Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
186
Countries
9
Sites
31
Generalized Myasthenia Gravis
Change from Baseline in MG-ADL Score for Antibody-positive Participants.
Key facts
- Sponsor
- Immunovant Sciences GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 13 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515979-35-00
- ClinicalTrials.gov
- NCT07039916
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic, Safety, Pharmacodynamic, Efficacy
Change from Baseline in MG-ADL Score for Antibody-positive Participants.
Conditions and MedDRA coding
Generalized Myasthenia Gravis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
- Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa at the Screening Visit
- Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1)
Exclusion criteria 3
- Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit.
- Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study
- Have any active or untreated malignant thymoma
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline in MG-ADL Score for Antibody-positive Participants
Secondary endpoints 3
- Change from baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants
- Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1
- Percentage of Antibody-Positive Participants with ≥50% Improvement in MG-ADL Score
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11127703 · Product
- Active substance
- Imeroprubart
- Substance synonyms
- Human IgG1 monoclonal antibody against FcRn receptor, IMVT-1402, HL161ANS
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 46800 mg milligram(s)
- Max treatment duration
- 78 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- IMMUNOVANT SCIENCES GMBH
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo is identical to IMP but with no active substance
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Immunovant Sciences GmbH
- Sponsor organisation
- Immunovant Sciences GmbH
- Address
- Viaduktstrasse 8
- City
- Basel Town
- Postcode
- 4051
- Country
- Switzerland
Scientific contact point
- Organisation
- Immunovant Sciences GmbH
- Contact name
- Immunovant Clinical Trials
Public contact point
- Organisation
- Immunovant Sciences GmbH
- Contact name
- Immunovant Clinical Trials
Third parties 15
| Organisation | City, country | Duties |
|---|---|---|
| Voisin Consulting Life Sciences ORG-100009282
|
Boulogne Billancourt, France | Code 12 |
| Splash Clinical LLC ORG-100049597
|
Wauwatosa, United States | Other |
| Medpace Inc. ORG-100026760
|
Cincinnati, United States | Laboratory analysis |
| Primevigilance USA Inc. ORG-100047266
|
Raleigh, United States | Code 8 |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring, Code 13, Code 2, Code 5 |
| Avance Biosciences Inc. ORG-100016282
|
Houston, United States | Laboratory analysis |
| Quest Diagnostics Inc. ORG-100013150
|
San Juan Capistrano, United States | Laboratory analysis |
| Syneos Health Clinique Inc. ORG-100028348
|
Quebec, Canada | Laboratory analysis |
| Syneos Health Hellas Single Member S.A. ORG-100043210
|
Vrilissia, Greece | On site monitoring, Code 2, Code 5 |
| EPL Pathology Archives LLC ORG-100042096
|
Leesburg, United States | Other |
| SVAR Life Science AB ORG-100046037
|
Malmo, Sweden | Laboratory analysis |
| Illingworth Research Group Limited ORG-100042356
|
Macclesfield, United Kingdom | Other |
| MEDPACE LABORATORIES ORG-100042942
|
Leuven, Belgium | Laboratory analysis |
| Catalent Pharma Solutions LLC ORG-100011506
|
Philadelphia, United States | Code 14 |
| Illingworth Research Group Limited ORG-100042356
|
Farnborough, United Kingdom | Other |
Locations
9 EU/EEA countries · 31 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 3 | 1 |
| Denmark | Ongoing, recruiting | 3 | 1 |
| Germany | Ongoing, recruiting | 20 | 5 |
| Greece | Ongoing, recruiting | 8 | 4 |
| Hungary | Ongoing, recruiting | 8 | 3 |
| Italy | Ongoing, recruiting | 13 | 4 |
| Poland | Ongoing, recruiting | 13 | 7 |
| Romania | Ongoing, recruiting | 7 | 2 |
| Spain | Ongoing, recruiting | 3 | 4 |
| Rest of world
United Kingdom, Mexico, Argentina, United States, Georgia, Serbia
|
— | 108 | — |
Investigational sites
Rigshospitalet
Neurology, Blegdamsvej 9, 2100, Copenhagen Oe
Katholisches Klinikum Bochum gGmbH
Neurology, Gudrunstrasse 56, Grumme, Bochum
Universitaetsklinikum Essen AöR
Klinik für Neurologie, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsmedizin Goettingen
Neurology, Robert-Koch-Strasse 40, Weende, Goettingen
Otto Von Guericke Universitaet Magdeburg
Neurology, Leipziger Strasse 44, Leipziger Str., Magdeburg
Klinikum Wuerzburg Mitte gGmbH
Neurology, Salvatorstrasse 7, Frauenland, Wuerzburg
University General Hospital Of Thessaloniki Ahepa
1st Department of Neurology, 1st St Kiriakidis Str, 546 36, Thessaloniki
General University Hospital Of Patras
Neurology, Rio, 265 04, Patras
Eginitio Hospital
1st Neurology Department of NKUA, Vassilissas Sofias Avenue 74, 115 28, Athens
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Second Department of Neurology of NKUA, Rimini 1, 124 61, Chaidari
Budapesti Jahn Ferenc Del Pesti Korhaz Es Rendelointezet
Neurology, Koves Ut 1, 1204, Budapest
Semmelweis University
Genomika Medicina és Ritka Betegségek Intézete, Gyulai Pal Utca 2, Kerulet, Budapest VIII
Kistarcsai Flor Ferenc Korhaz
Neurology, Semmelweis Ter 1, 2143, Kistarcsa
IRCCS Foundation Istituto Neurologico Carlo Besta
U.O. Neurologia IV, Via Giovanni Celoria 11, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Neurologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Federico II Di Napoli
U.O.C Clinica Neurologica, Via Sergio Pansini 5, 80131, Naples
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Neurology, Piazza Oms 1, 24127, Bergamo
Krakowska Akademia Neurologii Sp. z o.o.
Neurology, Ul. Arianska 7/3, 31-505, Cracow
Centrum Medyczne HOPE Clinic Sebastian Szklener
Neurology, Nałęczowska 18A/U7, 20-701, Lublin
Michalski I Partnerzy Lekarze sp.p.
Neurology, Ul. Zmujdzka 23/u1, 31-426, Cracow
Centrum Medyczne Neuroprotect
Neurology, Ul. Klaudyny 16c, 1 Piętro, Warsaw
Uniwersyteckie Centrum Kliniczne
Neurology, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Neurology, Ul. Mikolaja Kopernika 36, 31-501, Cracow
Neurologia Śląska Centrum Medyczne
Neurology, ul. Małachowskiego 51, 40-689, Katowice
Brainaxy Clinic S.R.L.
Neurology, Strada Muresanu Andrei No. 8, 900348, Constanta
Spitalul Clinic Judetean De Urgenta Targu Mures
Neurology I, Strada Marinescu Gheorghe 50, 540136, Targu Mures
Hospital Universitari General De Catalunya
Unitat d’Investigacio Clinica, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Hospital De La Santa Creu I Sant Pau
Neurology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Reina Sofia
Neurology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Ramon Y Cajal
Neurology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2025-12-17 | 2026-01-12 | |||
| Denmark | 2025-12-22 | 2026-04-21 | |||
| Germany | 2025-11-13 | 2026-02-04 | |||
| Greece | 2026-01-30 | 2026-02-16 | |||
| Hungary | 2025-11-28 | 2025-12-16 | |||
| Italy | 2025-12-18 | 2026-02-18 | |||
| Poland | 2026-02-27 | 2026-03-04 | |||
| Romania | 2025-11-20 | 2025-12-18 | |||
| Spain | 2025-12-19 | 2026-04-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 184 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Justification for Placebo use_2024-515979-35-00_GR_redacted | N/A |
| Protocol (for publication) | D1_Justification for Placebo use_2024-515979-35-00_redacted | N/A |
| Protocol (for publication) | D1_Protocol_2024-515979-35-00_GR_redacted | 4.1-EU |
| Protocol (for publication) | D1_Protocol_2024-515979-35-00_redacted | 4.1-EU |
| Protocol (for publication) | D1_Protocol_2024-515979-35-00_redacted_ | 2.2-EU |
| Protocol (for publication) | D1_Protocol_Myasthenia Gravis Activities of Daily Living_MG-ADL_EN | V1.1 |
| Protocol (for publication) | D1_Protocol_Quantitative Myasthenia Gravis_QMG_EN | V2.1 |
| Protocol (for publication) | D1_Protocol_Questionnaire 1_EN_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary_CZ_redacted | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary_DE_redacted | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary_DK_redacted | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary_EN_redacted | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary_ES_redacted | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary_GR_redacted | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary_HU_redacted | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary_IT_redacted | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary_PL_redacted | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Dosing Diary_RO_redacted | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 2_CZ_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 2_DE_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 2_DK_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 2_EN_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 2_ES_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 2_GR_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 2_HU_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 2_IT_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 2_PL_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 2_RO_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 3_CZ_redacted | V1.2 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 3_DE_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 3_DK_redacted | V1.1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 3_EN_redacted | V1.2 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 3_ES_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 3_GR_redacted | V1.1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 3_HU_redacted | V1.3 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 3_IT_redacted | V2.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 3_PL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 3_RO_redacted | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 4_CZ_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 4_DE_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 4_DK_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 4_EN_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 4_ES_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 4_GR_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 4_HU_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 4_IT_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 4_PL_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 4_RO_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 5_CZ_redacted | V2.5 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 5_DE_redacted | V2.1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 5_DK_redacted | V2.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 5_EN_redacted | V2.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 5_ES_redacted | V2.1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 5_GR_redacted | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 5_HU_redacted | V2.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 5_IT_redacted | V2.3 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 5_PL_redacted | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 5_RO_redacted | V2.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 6_CZ_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 6_DE_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 6_DK_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 6_EN_redacted | V2.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 6_ES_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 6_GR_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 6_HU_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 6_IT_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 6_PL_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire 6_RO_redacted | V1.0 |
| Protocol (for publication) | D4_Patient facing documents_SIAQ POST_CZ | N/A |
| Protocol (for publication) | D4_Patient facing documents_SIAQ POST_DE | N/A |
| Protocol (for publication) | D4_Patient facing documents_SIAQ POST_DK | N/A |
| Protocol (for publication) | D4_Patient facing documents_SIAQ POST_EN | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_SIAQ POST_ES | N/A |
| Protocol (for publication) | D4_Patient facing documents_SIAQ POST_GR | N/A |
| Protocol (for publication) | D4_Patient facing documents_SIAQ POST_HU | N/A |
| Protocol (for publication) | D4_Patient facing documents_SIAQ POST_IT | N/A |
| Protocol (for publication) | D4_Patient facing documents_SIAQ POST_PL | N/A |
| Protocol (for publication) | D4_Patient facing documents_SIAQ POST_RO | N/A |
| Protocol (for publication) | D4_Patient facing documents_SIAQ PRE_CZ | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_SIAQ PRE_DE | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_SIAQ PRE_DK | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_SIAQ PRE_EN | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_SIAQ PRE_ES | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_SIAQ PRE_GR | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_SIAQ PRE_HU | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_SIAQ PRE_IT | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_SIAQ PRE_PL | V2.2 |
| Protocol (for publication) | D4_Patient facing documents_SIAQ PRE_RO | V2.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K2_GP letter_IT_redacted | 1.1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Marketing and Print Materials_CZ_redacted | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Marketing and Print Materials_DE_redacted | 4.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Marketing and Print Materials_EL_redacted | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Marketing and Print Materials_ES_redacted | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Marketing and Print Materials_IT_redacted | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Marketing and Print Materials_PL_redacted | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Marketing and Print Materials_RO_redacted | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician to Patient Letter_HU_redacted | N/A |
| Subject information and informed consent form (for publication) | L1_Home Dosing Worksheet_CZ_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional Genetic research_HU | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_IFU_Autoinjector_redacted | V2.0 |
| Subject information and informed consent form (for publication) | L1_IFU_Video Script_redacted | V1.0 |
| Subject information and informed consent form (for publication) | L1_Patient Card_CZ | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient Card_HU | V1.1 |
| Subject information and informed consent form (for publication) | L1_Patient Card_HU_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_CZ_redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_Ongoing Participants_CZ_redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_Privacy Notice_CZ | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_Privacy Notice_Ongoing Participants_CZ | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_CZ_redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DE_redacted | 4.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DK_redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_EL_redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ES_redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_HU_redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_IT_redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Ongoing Participants_CZ_redacted | 4.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_PL_redacted | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Privacy Notice_CZ | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Privacy Notice_Ongoing Participants_CZ | 3.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RO_redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional genetic research_CZ_redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional genetic research_DK_redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Patient GO Travel and Reimbursement Policy_EL | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Consent to Process Data Form_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Consent to Process Data Form_DE | V1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Consent to Process Data Form_EL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Consent to Process Data Form_ES | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Consent to Process Data Form_HU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Consent to Process Data Form_IT | V1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Consent to Process Data Form_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Consent to Process Data Form_RO | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO EULA_CZ | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO EULA_DE | V1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO EULA_EL | V1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO EULA_ES | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO EULA_HU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO EULA_IT | V1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO EULA_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO EULA_RO | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Privacy Policy_CZ | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Privacy Policy_DE | V4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Privacy Policy_EL | V4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Privacy Policy_ES | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Privacy Policy_HU | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Privacy Policy_IT | V4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Privacy Policy_PL | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Privacy Policy_RO | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Travel and Reimbursement Policy_CZ | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Travel and Reimbursement Policy_DE | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Travel and Reimbursement Policy_ES_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Travel and Reimbursement Policy_HU_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Travel and Reimbursement Policy_IT_redacted | V2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Travel and Reimbursement Policy_PL_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PatientGO Travel and Reimbursement Policy_RO_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_DE_redacted | V1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_HU_redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_PL_redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy-Birth_IT_redacted | V1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_CZ_redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_EL_redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_ES_redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Ongoing Participants_CZ_redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Privacy Notice_CZ | 2.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_RO_redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy_IT | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Optional Genetic research_HU_redacted | 1.2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2024-515979-35-00_CZ | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2024-515979-35-00_EN | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2024-515979-35-00_ES | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2024-515979-35-00_GR | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2024-515979-35-00_HU | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2024-515979-35-00_IT | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2024-515979-35-00_PL | 3.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2024-515979-35-00_RO | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-515979-35-00_HU_redacted | 4.1-EU |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-30 | Italy | Acceptable 2025-10-20
|
2025-10-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-03 | Acceptable 2026-06-01
|
2026-06-02 |