Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
750
Countries
8
Sites
56
Adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma or muscle invasive gallbladder cancer GBC)
The primary objective is to demonstrate superiority of rilvegostomig + chemotherapy relative to placebo + chemotherapy by assessment of RFS in participants with BTC after resection with curative intent
Key facts
- Sponsor
- Astrazeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Jun 2024 → ongoing
- Decision date (initial)
- 2024-08-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- AstraZeneca AB (Sweden)
External identifiers
- EU CT number
- 2023-506054-20-00
- ClinicalTrials.gov
- NCT06109779
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Pharmacokinetic, Pharmacoeconomic, Safety, Pharmacogenetic
The primary objective is to demonstrate superiority of rilvegostomig + chemotherapy relative to placebo + chemotherapy by assessment of RFS in participants with BTC after resection with curative intent
Secondary objectives 1
- The key secondary objective is to demonstrate superiority of rilvegostomig in combination with chemotherapy relative to placebo in combination with chemotherapy by assessment of OS in participants with BTC after resection with curative intent
Conditions and MedDRA coding
Adenocarcinoma of the biliary tract (intrahepatic or extrahepatic cholangiocarcinoma or muscle invasive gallbladder cancer GBC)
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Period Within 28 days prior to first treatment
|
Randomised Controlled | Double | [{"id":183372,"code":2,"name":"Investigator"},{"id":183370,"code":1,"name":"Subject"},{"id":183371,"code":5,"name":"Carer"},{"id":183369,"code":3,"name":"Monitor"}] | |
| 2 | Intervention Period Participants will be randomized in a 1:1 ratio to receive the study intervention, Rilvestomig (AZD2936) or placebo in combination with investigator’s choice of chemotherapy
|
Randomised Controlled | Double | [{"id":183376,"code":2,"name":"Investigator"},{"id":183377,"code":1,"name":"Subject"},{"id":183375,"code":5,"name":"Carer"},{"id":183374,"code":3,"name":"Monitor"}] | Experimental arm: Rilvegostomig (AZD2936) Control Arm: Placebo (Sodium chloride or Dextrose) |
| 3 | Post-intervention Period Participants will undergo a safety follow-up visit 30 days after their last dose of study intervention, another safety follow-up visit 60 days after their last dose of study intervention, another safety follow-up visit 90 days after their last dose of study intervention. Survival follow-up will be performed after the safety follow-up period at the time of tumour imaging prior to recurrence. Following recurrence, survival will be assessed Q12W for 1st year, then Q24W thereafter.
|
Randomised Controlled | Double | [{"id":183380,"code":2,"name":"Investigator"},{"id":183381,"code":5,"name":"Carer"},{"id":183382,"code":3,"name":"Monitor"},{"id":183379,"code":1,"name":"Subject"}] |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- EMA paediatric investigation plan (PIP)
- EMEA-003501-PIP01-23
- Plan to share IPD
- Yes
- IPD plan description
- Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or extrahepatic) after macroscopically complete resection (R0 or R1)
- Provision of a tumor sample collected at surgical resection
- Randomization within 12 weeks after resection with adequate healing and removal of drains
- Confirmed to be disease-free by imaging within 28 days prior to randomization
- Eastern Cooperative Oncology Group performance status of 0 or 1
Exclusion criteria 7
- Participants with locally-advanced, unresectable, or metastatic disease at initial diagnosis
- Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine neoplasms and nonepithelial tumors
- Any anti-cancer therapy for BTC prior to surgery
- Active or prior documented autoimmune or inflammatory disorders or any severe or uncontrolled systemic disease
- Current or prior use of immunosuppressive medication within 14 days before the first dose
- Thromboembolic event within 3 months
- Active HBV or HCV infection unless treated
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Recurrence free survival (RFS) for Arm A vs. Arm B
Secondary endpoints 3
- Overall Survival (OS) for Arm A vs. Arm B
- Patient-reported tolerability Arm A vs. Arm B
- Progression Free Survival (PFS) following recurrence Arm A vs. Arm B
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10448215 · Product
- Active substance
- Rilvegostomig
- Substance synonyms
- AZD 2936, Bispecific IgG1 monoclonal antibody against PDCD1 and TIGIT
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 13500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13981MIG · Substance
- Active substance
- Glucose
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 8
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 25 mg/m2 milligram(s)/square meter
- Max total dose
- 400 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10870MIG · Substance
- Active substance
- Tegafur
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 13440 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2500 mg/m2 milligram(s)/square meter
- Max total dose
- 280000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02681MIG · Substance
- Active substance
- Infliximab
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- ORAL
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 999999 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07892MIG · Substance
- Active substance
- Gemcitabine
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 16000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10870MIG · Substance
- Active substance
- Tegafur
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 13440 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12474MIG · Substance
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2500 mg/m2 milligram(s)/square meter
- Max total dose
- 280000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astrazeneca AB
- Sponsor organisation
- Astrazeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- Astrazeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- Astrazeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
8 EU/EEA countries · 56 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 12 | 4 |
| Denmark | Ongoing, recruitment ended | 2 | 2 |
| France | Ongoing, recruitment ended | 26 | 8 |
| Germany | Ongoing, recruitment ended | 47 | 18 |
| Italy | Ongoing, recruitment ended | 30 | 8 |
| Norway | Ongoing, recruitment ended | 10 | 1 |
| Poland | Ongoing, recruitment ended | 18 | 6 |
| Spain | Ongoing, recruitment ended | 37 | 9 |
| Rest of world
United States, India, United Kingdom, Brazil, Thailand, Australia, Korea, Republic of, Japan, Canada, Hong Kong, China, Taiwan, Turkey
|
— | 568 | — |
Investigational sites
UZ Leuven
Digestive Oncology, Herestraat 49, 3000, Leuven
Hopital Erasme
Digestive Oncology, Lennikse Baan 808, 1070, Anderlecht
Antwerp University Hospital
Digestive Oncology, Drie Eikenstraat 655, 2650, Edegem
Cliniques Universitaires Saint-Luc
Hepato-Gastroenterology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Region Midtjylland
Departement of Oncology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Region Hovedstaden
Department of Oncology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Centre Hospitalier Universitaire De Montpellier
Oncologie médicale, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Regional Lutte Contre Le Cancer
Medical Oncology, Batiment Icans, 17 Rue Albert Calmette, Strasbourg
Institut Paoli Calmettes
Oncologie digestive, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Bordeaux
Service d'hépato-gastro-entérologie et oncologie digestive, Avenue Du Haut Leveque, 33600, Pessac
Hopital Paul Brousse
Gastro entérologie et Hépatologie, 12 Avenue Paul Vaillant Couturier, 94804, Villejuif Cedex
Centre Hospitalier Universitaire De Toulouse
Oncologie digestive, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Institut Curie
Département d’Oncologie Médicale, 35 Rue Dailly, 92210, Saint-Cloud
Centre De Lutte Contre Le Cancer Eugene Marquis
Oncologie médicale, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Universitaetsklinikum Schleswig-Holstein AöR
Medizinische Klinik I, Ratzeburger Allee 160, 23538, Luebeck
Klinikum Esslingen GmbH
Allgemeine Innere Medizin, Onkologie / Haematologie, Gastroenterologie und Infektiologie, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar
Universitaet Muenster
Med. Klinik A|Hämatologie/ Onkologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie, Augustenburger Platz 1, Wedding, Berlin
Asklepios Kliniken Hamburg GmbH
Abteilung Onkologie, Haematologie, Paul-Ehrlich-Strasse 1, Othmarschen, Hamburg
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik, Marchioninistrasse 15, Hadern, Munich
Technische Universitaet Dresden
Medizinische Klinik I, Studienzentrale internistische Onkologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Krankenhaus Nordwest GmbH
Institut fuer Klinisch-Onkologische Forschung (IKF), Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Muenchen Klinik gGmbH
Klinik fuer Haematologie und Onkologie, Oskar-Maria-Graf-Ring 51, Ramersdorf-Perlach, Munich
Klinikum Dortmund gGmbH
Klinik fuer Gastroenterologie, Haematologie und internistische Onkologie und Endokrinologie, Beurhausstrasse 40, Mitte, Dortmund
Universitaetsklinikum Ulm AöR
Zentrum für Innere Medizin Klinik für Innere Medizin I, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 1 - Gastroenterologie, Pneumologie und Endokrinologie, Ulmenweg 18, Innenstadt, Erlangen
Universitaetsklinikum Leipzig AöR
Medizinische Klinik II – Hepatologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Universitaetsklinikum Essen AöR
WTZ - Innere Klinik (Tumorfoschung), Hufelandstrasse 55, Holsterhausen, Essen
University Hospital Cologne AöR
Klinik fuer Gastroenterologie, Hepatologie und Infektiologie, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Heidelberg AöR
Medizinische Onkologie, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Universitaetsklinikum Tuebingen AöR
Universitätsklinikum Tübingen, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Universitaetsklinikum Bonn AöR
Medizinische Klinik und Poliklinik I, Venusberg-Campus 1, Venusberg, Bonn
Pia Fondazione Di Culto E Religione Card G Panico
Oncology, Via Pio X 4, 73039, Tricase
Humanitas Research Hospital
medical oncology and hematology, Via Alessandro Manzoni 56, 20089, Rozzano
ASST Grande Ospedale Metropolitano Niguarda
Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Ospedale San Raffaele S.r.l.
medical oncology, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero Universitaria Pisana
Oncology, Via Roma 67, 56126, Pisa
Fondazione IRCCS Istituto Nazionale Dei Tumori
medical oncology, Via Giacomo Venezian 1, 20133, Milan
Careggi University Hospital
Clinical Oncology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Istituto Oncologico Veneto
Oncology, Via Gattamelata 64, 35128, Padova
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.
Oddzial Onkologii, Ul. Jana Pawla II 35, 97-200, Tomaszow Mazowiecki
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Onkologii i Radioterapii, Ul. Wawelska 15, 02-034, Warsaw
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Oddzial Onkologiczny z Pododzialem Dziennej Chemioterapii, Ul. Monte Cassino 18, 37-700, Peremyshl
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Oddzial Onkologii Klinicznej i Chemioterapii, Ul. Radziwillowska 13, 20-080, Lublin
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Onkologii, Ul. Mikolaja Kopernika 50, 31-501, Cracow
Institut Catala D'oncologia
Servicio de Oncologia Medica, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Fundacion Jimenez Diaz
Oncologia Medica, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Unidad de cáncer gastrointestinal. Oncología médica, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Clinica Universidad De Navarra
Oncologia Medica, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario 12 De Octubre
Unidad de Tumores Digestivos. Unidad Cancer familiar., Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinic De Barcelona
Oncología Hepatica, Calle Villarroel 170, 08036, Barcelona
Hospital General Universitario Gregorio Maranon
Unidad de Investigación Oncológica HGUG Marañón, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario Marques De Valdecilla
Servicio de Oncologia Medica, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Regional De Malaga
UGCI de Oncología/Oncologia Médica, Avenida De Carlos De Haya Sn, 29010, Malaga
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 | 2024-12-12 | 2024-12-19 | 2025-09-16 | ||
| Denmark | 2024-11-13 | 2024-11-18 | 2025-09-16 | ||
| France | 2024-12-24 | 2025-01-03 | 2025-10-15 | ||
| Germany | 2024-11-13 | 2024-11-15 | 2025-10-29 | ||
| Italy | 2024-07-11 | 2024-07-24 | 2025-09-16 | ||
| Norway | 2024-08-21 | 2024-08-23 | 2025-08-14 | ||
| Poland | 2024-06-19 | 2024-06-21 | 2025-07-18 | ||
| Spain | 2024-06-05 | 2024-06-06 | 2025-08-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 87 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-506054-20-00_EN_redacted | 1.0 EU |
| Protocol (for publication) | D1_Protocol_lay language_2023-506054-20-00_EN_redacted | 1 |
| Protocol (for publication) | D1_Toxicity Management Guidelines_Rilvegostomig | 7.0 |
| Protocol (for publication) | D4_Patient facing documents PGI-TT | 1.0 |
| Protocol (for publication) | D4_Patient facing documents Questionnaires Germany_for publication | 1.0 |
| Protocol (for publication) | D4_Patient facing documents questionnairesx2_DK | NA |
| Protocol (for publication) | D4_Patient facing documents_PGI TT_DK | NA |
| Protocol (for publication) | D4_Patient facing documents_PGI-TT questionnaire_Poland | 1 |
| Protocol (for publication) | D4_Patient facing documents_PGI-TT_ES_for publication | 1 |
| Protocol (for publication) | D4_Patient facing documents_PGi-TT_NO_for publication | 1 |
| Protocol (for publication) | D4_Patient facing documents_quest_NCI-PRO-CTCAE_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_quest_PROMIS_redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaires PGI-TT_BE French | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaires PROMIS PF-SF 8c_PRO-CTCAE_BE Dutch | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaires PROMIS PF-SF 8c_PRO-CTCAE_BE French | NA |
| Protocol (for publication) | D4_Patient facing documents_Questionnaires_PGI-TT_BE Dutch | NA |
| Protocol (for publication) | D4_Patient facing documents_questionnaries_PGI-TT _IT_Italy_for publication | NA |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_DK_redacted | NA |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K1_ICF Summary_Dutch | 1.0 |
| Recruitment arrangements (for publication) | K1_ICF Summary_French | 1.0 |
| Recruitment arrangements (for publication) | K1_Other subject information material ICF Summary_NO | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NO | 1.1 |
| Recruitment arrangements (for publication) | K2_ICF Summary | 1.0 |
| Recruitment arrangements (for publication) | K2_Other subject information material ICF Summary | 1.0 |
| Recruitment arrangements (for publication) | K2_Other subject information material ICF summary | 1 |
| Recruitment arrangements (for publication) | K2_Other subject information material ICF Summary_DK_redacted | NA |
| Recruitment arrangements (for publication) | K2_Patient Recruitment Patient Guide_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Patient Study Guide_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ICF Summary | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ICF Summary PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_patient guide_redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Guide_redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Study Guide_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adult PL_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_DK_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_NO_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Genetic subject PL | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner PL | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_DK | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant partner_NO | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and adults_main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and birth_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum adults_main_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum02 adults_main_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult Optional_NO | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_German_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Data Privacy_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF for Optional procedure_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_German_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic Research_German_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE_Dutch_redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE_English_redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BE_French_redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional genetic | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional ICF_DK | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner BE_Dutch | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner BE_English | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner BE_French | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_German | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Study ICF for Pregnant Partners | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Study Subject Master ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adult Subject ICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Genetic ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and Pregnant Participant_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF and Optional Genetic_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Your rights as a subject in drug trials | NA |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_GP Letter_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material ICF Summary_NO | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE Dutch_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE French_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE German_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-506054-20-00_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_Lay Language_2023-506054-20-00_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language_ES_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay language_FR_EU CTR _redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language_NO_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Lay language_PL_Redacted | 1 |
Application history
18 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-19 | Spain | Acceptable 2024-05-03
|
2024-05-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-22 | Acceptable 2024-05-03
|
2024-05-22 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-05-23 | 2024-08-06 | ||
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-05-23 | 2024-08-03 | ||
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-05-23 | Acceptable 2024-05-03
|
2024-08-13 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-05-23 | Acceptable 2024-05-03
|
2024-08-02 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-18 | Acceptable | 2024-07-30 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-28 | Acceptable 2024-05-03
|
2024-08-28 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-29 | Acceptable | 2024-11-08 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-09 | Acceptable | 2024-10-17 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-11-27 | Spain | Acceptable | 2024-11-27 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-01-07 | Acceptable | 2025-01-07 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-03-21 | Acceptable | 2025-03-21 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-04-07 | Acceptable | 2025-04-07 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-14 | Spain | Acceptable 2025-07-21
|
2025-07-21 |
| 16 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-04 | Acceptable | 2025-09-17 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-01 | Spain | Acceptable 2026-01-19
|
2026-01-20 |
| 18 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-13 | Spain | Acceptable 2026-05-25
|
2026-05-26 |