Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
874
Countries
8
Sites
51
Breast Cancer
To compare the PFS of imlunestrant (Arm A) to the standard comparator of Investigator’s Choice Endocrine Therapy of either fulvestrant or eemestane (Arm B) in the ITT population To compare the PFS of Arm A to Arm B in the ESR1-mutation detected population To compare the PFS of imlunestrant plus abemaciclib (Arm C) …
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Sep 2021 → ongoing
- Decision date (initial)
- 2024-04-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506786-63-00
- EudraCT number
- 2021-000079-35
- WHO UTN
- U1111-1300-7818
- ClinicalTrials.gov
- NCT04975308
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenetic, Therapy, Pharmacokinetic, Pharmacodynamic, Efficacy, Safety
To compare the PFS of imlunestrant (Arm A) to the standard comparator of Investigator’s Choice Endocrine Therapy of either fulvestrant or eemestane (Arm B) in the ITT population
To compare the PFS of Arm A to Arm B in the ESR1-mutation detected population
To compare the PFS of imlunestrant plus abemaciclib (Arm C) to imlunestrant (Arm A) in the ITT population
Conditions and MedDRA coding
Breast Cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Participants must have HR+ HER2- breast cancer
- Participants must have cancer that is advanced or has spread to another part of the body
- Participants must have already received a drug that blocks the production of estrogen
- Participants must have adequate body organ function
- Participants must be in fair to good health
- Participants must be able to swallow capsules/tablets
Exclusion criteria 3
- Participants must not have received chemotherapy or some targeted therapies for advanced breast cancer
- Participants must not have cancer that has spread to the brain that has not been treated or is causing symptoms
- Participants must not have another serious medical condition
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Investigator-assessed PFS (between Arm A and Arm B) in the ITT population
- Investigator-assessed PFS (between Arm A and Arm B) in the ESR1-mutation detected population
- Investigator-assessed PFS(between Arm C and Arm A) in the ITT population
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD8876765 · Product
- Active substance
- LY3484356
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
SCP31805452 · ATC
- Active substance
- Abemaciclib
- Substance synonyms
- LY2835219
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XE50 — ABEMACICLIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Different primary packaging (bottles) than in marketing authorisation and clinical trial specific packaging and labeling.
Comparator 2
SCP15544179 · ATC
- Active substance
- Fulvestrant
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BA03 — FULVESTRANT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP136386 · ATC
- Active substance
- Exemestane
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BG06 — EXEMESTANE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 15
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | Code 10 |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Macrostat (Shanghai) Clinical Research Co. Ltd. ORG-100048828
|
Shanghai, China | Code 10 |
| Techdata Service Company LLC ORG-100047422
|
Kng Of Prussa, United States | Code 10 |
| IQVIA Limited ORG-100008655
|
Livingston, United Kingdom | On site monitoring |
| Biotel Research LLC ORG-100039864
|
Rochester, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| Brightech International LLC ORL-000002985
|
Somerset, New Jersey, United States | Code 10 |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Laboratory analysis |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Data management |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifisia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
| Labcorp Development (Asia) Pte Ltd ORG-100050418
|
Singapore, Singapore | Laboratory analysis |
Locations
8 EU/EEA countries · 51 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 5 | 3 |
| Belgium | Ongoing, recruitment ended | 34 | 6 |
| France | Ongoing, recruitment ended | 67 | 9 |
| Germany | Ongoing, recruitment ended | 19 | 7 |
| Greece | Ongoing, recruitment ended | 29 | 6 |
| Italy | Ongoing, recruitment ended | 24 | 6 |
| Netherlands | Ended | 3 | 2 |
| Spain | Ongoing, recruitment ended | 82 | 12 |
| Rest of world
Japan, Argentina, Australia, Brazil, Mexico, China, India, Russian Federation, Ukraine, Korea, Republic of, United States, Turkey, Taiwan
|
— | 611 | — |
Investigational sites
Medical University Of Vienna
Department of Obstetrics and Gynecology, Division of General Gynecology and Gynecologic Oncology, Waehringer Guertel 18-20, Alsergrund, Vienna
Medical University of Graz
Department of Obstetrics and Gynecology, Auenbruggerplatz 14, 8036, Graz
SCRI CCCIT Ges.m.b.H.
Department of Internal Medicine III, Muellner Hauptstrasse 48, 5020, Salzburg
UZ Brussel
Oncology, Laarbeeklaan 101, 1090, Jette
Universitair Ziekenhuis Gent
Oncology, Corneel Heymanslaan 10, 9000, Gent
Institut Jules Bordet
Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Vitaz
Oncology, Moerlandstraat 1, 9100, Sint-Niklaas
Algemeen Ziekenhuis Groeninge
Oncology, President Kennedylaan 4, 8500, Kortrijk
UZ Leuven
Oncology, Herestraat 49, 3000, Leuven
Centre Hospitalier De La Cote Basque
Medical Oncology, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Polyclinique De Blois
Unité de Recherche Clinique La Cerisaie, 1 Rue Robert Debre, 41260, La Chaussee St Victor
Institut Curie
Medical Oncology, 26 Rue D Ulm, 75005, Paris
Centre De Cancerologue Du Grand Montpellier
Medical Oncology, 25 Rue De Clementville, 34070, Montpellier
Besancon University Hospital Center
Medical Oncology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Regional Lutte Contre Le Cancer
Medical Oncology, Batiment Icans, 17 Rue Albert Calmette, Strasbourg
Clinique Victor Hugo
Oncology-Radiotherapy, Centre De Cancerologie De La Sarthe, 64 Rue De Degre, Le Mans
Institut Curie
Medical Oncology, 35 Rue Dailly, 92210, Saint-Cloud
Institut De Cancerologie De Lorraine
Medical Oncology, 6 Avenue De Bourgogne, Cs 30519, Vandoeuvre Les Nancy Cedex
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Klinik für Geburtshilfe und Frauenheilkunde, Posilipostrasse 4, Mitte, Ludwigsburg
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Gynäkologie und Geburtshilfe, Studienzentrale, Arnold-Heller-Strasse 3, Brunswik, Kiel
Onkologiezentrum Donauwörth
N/A, Neudegger Allee 10, Bayern, Donauwörth
Universitaetsklinikum Erlangen AöR
Klinik für Gynäkologie und Geburtshilfe, Universitaetsstrasse 21-23, Innenstadt, Erlangen
Klinikum der Universitaet Muenchen AöR
Frauenklinik Brustzentrum, Ziemssenstrasse 1, Ludwigsvorstadt-Isarvorstadt, Munich
KEM I Evang. Kliniken Essen-Mitte gGmbH
Klinik für Senologie/ Brustzentrum, Henricistrasse 92, Huttrop, Essen
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Brustzentrum, Wilhelm-Epstein-Strasse 4, Bockenheim, Frankfurt Am Main
General Hospital Of Thessaloniki Papageorgiou
Clinic of Medical Oncology, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
St Savas Hospital
2nd Department of Internal Medicine - Oncology, Alexandras Avenue 171, 115 22, Athens
University General Hospital Of Heraklion
Internal Medicine-Oncology Clinic, Stavrakia And Voutes, 715 00, Heraklion
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Alexandra Hospital
Oncology Department, University Clinic of Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
Athens Medical Center S.A.
3rd department of Oncology, Pylea, Asklipiou 10, Thessaloniki
Istituto Oncologico Veneto
Oncologia 2, Via Gattamelata 64, 35128, Padova
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Oncologia Clinica Sperimentale di Senologia, Via Mariano Semmola 52, 80131, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
SCIENZE DELLA SALUTE DELLA DONNA E DEL BAMBINO E DI SANITÀ PUBBLICA, Largo Agostino Gemelli 8, 00168, Rome
IRCCS Ospedale Policlinico San Martino
Oncologia Medica 2, Largo Rosanna Benzi 10, 16132, Genoa
Careggi University Hospital
SOD Radioterapia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Universitaria Federico II Di Napoli
Dipartimento di Medicina Clinica e Chirurgia, Via Sergio Pansini 5, 80131, Naples
Universiteit Maastricht
Oncology, P Debyelaan 25, 6229 HX, Maastricht
Frisius MC
Oncology, Henri Dunantweg 2, 8934 AD, Leeuwarden
Hospital Clinico Universitario De Valencia
Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital San Pedro De Alcantara
Oncology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Oncology, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital Universitario De Canarias
Oncology, Calle Ofra Sn La Cuesta, 38320, La Laguna
Hospital Universitari Vall D Hebron
Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Clinico San Carlos
Oncology, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitari Dexeus Grupo Quironsalud
Oncology, Calle De Sabino Arana 5-19, 08028, Barcelona
Hospital De La Santa Creu I Sant Pau
Oncology, Carrer De San Quinti 89, 08041, Barcelona
University Hospital Virgen Del Rocio S.L.
Oncology., Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Clinico San Cecilio
Oncology, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Quironsalud Valencia
Oncology, Avenida Blasco Ibanez 14, 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 |
|---|---|---|---|---|---|
| Austria | 2022-01-21 | 2022-02-22 | 2023-09-11 | ||
| Belgium | 2022-01-24 | 2022-02-14 | 2024-04-16 | ||
| France | 2021-10-01 | 2021-10-11 | 2023-09-26 | ||
| Germany | 2022-01-27 | 2022-03-02 | 2023-09-21 | ||
| Greece | 2022-01-14 | 2022-02-10 | 2023-10-19 | ||
| Italy | 2022-12-15 | 2022-12-29 | 2023-09-29 | ||
| Netherlands | 2022-08-24 | 2025-06-05 | 2022-09-01 | 2023-07-04 | |
| Spain | 2021-09-30 | 2021-10-04 | 2023-10-04 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-93559
- Event date
- 2025-07-25
- Submission date
- 2025-08-07
- Member states affected
- Austria, Belgium, France, Germany, Greece, Italy, Spain, Netherlands
- Event description
- See attached report and cover letter
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 95 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | LY3484356 J2J-OX-JZLC 04 CSR synopsis and body_Redacted | 1 |
| Protocol (for publication) | D1_Protocol 2023-506786-63-00_Redacted | d |
| Protocol (for publication) | D1_Protocol_2023-506786-63-00_GR_Redacted | d |
| Protocol (for publication) | D4_Patient Documents Copyright | 1.1 |
| Recruitment arrangements (for publication) | JZLC_Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | K1_Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | K1_JZLC_Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | K1_JZLC_Blank document for Recruitment Arrangement_Recruitment closed | 1 |
| Recruitment arrangements (for publication) | K1_JZLC_Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | K1_JZLC_Blank document for Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement_Recruitment closed | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K3_List of Planned Sites_Belgium_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Summary of Changes 2_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Summary of Changes 2_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Summary of Changes 2_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_Addendum ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Addendum_Beyond Disease Progression_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Main_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Main_GR_Redacted_ | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Summary of Changes_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_SoC_Main_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_Patient Reimbursement Program ICF_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 5.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary of Changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Biopsy_ITA_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF optional biopsy_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Progression | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Progression_ITA | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Optional Tissue_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Tumourprogression | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum BEDU | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum BEFR | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum ENG | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF BEDU_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF BEFR_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF ENG_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 9 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant BEDU_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant BEFR_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant ENG_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner BEDU_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner BEFR_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ENG_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Progression addendum | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement_Type 1_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement_Type 2_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes 1_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes 2 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_BEDU_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_BEFR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_Summary of Changes_1_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_Summary of Changes_3_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_GP Letter_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_List of ssICF contact details_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material_ICF Procedure | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Patient Card_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient emergency cards | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_VisitGuide_GR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Card_ITA | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Main ICF_Redacted | 10.1 |
| Subject information and informed consent form (for publication) | L2_Thank you card_ITA | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Greil | 3.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Greil_TC | 3.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Kolovetsiou-Kreiner | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Petru | 2.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Singer | 3.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Singer_TC | 3.0 |
| Subject information and informed consent form (for publication) | L3_Patient card_Weiss | 1.0 |
| Subject information and informed consent form (for publication) | L3_Patients cards | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | Blanket Statement - Document not published anymore | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | Blanket Statement - Document not published anymore | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopisis_2023-506786-63-00_ENG_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDE_2023-506786-63_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDU_2023-506786-63_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEFR_2023-506786-63_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-506786-63-00_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_France_Redacted | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GER_AT_2023-506786-63-00_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_IT_2023-506786-63-00_Redacted | d |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-28 | Spain | Acceptable 2024-03-27
|
2024-03-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-20 | Spain | Acceptable 2024-08-16
|
2024-08-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-15 | Acceptable | 2024-12-30 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-18 | Acceptable | 2024-11-13 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-21 | Spain | Acceptable 2025-06-23
|
2025-06-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-08 | Acceptable | 2025-10-03 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-09-25 | Acceptable | 2025-11-10 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-30 | Acceptable | 2025-12-11 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-30 | Acceptable | 2025-10-23 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-09-30 | Spain | Acceptable | 2025-10-27 |
| 11 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-10-09 | Acceptable | 2025-11-19 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-15 | 2026-01-19 | Spain | Acceptable 2026-03-19
|
2026-03-20 |