Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
44
Countries
5
Sites
6
Type 1 Diabetes Mellitus with Impaired Hypoglycemic Awareness and Severe Hypoglycemia
Evaluate the efficacy of VX-880 infusion in subjects who have T1D with impaired hypoglycemic awareness (IAH) and severe hypoglycemia
Key facts
- Sponsor
- Vertex Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 26 May 2023 → ongoing
- Decision date (initial)
- 2024-10-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513929-23-00
- EudraCT number
- 2022-002292-11
- ClinicalTrials.gov
- NCT04786262
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy
Evaluate the efficacy of VX-880 infusion in subjects who have T1D with impaired hypoglycemic awareness (IAH) and severe hypoglycemia
Secondary objectives 2
- Evaluate the efficacy of VX-880 infusion on metabolic control
- Evaluate the safety and tolerability of VX-880 infusion in subjects who have T1D with IAH and severe hypoglycemia
Conditions and MedDRA coding
Type 1 Diabetes Mellitus with Impaired Hypoglycemic Awareness and Severe Hypoglycemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10081605 | Severe hypoglycemia | 10027433 |
| 20.0 | PT | 10012601 | Diabetes mellitus | 100000004861 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase 1/2 Study Phase 1/2 Study
|
2 | None |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-002292-11 | A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia, Studio di fase 1/2 per valutare la sicurezza, la tollerabilità e l’efficacia di VX-880 in soggetti affetti da diabete mellito di tipo 1 con alterata sensibilità all’ipoglicemia e ipoglicemia grave |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Clinical history and laboratory evidence of T1D
- At least 2 episodes of severe hypoglycemia (confirmed by independent adjudication for subjects in Parts B and C) in the 12 months prior to signing of informed consent at Screening.
- Reduced awareness of hypoglycemia at Screening
- Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening. In regions where CGM is not standard of care for T1D, subjects are exempted from the requirement for use of CGM before Screening.
- Compatible blood group (A or AB)
Exclusion criteria 5
- Prior islet cell transplant, organ transplant, or cell therapy
- Advanced complications associated with diabetes including untreated proliferative retinopathy, skin ulcers, or amputations attributable to diabetes.
- Subjects who have any 1 of the following criteria: o Insulin requirements: >0.8 U/(kg*day), >55 U/day, or <10 U/day; o HbA1c: <6.0% or >9.5%
- Clinically significant active infection or chronic infection such as hepatitis B, hepatitis C, human immunodeficiency virus (HIV), and/or tuberculosis (TB); or invasive aspergillus, histoplasmosis, or coccidioidomycosis infection within 1 year prior to signing of informed consent at Screening.
- Negative screen for Epstein-Barr virus (EBV) by immunoglobulin G (IgG) determination
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Part A - Safety and tolerability based on treatment-emergent adverse events (TEAEs; including incidence and severity of adverse events [AEs] and serious adverse events [SAEs]), clinical laboratory values, vital signs, standard 12-lead ECGs, and imaging findings
- Part B and C - The following endpoints apply to the analysis of all infused subjects who intended to receive 0.8 × 10E9 total SC-islet cells with 1 infusion: •Proportion of subjects who are insulin independent at Day 365 after VX-880 infusion
Secondary endpoints 5
- Part B and C: Secondary Endpoints - Proportion of subjects free of SHEs from Day 90 through Day 365 (inclusive) and HbA1c <7.0% at Day 365 after VX 880 infusion
- Part B and C: Secondary Endpoints - Change from baseline in HbA1c at Day 365 after VX-880 infusion
- Part B and C: Secondary Endpoints- Proportion of subjects who achieve insulin independence and are insulin independent 12 months later, with absence of SHEs
- Part B and C: Secondary Endpoints- Proportion of subjects who maintain insulin independence for at least 1 year
- Part B and C: afety and tolerability based on TEAEs (including incidence and severity of AEs and SAEs), clinical laboratory values, vital signs, standard 12-lead ECGs, and imaging findings
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD8501686 · Product
- Active substance
- Zimislecel
- Substance synonyms
- VX-880, Allogeneic human stem cell-derived fully differentiated pancreatic islet cells, STx-02
- Other product name
- zimislecel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAPORTAL USE
- Max daily dose
- 8000000000 Other
- Max total dose
- 8000000000 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- VERTEX PHARMACEUTICALS, INCORPORATED
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vertex Pharmaceuticals Inc.
- Sponsor organisation
- Vertex Pharmaceuticals Inc.
- Address
- 50 Northern Avenue
- City
- Boston
- Postcode
- 02210-1862
- Country
- United States
Scientific contact point
- Organisation
- Vertex Pharmaceuticals Inc.
- Contact name
- Clinical Trials and Medical Info
Public contact point
- Organisation
- Vertex Pharmaceuticals Inc.
- Contact name
- Clinical Trials and Medical Info
Locations
5 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 1 | 2 |
| Germany | Ongoing, recruiting | 1 | 1 |
| Italy | Ongoing, recruiting | 1 | 1 |
| Netherlands | Ongoing, recruiting | 1 | 1 |
| Norway | Ongoing, recruiting | 4 | 1 |
| Rest of world
United States, Canada, United Kingdom, Switzerland
|
— | 36 | — |
Investigational sites
Les Hopitaux Universitaires De Strasbourg
Service Endocrinologie-Diabète-Nutrition, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Lille
Sce Chir Generale & Endocrinienne, Rue Michel Polonovski, 59037, Lille Cedex
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medizinische Klinik und Poliklinik III/Klinik und Poliklinik f. Viszeral-,Thorax- und Gefäßchirurgie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Ospedale San Raffaele S.r.l.
Department of Regenerative Medicine and Transplantation, Via Olgettina 60, 20132, Milan
Leiden University Medical Center
Leiden University Medical Centre, Albinusdreef 2, 2333 ZA, Leiden
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 |
|---|---|---|---|---|---|
| France | 2023-07-31 | 2023-10-30 | |||
| Germany | 2023-08-18 | 2023-10-17 | |||
| Italy | 2023-09-15 | 2023-09-18 | |||
| Netherlands | 2023-05-26 | 2023-07-26 | |||
| Norway | 2023-06-21 | 2024-06-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 128 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol _2024-513929-23-00_ Redacted | 11.9 |
| Recruitment arrangements (for publication) | K1_Addtional document_FR_Fr_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR_Fr | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Germany_English | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Italy_English | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Netherlands_English | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Norway_English | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_HCP Flyer_FR_En | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_HCP Flyer_Germany_English | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_HCP Flyer_Italy_English | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_HCP Slide Deck_FR_Fr_redacted | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_HCP Slide Deck_Germany_English_redacted | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_HCP Slide Deck_Italy_English_redacted | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_HCP Websites_FR_Fr | NA |
| Recruitment arrangements (for publication) | K2_Recruitment Material_HCP Websites_Germany_English | NA |
| Recruitment arrangements (for publication) | K2_Recruitment Material_HCP Websites_Italy_English | NA |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Facebook Advertisements_FR_Fr | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Facebook Advertisements_Germany_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Facebook Advertisements_Italy_Italian | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Facebook Advertisements_Netherlands_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Facebook Advertisements_Norway_Norwegian | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Google Advertisements_FR_Fr | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Google Advertisements_Germany_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Google Advertisements_Italy_Italian | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Google Advertisements_Netherlands_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Google Advertisements_Norway_Norwegian | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Landing Page Copy_FR_Fr | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Landing Page Copy_Germany_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Landing Page Copy_Italy_Italian | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Landing Page Copy_Netherlands_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Landing Page Copy_Norway_Norwegian | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Landing Page Screenshots_FR_Fr | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Landing Page Screenshots_Germany_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Landing Page Screenshots_Italy_Italian | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Landing Page Screenshots_Netherlands_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Landing Page Screenshots_Norway_Norwegian | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Patient Navigator Scripts_FR_Fr | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Patient Navigator Scripts_Germany_German | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Patient Navigator Scripts_Italy_Italian | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Patient Navigator Scripts_Netherlands_Dutch | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_MyTomorrows Patient Navigator Scripts_Norway_Norwegian | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Invitation to Trial Letter_FR_Fr | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Invitation to Trial Letter_Germany_German | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Invitation to Trial Letter_Italy_Italian | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Invitation to Trial Letter_Netherlands_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Invitation to Trial Letter_Norway_Norwegian | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Patient Invitation to Trial Letter_Norway_Norwegian_Superseded | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_PI to Physician Letter_FR_Fr | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_PI to Physician Letter_Germany_German | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_PI to Physician Letter_Italy_Italian | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_PI to Physician Letter_Netherlands_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_Study Specific_FR_Fr | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_Study Specific_Germany_German | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_Study Specific_Italy_Italian | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_Study Specific_Netherlands_Dutch | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_Study Specific_Norway_Norwegian | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_T1D Specific_Germany_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_T1D Specific_Italy_Italian | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_T1D_Netherlands_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Press Release Text_FR_Fr | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Press Release Text_Germany_German | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Press Release Text_Italy_Italian | NA |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Press Release Text_Netherlands_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Press Release Text_Norway_Norwegian_approved under CTD | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Press Release Text_Study Specific_FR_Fr | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Press Release Text_Study Specific_Germany_German | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Press Release Text_Study Specific_Italy_Italian | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Press Release Text_Study Specific_Netherlands_Dutch | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Press Release Text_Study Specific_Norway_Norwegian | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Press Release Text_Study Specific_Norway_Norwegian_Superseded | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Brochure_FR_Fr | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Brochure_Germany_German | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Brochure_Italy_Italian | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Brochure_Netherlands_Dutch | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Brochure_Norway_Norwegian | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Flyer_FR_Fr | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Flyer_Germany_German | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Flyer_Italy_Italian | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Flyer_Netherlands_Dutch | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Recruitment Flyer_Norway_Norwegian | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult Appendix A_Germany_German | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult Appendix_Norway_Norwegian | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult Part C_Netherlands_Dutch_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult Privacy_FR_Fr_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult Privacy_Italy_Italian_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_FR_Fr_redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_Germany_German_redacted | 10.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_Italy_Italian_redacted | 9.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_Norway_Norwegian_Redacted | 9.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_Norway_Norwegian_Superseded_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_FR_Fr_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_Germany_German_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_Italy_Italian_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_Netherlands_Dutch_redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_Norway_Norwegian_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-Screening_Privacy_Italy_Italian_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Adult ICF_FR_Fr | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_Germany_German | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_Italy_Italian | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_Netherlands_Dutch | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_Norway_Norwegian_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_Privacy_Italy_Italian | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Suvoda_Germany_German | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Suvoda_Netherlands_Dutch | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Suvoda_Norway_Norwegian | 3.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_Italy_Italian | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ICF tool_FR_Fr | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ICF tool_Germany_German | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ICF tool_Italy_Italian | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ICF tool_Netherlands_Dutch | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ICF tool_Norway_Norwegian | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Fact Sheet_FR_Fr | 5.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Fact Sheet_Germany_German | 5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Fact Sheet_Italy_Italian | 5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Fact Sheet_Netherlands_Dutch | 5.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Fact Sheet_Norway_Norwegian | 5 |
| Synopsis of the Protocol - Extract (for publication) | D1_Protocol lay summary DE 2024-513929-23-00 | 11.9 |
| Synopsis of the Protocol - Extract (for publication) | D1_Protocol lay summary ENG 2024-513929-23-00 | 11.9 |
| Synopsis of the Protocol - Extract (for publication) | D1_Protocol lay summary FR 2024-513929-23-00 | 11.9 |
| Synopsis of the Protocol - Extract (for publication) | D1_Protocol lay summary IT 2024-513929-23-00 | 11.9 |
| Synopsis of the Protocol - Extract (for publication) | D1_Protocol lay summary NL 2024-513929-23-00 | 11.9 |
| Synopsis of the Protocol - Extract (for publication) | D1_Protocol lay summary NO 2024-513929-23-00 | 11.9 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ENG 2024-513929-23-00_Redacted | 11.9 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis DE 2024-513929-23-00_Redacted | 11.9 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis FR 2024-513929-23-00_Redacted | 11.9 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis IT 2024-513929-23-00_Redacted | 11.9 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis NL 2024-513929-23-00_Redacted | 11.9 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis NO 2024-513929-23-00_Redacted | 11.9 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-05 | Netherlands | Acceptable with conditions 2024-10-02
|
2024-10-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-11 | Netherlands | Acceptable 2025-04-04
|
2025-04-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-16 | Netherlands | Acceptable 2025-09-17
|
2025-09-17 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-23 | Netherlands | Acceptable 2025-09-17
|
2025-09-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-24 | Acceptable | 2025-10-28 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-24 | Acceptable | 2025-10-01 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-25 | Netherlands | Acceptable | 2025-10-23 |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-25 | Acceptable | 2025-10-23 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-26 | Acceptable | 2025-11-12 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-09 | Netherlands | Acceptable 2026-04-21
|
2026-04-21 |