Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
180
Countries
7
Sites
43
Primary Sjogren’s Disease
To evaluate the efficacy of IMVT-1402 dose 1 SC QW compared to placebo as assessed by clinESSDAI score
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
- 12 Dec 2025 → ongoing
- Decision date (initial)
- 2025-11-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520831-18-00
- ClinicalTrials.gov
- NCT06979531
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenetic, Efficacy, Dose response, Safety, Pharmacokinetic, Therapy, Pharmacodynamic
To evaluate the efficacy of IMVT-1402 dose 1 SC QW compared to placebo as assessed by clinESSDAI score
Conditions and MedDRA coding
Primary Sjogren’s Disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Have a diagnosis of primary SjD for a least 12 months prior to the Screening Visit and meet classification criteria for primary SjS according to the 2016 ACR/EULAR Classification Criteria for Primary Sjogren’s Syndrome at the time of screening.
- Have moderate to severe systemic disease activity as determined by a clinESSDAI total score ≥ 5 at the Screening Visit.
- Are seropositive for antibodies to SSA/Ro at the Screening Visit.
- Have residual salivary flow as measured by a stimulated whole salivary flow rate ≥ 0.01 mL/min at the Screening Visit.
Exclusion criteria 2
- Participants with a diagnosis of secondary SjD or an autoimmune disease other than primary SjD that constitutes the principal illness, including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, pre-existing fibromyalgia or polymyositis, at the Screening Visit.
- Participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined significance, history of multiple myeloma or non-Hodgkin's lymphoma, or have an active malignancy or history of malignancy within 5 years prior to the Screening Visit.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from Baseline in clinESSDAI score at Week 24.
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
- 28800 mg milligram(s)
- Max treatment duration
- 48 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 18
| Organisation | City, country | Duties |
|---|---|---|
| Fisher Clinical Services GmbH ORG-100017323
|
Weil Am Rhein, Germany | Code 14 |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Medpace Reference Laboratories LLC ORG-100041727
|
Cincinnati, United States | Laboratory analysis |
| Fisher Clinical Services GmbH ORG-100017323
|
Rheinfelden (Baden), Germany | Code 14 |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| MEDPACE LABORATORIES ORG-100042942
|
Leuven, Belgium | Laboratory analysis |
| Fisher Clinical Services Inc. ORG-100014726
|
Allentown, United States | Code 14 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other, Code 5 |
| Exagen Inc. ORG-100053206
|
Vista, United States | Laboratory analysis |
| Clariness GmbH ORG-100045306
|
Hamburg, Germany | Other |
| EPL Pathology Archives LLC ORG-100042096
|
Leesburg, United States | Other |
| Voisin Consulting Life Sciences ORG-100009282
|
Boulogne Billancourt, France | Code 12 |
| Avantor Inc. ORG-100050885
|
Wayne, United States | Other |
| Primevigilance USA Inc. ORG-100047266
|
Raleigh, United States | Code 8 |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | On site monitoring, Code 5 |
| Avance Biosciences Inc. ORG-100016282
|
Houston, United States | Laboratory analysis |
| Syneos Health Clinique Inc. ORG-100028348
|
Quebec, Canada | Laboratory analysis |
| Clinical Ink Inc. ORG-100042433
|
Winston Salem, United States | Other, E-data capture |
Locations
7 EU/EEA countries · 43 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 10 | 6 |
| Greece | Authorised, recruiting | 4 | 2 |
| Hungary | Ongoing, recruiting | 7 | 4 |
| Italy | Ongoing, recruiting | 11 | 7 |
| Poland | Ongoing, recruiting | 24 | 16 |
| Romania | Ongoing, recruiting | 7 | 3 |
| Spain | Ongoing, recruiting | 9 | 5 |
| Rest of world
United States, Colombia, Argentina, United Kingdom, Brazil, Chile, Canada, Mexico, Peru
|
— | 108 | — |
Investigational sites
Prof. Dr. med. Gunther Neeck MVZ GmbH
Rheumazentrum, Goethestrasse 40, 18209, Bad Doberan
LMU Klinikum Muenchen AöR
Department rheumatology and clinical immunology, Pettenkoferstrasse 8a, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsklinikum Heidelberg AöR
Medizinische Klinik V, Sektion Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Medicover GmbH
Medicover München Ost MVZ, Orleansplatz 3, Au-Haidhausen, Munich
Medizinische Hochschule Hannover
Rheumatologisch e Studienambulanz, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Hamburger Rheuma Forschungszentr um II, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Athens Euroclinic S.A.
Department of Internal Medicine and Autoimmune Diseases, Athanassiadou 7-9, 115 21, Athens
Laiko General Hospital Of Athens
Department of Pathophysiology, Agiou Thoma (goudi) 17, 115 27, Athens
Je-Med Bt.
NA, Kossuth Lajos Utca 9, 6300, Kalocsa
Revita Kft.
NA, Margit Korut 50-52 Fszt. 9, Kerulet, Budapest II
Complex Rendelo Med Zrt.
NA, Seregelyesi Ut 92, 8000, Szekesfehervar
Vasarhelyi Sarkanyfu Kft.
NA, Nagy Sandor Utca 11, 6800, Hodmezovasarhely
Azienda Ospedaliera Universitaria Integrata Verona
U.O.C. Reumatologia, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Ospedale San Raffaele S.r.l.
Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare, Via Olgettina 60, 20132, Milan
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
UOC Immunoreumatologia, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
U.O. Reumatologia, Via Del Vespro 129, 90127, Palermo
Hospital Santa Maria Della Misericordia
SC Reumatologia, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOC Reumatologia, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
U.O. Reumatologia, Via Santa Sofia 78, 95123, Catania
Lukmed 2 Sp. z o.o.
ETG Siedlce, Ul. Mlynarska 16 B, 08-110, Siedlce
Reumed Sp. z o.o.
Zespół Poradni Specjalistycznych Reumed, Filia nr 1 Wallenroda, Ul. Konrada Wallenroda 2f/4, 20-607, Lublin
Etg Warszawa Sp. z o.o.
ETG Warszawa, Ul. Wynalazek 4, 02-677, Warsaw
Magdalena Gołąbek
Pracownia Badań Klinicznych Salus, Ul. Ołtaszyńska 92c/3, 53-034, Wrocław
Med Polonia Sp. z o.o.
Przychodnia Med-Polonia, Obornicka 262, 60-693, Poznan
Prywatna Praktyka Lekarska Prof. Dr Hab. Med. Paweł Hrycaj
N/A, Os. Rzeczypospolitej 6/202, 61-397, Poznań
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Warszawa, Ul Wronia 53 Lok B 10, 00-874, Warsaw
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Uniwersyteckie Centrum Wsparcia Badań Klinicznych, Ul. Borowska 211a, 50-556, Wroclaw
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Centrum Wsparcia Badań Klinicznych, Ul. Spartanska 1, 02-637, Warsaw
Michalski I Partnerzy Lekarze sp.p.
N/A, Ul. Zmujdzka 23/u1, 31-426, Cracow
Futuremeds Sp. z o.o.
FutureMeds Łódź, Ul. Gruszowa 2, 91-363, Lodz
Klinika Reuma Park Sp. z o.o. S.K.
Centrum Medyczne Reuma Park, Aleja Wilanowska 333, 02-665, Warsaw
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Specjalista w dziedzinie alergologii, immunologii klinicznej i chorób wewnętrznych, Ul. Tadeusza Szafrana 5d / U2-U5, 30-363, Cracow
K2J2 Katarzyna Viktoria Jachimowska
Centrum Medyczne K2J2, ul. Gdyńska 1/3, 05-200, Wołomin
ETG Lublin Sp. z o.o.
ETG Lublin Poradnie Specjalistyczne, Ul. Wladyslawa Kunickiego 26a, 20-412, Lublin
Medicover Integrated Clinical Services Sp. z o.o.
MICS Centrum Medyczne Bydgoszcz, Ul. Jana Karola Chodkiewicza 19c, 85-065, Bydgoszcz
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Rheumatology, Block 1 Staircase C Apartment 2 Room 2, Strada Crisului Nr 1, Brasov
Saint Maria Hospital
Internal Medicine I, Bulevardul Mihalache Ion 37-39, 011172, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
Rheumatology, Strada Clinicilor 4-6, 400006, Cluj-Napoca
Futuremeds Spain S.L.
Rheumatology, Avenida Octavio Augusto S/n, 11139, Chiclana De La Frontera
Hospital Universitario Basurto
Rheumatology, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital De Merida
Rheumatology, Avenida De Don Antonio Campos Hoyos No 26, 06800, Merida
Hospital Universitario Reina Sofia
Rheumatology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Clinico Universitario De Valencia
Rheumatology, Avenida Blasco Ibanez 17, 46010, Valencia
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 |
|---|---|---|---|---|---|
| Germany | 2026-01-22 | 2026-02-04 | |||
| Greece | 2026-03-05 | ||||
| Hungary | 2025-12-19 | 2026-01-08 | |||
| Italy | 2026-03-23 | 2026-05-14 | |||
| Poland | 2025-12-18 | 2025-12-30 | |||
| Romania | 2025-12-12 | 2025-12-16 | |||
| Spain | 2025-12-19 | 2026-01-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 178 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-520831-18-00_EN_Redacted | 3.1-EU |
| Protocol (for publication) | D1_Protocol_2025-520831-18-00_GR_Redacted | 3.1-EU |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_DE_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_EN_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_ES_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_GR_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_HU_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_IT_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_PL_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Dosing Diary_RO_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_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_GR_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_PL_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 1_RO_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_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_GR_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_PL_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 2_RO_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_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_GR_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_PL_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 3_RO_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_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_GR_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_PL_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 4_RO_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 5_DE_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 5_EN_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 5_ES_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 5_GR_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 5_HU_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 5_IT_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 5_PL_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 5_RO_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 6_DE_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 6_EN_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 6_ES_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 6_GR_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 6_HU_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 6_IT_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 6_PL_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing document_Questionnaire 6_RO_Redacted | N/A |
| Protocol (for publication) | D4_PI facing document_PhGA_Redacted | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_DE | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_ES | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_GR | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_HU | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_IT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_PL | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_RO | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Group Sheet_DE_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Group Sheet_ES_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Group Sheet_GR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Group Sheet_HU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Group Sheet_IT_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Group Sheet_PL_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advocacy Group Sheet_RO_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_DE_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_ES_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_GR_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_HU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_IT_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_PL_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_RO_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dear patient letter_DE_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dear patient letter_ES_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dear patient letter_GR_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dear patient letter_HU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dear patient letter_IT_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dear patient letter_PL_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dear patient letter_RO_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_General Trial Webposting_DE_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_General Trial Webposting_ES_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_General Trial Webposting_HU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_General Trial Webposting_IT_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_General Trial Webposting_PL_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_General Trial Webposting_RO_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Marketing_EC_DE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Marketing_EC_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Marketing_EC_HU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Marketing_EC_IT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Marketing_EC_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Marketing_EC_RO | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Screener_EC_DE_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Screener_EC_ES_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Screener_EC_HU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Screener_EC_IT_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Screener_EC_PL_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Master Screener_EC_RO_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_DE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_GR | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_HU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_RO | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ad_DE | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ad_ES | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ad_GR | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ad_HU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ad_IT | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ad_PL | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social Media Ad_RO | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Concept_DE | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Concept_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Concept_GR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Concept_HU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Concept_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Concept_PL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Video Concept_RO | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website Copy_DE_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website Copy_ES_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website Copy_HU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website Copy_IT_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website Copy_PL_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website Copy_RO_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional Genetic Testing_HU | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Caregiver_IT | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_DE_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ES_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_HU_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RO_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetic Testing_DE_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetic Testing_ES_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetic Testing_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetic Testing_RO_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_DE_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_ES_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_HU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_RO_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy_IT | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_DE | s0.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_ES_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_GR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_HU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_IT | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Scout_RO | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Supporting Designee_DE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Supporting Designee_ES | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Supporting Designee_GR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Supporting Designee_HU | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Supporting Designee_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Supporting Designee_RO | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Optional Genetic Testing_HU_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Emergency Patient Card_HU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Emergency Patient Card_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Investigator to GP letter_IT_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2025-520831-18-00_EN | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2025-520831-18-00_ES | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2025-520831-18-00_GR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2025-520831-18-00_HU | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2025-520831-18-00_IT | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2025-520831-18-00_PL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Language synopsis_2025-520831-18-00_RO | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-520831-18-00_HU_Redacted | 3.1-EU |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-01 | Italy | Acceptable 2025-11-24
|
2025-11-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-16 | Italy | Acceptable 2026-03-05
|
2026-03-08 |