consulting Life Sciences","duties_or_roles":"code 12","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"code 15: Ediary; code 7","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Voisin Consulting Life Sciences (duplicate?)","duties_or_roles":"code 12","organisation_type":"Pharmaceutical company"}
- {"country":"","full_name":"Other listed third parties (multiple organisations for distribution, storage and logistics including Fisher Clinical Services GmbH entries, Avantor Inc., etc.)","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 per day
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