Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
180
Countries
7
Sites
40
Thyroid Eye Disease (TED)
To describe batoclimab maintenance of efficacy as assessed by proptosis.
Key facts
- Sponsor
- Immunovant Sciences GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 13 Dec 2023 → 3 Apr 2026
- Decision date (initial)
- 2024-07-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512650-21-00
- EudraCT number
- 2022-002839-66
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety, Pharmacokinetic, Efficacy, Therapy
To describe batoclimab maintenance of efficacy as assessed by proptosis.
Secondary objectives 2
- To describe the efficacy of batoclimab in participants previously treated with placebo and did not achieve proptosis response in the feeder studies.
- To describe the treatment effect of batoclimab in participants previously treated with batoclimab but did not achieve proptosis response in the feeder studies.
Conditions and MedDRA coding
Thyroid Eye Disease (TED)
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-003162-PIP02-22
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-002788-30 | A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED), Multicentrická, randomizovaná, čtyřikrát maskovaná, placebem kontrolovaná studie fáze 3 batoklimabu pro léčbu účastníků s aktivní endokrinní orbitopatií , A batoklimab III. fázisú, többközpontú, randomizált, négyszeresen maszkolt, placebo-kontrollos vizsgálata aktív pajzsmirigy okozta szembetegségben (TED) szenvedő résztvevők kezelésére, 3. fáza multicentrického, randomizovaného, štvorito zaslepeného, placebom kontrolovaného klinického skúšania batoclimabu na liečbu účastníkov s aktívnym očným ochorením spôsobeným poruchou štítnej žľazy (TED), 3. fáza multicentrického, randomizovaného, štvorito zaslepeného, placebom kontrolovaného klinického skúšania batoclimabu na liečbu účastníkov s aktívnym očným ochorením spôsobeným poruchou štítnej žľazy (TED), Estudio de fase III, multicéntrico, aleatorizado, cuádruple ciego y controlado con placebo de batoclimab para el tratamiento de participantes con enfermedad ocular tiroidea (EOT) activa, Estudio de fase III, multicéntrico, aleatorizado, cuádruple ciego y controlado con placebo de batoclimab para el tratamiento de participantes con enfermedad ocular tiroidea (EOT) activa | |
| 2022-002787-68 | A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED), Studio controllato con placebo di fase 3, multicentrico, randomizzato, in quadruplo cieco di batoclimab per il trattamento di partecipanti affetti da oftalmopatia tiroidea (TED) attiva |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- For all participants: have completed the Week 24 visit of the feeder study.
- For participants assigned to the Open-label Treatment Cohort: 1. Do not require immediate surgical intervention and is not planning corrective surgery/irradiation or medical therapy for TED during the course of the study. 2. Did not permanently discontinue study drug.
Exclusion criteria 1
- For all participants: in the Investigator's judgement, the benefits of entry in the study do not outweigh the risk.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Duration of proptosis response off treatment in study eye in participants who were batoclimab responders in the feeder studies.
Secondary endpoints 2
- Proportion of proptosis responders at Week 24 in study eye in participants who were placebo non-responders in the feeder studies.
- Proportion of proptosis responders at Week 24 in study eye in participants who were batoclimab non-responders in the feeder studies.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD8790010 · Product
- Active substance
- Batoclimab
- Substance synonyms
- Immunoglobulin G1(238-alanine, 239-alanine), anti-(human FcRn receptor) (human monoclonal HL161BKN gamma1-chain), disulfide with human monoclonal HL161BKN lambda-chain, dimer, HL161BKN, HBM-9161, RVT-1401
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 680 mg milligram(s)
- Max total dose
- 12240 mg milligram(s)
- Max treatment duration
- 24 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 9
| Organisation | City, country | Duties |
|---|---|---|
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring, Other, Code 2, Code 5, Data management, E-data capture |
| Interdisziplinaeres Zentrum Klinische Studien (IZKS) ORG-100029409
|
Mainz, Germany | Laboratory analysis |
| Illingworth Research Group Limited ORG-100042356
|
Macclesfield, United Kingdom | Other |
| Voisin Consulting Life Sciences ORG-100009282
|
Boulogne Billancourt, France | Code 12 |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Deltamed Solutions Inc. ORG-100051316
|
Somerset, United States | Other |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| MEDPACE LABORATORIES ORG-100042942
|
Leuven, Belgium | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
7 EU/EEA countries · 40 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 12 | 5 |
| Hungary | Ended | 9 | 3 |
| Italy | Ended | 10 | 10 |
| Latvia | Ended | 6 | 3 |
| Poland | Ended | 10 | 8 |
| Slovakia | Ended | 8 | 4 |
| Spain | Ended | 18 | 7 |
| Rest of world
Georgia, United Kingdom, United States, Canada, Turkey, New Zealand, Israel, Australia
|
— | 107 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Endocrinology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Endocrinology, Corneel Heymanslaan 10, 9000, Gent
Centre hospitalier universitaire de Liege
Endocrinology, Avenue De L'hopital 1, 4000, Liege
Hopital Erasme
Endocrinology, Lennikse Baan 808, 1070, Anderlecht
Az St-Jan Brugge-Oostende A.V.
Endocrinology, Ruddershove 10, 8000, Brugge
Nozologen Kft.
Ophthalmology, Varady Antal Utca 10 Fszt. 5, 7621, Pecs
Budapest Retina Associates Kft.
Ophthalmology, Vaci Ut 76, Kerulet, Budapest XIII
University Of Pecs
Ophthalmology, Rakoczi Ut 2, 7623, Pecs
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Endocrinologia, Via Francesco Sforza 35, 20122, Milan
Azienda Ospedaliero Universitaria Pisana
SD Medicina Interna ad indirizzo Immuno-Endocrino (Endocrinology), Via Roma 67, 56126, Pisa
Istituto Auxologico Italiano IRCCS
U.O. Endocrinologia e Malattie del Metabolismo (Endocrinology), Piazzale Brescia 20, 20149, Milan
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
U.O.C. di Malattie Endocrine del Ricambio e della Nutrizione Clinical Endocrinology, Via Del Vespro 129, 90127, Palermo
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Dipartimento Organi di Senso (Ophtalmology), Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliera Universitaria Federico II Di Napoli
U.O.S. Oftalmoplastica (Ophtalmology), Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero-Universitaria Sant Andre
U.O.C. UOS Endocrinologia (Endocrinology), Via Di Grottarossa 1035-1039, 00189, Rome
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 (Endocrinology), Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliero Universitaria Pisana
UO Endocrinologia (Endocrinology), Via Paradisa 2, 56124, Pisa
ARNAS Garibaldi Catania
U.O. Endocrinologia (Endocrinology), Piazza Santa Maria Di Gesu, 95123, Catania
Rigas Austrumu kliniska universitates slimnica SIA
Clinical Centre "Bikernieki", Ophthalmology Clinic, Hipokrata Iela 2, LV-1079, Riga
Ziemelkurzemes regionala slimnica SIA
Ophtalmology, Inzenieru Iela 60, 3601, Ventspils
Daces Teterovskas arsta prakse endokrinologija SIA
Endocrinology, Brivibas Street 22, 5001, Ogre
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Endokrynologii (Endocrinology), Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Klinika Endokrynologii i Nowotworów Neuroendokrynnych (Endocrinology), Ul. Ceglana 35, 40-514, Katowice
Centrum Medyczne Hope Clinic
N/A, ul Nałęczowska 18A/U7, 20-701, Lublin
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
Klinika Endokrynologii, Przemiany Materii i Chorób Wewnętrznych (Endocrinology), Ul. Marcelinska 42, 60-354, Poznan
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Klinika Chorób Wewnętrznych i Endokrynologii (Endocrinology), Ul. Ulica Stefana Banacha 1a, 02-097, Warsaw
Ophthal Sp. z o.o.
Katedra i Klinika Okulistyki Ogolnej i Dzieciecej, ul. Szczytowa 7, 20-079, Lublin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Państwowy Instytut Badawczy, Oddział w Gliwicach (Endocrinology), Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Wojewodzki Szpital Specjalistyczny W Olsztynie
Klnika Endokrynologii, Diabetologii i Chorób Wewnętrznych (Endocrinology), Ul. Zolnierska 18, 10-561, Olsztyn
University Hospital Bratislava
Klinika oftalmológie LFUK a UNB (Ophtalmology), Ruzinovska 6, Ruzinov, Bratislava
Univerzitna nemocnica Nemocnica svaeteho Michala a.s.
Oftalmolgická ambulancia (Ophtalmology), Satinskeho 7770/1, 811 08, Stare Mesto
Fakultna Nemocnica Trencín
Očná klinika (Ophtalmology), Legionarska 28, 911 01, Trencin
University Hospital Bratislava
Očná Klinika SZU a UNB (Ophtalmology), Antolska 11, Petrzalka, Bratislava
Complexo Hospitalario Universitario De Santiago
Ophthalmology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Virgen De La Macarena
Ophthalmology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Clinica Arc Clinic
Ophthalmology, Balmes 323, 08006, Barcelona
Hospital General Universitario Gregorio Maranon
Ophthalmology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Instituto De Microcirugia Ocular Dos S.L.
Ophthalmology, Calle De Josep Maria Llado 3, 08017, Barcelona
Hospital Universitario Y Politecnico La Fe
Ophthalmology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Ramon Y Cajal
Ophthalmology, 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 |
|---|---|---|---|---|---|
| Belgium | 2023-12-13 | 2023-12-13 | 2025-10-13 | ||
| Hungary | 2024-01-23 | 2025-10-06 | 2024-01-23 | 2025-04-08 | |
| Italy | 2024-07-04 | 2024-09-11 | 2025-10-29 | ||
| Latvia | 2024-03-18 | 2024-03-18 | 2025-12-10 | ||
| Poland | 2024-10-15 | 2024-10-22 | 2025-10-27 | ||
| Slovakia | 2024-06-12 | 2024-06-12 | 2026-01-30 | ||
| Spain | 2024-01-02 | 2026-02-05 | 2024-01-02 | 2025-07-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 100 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-512650-21-00_Redacted | 2.1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_EQ-5D-5L_BE-FR_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_EQ-5D-5L_BE-NL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_EQ-5D-5L_EN_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_EQ-5D-5L_ES_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_EQ-5D-5L_HU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_EQ-5D-5L_IT_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_EQ-5D-5L_LV_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_EQ-5D-5L_PL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_EQ-5D-5L_RU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_EQ-5D-5L_SK_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_GO-QOL_BE-FR_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_GO-QOL_BE-NL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_GO-QOL_EN_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_GO-QOL_ES_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_GO-QOL_HU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_GO-QOL_IT_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_GO-QOL_LV_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_GO-QOL_PL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_GO-QOL_RU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_GO-QOL_SK_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_SATMED-Q_BE-FR_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_SATMED-Q_BE-NL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_SATMED-Q_EN_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_SATMED-Q_ES_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_SATMED-Q_HU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_SATMED-Q_IT_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_SATMED-Q_LV_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_SATMED-Q_PL_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_SATMED-Q_RU_redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_SATMED-Q_SK_redacted | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_Recruitment of Subjects | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Selection Procedures | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flowchart_BE-FR_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flowchart_BE-NL_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flowchart_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flowchart_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flowchart_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flowchart_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flowchart_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flowchat_LV_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flowchat_RU_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Resource Guide | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Resource Guide_BE-FR_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Resource Guide_BE-NL_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Resource Guide_LV_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Resource Guide_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Resource Guide_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Resource Guide_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Resource Guide_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Resource Guide_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Participant Resource Guide_RU_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Observational cohort_FR_Redacted | 5.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Observational cohort_LV_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Observational cohort_NL_Redacted | 5.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Observational cohort_Redacted | 5.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Observational cohort_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Observational cohort_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Observational cohort_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Observational cohort_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Observational cohort_RU_Redacted | 5.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Treatment cohort_FR_Redacted | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Treatment cohort_LV_Redacted | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Treatment cohort_NL_Redacted | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Treatment cohort_Redacted | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Treatment cohort_Redacted | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Treatment cohort_Redacted | 6.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Treatment cohort_Redacted | 6.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Treatment cohort_Redacted | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Treatment cohort_RU_Redacted | 6.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy and birth_Redacted | 1.2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_FR_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_LV_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_NL_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_Redacted | 1.3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_RU_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy Notice | 1.3.0 |
| Subject information and informed consent form (for publication) | L2_Packaging instructions_Isothermal Cooler Bag 1_2L | 2 |
| Subject information and informed consent form (for publication) | L2_Packaging instructions_Isothermal Cooler Bag 3_6L | 2 |
| Subject information and informed consent form (for publication) | L2_Packaging instructions_Isothermal Cooler Bag PDS | N/A |
| Subject information and informed consent form (for publication) | L2_Patient_Card | 2.2.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Dosing_Compliance_Worksheet_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Patients_Instructions_For_Use_redacted | 2.1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-DE_2024-512650-21-00_redacted | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR_2024-512650-21-00_redacted | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL_2024-512650-21-00_redacted | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2024-512650-21-00_redacted | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU_2024-512650-21-00_redacted | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2024-512650-21-00_redacted | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2024-512650-21-00_redacted | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SK_2024-512650-21-00_redacted | 2.1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Belgium | Acceptable with conditions 2024-07-15
|
2024-07-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-20 | Belgium | Acceptable 2025-04-07
|
2025-04-08 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-29 | Acceptable 2025-04-07
|
2025-08-29 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-29 | Belgium | Acceptable | 2025-10-08 |