Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
372
Countries
11
Sites
93
Graves’ Disease
To evaluate the efficacy of IMVT-1402 as assessed by maintenance of euthyroidism, off ATD, and off IMVT-1402 for 52 weeks in Group A 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] - Immune System Diseases [C20]
- Trial duration
- 22 May 2026 → ongoing
- Decision date (initial)
- 2026-05-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacodynamic, Efficacy, Pharmacokinetic, Safety
To evaluate the efficacy of IMVT-1402 as assessed by maintenance of euthyroidism, off ATD, and off IMVT-1402 for 52 weeks in Group A Participants
Conditions and MedDRA coding
Graves’ Disease
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-521920-31-00 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease | Immunovant Sciences GmbH |
| 2024-516020-33-00 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease | Immunovant Sciences GmbH |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Participants who completed Study IMVT-1402-2502 or Study IMVT-1402-2503.
Exclusion criteria 1
- Have permanently discontinued IMP during the treatment period in the feeder study or have met study stopping criteria at any point up until the end of participation in the feeder study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of Group A Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time Frame: At Week 52]
Secondary endpoints 12
- Percentage of Group A Participants who are euthyroid and off ATD [Time Frame: At Week 26]
- Percentage of Group A Participants who are euthyroid and off ATD [Time Frame: Up to Week 52]
- Percentage of Group A Participants who are euthyroid, off ATD, and off IMVT-1402 [Time Frame: Up to Week 52]
- Time to earliest date of euthyroidism, off ATD, and off IMVT-1402 to the earliest date of confirmed relapse in Group A Participants [Time Frame: Up to Week 52]
- Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time Frame: Up to Week 52]
- Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time Frame: At Week 52]
- Time from Week 0 to the earliest date of confirmed relapse in Group B Participants [Time Frame: Up to Week 52]
- Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time Frame: Up to Week 52]
- Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402 [Time Frame: At Week 52]
- Time From Week 0 to the earliest date of confirmed relapse in Group C Participants [Time Frame: Up to Week 52]
- Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb [Time Frame: At Week 26]
- Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb [Time Frame: Up to Week 52]
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 USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 31200 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- IMMUNOVANT SCIENCES GMBH
- Paediatric formulation
- No
- Orphan designation
- 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 16
| Organisation | City, country | Duties |
|---|---|---|
| Primevigilance USA Inc. ORG-100047266
|
Raleigh, United States | Code 8 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Other, Code 2, Code 5 |
| Avantor Inc. ORG-100050885
|
Wayne, United States | Other |
| Pharmaceutical Research Associates Group B.V. ORG-100006268
|
Assen, Netherlands | Laboratory analysis |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Eclinical Solutions LLC ORG-100044778
|
Mansfield, United States | Data management |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | On site monitoring |
| Fisher Clinical Services Inc. ORG-100014726
|
Allentown, United States | Code 14 |
| Fisher Clinical Services GmbH ORG-100017323
|
Weil Am Rhein, Germany | Code 14 |
| Fisher Clinical Services GmbH ORG-100017323
|
Rheinfelden (Baden), Germany | Code 14 |
| Syneos Health Clinique Inc. ORG-100028348
|
Quebec, Canada | Laboratory analysis |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Voisin Consulting Life Sciences ORG-100009282
|
Boulogne Billancourt, France | Code 12 |
| Clinical Ink Inc. ORG-100042433
|
Winston Salem, United States | Other, E-data capture |
Locations
11 EU/EEA countries · 93 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 4 | 2 |
| Bulgaria | Authorised, recruiting | 17 | 14 |
| Czechia | Authorised, recruiting | 6 | 4 |
| Germany | Authorised, recruitment pending | 9 | 5 |
| Greece | Authorised, recruitment pending | 4 | 4 |
| Hungary | Authorised, recruitment pending | 18 | 6 |
| Italy | Authorised, recruitment pending | 16 | 22 |
| Latvia | Authorised, recruitment pending | 7 | 6 |
| Netherlands | Authorised, recruitment pending | 2 | 4 |
| Poland | Authorised, recruitment pending | 32 | 18 |
| Spain | Authorised, recruitment pending | 13 | 8 |
| Rest of world
New Zealand, United States, Korea, Republic of, Chile, Japan, United Kingdom, Brazil, Mexico, Israel, Australia, Georgia
|
— | 244 | — |
Investigational sites
Hopital Erasme
Division of Endocrinology, Lennikse Baan 808, 1070, Anderlecht
AZ ST-JAN Brugge A.V.
Internal Medicine / Endocrinology, Ruddershove 10, 8000, Brugge
Medical Center Viva Phoenix OOD
N/A, Ulitsa Nezavisimost 2, 9300, Dobrich
Medical Center Berbatov Ltd.
N/A, Ulitsa Beli Drin 9, 8600, Yambol
Medical Centre Pratia Clinic EOOD
N/A, Bulevard Republika 15, 9020, Varna
Medical Center Smolyan Klinikal Research Ltd.
N/A, Ulitsa Han Asparuh 2, 4700, Smolyan
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Clinic of Endocrinology and Metabolic Diseases, Zapaden District, Sofia Str 64, Plovdiv
Medcenter Nova Clinic Ltd.
N/A, Ulitsa Vyara 7, 9020, Varna
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department of Endocrinology and Metabolic Diseases, Bulevard Gen. Stoletov No 67a, 1233, Sofia
Kalimat Medical Center Ltd.
N/A, Ulitsa Yastrebets 11, 1680, Sofia
Diagnostic Consultative Center Equita OOD
N/A, Bulevard Tsar Osvoboditel 5, 9000, Varna
University Multiprofile Hospital For Active Treatment Sofiamed OOD
Clinic of Endocrinology and Metabolic Diseases, Ulitsa Dimitir Mollov 10, 1750, Sofiya
University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
Third Clinic of Endocrinology and Metabolic Diseases, Ulitsa Zdrave 2, 1431, Sofia
University Multiprofile Hospital For Active Treatment Pulmed Ltd.
Department of Endocrinology and Metabolic Diseases at Clinic of Internal Diseases, Ulitsa Perushtitsa 1a, 4002, Plovdiv
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
Department of Endocrinology and Metabolic Diseases, Ulitsa Dimitir Pehlivanov 5, 8800, Sliven
Alexandrovska University Hospital
Clinic of Endocrinology and Metabolic Diseases, Georgy Sofiiski Str 1, 1431, Sofia
ResTrial s.r.o.
Klinika ResTrial, Zhorelecka 514/2, Bohnice, Prague 8
Endokrinologie Klanovice s.r.o.
N/A, Axmanova 131, Klanovice, Prague
Milan Kvapil s.r.o.
Diabetologická ambulance, Michnova 1622/4, Chodov, Prague
Edumed s.r.o.
N/A, Mlynska 189, 547 01, Nachod
Technische Universitaet Dresden
Department of Medicine III, Devision of Endocrinology, Diabetes and Bone diseases, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik I, Endokrinologie, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Medicover Medizin gGmbH
Medizinische Klinik und Poliklinik IV, Orleansplatz 3, Au-Haidhausen, Munich
Medical Center - University Of Freiburg
Medizinische Klinik II, Gastroenterologie, Hepatologie, Infektiologie and Endokrinologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
HELIOS Kliniken Schwerin GmbH
Internal Medecine, Endocrinology, Diabetology, Wismarsche Strasse 393-397, Lewenberg, Schwerin
Laiko General Hospital Of Athens
1st department of internal medecine, Endocrinology Unit, Agiou Thoma (goudi) 17, 115 27, Athens
General Hospital Of Athens Alexandra
Endocrine Department and Diabetological Center, Vassilissis Sofias Avenue 80, 115 28, Athens
Evaggelismos Hospital
Department of Endocrinology "D.IKKOS", Ipsiladou 45-47, 106 76, Athens
Ippokratio General Hospital Of Thessaloniki
Department of Endocrinology, Diabetes & Metabolism, Konstadinoupoleos 49, 546 42, Thessaloniki
University Of Pecs
Clinical Center, 1st Department of Internal Medicine, Department of Endocrinology and Metabolism, Ifjusag Utja 13, 7624, Pecs
Trial Pharma Kft.
Endocrinology, Gyulai Ut 94-96, 5600, Bekescsaba
University Of Debrecen
Internal Medicine Clinic, Endocrinology, Nagyerdei Korut 98, 4032, Debrecen
Semmelweis University
Department of Internal Medicine and Oncology, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
Obudai Egeszseguegyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
University Of Szeged
Clinical Center, Internal Medicine Clinic, Endocrinology, Kalvaria Sugarut 57, 6725, Szeged
Azienda Ospedaliero Universitaria Pisana
UO Endocrinologia II, Via Paradisa 2, 56124, Pisa
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Unit of Endocrinology, Via Francesco Sforza 35, 20122, Milan
Azienda Unita' Sanitaria Locale Toscana Nord Ovest
U.O. Aziendale di Endocrinologia, Viale Vittorio Alfieri 36, 57124, Leghorn
Istituti Clinici Scientifici Maugeri S.p.A. Societa' Benefit In Forma Abbreviata Istituti Clinici Scientifici Maugeri S.p.A. Sb O Anche Ics Maugeri S.p.A. Sb O Maugeri S.p.A. Sb
Unit of Endocrinology and Metabolic Diseases, Via Salvatore Maugeri 10, 27100, Pavia
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
UoC endocrinologia, Via Antonio Cardarelli 9, 80131, Naples
Istituto Auxologico Italiano
Endocrinologia e Malattie del Metabolismo, Piazzale Brescia 20, 20149, Milan
Azienda Ospedaliera Universitaria Federico II Di Napoli
DIPARTIMENTO DI SANITA' PUBBLICA, Via Sergio Pansini 5, 80131, Naples
Ospedale San Raffaele S.r.l.
Endocrinology Department, Via Olgettina 60, 20132, Milan
Hospital Santa Maria Della Misericordia
Medicine and Surgery, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department of Experimental Medicine, Sapienza University of Rome, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliera Santa Croce E Carle
Endocrinology, Via Michele Coppino 26, 12100, Cuneo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Endocrinologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero-Universitaria Sant Andre
UOC Medicina Specialistica Endocrino-Metabolica, Via Di Grottarossa 1035-1039, 00189, Rome
Azienda Sanitaria Universitaria Friuli Centrale
Oncology Area Department, Via Pozzuolo 330, 33100, Udine
Azienda Ospedaliero-Universitaria Di Cagliari
U.O Endocrinologia, Via Ospedale N. 54, 09124, Cagliari
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
SC Malattie Endocrine-Diabetologia, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
U.O.C. Endocrinologia e prevenzione e cura del diabete, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Dipartimento di Medicinina Generale e Specilistica, Corso Bramante 88, 10126, Turin
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
UOC Malattie Endocrine, del ricambio e della nutrizione, Via Del Vespro 129, 90127, Palermo
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
SC Endocrinologia, Viale Luigi Borri 57, 21100, Varese
Universita Humanitas
Department of Biomedical Sciences, Via Rita Levi Montalcini 4, 20072, Pieve Emanuele
Azienda Ospedaliero-Universitaria Senese
Medical Sciences, Strada Delle Scotte 14, 53100, Siena
Siguldas Slimnica
Outpatient Department, Ziedu Iela 5, 2150, Siguldas Pagasts
Riga East University Hospital
Clinical Centre "Bikernieki", Ophthalmology clinic, Lielvardes Street 68, LV-1006, Riga
Veselibas un socialas aprupes klinika APS SIA
Endocrinology, Lastadijas Iela 40, 1050, Riga
Daces Teterovskas arsta prakse endokrinologija SIA
N/A, Brivibas Street 22, 5001, Ogre
Pauls Stradins Clinical University Hospital
Center of Endrocrinology, Pilsonu Iela 13, 1002, Riga
Ziemelkurzemes regionala slimnica SIA
Ophthalmology, Inzenieru Iela 60, 3601, Ventspils
Sint Franciscus Vlietland Groep Stichting
Internal Medicine, Kleiweg 500, 3045 PM, Rotterdam
Ikazia Ziekenhuis
Internal medicine, Montessoriweg 1, 3083 AN, Rotterdam
Albert Schweitzer Ziekenhuis
N/A, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Maasstad Ziekenhuis Stichting
Internal Medicine, Maasstadweg 21, 3079 DZ, Rotterdam
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Centrum Diabetologiczne Kliniki Chorób Wewnętrznych, Endokrynologii i Diabetologii, Ul. Woloska 137, 02-507, Warsaw
Clinicly Sp. z o.o.
Centrum Medyczne Clinicly, Ul. Ludwika Warynskiego 30, 45-047, Opole
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
Poradnia Internistyczn, Ul. Marcelinska 42, 60-354, Poznan
Diab Serwis Popenda Sp. j.
N/A, Ul. Jozefa Ryszki 51, 41-516, Chorzow
Reumed Sp. z o.o.
Poradnia endokrynologicz na i diabetologiczna, Ul. Konrada Wallenroda 2f/4, 20-607, Lublin
Trialmed Sp. z o.o.
Clinical Trials, Solipska 27/ Lu 3, 02-482, Warsaw
Uniwersytecki Szpital Kliniczny W Bialymstoku
Klinika Endokrynologii, Diabetologii i Chorób Wewnętrznych, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Etyka Ośrodek Badań Klinicznych, Ul. 1 Maja 13 C, 10-117, Olsztyn
Centrum Medyczne Hope Clinic Sebastian Szklener
N/A, Nałęczowska 18A/U7, 20-701, Lublin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Zakład Medycyny Nuklearnej i Endokrynologii Onkologicznej Centrum Wsparcia Badań Klinicznych, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Med Polonia Sp. z o.o.
Dział badań klinicznych, Obornicka 262, 60-693, Poznan
Eb Group Sp. z o.o.
Centrum Zdrowia MDM, Ul. Inflancka 4a, 00-189, Warsaw
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Endokrynologii, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Centrum Medyczne Intercor Sp. z o.o.
N/A, Ul. Kasztanowa 57, 85-605, Bydgoszcz
Clinical Best Solutions Sp. z o.o. S.K.
N/A, Aleja Jozefa Pilsudskiego 11, 20-011, Lublin
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Endokrynologii i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Ośrodek Medyczny “Osteomed”
N/A, ul. Kazimierza Wielkiego 57, 30-074, Krakow
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Endokrynologii, Endokrynologii Onkologicznej, Med Nuklearnej i Chorób Wewnętrznych, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Hospital Universitario Virgen De Las Nieves
Endocrinology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Germans Trias I Pujol
Endocrinology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitari Vall D Hebron
Endocrinology and Nutrition, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario De La Princesa
Endocrinology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario Virgen De La Macarena
Ophtalmology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Reina Sofia
Endocrinology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Clinico San Carlos
Servicio de Endocrinología, Metabolismo y Nutrición, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Clinic De Barcelona
Nutrition and endocrinology, Calle Villarroel 170, 08036, Barcelona
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 |
|---|---|---|---|---|---|
| Bulgaria | 2026-05-28 | ||||
| Czechia | 2026-05-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 174 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PI facing_Questionnaire 1_EN_redacted | N/A |
| Protocol (for publication) | D1_PI facing_Questionnaire 2_EN_redacted | N/A |
| Protocol (for publication) | D1_Protocol_2025-524001-33-00_EL_redacted | 1.0 |
| Protocol (for publication) | D1_Protocol_2025-524001-33-00_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_BE-DE_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_BE-FR_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_BE-NL_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_BG_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_CZ_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_DE_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_EL_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_EN_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_ES_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_HU_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_IT_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_LV_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_LV-RU_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_NL_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_PL_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_BE-DE_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_BE-FR_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_BE-NL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_BG_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_CZ_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_DE_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_EL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_EN_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_ES_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_HU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_IT_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_LV_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_LV-RU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_PL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_BE-DE_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_BE-FR_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_BE-NL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_BG_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_CZ_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_DE_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_EL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_EN_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_ES_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_HU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_IT_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_LV_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_LV-RU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_PL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_BE-DE_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_BE-FR_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_BE-NL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_BG_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_CZ_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_DE_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_EL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_EN_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_ES_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_HU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_IT_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_LV_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_LV-RU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_PL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_BE-DE_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_BE-FR_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_BE-NL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_BG_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_CZ_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_DE_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_EL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_EN_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_ES_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_HU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_IT_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_LV_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_LV-RU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_PL_redacted | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_ Dosing Diary_redacted | N/A |
| Subject information and informed consent form (for publication) | L1_Emergency Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L1_Emergency Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L1_Instruction for Use_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Instruction for Use_Video Script_redacted | N/A |
| Subject information and informed consent form (for publication) | L1_Patient Dosing Diary_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_BE-DE_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_BE-FR_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_BE-NL_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_BG_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_EN_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_LV | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_LV-RU | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data Privacy | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Appendix 1_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE-DE_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE-FR_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE-NL_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BG_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_EN_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_LV_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_LV-RU_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_main_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_main_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Off-site | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Off-Site Healthcare_BE-DE | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Off-Site Healthcare_BE-FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Off-Site Healthcare_BE-NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BE-DE_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BE-FR_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BE-NL_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BG_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_EN_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_LV_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_LV-RU_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_BE-DE_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_BE-FR_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_BE-NL_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_BG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_LV_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_LV-RU_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Supporting Person | 1.0 |
| Subject information and informed consent form (for publication) | L2_ICF_Sponsor Statement_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_GP letter_redacted | 1.1 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_BE-DE | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_BE-FR | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_BE-NL | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_BG | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_CZ | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_EL | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_EN | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_ES | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_HU | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_IT | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_LV | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_LV-RU | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_NL | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language Synopsis_2025-524001-33-00_PL | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524001-33-00_HU_redacted | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-20 | Italy | Acceptable with conditions 2026-05-05
|
2026-05-05 |