Clinical trial • Phase II • Immunology
IMEROPRUBART for Graves' disease
Phase II trial of IMEROPRUBART for Graves' disease. Randomised, placebo ("placebo is identical to imp but with no active substance.")-controlled.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Graves' disease
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 27-06-2025
- First CTIS Authorization Date
- 17-10-2025
Trial design
Randomised, placebo ("placebo is identical to imp but with no active substance.")-controlled Phase II trial in Czechia, Latvia, Netherlands and others.
- Randomised
- Yes
- Comparator
- Placebo ("Placebo is identical to IMP but with no active substance.")
- Target Sample Size
- 58
- Trial Duration For Participant
- 182
Eligibility
Recruits 58 No vulnerable populations selected. Participants must be adults (aged ≥ 18 years) able to understand the trial requirements and provide written informed consent; caregiver/supporting-person documents and consent aids are provided where applicable..
- Vulnerable Population
- No vulnerable populations selected. Participants must be adults (aged ≥ 18 years) able to understand the trial requirements and provide written informed consent; caregiver/supporting-person documents and consent aids are provided where applicable.
Inclusion criteria
- {"criterion_text":"- Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures"}
- {"criterion_text":"- Male or female participants aged ≥ 18 years"}
- {"criterion_text":"- Participants with diagnosis of GD who are hyperthyroid despite ATD treatment"}
Exclusion criteria
- {"criterion_text":"- Have previously been successfully treated with RAI therapy or have undergone total thyroidectomy."}
- {"criterion_text":"- Have an autoimmune disease other than GD requiring treatment that, in the Investigator’s judgment, puts the participant at undue risk"}
- {"criterion_text":"- Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants who are euthyroid and off ATD at Week 26","definition_or_measurement_approach":"Assessed at Week 26 by thyroid function and treatment status (evaluated using T3 (Total T3 or FT3), FT4, TSH and ATD dose/status as per main objective)."}
Secondary endpoints
- {"endpoint_text":"- Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26","definition_or_measurement_approach":"Laboratory measurements of T3 (Total T3 or FT3) and FT4 compared to ULN at Week 26 and ATD treatment status (off ATD)."}
- {"endpoint_text":"- Proportion of participants who are euthyroid, off ATD, and seronegative at Week 26","definition_or_measurement_approach":"Euthyroid status plus off ATD at Week 26 and seronegativity (antibody status) as measured by relevant serology assays at Week 26."}
- {"endpoint_text":"- Proportion of participants who are euthyroid and off ATD at Week 26","definition_or_measurement_approach":"Same as primary: assessed by thyroid function tests and ATD status at Week 26."}
- {"endpoint_text":"- Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26","definition_or_measurement_approach":"Laboratory assessment of T3 (Total T3 or FT3) and FT4 relative to ULN and ATD cessation at Week 26."}
- {"endpoint_text":"- Proportion of participants who are euthyroid, off ATD, and seronegative at Week 26","definition_or_measurement_approach":"Euthyroid by laboratory testing, off ATD at Week 26, and seronegative by antibody testing at Week 26."}
- {"endpoint_text":"- Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline","definition_or_measurement_approach":"Among participants with elevated baseline T3 and/or FT4, proportion achieving T3 and FT4 ≤ ULN at Week 4 by laboratory testing."}
- {"endpoint_text":"- Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline","definition_or_measurement_approach":"Among participants with elevated baseline T3 and/or FT4, proportion achieving T3 and FT4 ≤ ULN at Week 2 by laboratory testing."}
- {"endpoint_text":"- Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline","definition_or_measurement_approach":"Duplicate entry: as above, Week 4 assessment of T3 and FT4 relative to ULN in those elevated at baseline."}
- {"endpoint_text":"- Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline","definition_or_measurement_approach":"Duplicate entry: as above, Week 2 assessment of T3 and FT4 relative to ULN in those elevated at baseline."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 58
- Recruitment Window Months
- 17
- Consent Approach
- Written informed consent is required from each participant (participants are adults aged ≥ 18 years). Participant information sheets and consent forms (L1_SIS and ICF_Main and related documents) are provided; there are specific pregnancy and caregiver consent documents (L1_SIS and ICF_Pregnancy, L1_SIS and ICF_Caregiver) and consent aids. Consent materials are available in multiple languages (documents indicate availability in English, German, Spanish, Greek, Italian, Latvian, Latvian-Russian, Polish, Bulgarian, Czech, Dutch and others).
Methods
- Physician referral letters (documents: K2_Physician Referral Letter) targeting physicians for patient referral
- Posters and printed patient brochures (K2_Recruitment material_Poster; K2_Recruitment material_Patient Brochure) for clinic/hospital display and patient distribution
- Online digital recruitment: banner ads and recruitment animation (K2_Recruitment material_Recruitment_Banner Ads; Recruitment Animation) targeted at patients via digital channels
- Study guides and patient brochures (K2_Recruitment material_Study Guide) provided to potential participants
- Pre-screening services provided by third party (Clariness GmbH) - pre-screening of potential participants
- Physician and site outreach and site training activities (Icon Clinical Research Limited duties include Site Training)
- Patient navigator and patient reimbursement support (documents and third-party duties referenced; patient reimbursement services provided by Scout Clinical and others)
- Localized and translated recruitment materials and outreach in multiple countries/languages (documents for LV, IT, GR, EN, ES, DE, CZ, BG, PL, NL, LV-RU etc.)
Geography
- Total Number Of Sites
- 69
- Total Number Of Participants
- 158
Czechia
- Earliest CTIS Part Ii Submission Date
- 18-09-2025
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 32
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Endokrinologie Klanovice s.r.o.
- Contact Person Name
- Markéta Weichetová
- Contact Person Email
- m.weichetova@post.cz
- Site Name
- Edumed s.r.o.
- Department Name
- Private Practice
- Contact Person Name
- Alica Veselá
- Contact Person Email
- Alica.vesela@edu-med.cz
- Site Name
- ResTrial s.r.o.
- Department Name
- Klinika ResTrial
- Contact Person Name
- Emília Malicherová
- Contact Person Email
- Emilia.Malicherova@restrial.com
- Site Name
- Milan Kvapil s.r.o.
- Department Name
- Diabetologická ambulance
- Contact Person Name
- František Loos
- Contact Person Email
- frankyloos@gmail.com
Latvia
- Earliest CTIS Part Ii Submission Date
- 22-09-2025
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 28
- Number Of Sites
- 6
- Number Of Participants
- 15
Sites
- Site Name
- Pauls Stradins Clinical University Hospital
- Department Name
- Centre of Endocrinology
- Contact Person Name
- Kristine Geldnere
- Contact Person Email
- kristineab@inbox.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
- Riga East University Hospital
- Department Name
- Clinical Centre "Bikernieki", Ophthalmology clinic
- Contact Person Name
- Kristine Baumane
- Contact Person Email
- baumanek@ml.lv
- Site Name
- Siguldas Slimnica
- Department Name
- Outpatient Department
- Contact Person Name
- Renate Helda
- Contact Person Email
- slimnica@siguldasslimnica.lv
- Site Name
- Daces Teterovskas arsta prakse endokrinologija SIA
- Contact Person Name
- Dace Teterovska
- Contact Person Email
- dace.fonds@inbox.lv
- Site Name
- Ziemelkurzemes regionala slimnica SIA
- Department Name
- Ophthalmology
- Contact Person Name
- Kaspars Ozols
- Contact Person Email
- mr.kaspars.ozols@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-10-2025
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 17
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Albert Schweitzer Ziekenhuis
- Department Name
- Internal Medicine
- 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
- Site Name
- Ikazia Ziekenhuis
- Department Name
- Internal medicine
- Contact Person Name
- Carolien Beukhof
- Contact Person Email
- c.beukhof@ikazia.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 16-09-2025
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 34
- Number Of Sites
- 16
- Number Of Participants
- 54
Sites
- Site Name
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Department Name
- SC Endocrinologia
- Contact Person Name
- Maurillo Deandrea
- Contact Person Email
- mdeandrea@mauriziano.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Endocrinologia
- Contact Person Name
- Alfredo Pontecorvi
- Contact Person Email
- alfredo.pontecorvi@unicatt.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
- 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 Ospedaliera Universitaria Policlinico Paolo Giaccone
- Department Name
- PROMISE / DAI Medico / UOC Malattie Endocrine, del ricambio e della nutrizione
- Contact Person Name
- Giorgio Arnaldi
- Contact Person Email
- giorgio.arnaldi@policlinico.pa.it
- Site Name
- Ente Ecclesiastico Ospedale Generale Regionale Miulli
- Department Name
- Division of Endocrinology and Metabolic Diseases
- Contact Person Name
- Sebastio Perrini
- Contact Person Email
- s.perrini@lum.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 Santa Croce E Carle
- Department Name
- Endocrinology
- Contact Person Name
- Federico Arecco
- Contact Person Email
- arecco.f@ospedale.cuneo.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
- Ospedale San Raffaele S.r.l.
- Department Name
- Endocrinology Department
- Contact Person Name
- Andrea Giustina
- Contact Person Email
- Giustina.andrea@hsr.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
- 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
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
- Department Name
- Osteo-metabolic and Thyroid Disorders
- Contact Person Name
- Andrea Palermo
- Contact Person Email
- a.palermo@unicampus.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.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
- 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
Poland
- Earliest CTIS Part Ii Submission Date
- 17-09-2025
- Latest Decision Or Authorization Date
- 21-10-2025
- Processing Time Days
- 34
- Number Of Sites
- 13
- Number Of Participants
- 24
Sites
- 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
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
- Contact Person Name
- Wojciech Matuszewski
- Contact Person Email
- wojciechmatuszewski@etykaosrodek.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
- 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
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
- Department Name
- Cetrum Diabetologiczne Kiliniki Chorób Wewnętrznych, Endokrynologii i Diabetologii
- Contact Person Name
- Edward Franek
- Contact Person Email
- edward.franek@pimmswia.gov.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Endokrynologii
- Contact Person Name
- Marek Bolanowski
- Contact Person Email
- marek.bolanowski@umw.edu.pl
- Site Name
- Trialmed Sp. z o.o.
- Department Name
- Clinical Trials
- Contact Person Name
- Iwona Kaczor- Zabój
- Contact Person Email
- ikz@trialmed.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
- Department Name
- Centrum Wsparcia Badań Klinicznych Pomorskiego Uniwersytetu Medycznego
- Contact Person Name
- Anhelli Syrenicz
- Contact Person Email
- cwbk@pum.edu.pl
- Site Name
- Centrum Medyczne Intercor Sp. z o.o.
- Contact Person Name
- Roman Junik
- Contact Person Email
- intercor@farmepo.com
- Site Name
- Diab Serwis Popenda Sp. j.
- Contact Person Name
- Grażyna Popenda
- Contact Person Email
- grazyna.popenda.diabserwis@gmail.com
- Site Name
- Reumed Sp. z o.o.
- Department Name
- Poradnia endokrynologiczna i diabetologiczna
- Contact Person Name
- Agnieszka Zwolak
- Contact Person Email
- zwolakag@wp.pl
- Site Name
- Clinicly Sp. z o.o.
- Department Name
- Clinicly Sp. z o.o. Centrum Medyczne Clinicly
- Contact Person Name
- Agata Bronisz
- Contact Person Email
- agata.bronisz.opole@gmail.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 10-09-2025
- Latest Decision Or Authorization Date
- 22-10-2025
- Processing Time Days
- 42
- Number Of Sites
- 16
- Number Of Participants
- 22
Sites
- Site Name
- Medical Center Berbatov Ltd.
- Contact Person Name
- Dimitar Berbatov
- Contact Person Email
- dr.berbatov@gmail.com
- Site Name
- Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
- Department Name
- Department of Endocrinology and Metabolic Diseases
- Contact Person Name
- Ghassan Farah
- 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
- Diagnostic Consultative Center Equita OOD
- Contact Person Name
- Neli Klyuchkova
- Contact Person Email
- klychkova@gmail.com
- Site Name
- Medical Center Viva Phoenix OOD
- Contact Person Name
- Kaloyan Velkov
- Contact Person Email
- kaloyanvelkov@gmail.com
- Site Name
- Medical Centre Pratia Clinic EOOD
- Contact Person Name
- Artin Magardichyan
- Contact Person Email
- dr.artin.amagardichiyan@gmail.com
- 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
- 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
- Kalimat Medical Center Ltd.
- Contact Person Name
- Mariana Yoncheva-Mihaylova
- Contact Person Email
- mdyoncheva@gmail.com
- Site Name
- Medcenter Nova Clinic Ltd.
- Contact Person Name
- Gergana Marinova
- Contact Person Email
- gergana_tosheva@abv.bg
- 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 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
- University Multiprofile Hospital For Active Treatment Pulmed Ltd.
- Contact Person Name
- Mitko Mitkov
- 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
- Site Name
- Medical Center Berbatov Ltd. (additional site entries exist in listing)
- Contact Person Name
- Additional contacts available in source
Germany
- Earliest CTIS Part Ii Submission Date
- 22-09-2025
- Latest Decision Or Authorization Date
- 17-10-2025
- Processing Time Days
- 25
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Department of Medicine I
- Contact Person Name
- George Kahaly
- Contact Person Email
- george.kahaly@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Department of Medicine III, Devision of Endocrinology, Diabetes and Bone deseases
- Contact Person Name
- Lorenz Christian Hofbauer
- Contact Person Email
- Lorenz.hofbauer@uniklinikum-dresden.de
Spain
- Earliest CTIS Part Ii Submission Date
- 26-08-2025
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 55
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- 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
- Endocrinology
- Contact Person Name
- Maria del Carmen Montañez Zorilla
- Contact Person Email
- mariacarmen.montanez@salud.madrid.org
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Ophthalmology
- Contact Person Name
- Antonio Garrido
- Contact Person Email
- gaherfamily@hotmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Endocrinology
- Contact Person Name
- Federico Vazquez
- Contact Person Email
- fvazquezs.germanstrias@gencat.cat
Greece
- Earliest CTIS Part Ii Submission Date
- 17-07-2025
- Latest Decision Or Authorization Date
- 21-10-2025
- Processing Time Days
- 96
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Alexandra Hospital
- Department Name
- Endocrine Department and Diabetical Center
- Contact Person Name
- Vasiliki Vasileiou
- Contact Person Email
- Vasvasendo@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
- 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 and Metabolism
- Contact Person Name
- Fotini Adamidou
- Contact Person Email
- Fotini.adamidou@gmail.com
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
- Site Training, HHC, Patient Reimbursement, Equipment
- Name
- PRA Hellas CRO A.E.
- Responsibilities
- code:1; code:5
- Name
- Syneos Health Clinique Inc.
- Responsibilities
- code:4
Third parties
- {"country":"United States","full_name":"Avance Biosciences Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Pre-screening","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Voisin Consulting Life Sciences","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement services","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Site Training, HHC, Patient Reimbursement, Equipment; code:5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Mayo Collaborative Services LLC","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code:3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Catalent Cts (Edinburgh) Limited","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Catalent Pharma Solutions LLC","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Avantor Inc.","duties_or_roles":"Long-term storage","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Certe Medische Diagnostiek en Advies Stichting","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"code:8","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"code:1; code:5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"e-diary; code:7","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"}
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 indicated as 600 mg); max total dose amount 15600 mg
- Investigational Product Name
- Placebo is identical to IMP but with no active substance.
- Modality
- Other
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