Clinical trial • Phase III • Neurology
IMVT-1402 for Generalized myasthenia gravis
Phase III trial of IMVT-1402 for Generalized myasthenia gravis. Randomised, placebo is identical to imp but with no active substance-controlled.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Generalized myasthenia gravis
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 30-06-2025
- First CTIS Authorization Date
- 20-10-2025
Trial design
Randomised, placebo is identical to imp but with no active substance-controlled Phase III trial in Poland, Germany, Greece and others.
- Randomised
- Yes
- Comparator
- Placebo is identical to IMP but with no active substance
- Target Sample Size
- 153
Eligibility
Recruits 153 No vulnerable population selected; participants must be able to provide written informed consent ("Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.")..
- Vulnerable Population
- No vulnerable population selected; participants must be able to provide written informed consent ("Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.").
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.\n- Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IV at the Screening Visit\n- Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1)"}
Exclusion criteria
- {"criterion_text":"- Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit.\n- Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study\n- Have any active or untreated malignant thymoma"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in MG-ADL Score for Antibody-positive Participants","definition_or_measurement_approach":"Change from baseline in the MG-ADL (Myasthenia Gravis Activities of Daily Living) score measured in antibody‑positive participants."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants","definition_or_measurement_approach":"Change from baseline in QMG (Quantitative Myasthenia Gravis) score measured to Week 12 in antibody-positive participants."}
- {"endpoint_text":"- Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1","definition_or_measurement_approach":"Proportion of antibody-positive participants achieving an MG-ADL score of 0 or 1."}
- {"endpoint_text":"- Percentage of Antibody-Positive Participants with ≥50% Improvement in MG-ADL Score","definition_or_measurement_approach":"Proportion of antibody-positive participants with at least a 50% improvement from baseline in MG-ADL score."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 153
- Recruitment Window Months
- 26
- Consent Approach
- Participants must provide written informed consent. Subject information and informed consent forms (L1_SIS and ICF) are provided and available in multiple country/language versions (examples in the documents list: PL, DE, EL, EN, HU, IT, RO, CZ, ES). PatientGO digital consent/processing forms and EULA/Privacy Policy documents are referenced for several countries, indicating electronic/data-processing consent materials are used alongside standard written informed consent.
Methods
- Digital Marketing and Print Materials referenced (K2_Recruitment material_Digital Marketing and Print Materials_* documents) for multiple countries
- Physician to Patient Letter (country-specific K2 recruitment documents e.g. physician letters referenced for some countries)
- Use of PatientGO platform materials (Consent to Process Data forms, EULA, Privacy Policy referenced in subject information documents)
- Third-party patient recruitment services (e.g. Splash Clinical LLC listed with duty 'Patient recruitment')
- Patient concierge and reimbursement support provided by Illingworth Research Group Limited (duty described as 'Patient Concierge and Reimbursement')
Geography
- Total Number Of Sites
- 32
- Total Number Of Participants
- 78
Poland
- Earliest CTIS Part Ii Submission Date
- 17-09-2025
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 160
- Number Of Sites
- 8
- Number Of Participants
- 13
Sites
- Site Name
- Centrum Medyczne HOPE Clinic Sebastian Szklener
- Department Name
- Neurology
- Principal Investigator Name
- Sebastian Szklener
- Principal Investigator Email
- sebastianszklener@gmail.com
- Contact Person Name
- Sebastian Szklener
- Contact Person Email
- sebastianszklener@gmail.com
- Site Name
- Krakowska Akademia Neurologii Sp. z o.o.
- Department Name
- Neurology
- Principal Investigator Name
- Andrzej Szczudlik
- Principal Investigator Email
- Andrzej.szczudlik@neurologia.org.pl
- Contact Person Name
- Andrzej Szczudlik
- Contact Person Email
- Andrzej.szczudlik@neurologia.org.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Neurology
- Principal Investigator Name
- Malgorzata Bilinska
- Principal Investigator Email
- malbili@gumed.edu.pl
- Contact Person Name
- Malgorzata Bilinska
- Contact Person Email
- malbili@gumed.edu.pl
- Site Name
- Neurologia Śląska Centrum Medyczne
- Department Name
- Neurology
- Principal Investigator Name
- Marek Śmiłowski
- Principal Investigator Email
- marek.smilowski@neurologiaslaska.pl
- Contact Person Name
- Marek Śmiłowski
- Contact Person Email
- marek.smilowski@gmail.com
- Site Name
- Michalski I Partnerzy Lekarze sp.p.
- Department Name
- Neurology
- Principal Investigator Name
- Agnieszka Kulaga
- Principal Investigator Email
- kulaga_a@poczta.onet.pl
- Contact Person Name
- Agnieszka Kulaga
- Contact Person Email
- kulaga_a@poczta.onet.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Neurology
- Principal Investigator Name
- Agnieszka Slowik
- Principal Investigator Email
- neurologiabk@su.krakow.pl
- Contact Person Name
- Agnieszka Slowik
- Contact Person Email
- neurologiabk@su.krakow.pl
- Site Name
- Centrum Medyczne Neuroprotect
- Department Name
- Neurology
- Principal Investigator Name
- Mariusz Grudniak
- Principal Investigator Email
- mariusz.grudniak@neuroprotect.pl
- Contact Person Name
- Mariusz Grudniak
- Contact Person Email
- mariusz.grudniak@neuroprotect.pl
- Site Name
- Centrum Medyczne HOPE Clinic Sebastian Szklener (second listing not available as duplicate)
- Department Name
- Neurology
- Principal Investigator Name
- Sebastian Szklener
- Principal Investigator Email
- sebastianszklener@gmail.com
- Contact Person Name
- Sebastian Szklener
- Contact Person Email
- sebastianszklener@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 18-09-2025
- Latest Decision Or Authorization Date
- 27-10-2025
- Processing Time Days
- 39
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Katholisches Klinikum Bochum gGmbH
- Department Name
- Neurology
- Principal Investigator Name
- Christiane Schneider-Gold
- Principal Investigator Email
- christiane.schneider-gold@rub.de
- Contact Person Name
- Christiane Schneider-Gold
- Contact Person Email
- christiane.schneider-gold@rub.de
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Neurology
- Principal Investigator Name
- Stefanie Schreiber
- Principal Investigator Email
- stefanie.schreiber@med.ovgu.de
- Contact Person Name
- Stefanie Schreiber
- Contact Person Email
- stefanie.schreiber@med.ovgu.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Tim Hagenacker
- Principal Investigator Email
- Tim.Hagenacker@uk-essen.de
- Contact Person Name
- Tim Hagenacker
- Contact Person Email
- Tim.Hagenacker@uk-essen.de
- Site Name
- Klinikum Wuerzburg Mitte gGmbH
- Department Name
- Neurology
- Principal Investigator Name
- Mathias Maurer
- Principal Investigator Email
- mathias.maeurer@kwm-klinikum.de
- Contact Person Name
- Mathias Maurer
- Contact Person Email
- mathias.maeurer@kwm-klinikum.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Neurology
- Principal Investigator Name
- Jana Zschuntzsch
- Principal Investigator Email
- j.zschuentzsch@med.uni-goettingen.de
- Contact Person Name
- Jana Zschuntzsch
- Contact Person Email
- j.zschuentzsch@med.uni-goettingen.de
Greece
- Earliest CTIS Part Ii Submission Date
- 15-09-2025
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 35
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- Second Department of Neurology of NKUA
- Principal Investigator Name
- George Tsivgoulis
- Principal Investigator Email
- tsivgoulisgiorg@yahoo.gr
- Contact Person Name
- George Tsivgoulis
- Contact Person Email
- tsivgoulisgiorg@yahoo.gr
- Site Name
- Eginitio Hospital
- Department Name
- 1st Neurology Department of NKUA
- Principal Investigator Name
- Vasiliki Zouvelou
- Principal Investigator Email
- vzouvelu@med.uoa.gr
- Contact Person Name
- Vasiliki Zouvelou
- Contact Person Email
- vzouvelu@med.uoa.gr
- Site Name
- University General Hospital Of Thessaloniki Ahepa
- Department Name
- 1st Department of Neurology
- Principal Investigator Name
- Vasilios Kimiskidis
- Principal Investigator Email
- kimiskid@auth.gr
- Contact Person Name
- Vasilios Kimiskidis
- Contact Person Email
- kimiskid@auth.gr
- Site Name
- General University Hospital Of Patras
- Department Name
- Neurology
- Principal Investigator Name
- Elisabeth Chroni
- Principal Investigator Email
- echroni@upatras.gr
- Contact Person Name
- Elisabeth Chroni
- Contact Person Email
- echroni@upatras.gr
Hungary
- Earliest CTIS Part Ii Submission Date
- 21-08-2025
- Latest Decision Or Authorization Date
- 27-10-2025
- Processing Time Days
- 67
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Kistarcsai Flor Ferenc Korhaz
- Department Name
- Neurology
- Principal Investigator Name
- Gyula Pánczél
- Principal Investigator Email
- panczel.gyula@florhosp.hu
- Contact Person Name
- Gyula Pánczél
- Contact Person Email
- panczel.gyula@florhosp.hu
- Site Name
- Semmelweis University
- Department Name
- Genomika Medicina és Ritka Betegségek Intézete
- Principal Investigator Name
- Maria Molnar
- Principal Investigator Email
- molnarmj@gmail.com
- Contact Person Name
- Maria Molnar
- Contact Person Email
- molnarmj@gmail.com
- Site Name
- Budapesti Jahn Ferenc Del Pesti Korhaz Es Rendelointezet
- Department Name
- Neurology
- Principal Investigator Name
- Csilla Rozsa
- Principal Investigator Email
- Rozsa.cilla@delpestikorhaz.hu
- Contact Person Name
- Csilla Rozsa
- Contact Person Email
- Rozsa.cilla@delpestikorhaz.hu
Italy
- Earliest CTIS Part Ii Submission Date
- 22-09-2025
- Latest Decision Or Authorization Date
- 21-10-2025
- Processing Time Days
- 29
- Number Of Sites
- 4
- Number Of Participants
- 13
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Neurologia
- Principal Investigator Name
- Raffaele Iorio
- Principal Investigator Email
- raffaele.iorio@policlinicogemelli.it
- Contact Person Name
- Raffaele Iorio
- Contact Person Email
- raffaele.iorio@policlinicogemelli.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Neurology
- Principal Investigator Name
- Manilo Sgarzi
- Principal Investigator Email
- msgarzi@asst-pg23.it
- Contact Person Name
- Manilo Sgarzi
- Contact Person Email
- msgarzi@asst-pg23.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- U.O.C Clinica Neurologica
- Principal Investigator Name
- Francesco Sacca
- Principal Investigator Email
- francesco.sacca@unina.it
- Contact Person Name
- Francesco Sacca
- Contact Person Email
- francesco.sacca@unina.it
- Site Name
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- U.O. Neurologia IV
- Principal Investigator Name
- Lorenzo Maggi
- Principal Investigator Email
- lorenzo.maggi@istituto-besta.it
- Contact Person Name
- Lorenzo Maggi
- Contact Person Email
- lorenzo.maggi@istituto-besta.it
Romania
- Earliest CTIS Part Ii Submission Date
- 03-10-2025
- Latest Decision Or Authorization Date
- 27-10-2025
- Processing Time Days
- 24
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Spitalul Clinic Judetean De Urgenta Targu Mures
- Department Name
- Neurology I
- Principal Investigator Name
- Rodica Bălașa
- Principal Investigator Email
- rodica.balasa@umfst.ro
- Contact Person Name
- Rodica Bălașa
- Contact Person Email
- rodica.balasa@umfst.ro
- Site Name
- Brainaxy Clinic S.R.L.
- Department Name
- Neurology
- Principal Investigator Name
- Any Docu Axelerad
- Principal Investigator Email
- Brainaxy_neurofeedback@yahoo.com
- Contact Person Name
- Any Docu Axelerad
- Contact Person Email
- Brainaxy_neurofeedback@yahoo.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 29-08-2025
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 52
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- MINKSneuro s.r.o.
- Principal Investigator Name
- Eduard Minks
- Principal Investigator Email
- eduardminks@seznam.cz
- Contact Person Name
- Eduard Minks
- Contact Person Email
- eduardminks@seznam.cz
Denmark
- Earliest CTIS Part Ii Submission Date
- 09-10-2025
- Latest Decision Or Authorization Date
- 20-10-2025
- Processing Time Days
- 11
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Rigshospitalet
- Department Name
- Neurology
- Principal Investigator Name
- Nicolai Preisler
- Principal Investigator Email
- nicolai.rasmus.preisler@regionh.dk
- Contact Person Name
- Nicolai Preisler
- Contact Person Email
- nicolai.rasmus.preisler@regionh.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 28-08-2025
- Latest Decision Or Authorization Date
- 23-10-2025
- Processing Time Days
- 56
- Number Of Sites
- 4
- Number Of Participants
- 3
Sites
- Site Name
- Hospital Universitari General De Catalunya
- Department Name
- Unitat d’Investigacio Clinica
- Principal Investigator Name
- Josep Gamez
- Principal Investigator Email
- Josepgamez.bcn@gmail.com
- Contact Person Name
- Josep Gamez
- Contact Person Email
- Josepgamez.bcn@gmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Neurology
- Principal Investigator Name
- Elena Cortes Vicente
- Principal Investigator Email
- ECortes@santpau.cat
- Contact Person Name
- Elena Cortes Vicente
- Contact Person Email
- ECortes@santpau.cat
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Neurology
- Principal Investigator Name
- Eduardo Aguera Morales
- Principal Investigator Email
- doctoredu@gmail.com
- Contact Person Name
- Eduardo Aguera Morales
- Contact Person Email
- doctoredu@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Neurology
- Principal Investigator Name
- Rodrigo Alvarez Velasco
- Principal Investigator Email
- Rodrigo.alvarez@salud.madrid.org
- Contact Person Name
- Rodrigo Alvarez Velasco
- Contact Person Email
- Rodrigo.alvarez@salud.madrid.org
Sponsor
Primary sponsor
- Full Name
- Immunovant Sciences GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Syneos Health Hellas Single Member S.A.
- Responsibilities
- codes: 1,2,5
- Name
- Syneos Health Inc.
- Responsibilities
- codes: 1,13,2,5
- Name
- Catalent Pharma Solutions LLC
- Responsibilities
- codes: 14
- Name
- Medpace Inc.
- Responsibilities
- codes: 4
- Name
- Primevigilance USA Inc.
- Responsibilities
- codes: 8
Third parties
- {"country":"Greece","full_name":"Syneos Health Hellas Single Member S.A.","duties_or_roles":"codes: 1,2,5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Catalent Pharma Solutions LLC","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Splash Clinical LLC","duties_or_roles":"Patient recruitment","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"codes: 1,13,2,5","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"Patient Concierge and Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Sweden","full_name":"SVAR Life Science AB","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Voisin Consulting Life Sciences","duties_or_roles":"codes: 12","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medpace Inc.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Avance Biosciences Inc.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Quest Diagnostics Inc.","duties_or_roles":"codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Long term samples storage facility","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- IMVT-1402
- Active Substance
- IMVT-1402
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Maximum Dose
- 600 mg (max daily dose amount); 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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