Clinical trial • Phase II • Immunology

IMEROPRUBART for Graves' disease

Phase II trial of IMEROPRUBART for Graves' disease.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Graves' disease
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
14-02-2025
First CTIS Authorization Date
05-06-2025

Trial design

Randomised, placebo ("placebo is identical to imp but with no active substance.") — no dose/schedule for placebo specified in ctis record-controlled Phase II trial across 46 sites in Belgium, Germany, Hungary and others.

Randomised
Yes
Comparator
Placebo ("Placebo is identical to IMP but with no active substance.") — no dose/schedule for placebo specified in CTIS record
Target Sample Size
158
Trial Duration For Participant
728

Eligibility

Recruits 158 CTIS indicates isVulnerablePopulationSelected = true. Subject information and informed consent forms and related materials are provided (multiple documents listed), including caregiver consent forms, patient navigator consent, consent aid, pregnancy-related forms and supporting person forms (multiple country/language versions). Participants must be ≥18 per inclusion criteria; no assent process for minors is described in the CTIS record..

Vulnerable Population
CTIS indicates isVulnerablePopulationSelected = true. Subject information and informed consent forms and related materials are provided (multiple documents listed), including caregiver consent forms, patient navigator consent, consent aid, pregnancy-related forms and supporting person forms (multiple country/language versions). Participants must be ≥18 per inclusion criteria; no assent process for minors is described in the CTIS record.

Inclusion criteria

  • {"criterion_text":"-Are ≥ 18 and ≤ 75 years of age at the time of signing the informed consent form (ICF)\n-Have a prior diagnosis of GD documented\n-Have TSH assessed by the local laboratory below the following thresholds at the Screening Visit\n-Meet both of the following at the Screening Visit: a. Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and the following: i. Are on ATD at the Screening Visit with an ATD dose ≥ 20 mg/day methimazole or equivalent (i.e., ≥ 30 mg/day carbimazole, ≥ 200 mg/day propylthiouracil) for the 4-week period immediately preceding the Screening Visit. ii. Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization. b. Have been on ATD for ≥ 6 months in the period immediately preceding the Screening Visit and both of the following: i. Have been treated with ≥ 15 mg/day methimazole or equivalent (i.e., ≥ 20 mg/day carbimazole, ≥ 150 mg/day propylthiouracil) at any point during the participant's treatment history. ii. Are on ATD at the Screening Visit with an ATD dose ≥ 10 mg/day methimazole or equivalent (i.e., ≥ 15 mg/day carbimazole, ≥ 100 mg/day propylthiouracil) for the 4-week period immediately preceding the Screening Visit. iii. Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization."}

Exclusion criteria

  • {"criterion_text":"-Have previously been successfully treated with RAI therapy or have undergone total thyroidectomy.\n-Have a T3 (Total T3 or FT3, as available and per standard of care at local laboratory) or FT4 value < LLN as assessed by the local laboratory at the Screening Visit\n-Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks of the Screening Visit. Note: Participants receiving block-and-replace treatment are not eligible.\n-Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within 6 months of the Screening Visit\n-Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.\n-Have moderate-to-severe active 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":"As stated in the main objective: efficacy assessed by T3 (Total T3 or FT3), FT4, TSH, and ATD status at Week 26"}

Secondary endpoints

  • {"endpoint_text":"-Proportion of participants who are euthyroid and off ATD at Week 52\n-Proportion of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52\n-Proportion of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78\n-Proportion of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104\n-Proportion of participants who have a TRAb value at Week 25 and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52\n-Proportion of participants who have a TRAb value at Week 25 and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78\n-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\n-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\n-Proportion of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26\n-Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26\n-Proportion of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 52","definition_or_measurement_approach":"Endpoints are defined by biochemical thyroid measures (T3/FT3, FT4, TSH), TRAb serostatus, ATD use status, and specified timepoints (Weeks 2, 4, 26, 52, 78, 104) as described in endpoint list"}

Recruitment

Registry Or Advocacy Recruitment
True: 'Advocacy Study Alert' recruitment materials present (no specific advocacy organisation named in CTIS documents)
Digital Remote Recruitment
True: country-specific banner ads, recruitment animations, online patient-facing materials and eDiary/ePRO tools are listed in recruitment materials
Planned Sample Size
158
Recruitment Window Months
38
Consent Approach
Informed consent materials and subject information sheets are provided in multiple language/country-specific versions (documents include Main ICF and SIS in BE-DE, BE-NL, BE-FR, EN, HU, IT, PL, IE-EN and specific ICFs for caregiver, pregnancy, off-site healthcare, scout, patient navigator consent, consent aids). Participants provide written informed consent (participants must be ≥18). Caregiver/supporting person consent documents are available where applicable; multiple language translations are provided as per document list.

Methods

  • Physician referral letters (K2_Physician Referral Letter documents listed)
  • Posters (country-specific recruitment posters listed: BE, DE, IT, PL etc.)
  • Banner ads (recruitment banner ads documents listed, country-specific)
  • Recruitment animations (country-specific recruitment animation documents listed)
  • Patient brochures and study guides (country/language-specific patient brochure and study guide documents listed)
  • Advocacy Study Alert materials (documents titled 'Advocacy Study Alert' present)
  • Pre-screening and pre-screening vendor activity (documents and third-party Clariness GmbH listed with duty 'Pre-screening')
  • Recruitment and retention vendor support (Innovative Trials Limited listed with duty 'Recruitment and retention vendor')
  • Patient navigator support (Patient Navigator Consent documents listed)
  • Electronic/online tools referenced in patient-facing materials (eDiary, SIAQ questionnaires, ePROs indicated by patient-facing documents)

Geography

Total Number Of Sites
46
Total Number Of Participants
158

Belgium

Earliest CTIS Part Ii Submission Date
09-05-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
308
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Hopital Erasme
Department Name
Division of Endocrinology
Contact Person Name
Aglaia Kyrilli
Contact Person Email
aglaia.kyrilli@hubruxelles.be
Site Name
Imelda
Department Name
Endocrinology and Nephrology
Contact Person Name
Chris Vercammen
Contact Person Email
chris.vercammen@imelda.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Internal Medicine / Endocrinology
Contact Person Name
Annick Van den Bruel

Germany

Earliest CTIS Part Ii Submission Date
22-05-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
295
Number Of Sites
7
Number Of Participants
25

Sites

Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Department of Medicine I
Contact Person Name
George J Kahaly
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
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik IV
Contact Person Name
Christian Lottspeich
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik I, Endokrinologie
Contact Person Name
Ulrich Dischinger
Contact Person Email
dischinger_u@ukw.de
Site Name
HELIOS Kliniken Schwerin GmbH
Department Name
Internal Medicine, Endocrinology/Diabetology
Contact Person Name
Urs Lichtenauer
Site Name
Technische Universitaet Dresden
Department Name
Department of Medicine III, Devision of Endocrinology, Diabetes and Bone deseases
Contact Person Name
Lorenz Hofbauer

Hungary

Earliest CTIS Part Ii Submission Date
07-04-2025
Latest Decision Or Authorization Date
10-04-2026
Processing Time Days
368
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
University Of Szeged
Department Name
Clinical Center, Internal Medicine Clinic, Endocrinology
Contact Person Name
Zsuzsanna Valkusz
Site Name
Semmelweis University
Department Name
Department of Internal Medicine and Oncology
Contact Person Name
István Takács
Contact Person Email
takacs.istvan@semmelweis.hu
Site Name
University Of Pecs
Department Name
Clinical Center, 1st Department of Internal Medicine, Department of Endocrinology and Metabolism
Contact Person Name
Emese Mezősi
Contact Person Email
mezosi.emese@pte.hu
Site Name
Obudai Egeszseguegyi Centrum Kft.
Contact Person Name
István Páll
Contact Person Email
istvan.pall@oec.hu
Site Name
Trial Pharma Kft.
Department Name
Endocrinology
Contact Person Name
Tivadar Bányai
Contact Person Email
banyai.tivadar@bmkk.eu
Site Name
University Of Debrecen
Department Name
Internal Medicine Clinic, Endocrinology
Contact Person Name
Miklos Bodor
Contact Person Email
bodor.miklos@med.unideb.hu

Italy

Earliest CTIS Part Ii Submission Date
12-05-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
305
Number Of Sites
13
Number Of Participants
50

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Endocrinology Unit
Contact Person Name
Iacopo Chiodini
Site Name
IRCCS Azienda Ospedaliero Universitaria di Bologna, Policlinico di Sant’Orsola
Department Name
U.O.C. Endocrinologia e prevenzione e cura del diabete
Contact Person Name
Uberto Pagotto
Contact Person Email
uberto.pagotto@unibo.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
SD Medicina Interna ad indirizzo Immuno-Endocrino
Contact Person Name
Alessandro Antonelli
Contact Person Email
alessandro.antonelli@unipi.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
ARNAS Garibaldi Di Catania
Department Name
UOC Endocrinologia
Contact Person Name
Rosario Le Moli
Contact Person Email
rosario.lemoli@unikore.it
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
Azienda Ospedaliera Universitaria Senese
Department Name
P.O. Duilio Casula UOC Endocrinologia e Malattie Metaboliche
Contact Person Name
Francesco Boi
Contact Person Email
francesco.boi@unica.it
Site Name
Azienda Ospedaliero Universitaria Pisana (second site)
Department Name
UO Endocrinologia II
Contact Person Name
Michele Marinò
Contact Person Email
michele.marino@med.unipi.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 Ospedaliera Ospedale Di Circolo E Fondazione Macchi
Department Name
SC Endocrinologia
Contact Person Name
Maria Laura Tanda
Contact Person Email
marialaura.tanda@uninsubria.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clinica endocrinologica
Contact Person Name
Lara Vera
Contact Person Email
lara.vera@hsanmartino.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 Universitaria Senese (other site)
Department Name
Medical Sciences
Contact Person Name
Maria Grazia Castagna
Contact Person Email
mariagrazia.castagna@unisi.it

Spain

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
336
Number Of Sites
9
Number Of Participants
25

Sites

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
Clinica Universidad De Navarra (Pamplona)
Department Name
Endocrinology
Contact Person Name
Sonsoles Guadalix Iglesias
Contact Person Email
sguadalixi@unav.es
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 Clinic De Barcelona
Department Name
Nutrition and endocrinology
Contact Person Name
Mireia Mora
Contact Person Email
mporta@clinic.cat
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Endocrinology
Contact Person Name
Sonsoles Guadalix Iglesias
Contact Person Email
sguadalixi@unav.es
Site Name
Hospital Universitario De La Princesa
Department Name
Endocrinology
Contact Person Name
Monica Marazuela
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
Site Name
Hospital Germans Trias I Pujol
Department Name
Endocrinology
Contact Person Name
Federico Vázquez

Poland

Earliest CTIS Part Ii Submission Date
13-05-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
304
Number Of Sites
8
Number Of Participants
25

Sites

Site Name
Clinical Best Solutions Sp. z o.o. S.K.
Department Name
Endocrinology
Contact Person Name
Jolanta Patro-Malysza
Contact Person Email
jolapatro@wp.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Endocrinology
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
Endocrinology, Metabolism, and Internal Diseases
Contact Person Name
Marek Ruchala
Contact Person Email
mruchala@ump.edu.pl
Site Name
Reumed Sp. z o.o.
Contact Person Name
Agnieszka Zwolak
Contact Person Email
rejestracja@reumed.pl
Site Name
Eb Group Sp. z o.o.
Department Name
Endocrinology
Contact Person Name
Tomasz Bednarczuk
Contact Person Email
thomasz.bednarczuk@wum.edu.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Nuclear Medicine and Endocrine Oncology
Contact Person Name
Barbara Jarząb
Contact Person Email
barbara.jarzab@io.gliwice.pl
Site Name
Ośrodek Medyczny “Osteomed”
Department Name
Badania Kliniczne
Contact Person Name
Mirosław Szlachcic
Contact Person Email
badania@medistica.com.pl
Site Name
Centrum Medyczne Hope Clinic Sebastian Szklener
Department Name
Endocrinology
Contact Person Name
Marcin Lewicki
Contact Person Email
lewicki-marcin@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
Listed among third parties with duties including study support/site services (sponsorDuties codes present; contact Jorden.empsom@iconplc.com / cliff.dobrovolec@iconplc.com)
Name
Pharmaceutical Research Associates Group B.V.
Responsibilities
Third-party vendor contact (sponsorDuties codes present; contact lynnvan.oene@iconplc.com)
Name
Syneos Health Clinique Inc.
Responsibilities
Third-party clinical services listed (contact Mounia.khyari@syneoshealth.com)

Third parties

  • {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"sponsorDuties codes: [{\"id\":902468,\"code\":\"4\"}] (contact: lynnvan.oene@iconplc.com)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Innovative Trials Limited","duties_or_roles":"Recruitment and retention vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [{\"id\":902467,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: [{\"id\":902469,\"code\":\"3\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Certe Medische Diagnostiek en Advies Stichting","duties_or_roles":"sponsorDuties codes: [{\"id\":902462,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"sponsorDuties codes: [{\"id\":902461,\"code\":\"4\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Catalent Pharma Solutions LLC","duties_or_roles":"sponsorDuties codes: [{\"id\":902465,\"code\":\"14\"}]","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":"France","full_name":"Voisin Consulting Life Sciences","duties_or_roles":"sponsorDuties codes: [{\"id\":902474,\"code\":\"12\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Pre-screening","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [{\"id\":902477,\"code\":\"4\"}] (also listed with duties 'Site Training, HHC, Patient Reimbursement, Equipment' in another entry)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Avantor Inc.","duties_or_roles":"Long-term storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"Pharmacovigilance (sponsorDuties code 8)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Catalent Cts (Edinburgh) Limited","duties_or_roles":"sponsorDuties codes: [{\"id\":902470,\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"eDiary and related electronic data capture","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Mayo Collaborative Services LLC","duties_or_roles":"sample testing","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Catalent Cts (Edinburgh) Limited","duties_or_roles":"manufacturing/distribution support (sponsorDuties code 14)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
IMVT-1402
Active Substance
IMEROPRUBART
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Maximum Dose
Max daily dose: 600 mg (doseUom: mg)
Investigational Product Name
Placebo is identical to IMP but with no active substance.
Modality
Other
Combination Treatment
Yes

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