Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
501
Countries
10
Sites
55
Locally Advanced Head & Neck Squamous Cell Carcinoma
To evaluate survival outcomes in subjects treated with intratumorally injected JNJ- 90301900 (NBTXR3) activated by Investigator’s choice of radiotherapy (RT) alone or RT in combination with cetuximab in comparison to Investigator’s choice alone hereafter referred to as JNJ-90301900 (NBTXR3) /RT±cetuximab versus RT±cetu…
Key facts
- Sponsor
- Johnson & Johnson Enterprise Innovation Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Sep 2025 → ongoing
- Decision date (initial)
- 2025-06-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Johnson & Johnson Enterprise Innovation, Inc
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Pharmacokinetic, Safety
To evaluate survival outcomes in subjects treated with intratumorally injected JNJ- 90301900 (NBTXR3) activated by Investigator’s choice of radiotherapy (RT) alone or RT in combination with cetuximab in comparison to Investigator’s choice alone hereafter referred to as JNJ-90301900 (NBTXR3) /RT±cetuximab versus RT±cetuximab
Conditions and MedDRA coding
Locally Advanced Head & Neck Squamous Cell Carcinoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10067821 | Head and neck cancer | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-513082-39-00 | A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy ineligible Elderly Patients with Locally Advanced Head & Neck Squamous Cell Carcinoma | Nanobiotix |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Age ≥ 60 years old
- 2. Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab
- 3. Clinical stage T3-4 NX or T2 N2-3 disease according to the 8th edition of AJCC
- 4. One primary tumor lesion amendable for intratumoral injection
- "5. Ineligible to receive platinum-based chemotherapy with radiation: a. Estimated creatinine clearance ≥30 and <50 mL/min (per Cockcroft-Gault equation), Grade ≥2 hearing loss or tinnitus, Grade ≥2 peripheral neuropathy, ECOG Performance Status 2, New York Heart Association Class 3 b. Age 70-74 years old with Geriatric 8 (G8) score ≤ 14 c. Age ≥ 75 years old"
Exclusion criteria 6
- 1. Carcinoma of the nasopharynx, paranasal sinus(es), salivary gland, thyroid gland, or unknown primary
- 2. Non-squamous cell histology
- 3. Clinical stage T1-2 N0, T2 N1, or M1 disease according to the 8th edition of AJCC
- 4. Loco-regionally recurrent head & neck cancer that has been previously treated with surgery, radiation therapy, and/or chemotherapy
- 5. Prior or concurrent primary malignancy (including second synchronous head & neck cancer) within the last 2 years of informed consent and whose natural history has the potential to interfere with the safety and efficacy assessment of the investigational agent
- 6. Ongoing or active infection requiring treatment with antimicrobial therapy within 2 weeks of randomization
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-free survival (PFS): time from randomization to loco-regional recurrence, loco-regional progression, distant progression, or death from any cause, whichever occurs first
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11423703 · Product
- Active substance
- Hafnium Oxide
- Substance synonyms
- NBTXR3
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRATUMORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 999 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
Erbitux 5 mg/mL solution for infusion
PRD327539 · Product
- Active substance
- Cetuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/m2 milligram(s)/square meter
- Max total dose
- 0 mg/m2 milligram(s)/square meter
- Max treatment duration
- 999 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FE01 — -
- Marketing authorisation
- EU/1/04/281/003
- MA holder
- MERCK EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Johnson & Johnson Enterprise Innovation Inc.
- Sponsor organisation
- Johnson & Johnson Enterprise Innovation Inc.
- Address
- 1 Johnson And Johnson Plaza
- City
- New Brunswick
- Postcode
- 08933-0001
- Country
- United States
Scientific contact point
- Organisation
- Johnson & Johnson Enterprise Innovation Inc.
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Johnson & Johnson Enterprise Innovation Inc.
- Contact name
- CTIS Point of Contact
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Cerba Research ORG-100042694
|
Gent, Belgium | Laboratory analysis |
| Icon Clinical Research LLC ORG-100039864
|
Rochester, United States | Other |
| Medidata Solutions International Limited ORG-100048319
|
London, United Kingdom | Interactive response technologies (IRT), E-data capture |
| Quipment ORG-100043496
|
Nancy, France | Other |
| Imaging Endpoints II LLC ORG-100045399
|
Scottsdale, United States | Other |
| Creapharm Clinical Supplies ORG-100020131
|
Le Haillan, France | Code 14 |
| Quality Assistance ORG-100011766
|
Thuin, Belgium | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Data management |
| Fortrea Inc. ORG-100012602
|
Durham, United States | Code 8 |
| Aquilab By Coexya ORG-100052641
|
Loos, France | Other |
| Clinical Services International LLC ORG-100052522
|
Horsham, United States | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
Locations
10 EU/EEA countries · 55 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 18 | 3 |
| Belgium | Ongoing, recruiting | 10 | 3 |
| Czechia | Ongoing, recruitment ended | 1 | 1 |
| France | Ongoing, recruiting | 65 | 17 |
| Germany | Ongoing, recruiting | 15 | 7 |
| Greece | Ongoing, recruiting | 15 | 3 |
| Hungary | Ongoing, recruiting | 20 | 3 |
| Portugal | Ongoing, recruiting | 10 | 2 |
| Romania | Ongoing, recruiting | 10 | 1 |
| Spain | Ongoing, recruiting | 30 | 15 |
| Rest of world
Philippines, United Kingdom, Canada, India, Japan, China, Brazil, Taiwan, United States, Israel, Georgia, Korea, Republic of
|
— | 307 | — |
Investigational sites
University Hospital Graz
Clinical Department of General ENT (Klinische Abteilung für Allgemeine HNO), Auenbruggerplatz 52, 8036, Graz
Ordensklinikum Linz GmbH
Department of ENT, head and neck surgery (HNO, Kopf- und Halschirurgie), Seilerstaette 4, 4010, Linz
Medical University Of Vienna
Clinical Department of Oncology (“Klinische Abteilung für Onkologie”), Waehringer Guertel 18-20, Alsergrund, Vienna
Cliniques Universitaires Saint-Luc
Cancer et Hématologie adulte et pédiatrique, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Leuven
Radiotherapy-Oncology, Herestraat 49, 3000, Leuven
Grand Hopital De Charleroi
Service d’Oncologie-Hématologie, Rue Du Campus Des Viviers 1, 6060, Charleroi
Assistance Publique Hopitaux De Paris
ENT (Ear, Nose, and Throat) and Head and Neck Surgery Department, 20 Rue Leblanc, 75908, Paris Cedex 15
Centre Hospitalier Universitaire De Saint Etienne
Radiology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Henri Becquerel
Radiotherapy, Rue D Amiens, 76038, Rouen Cedex
Oncopole Claudius Regaud
Radiation oncology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut De Cancerologie De Lorraine
Oncology-Radiotherapy, 6 Avenue De Bourgogne, Cs 30519, Vandoeuvre Les Nancy Cedex
Hopital Tenon
Oncology Radiotherapy, 4 Rue De La Chine, 75970, Paris Cedex 20
Centre Francois Baclesse
Radiation Oncology, 3 Avenue Du General Harris, Cs 45026, Caen Cedex 5
Centre Medico Chirurgical Ambroise Pare Hartmann
Radiation Oncology, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Centre Hospitalier Universitaire Amiens Picardie
Medical oncology and radiotherapy department, 30 Avenue De La Croix Jourdain, 80054, Amiens Cedex 1
Centre Hospitalier Regional De Marseille
Medical Oncology, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Regional Et Universitaire De Brest
Radiotherapy, Boulevard Tanguy Prigent, 29200, Brest
Institut Curie
ENT and cervico facial surgery, 26 Rue D Ulm, 75005, Paris
Centre Oscar Lambret
Radiotherapy, 3 Rue Frederic Combemale, 59000, Lille
Centre Hospitalier Universitaire De Bordeaux
Radiotherapy, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Rennes
ENT and cervical facial surgery department, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Centr Georges Francois Leclerc
Radiotherapy, 1 Rue Professeur Marion, 21000, Dijon
Institut Gustave Roussy
Radiotherapy, 114 Rue Edouard Vaillant, 94800, Villejuif
Universitaetsklinikum Mannheim GmbH
Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie (HNO), Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Medizinische Hochschule Hannover
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Jena KöR
Department of Ear, Nose and Throat Medicine (“Klinik für Hals-, Nasen- und Ohrenheilkunde”), Am Klinikum 1, Lobeda, Jena
Rostock University Medical Center
Clinic and Polyclinic for Radiation Therapy (“Klinik und Poliklinik für Strahlentherapie”), Nr. 05, Suedring 75, Rostock
University Hospital Cologne AöR
Department of Othorinolaryngology, Head and Neck Surgery, Kerpener Strasse 62, Lindenthal, Cologne
Justus-Liebig-Universitaet Giessen
Ear, nose and throat clinic (“Hals- Nasen- und Ohrenklinik”), Klinikstrasse 33, 35392, Giessen
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department of Radiation Oncology, Ismaninger Strasse 22, Au-Haidhausen, Munich
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
University General Hospital Attikon
Internal Medicine Clinic / Oncology Unit, Rimini Street 1, 124 62, Athens
General University Hospital Of Larissa
Oncology Department / 1st Internal Medicine Division, P. O. Box 1425, 411 10, Larissa
Central Hospital Of Northern Pest Military Hospital
Fül-Orr-Gége, Fej- és Nyaksebészeti Osztály, Podmaniczky Utca 109, 1062, Budapest VI
University Of Szeged
Szent-György Albert Klinikai Központ Onkoterápiás Klinika), Koranyi Fasor 12, 6720, Szeged
Orszagos Onkologiai Intezet
Sugárterápiás Központ, Sugárterápiás Osztály, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Hospital Cuf Descobertas S.A.
Oncology, Rua Mario Botas 1, 1998-018, Lisbon
Unidade Local De Saude De Gaia/Espinho E.P.E.
Medical oncology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Radiotherapy Department II, Soseaua Fundeni 252, 022328, Bucharest
Hospital Universitario Regional De Malaga
Radiation oncology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital General Universitario De Valencia
Medical Oncology, Avenida Del Tres Cruces 2, 46014, Valencia
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Marques De Valdecilla
Medical Oncology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario De Cruces
Radiotherapeutic Oncology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Clinico Universitario Lozano Blesa
Medical Oncology, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
Medical Oncology, Avenida De Cordoba Sn, 28041, Madrid
Fundacion Instituto Valenciano De Oncologia
Medical Oncology, Calle De Gregorio Gea 3 1 A Planta, 46009, Valencia
Hospital Universitario Lucus Augusti
Radiation Oncology, Rua Dr. Ulises Romero 1, 27003, Lugo
Hospital General Universitario Gregorio Maranon
Oral and Maxillofacial Surgery, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Hm Sanchinarro
Head and Neck and Cancer, Gastrointestinal Cancer Unit, Calle Ona 10, 28050, Madrid
Hospital Clinic De Barcelona
Medical Oncology, Head and Neck and Tyroid Unit, Calle Villarroel 170, 08036, Barcelona
Institut Catala D'oncologia
Radiation Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Radiation Oncology, Passeig De La Vall D'Hebron 119-129, 08035, 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 |
|---|---|---|---|---|---|
| Austria | 2025-09-22 | 2025-09-22 | |||
| Belgium | 2025-09-22 | 2025-09-22 | |||
| Czechia | 2026-01-21 | 2026-01-21 | 2026-01-21 | ||
| France | 2025-09-22 | 2025-09-22 | |||
| Germany | 2025-09-22 | 2025-09-22 | |||
| Greece | 2025-09-22 | 2025-09-22 | |||
| Hungary | 2025-09-22 | 2025-09-22 | |||
| Portugal | 2025-09-22 | 2025-09-22 | |||
| Romania | 2025-09-22 | 2025-09-22 | |||
| Spain | 2025-09-22 | 2025-09-22 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Urgent safety measures 1 · Art. 54 CTR
Urgent safety measure US-124965
- Event date
- 2026-03-19
- Submission date
- 2026-03-24
- In response to
- OTHER
- Member states affected
- Austria, Belgium, France, Germany, Greece, Hungary, Portugal, Romania, Spain, Czechia
- Event description
- Following a review by the Independent Data Monitoring Committee (IDMC) on 18 March 2026, the IDMC identified an imbalance between treatment arms within the ECOG Performance Status 2 subgroup and that these patients were associated with a higher number of early deaths.
- Measures taken
- The IDMC recommended to continue the study with a modification to exclude future patients with an ECOG Performance Status of 2 from enrollment. The Sponsor agrees with the IDMC recommendation and decided to implement an USM for Study NANORAY-312 on 19 March 2026. As part of this USM, a Dear Investigator Letter is being sent to investigators for NANORAY-312, dated 20 March 2026, and a copy of this letter is being provided as an attachment to this submission.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 127 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | REDACTED_D1_Protocol_2024-520386-31 | Am6 |
| Protocol (for publication) | REDACTED_D4_PF_EORTC QLQ-HN35_multicountry_multilingual_2024-520386-31 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_EQ-5D-5L_multicountry_multilingual_2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arr_DE_ENG_2024-520386-31-00 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_AT_eng_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_BE_Eng_2024-520-386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_CZ_cze_2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_ES_ENG_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_FR_fre_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_GR_eng_2024-520386-31-00 | 2.1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_PT_ENG_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_RO_ENG_2024-520386-31 | 3 |
| Recruitment arrangements (for publication) | REDACTED_K2_Rec Mat_Caregiver Brochure__DE_GER-2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Rec Mat_Participant Trial Overview_DE_GER-2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Caregiver Brochure_AT_ger_2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Caregiver Brochure_BE_Dut_2024-520-386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Caregiver Brochure_BE_Fre_2024-520-386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Caregiver Brochure_ES_SPA_2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Caregiver Brochure_HU_HUN_ 2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Caregiver Brochure_RO_RUM_2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Flip Chart_BE_Dut_2024-520-386-31 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Flip Chart_BE_Fre_2024-520-386-31 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material ICF Guide Flipchart_RO_RUM_2024-520386-31 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Participant Clin Trial Overview_HU_HUN_ 2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Participant ClinTrial Overview_BE_Dut_2024-520-386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Participant ClinTrial Overview_BE_Fre_2024-520-386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Participant ClinTrial Overview_RO_RUM_2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Participant CT Overview_ES_SPA_2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Participant Trial Overview_AT_ger_2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Patient Brochure_BE_Dut_2024-520-386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Patient Brochure_BE_Fre_2024-520-386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Brochure_RO_RUM_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Patient Letter_BE_Dut_2024-520-386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Patient Letter_BE_Fre_2024-520-386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Patient Letter_PT_ENG_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Patient Letter_PT_POR_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Letter_RO_RUM_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material Patient Poster_RO_RUM_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Study Poster_BE_Dut_2024-520-386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material Study Poster_BE_Fre_2024-520-386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Caregiver Brochure_FR_fre_2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Caregiver Brochure_PT_POR_2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_Caregiver_Brochure_GR_gre_2024-520386-31-00 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Flipchart_ES_SPA_2024-520386-31 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_ICF Flipchart_AT_ger_2024-520386-31 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_ICF Flipchart_FR_fre_2024-520386-31 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_ICF Flipchart_GR_gre_2024-520386-31-00 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_ICF Flipchart_HU_HUN_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_ICF-Flipchart_DE_GER-2024-520386-31-00 | 4 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Participant Trial overview_FR_fre_2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Participant Trial overview_PT_POR_2024-520386-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_Participant_Trial_Overview_GR_gre_2024-520386-31-00 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_Patient Brochure__DE_GER-2024-520386-31-00 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_Patient Brochure_AT_ger_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Patient Brochure_ES_SPA_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Patient Brochure_FR_fre_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_Patient Brochure_GR_gre_2024-520386-31-00 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Patient Brochure_HU_HUN_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_Patient Letter__DE_GER-2024-520386-31-00 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_Patient Letter_AT_ger_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Patient Letter_ES_SPA_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Patient Letter_FR_fre_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_Patient Letter_GR_gre_2024-520386-31-00 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Patient Letter_HU_HUN_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_Study Poster__DE_GER-2024-520386-31-00 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_Study Poster_AT_ger_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Study Poster_ES_SPA_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Study Poster_FR_fre_2024-520386-31 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment Material_Study Poster_GR_gre_2024-520386-31-00 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K2_Recruitment material_Study Poster_HU_HUN_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_CZ_cze_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_ES_SPA_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main _HU_HUN_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main 3000005_GR_GRE_2024-520386-31-00 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Dut_2024-520-386-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Fre_2024-520-386-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_GR_gre_2024-520386-31-00 | 1.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_BE_Dut_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_BE_Fre_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy_ES_SPA_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner _HU_HUN_2024-520386-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant_Partner_GR_gre_2024-520386-31-00 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy data_CZ_cze_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_CZ_cze_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_SPA_2024-520386-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_GR_gre_2024-520386-31-00 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_HU_HUN_2024-520386-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PT_POR_2024-520386-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Clinical ICF_RO_RUM_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_main ICF_AT_ger_2024-520386-31 | 4.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_FR_fre_2024-520386-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_POR_PT_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_PT_ENG_2024-520386-31 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_Site 25000017_Haut Leveque_FR_fre_2024-520386-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_Site 2500006_La Timone_FR_fre_2024-520386-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_Site 2500015_CHU Brest_FR_fre_2024-520386-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_Site 2500020_Hopital Pontchaillou_FR_fre_2024-520386-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnancy ICF_AT_ger_2024-520386-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnancy ICF_RO_RUM_2024-520386-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnancy_FR_fre_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_PT_POR_2024-520386-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_site contact details for ICF_AT_ger_2024-520386-31 | 1.3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal ICF_RO_RUM_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal_FR_fre_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS-ICF_Main_DE-GER_2024-520386-31-00 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS-ICF_Pregnancy_DE-GER_2024-520386-31-00 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS-ICF_Withdrawal_DE-GER_2024-520386-31-00 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_AT_ger_2024-520386-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_CZ_cze_2024-520386-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_ES_SPA_2024-520386-31 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_fre_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_GR_gre_2024-520386-31-00 | 1.1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_HU_HUN_2024-520386-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PT_POR_2024-520386-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_RO_RUM_2024-520386-31 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Glucose | 1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_AT_ger_2024-520386-31 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Dut_2024-520386-31 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Fre_2024-520386-31 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Ger_2024-520386-31 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_CZ_cze_2024-520386-31 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_SPA_2024-520386-31 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_FR_fre_2024-520386-31 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_GR_Gre_2024-520386-31 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_HU_HUN_2024-520386-31 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PT_POR_2024-520386-31 | Am6 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_RO_RUM_2024-520386-31 | Am6 |
Application history
18 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-05 | Austria | Acceptable 2025-06-23
|
2025-06-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-23 | Austria | Acceptable | 2025-09-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-23 | Acceptable | 2025-09-15 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-23 | Acceptable | 2025-08-08 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-23 | Acceptable | 2025-08-07 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-23 | Acceptable | 2025-10-20 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-23 | Acceptable | 2025-08-28 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-23 | Acceptable | 2025-08-22 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-07-23 | Acceptable | 2025-09-08 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-07-23 | Acceptable | 2025-08-07 | |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2025-09-22 | 2025-12-22 | ||
| 12 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-11-24 | Acceptable | 2025-12-04 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-12-04 | Austria | Acceptable | 2026-01-30 |
| 14 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-12-09 | Acceptable | 2026-01-12 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-14 | 2026-01-22 | Acceptable | 2026-03-10 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-13 | 2026-01-26 | Acceptable | 2026-02-19 | |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-13 | Austria | Acceptable | 2026-03-13 |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-13 | Austria | Acceptable | 2026-03-13 |