Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
704
Countries
9
Sites
44
Prostate cancer
Further characterize the long-term outcome (for up to 10 years after the first dose of AAA617) of 1) known or potential risks of AAA617 including myelosuppression, renal failure, xerostomia, xerophthalmia, and secondary malignancies including myelodysplastic syndrome and acute myeloid leukemia (MDS/AML) and 2) other AA…
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Apr 2024 → ongoing
- Decision date (initial)
- 2023-11-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novartis Pharma AG
External identifiers
- EU CT number
- 2023-503208-94-00
- ClinicalTrials.gov
- NCT05803941
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
Further characterize the long-term outcome (for up to 10 years after the first dose of AAA617) of
1) known or potential risks of AAA617 including myelosuppression, renal failure, xerostomia, xerophthalmia, and secondary malignancies including myelodysplastic syndrome and acute myeloid leukemia (MDS/AML) and
2) other AAA617 causally related serious adverse events
Secondary objectives 2
- Evaluate incidence of death
- Determine if the dosimetry estimates in kidney and selected organs (when collected in the parent treatment studies) are associated with any long term safety events of AAA617
Conditions and MedDRA coding
Prostate cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2020-003969-19 | PSMAfore : A phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of androgen receptor-directed therapy in the Treatment of Taxane Naïve Men with Progressive Metastatic Castrate Resistant Prostate Cancer, PSMAfore: Otvorené, multicentrické, randomizované klinické skúšanie fázy III, porovnávajúce 177Lu-PSMA-617 so zmenou v sekvencii priamej antiandrogénnej liečby u pacientov s progredujúcim metastatickým kastračne rezistentným karcinómom prostaty, ktorí neboli predliečení taxánom., PSMAfore: Otvorené, multicentrické, randomizované klinické skúšanie fázy III, porovnávajúce 177Lu-PSMA-617 so zmenou v sekvencii priamej antiandrogénnej liečby u pacientov s progredujúcim metastatickým kastračne rezistentným karcinómom prostaty, ktorí neboli predliečení taxánom., PSMAfore: Otvorené, multicentrické, randomizované klinické skúšanie fázy III, porovnávajúce 177Lu-PSMA-617 so zmenou v sekvencii priamej antiandrogénnej liečby u pacientov s progredujúcim metastatickým kastračne rezistentným karcinómom prostaty, ktorí neboli predliečení taxánom., PSMAfore: Otvorené, multicentrické, randomizované klinické skúšanie fázy III, porovnávajúce 177Lu-PSMA-617 so zmenou v sekvencii priamej antiandrogénnej liečby u pacientov s progredujúcim metastatickým kastračne rezistentným karcinómom prostaty, ktorí neboli predliečení taxánom., PSMAfore: Otvorené, multicentrické, randomizované klinické skúšanie fázy III, porovnávajúce 177Lu-PSMA-617 so zmenou v sekvencii priamej antiandrogénnej liečby u pacientov s progredujúcim metastatickým kastračne rezistentným karcinómom prostaty, ktorí neboli predliečení taxánom., PSMAfore: Otvorené, multicentrické, randomizované klinické skúšanie fázy III, porovnávajúce 177Lu-PSMA-617 so zmenou v sekvencii priamej antiandrogénnej liečby u pacientov s progredujúcim metastatickým kastračne rezistentným karcinómom prostaty, ktorí neboli predliečení taxánom., PSMAfore: Otevřené, multicentrické, randomizované klinické hodnocení fáze III porovnávající 177Lu-PSMA-617 se změnou terapie cílené na androgenní receptory v léčbě taxan-naivních pacientů s progresivním metastatickým kastračně rezistentním karcinomem prostaty | |
| 2020-003968-56 | PSMAddition : An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic Hormone Sensitive Prostate Cancer (mHSPC), PSMAddition: Międzynarodowe, prospektywne, randomizowane badanie fazy III prowadzone metodą otwartej próby porównujące 177Lu-PSMA-617 w połączeniu ze standardem leczenia do samego standardu leczenia u dorosłych mężczyzn z przerzutowym, hormonowrażliwym rakiem gruczołu krokowego (mHSPC), PSMAddition: Międzynarodowe, prospektywne, randomizowane badanie fazy III prowadzone metodą otwartej próby porównujące 177Lu-PSMA-617 w połączeniu ze standardem leczenia do samego standardu leczenia u dorosłych mężczyzn z przerzutowym, hormonowrażliwym rakiem gruczołu krokowego (mHSPC), PSMAddition: Międzynarodowe, prospektywne, randomizowane badanie fazy III prowadzone metodą otwartej próby porównujące 177Lu-PSMA-617 w połączeniu ze standardem leczenia do samego standardu leczenia u dorosłych mężczyzn z przerzutowym, hormonowrażliwym rakiem gruczołu krokowego (mHSPC), PSMAddition: Mezinárodní, prospektivní, otevřené, randomizované klinické hodnocení fáze III porovnávající 177Lu-PSMA-617 v kombinaci se standardní léčbou oproti samotné standardní léčbě u dospělých pacientů s metastatickým hormonálně senzitivním karcinomem prostaty | |
| 2018-000459-41 | VISION: An international, prospective, open label, multicenter, randomized Phase 3 study of 177LU-PSMA-617 in the treatment of patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC), VISION: een internationale, prospectieve, multicentrische, gerandomiseerde fase 3 open-labelstudie naar 177Lu-PSMA-617 bij de behandeling van patiënten met progressieve, PSMA-positieve, metastatische, castratieresistente prostaatkanker (mCPRC), VISION : Étude de phase III, multicentrique, internationale, prospective, en ouvert, randomisée évaluant le 177Lu-PSMA-617 dans le traitement de patients atteints d’un cancer de la prostate résistant à la castration métastatique (CPRCm), évolutif et positif au PSMA, VISION: een internationale, prospectieve, multicentrische, gerandomiseerde fase 3 open-labelstudie naar 177Lu-PSMA-617 bij de behandeling van patiënten met progressieve, PSMA-positieve, metastatische, castratieresistente prostaatkanker (mCPRC), VISION : Étude de phase III, multicentrique, internationale, prospective, en ouvert, randomisée évaluant le 177Lu-PSMA-617 dans le traitement de patients atteints d’un cancer de la prostate résistant à la castration métastatique (CPRCm), évolutif et positif au PSMA, VISION: een internationale, prospectieve, multicentrische, gerandomiseerde fase 3 open-labelstudie naar 177Lu-PSMA-617 bij de behandeling van patiënten met progressieve, PSMA-positieve, metastatische, castratieresistente prostaatkanker (mCPRC), VISION : Étude de phase III, multicentrique, internationale, prospective, en ouvert, randomisée évaluant le 177Lu-PSMA-617 dans le traitement de patients atteints d’un cancer de la prostate résistant à la castration métastatique (CPRCm), évolutif et positif au PSMA, VISION: een internationale, prospectieve, multicentrische, gerandomiseerde fase 3 open-labelstudie naar 177Lu-PSMA-617 bij de behandeling van patiënten met progressieve, PSMA-positieve, metastatische, castratieresistente prostaatkanker (mCPRC), VISION : Étude de phase III, multicentrique, internationale, prospective, en ouvert, randomisée évaluant le 177Lu-PSMA-617 dans le traitement de patients atteints d’un cancer de la prostate résistant à la castration métastatique (CPRCm), évolutif et positif au PSMA, VISION: een internationale, prospectieve, multicentrische, gerandomiseerde fase 3 open-labelstudie naar 177Lu-PSMA-617 bij de behandeling van patiënten met progressieve, PSMA-positieve, metastatische, castratieresistente prostaatkanker (mCPRC), VISION : Étude de phase III, multicentrique, internationale, prospective, en ouvert, randomisée évaluant le 177Lu-PSMA-617 dans le traitement de patients atteints d’un cancer de la prostate résistant à la castration métastatique (CPRCm), évolutif et positif au PSMA, VISION: een internationale, prospectieve, multicentrische, gerandomiseerde fase 3 open-labelstudie naar 177Lu-PSMA-617 bij de behandeling van patiënten met progressieve, PSMA-positieve, metastatische, castratieresistente prostaatkanker (mCPRC), VISION : Étude de phase III, multicentrique, internationale, prospective, en ouvert, randomisée évaluant le 177Lu-PSMA-617 dans le traitement de patients atteints d’un cancer de la prostate résistant à la castration métastatique (CPRCm), évolutif et positif au PSMA, VISION: een internationale, prospectieve, multicentrische, gerandomiseerde fase 3 open-labelstudie naar 177Lu-PSMA-617 bij de behandeling van patiënten met progressieve, PSMA-positieve, metastatische, castratieresistente prostaatkanker (mCPRC), VISION : Étude de phase III, multicentrique, internationale, prospective, en ouvert, randomisée évaluant le 177Lu-PSMA-617 dans le traitement de patients atteints d’un cancer de la prostate résistant à la castration métastatique (CPRCm), évolutif et positif au PSMA | |
| 2023-503925-20-00 | An Open-label Dosimetry, Biodistribution, Tolerability and Safety Study of lutetium (177Lu) vipivotide tetraxetan in Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Moderately and Severely Impaired and with normal Renal Function | Novartis Pharma AG |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Must have received at least one dose of AAA617 within an interventional, phase I-IV Novartis sponsored clinical trial in prostate cancer and have fulfilled the trial's requirements that allows them to participate in this study.
Exclusion criteria 1
- Inability to complete the needed investigational examinations due to any reason.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number and proportion of participants with selected AEs and serious adverse events (SAEs), changes in laboratory values
Secondary endpoints 2
- Number and proportion of participants who have died
- Potential correlation between absorbed radiation dose in kidney or other selected organs and safety of AAA617 (if sufficient amount of dosimetry data is available from the parent treatment study)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Pluvicto 1 000 MBq/mL solution for injection/infusion
PRD10117050 · Product
- Active substance
- Lutetium (177LU) Vipivotide Tetraxetan
- Substance synonyms
- Lutetium Lu 177 vipivotide tetraxetan, 177LU-PSMA-617, VIPIVOTIDE TETRAXETAN LUTETIUM LU-177, LUTETIUM (177LU) PROSTATE-SPECIFIC MEMBRANE ANTIGEN, PSMA-617 LU-177
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 7.4 GBq gigabecquerel(s)
- Max total dose
- 44.4 GBq gigabecquerel(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- V10XX — VARIOUS THERAPEUTIC RADIOPHARMACEUTICALS
- Marketing authorisation
- EU/1/22/1703/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 11, Code 12, Other, Code 2, Code 5 |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
Locations
9 EU/EEA countries · 44 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 19 | 2 |
| Belgium | Ongoing, recruiting | 10 | 3 |
| Czechia | Authorised, recruitment pending | 8 | 2 |
| France | Ongoing, recruiting | 85 | 9 |
| Germany | Ongoing, recruiting | 21 | 4 |
| Netherlands | Ongoing, recruiting | 17 | 3 |
| Poland | Authorised, recruitment pending | 41 | 3 |
| Spain | Ongoing, recruiting | 85 | 15 |
| Sweden | Ongoing, recruiting | 12 | 3 |
| Rest of world
Canada, Taiwan, Hong Kong, Singapore, Switzerland, United States, Japan, China, Korea, Republic of, United Kingdom
|
— | 406 | — |
Investigational sites
Ordensklinikum Linz GmbH
#2000: Department of Urology, Fadingerstrasse 1, 4020, Linz
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
#2002: University Hospital for Urology, Waehringer Guertel 18-20, Alsergrund, Vienna
Institut Jules Bordet
#2052: Oncologie Médicale, Mijlenmeersstraat 90, 1070, Brussels
Algemeen Ziekenhuis Delta
#2053: Oncologie, Deltalaan 1, 8800, Roeselare
Universitair Ziekenhuis Gent
#2050: Urologie, Corneel Heymanslaan 10, 9000, Gent
Fakultni Nemocnice V Motole
#2700: Urologicka klinika, V Uvalu 84/1, Motol, Prague 5
University Hospital Olomouc
#2701: Onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Centre Jean Perrin
#2157: Oncology, 58 Rue Montalembert, 63000, Clermont-Ferrand
Centre Hospitalier Universitaire De Nantes
#2155: Urology, 1 Place Alexis Ricordeau, 44000, Nantes
Assistance Publique Hopitaux De Paris
#2151: Medical Oncology, 20 Rue Leblanc, 75015, Paris
Institut Gustave Roussy
#2158: Nuclear Medicine Department, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Leon Berard
#2150: Medical Oncology, 28 Rue Laennec, 69008, Lyon
CHRU De Nancy
#2153: Nuclear Medicine, Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Nancy Cedex
Institut De Cancerologie De L Ouest
#2160: Radiology, 15 Rue Andre Boquel, 49100, Angers
Institut Bergonie
#2161: Medical Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Assistance Publique Hopitaux De Paris
#2159: Oncology, 7 Rue Du Fer A Moulin, 75005, Paris
Klinikum rechts der Isar der TU Muenchen AöR
#2203: Nuclear Medicine, Ismaninger Strasse 22, Au-Haidhausen, Munich
University Hospital Cologne AöR
#2204: Klinik und Poliklinik fuer Nuklearmedizin, Kerpener Strasse 62, Lindenthal, Cologne
Rostock University Medical Center
#2201: Nuklearmedizin, Gertrudenplatz 1, Kroepeliner Tor Vorstadt, Rostock
Universitaetsklinikum Essen AöR
#2200: Klinik für Nuklearmedizin, Hufelandstrasse 55, Holsterhausen, Essen
Stichting Radboud University Medical Center
#2300, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Universiteit Maastricht
#2301, P Debyelaan 25, 6229 HX, Maastricht
Reinier de Graaf Groep
#2303: Oncology, Reinier De Graafweg 5, 2625 AD, Delft
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
#2352: Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
#2350: Oddzial Kliniczny Onkologii oraz Poradnia Onkologiczna, Ul. Mikolaja Kopernika 50, 31-501, Cracow
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
#2351: Klinika Nowotworow Ukladu Moczowego, Oddzial Zachowawczy, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Universitario La Paz
#2451: Oncología Médica, Paseo Castellana 261, 28046, Madrid
Hospital Clinico San Carlos
#2450: Oncología Médica, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario Ramon Y Cajal
#2457: Oncología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Institut Catala D'oncologia
#2455: Oncologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Y Politecnico La Fe
#2452: Oncología, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Parc Tauli Hospital Universitari
#2456: Oncología, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Hospital Clinic De Barcelona
#2458: Oncología, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Puerta De Hierro De Majadahonda
#2453: Oncología, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Universitari Vall D Hebron
#2461: Urología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
#2459: Oncología Médica, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Regional De Malaga
2462:Oncología, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital De La Santa Creu I Sant Pau
2464:Oncología, Calle De San Antonio Maria Claret 167, 08025, Barcelona
University Hospital Virgen Del Rocio S.L.
2466:Oncología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital General Universitario Gregorio Maranon
2467:Oncología, Calle Del Doctor Esquerdo 46, 28007, Madrid
Clinica Universidad De Navarra
2468:Oncologia, Pio XII Etorbidea 36, 31008, Pamplona
Region Skane Skanes Universitetssjukhus
#2501: Clinical Reasearch Unit, Dept. Of Oncology, Entregatan 7, 222 42, Lund
Sahlgrenska University Hospital-Vastra Gotalandsregionen
#2502: Department of oncology, Bla Straket 5, 413 46, Goteborg
Karolinska University Hospital
#2500: Department of Pelvic Cancer, Theme Cancer, Eugeniavagen 3, 171 64, Solna
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 | 2024-12-17 | 2024-12-17 | |||
| France | 2024-09-17 | 2024-09-17 | |||
| Germany | 2024-04-04 | 2024-04-04 | |||
| Netherlands | 2025-08-25 | 2025-08-25 | |||
| Spain | 2025-02-10 | 2025-02-10 | |||
| Sweden | 2026-02-17 | 2026-02-17 | |||
| Austria | |||||
| Czechia | |||||
| Poland |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 60 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol - Signature Page_2023-503208-94-00_1_English_Red | 01 |
| Protocol (for publication) | D1_Protocol_2023-503208-94-00_1_English_Red | 01 |
| Recruitment arrangements (for publication) | K1_AUT Recruitment Procedure Description English CAAA617A12402 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_BEL Recruitment Procedure Description English CAAA617A12402 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_CZE Country ICF Procedure English CAAA617A12402 Public | 1 |
| Recruitment arrangements (for publication) | K1_DEU Recruitment Procedure Description English CAAA617A12402 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_ESP Recruitment Procedure Description CAAA617A12402 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_FRA Recruitment Procedure Description English CAAA617A12402 Public | 1.1 |
| Recruitment arrangements (for publication) | K1_NLD Recruitment Procedure Description English CAAA617A12402 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_POL Recruitment Procedure Description Polish CAAA617A12402 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_SWE Patient Recruitment Procedure Swedish CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_AUT Country ICF Main Adult German CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_AUT Country ICF Other Adult German CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_AUT Country ICF Procedure English CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_AUT Subject Information Sheet German CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_AUT Subject Materials Other English CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Dutch CAAA617A12402 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main English CAAA617A12402 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main French CAAA617A12402 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Procedure English CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Procedure Sponsor s Statement English CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BEL ICF for Pregnant Partner Dutch CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BEL ICF for Pregnant Partner English CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BEL ICF for Pregnant Partner French CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_BEL Information for Female Partner Dutch CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_BEL Information for Female Partner English CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_BEL Information for Female Partner French CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Data Protection Adult Czech CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Main Adult Czech CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZE Information for female partner of study participant Czech CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE Optional Offsite Visit ICF Czech CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZE Pregnant Partner ICF Czech CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Main German CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Other German CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Procedure English CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_DEU Subject Information Sheet German CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Spanish CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Other Pregnant Partner Spanish CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ESP Subject Information Sheet Spanish CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Main French CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Other French CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Main Dutch CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Other Pregnant Partner ICF Dutch CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_NLD Female Partner Information Dutch CAAA617A12402 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Main Polish CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Other Pregnant Partner Polish CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_POL Female Partner Information Polish CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_POL Informed Consent Procedure Polish CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SWE Female Partner ICF Swedish CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SWE informed consent procedure Swedish CAAA617A12402 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SWE Model ICF Main Swedish CAAA617A12402 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SWE Model Pregnant Medical Release Form ICF Swedish CAAA617A12402 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-503208-94-00_1_Czech_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-503208-94-00_1_Dutch_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-503208-94-00_1_English_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-503208-94-00_1_French_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-503208-94-00_1_German_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-503208-94-00_1_Polish_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-503208-94-00_1_Spanish_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-503208-94-00_1_Swedish_Red | 01 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-11 | Sweden | Acceptable with conditions 2023-11-27
|
2023-11-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-29 | Sweden | Acceptable 2024-06-14
|
2024-06-14 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-12 | Sweden | Acceptable 2025-03-19
|
2025-03-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-16 | Sweden | Acceptable 2025-08-13
|
2025-08-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-12 | Acceptable | 2025-10-27 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-09-12 | Acceptable | 2025-10-17 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-09-12 | Sweden | Acceptable | 2025-10-01 |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-09-12 | Acceptable | 2025-10-24 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-09-25 | Acceptable | 2025-11-17 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-10-03 | Acceptable | 2025-10-28 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-12-18 | Acceptable | 2026-01-26 |