Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
86
Countries
10
Sites
35
Crohn’s Disease
For CD ISA: To evaluate the efficacy of mirikizumab in pediatric participants with Crohn's disease. For UC ISA: To evaluate the efficacy of mirikizumab in pediatric participants with UC.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 13 Dec 2022 → ongoing
- Decision date (initial)
- 2024-09-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506239-14-00
- EudraCT number
- 2020-005311-49
- WHO UTN
- U1111-1295-0599
- ClinicalTrials.gov
- NCT04844606
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacoeconomic, Pharmacokinetic, Efficacy, Therapy
For CD ISA:
To evaluate the efficacy of mirikizumab in pediatric participants with Crohn's disease.
For UC ISA:
To evaluate the efficacy of mirikizumab in pediatric participants with UC.
Conditions and MedDRA coding
Crohn’s Disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants from originating studies (I6T-MC-AMBA [NCT05784246], I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130], I6T-MC-AMAY [NCT05509777]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab.
- Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
- Female participants must agree to contraception requirements.
Exclusion criteria 6
- Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.
- Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.
- Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
- Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant’s safety or confound data interpretation.
- Participants must not have adenomatous polyps that have not been removed.
- Participants must not be pregnant or breastfeeding.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission. Clinical Remission based on the MMS [Time Frame: Week 52]
- Percentage of Participants with CD in Pediatric Crohn’s Disease Activity Index (PCDAI) Clinical Remission. Clinical Remission based on the PCDAI [Time Frame: Week 52]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10725963 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION OR INFUSION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10082863 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION OR INFUSION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10082852 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION OR INFUSION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- 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 9
| Organisation | City, country | Duties |
|---|---|---|
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Laboratory analysis |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
Locations
10 EU/EEA countries · 35 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 1 | 1 |
| Belgium | Ongoing, recruiting | 6 | 5 |
| France | Authorised, recruitment pending | 12 | 4 |
| Germany | Ongoing, recruiting | 9 | 2 |
| Italy | Ongoing, recruiting | 8 | 6 |
| Netherlands | Authorised, recruitment pending | 1 | 1 |
| Norway | Authorised, recruitment pending | 4 | 4 |
| Poland | Ongoing, recruiting | 19 | 5 |
| Portugal | Ongoing, recruiting | 1 | 3 |
| Spain | Authorised, recruiting | 4 | 4 |
| Rest of world
United States, Korea, Republic of, Japan
|
— | 21 | — |
Investigational sites
Medical University Of Vienna
Division of Pediatric Nephrology and Gastroenterology, Waehringer Guertel 18-20, Alsergrund, Vienna
Cliniques Universitaires Saint-Luc
Hepato gastroenterology pediatric, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Antwerp University Hospital
Pediatrics, Drie Eikenstraat 655, 2650, Edegem
UZ Leuven
Gastroenterology - Inflammatory Bowel Disease, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Pediatric Gastro-Enterology, Corneel Heymanslaan 10, 9000, Gent
UZ Brussel
Pediatrics, Laarbeeklaan 101, 1090, Jette
Assistance Publique Hopitaux De Paris
Nutrition et gastroentérologie pédiatrique, 26 Avenue Du Docteur Arnold Netter, 75012, Paris
Centre Hospitalier Universitaire Amiens Picardie
Centre de Recherche Clinique, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Hopital Necker Enfants Malades
Centre d'Investigation Clinique, 149 Rue De Sevres, 75015, Paris
Hôpital Jeanne de Flandre
Centre d'investigation clinique - Antenne Pédiatrique, Avenue Eugène Avinée, 59037, Lille
Klinikum der Universitaet Muenchen AöR
Dr. von Haunersches Kinderspital, Lindwurmstrasse 4, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Zentrum für Kinder- und Jugendmedizin, Langenbeckstrasse 1, Oberstadt, Mainz
ASST FBF-Sacco Ospedale dei Bambini "V.Buzzi"
Gastroenterologia Pediatrica, Via Castelvetro 32, 20154, Milano
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Paediatric Hepatology Gastroenterology and Transplantation, Piazza Oms 1, 24127, Bergamo
Ospedale Pediatrico Bambino Gesu
Hepatogastroenterology and Nutrition, Piazza Di Sant'onofrio 4, 00165, Rome
Azienda Unita Sanitaria Locale Di Bologna
Paediatric Gastroenterology, Largo Bartolo Nigrisoli 2, 40133, Bologna
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Gastroenterologia ed Epatologia Pediatrica, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliera Universitaria Meyer IRCCS
Gastroenterology and Nutrition Unit, Viale Gaetano Pieraccini 24, 50139, Florence
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Pediatric gastroenterology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Oslo Universitetssykehus HF
Pediatric dept. gastroenterology, Kirkeveien 166, 0450, Oslo
Akershus University Hospital
Dept. Paediatric and Adolescent Medicine, Sykehusveien 27, 1478, Lorenskog
Universitetssykehuset Nord-Norge HF
Department of Pediatrics and Neonatal Medicine, Sykehusvegen 38, 9019, Tromsoe
St. Olavs Hospital HF
Department of Pediatrics, P. O. Box 3250, Torgarden, Trondheim
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
NA, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Korczowski Bartosz, Gabinet Lekarski
NA, ul. Litewska 4A/7, 35-302, Rzeszów
WIP Warsaw IBD Point Profesor Kierkus
NA, Ul. Bobrowiecka 9b, Mazowieckie, Warszawa
Instytut Pomnik Centrum Zdrowia Dziecka
Centrum Zdrowia Dziecka w Warszawie, Aleja Dzieci Polskich 20, 04-730, Warsaw
Centrum Medyczne Oporow
N/A, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Unidade Local De Saude De Santa Maria E.P.E.
Pediatric, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local de Saude de Sao Joao E.P.E.
Pediatric - Gastroenterology Unit, Alameda Professor Hernani Monteiro, 4200-319, Porto
CCAB Centro Clinico Academico Braga Associacao
Pediatric, Lugar De Sete Fontes S Victor, 4710-243, Braga
Hospital Universitario Y Politecnico La Fe
Digestive medicine, gastroenterology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Reina Sofia
Pediatric Gastroenterology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Sant Joan De Deu Barcelona
Pediatric Gastroenterology, Hepatology and Nutrition, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Parc Tauli Hospital Universitari
Pediatric Gastroenterology & Nutrition Unit, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
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 | 2026-02-02 | 2026-03-19 | |||
| Germany | 2025-08-12 | 2025-09-02 | |||
| Italy | 2022-12-13 | 2022-12-14 | |||
| Poland | 2023-01-24 | 2023-01-25 | |||
| Portugal | 2026-02-23 | 2026-03-10 | |||
| Spain | 2026-05-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 360 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Master Protocol 2023-506239-14-00_Redacted | f |
| Protocol (for publication) | D1_Protocol 2023-506239-14-00 ISA 1_Redacted | e |
| Protocol (for publication) | D1_Protocol 2023-506239-14-00 ISA 2 _Redacted | d |
| Protocol (for publication) | D1_Protocol 2023-506239-14-00 ISA 3 _Redacted | initial |
| Protocol (for publication) | D1_Protocol 2023-506239-14-00 ISA 4 _Redacted | initial |
| Protocol (for publication) | D4_ Patient Facing Documents_AMAZ_Patient Documents Copyright | 1.0 |
| Protocol (for publication) | D4_Patient Documents Copyright | 1.0 |
| Recruitment arrangements (for publication) | Blanket Statement - Document not published anymore | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| 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 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_FR | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NO_clean | V2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_TC | 2.0 |
| Recruitment arrangements (for publication) | K3_List of Planned Sites_Belgium_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K4_Recruitment arrangements_Informed consent and patient recruitment procedure | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Older Child ICF _Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Adult_ISA1_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF Adult_ISA2_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_ICF Adult_ISA3_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Adult_ISA4_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_addendum ISA1_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_addendum ISA2_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_addendum ISA3_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_addendum ISA4_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Pregnancy_PT | 1 |
| Subject information and informed consent form (for publication) | L1_ISA4_Assent_12 to less than 16y_PT_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ISA4_Assent_5 to 11y_PT_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ISA4_ICF_Continued Access Optional_PT_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ISA4_ICF_CountrySpecific_Main_PT_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_Older Child Assent ISA1_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Older Child Assent ISA2_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_Older Child Assent ISA3_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Older Child Assent ISA4_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_patient 16 plus and parent_ISA1_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_patient 16 plus and parent_ISA2_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_patient 16 plus and parent_ISA3_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_patient 16 plus and parent_ISA4_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient Reimbursement Program Germany_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner Consent | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Continued Access ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Older Child ISA 4_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Form Older Child_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Younger Child ISA 4_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_adults_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Travel Arrangements_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Younger Child_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Continued Access ISA1_Clean_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Continued Access ISA2_clean_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Continued Access ISA3_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Continued Access ISA4_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Continued Access_ISA1_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_Continued Access_ISA2_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adulte_ISA1_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adulte_ISA2_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 11 a 17 ans_ISA3_FRA_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 11 a 17 ans_ISA4_FRA_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 7 a 11 ans_ISA3_FRA_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 7 a 11 ans_ISA4_FRA_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form ISA1 Older Child_Clean version_ Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form ISA1 Young Child_ Clean_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form ISA3 Older Child_ Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form ISA3 Young Child_ Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form_ISA1_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form_ISA1_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form_ISA1_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form_ISA2_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form_ISA2_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form_ISA2_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form_ISA3_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form_ISA4_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_11-14 ans_ISA1_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_11-14 ans_ISA2_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_15-17ans_ISA1_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_15-17yo_ISA2_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_6-10 ans_ISA2_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_7-10 ans_ISA1_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_Older Child_ISA1_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_Older Child_ISA2_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_Younger Child_ISA1_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent_Younger Child_ISA2_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum ICF_ISA4_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum_ISA1_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum_ISA1_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum_ISA1_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum_ISA2_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum_ISA2_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum_ISA2_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum_ISA3_BEFR_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum_ISA3_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum_ISA4_FRA_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum_ISA4_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access ISA 4_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Country Reimbursement and Reminder Addendum ICF_Adultos_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Country Reimbursement and Reminder Addendum ICF_Padres_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Main Adult ISA2_clean_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Main ISA4_clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ICF Main Parent ISA2_clean_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 1 Main ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 1 Parent or Guardian ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 2 Main ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 2 Parent or Guardian ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 2_Adenda acceso ininterrumpido_Adultos_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 2_Adenda acceso ininterrumpido_Padres_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 2_Assent Older children_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 2_Assent Younger children_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 2_Main Adults_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 2_Main Parents_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 4_ Main Adults_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 4_ Main Parents_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 4_16-17 years Assent_NO_redacted | V1.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 4_Adenda acceso ininterrumpido Adultos_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 4_Adenda acceso ininterrumpido Ninos entre 12-18_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 4_Adenda acceso ininterrumpido Padres_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 4_Assent Older children_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 4_Assent Younger children_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 4_Child Assent Form_NO_redacted | V1.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 4_Continued Access Assent Form 12-15 years_NO_redacted | V1.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 4_Continued Access ICF 16-17 years_NO_redacted | V1.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA 4_Main Parent_NO_redacted | V1.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA1 Adults_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA1 Continued Access Addendum ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA1 Legal Rep_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA2 Adults_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA2 Adults_TC_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA2 Continued Access Addendum ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA2 Legal Rep_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA4_Adolescent Assent Form_NO_redacted | V1.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA4_Continued Access ICF Parents_NO_redacted | V1.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA4_Main Adult ICF_NO_redacted | V1.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF ISA 1 Adult_ Clean version_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF ISA 4_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF ISA1_Parent_Clean version_ Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF ISA3_ Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_14-17 years old ISA 4_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA1_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA1_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA1_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA2_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA2_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA2_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA3_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA3_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA3_FRA_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA3_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA4_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA4_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA4_FRA_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA4_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ISA4_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Mineur Majeur_ISA1_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Mineur-Majeur_ISA2_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older Child Assent Form_ISA4_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older child Assent ISA2_clean_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older child Assent ISA4_clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE Addendum_ISA3_FRA_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent ICF_ ISA 4_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent ICF_ISA 4_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parent ICF_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_BEDU_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_BEFR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BEDU_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_BEFR_Redacted | 1.1 |
| 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_Reimbursement Form_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Rep Legaux_ISA1_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Rep Legaux_ISA2_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent Form_ISA4_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger child Assent ISA2_clean_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger child Assent ISA4_clean_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ISA1_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ISA1_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ISA1_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ISA2_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ISA2_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ISA2_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ISA3_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ISA3_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ISA3_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ISA4_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ISA4_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger Child Assent_ISA4_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ISA1_Main ICF 16-17yo_clean_DE_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_ISA1_Main ICF adults_clean_DE_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_ISA1_Main ICF Parents_clean_DE_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_ISA3_Main ICF_clean_DE_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_CAP-Letter_PT | 1 |
| Subject information and informed consent form (for publication) | L2_Confidentiality Company Information Notice (Phase 3,4)_PT | 2 |
| Subject information and informed consent form (for publication) | L2_Electronic-Appointment-Reminder-Card_PT | 1 |
| Subject information and informed consent form (for publication) | L2_Emergency-Toilet-Card_PT | 1 |
| Subject information and informed consent form (for publication) | L2_ISA1_Addendum Continued Access ICF_clean_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_ISA1_Assent older child_clean_DE_redacted | 5 |
| Subject information and informed consent form (for publication) | L2_ISA1_Assent younger child_clean_DE_redacted | 5 |
| Subject information and informed consent form (for publication) | L2_ISA3_Addendum ICF_Continued Access_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ISA3_Assent_older child_clean_DE_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ISA3_Assent_younger child_clean_DE_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_List of ssICF Contact Details_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Emergency Card AMAZ - Poland | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Ancillary Supply List_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Ancillary Supply List_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appointment Reminder Card_Redacted | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appointment Reminder Card_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CAP-Letter_FR_Redacted | 1.0 |
| 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_Continuous access welcome letter_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Continuous access welcome letter_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Electronic Appointment Card_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Electronic Appointment Card_BEFR_Reacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Electronic Appt Reminder Card_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency Toilet Card | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency Toilet Card_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency Toilet Card_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency Toilet Card_FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Letter | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Letter_ISA 1_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Letter_ISA 2_Redacted | 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_ICF Sponsor Statement_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_ISA1_BEDU_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_ISA1_BEFR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_ISA1_DE_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_ISA1_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_ISA2_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_ISA2_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_ISA2_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_UC_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ISA1_Visit-Guide_FR_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ISA1_Welcome-Letter_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ISA2_Visit Guide_FR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ISA2_Welcome-Letter_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Older kids assent form_ISA 1_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Older kids assent form_ISA 2_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant ID Card | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant ID Card_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant ID Card_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_1_CD_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_1_ISA1_BEDU_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_1_ISA1_BEFR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_1_ISA2_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_1_ISA2_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_1_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_2_CD_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_2_ISA1_BEDU_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_2_ISA1_BEFR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_2_ISA1_DE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_2_ISA2_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_2_ISA2_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_UC_DE_redacted | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Administration Log_UC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Self Administration Log_CD_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Self Administration Log_UC_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Self_Admin_Training Log_ISA2_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Self_Administration Log_UC_ISA1_FR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Self_Administration Training Log_ISA1_FR_Re | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug Self-Administration Log_ISA2_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug SelfAdministration Training Log_CD_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Drug SelfAdministration Training Log_UC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient_Pregnancy Test Log_DE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PFS IFU_CD_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PFS IFU_UC_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Pregnancy Test Log_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Pregnancy Test Log_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Pregnancy Test Log_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Pregnancy Test Log_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Card | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Card_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank You Card_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Toilet Emergency Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit guide ISA1_Redacted | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit guide ISA2_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide_ISA1_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide_ISA1_BEFR_Readcted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide_ISA2_BEDU_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide_ISA2_BEFR_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Visit-Guide-ISA1_IT_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Visit-Guide-ISA2_IT_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Welcome Letter ISA1_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Welcome Letter ISA2_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Welcome Letter_ISA1_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Welcome Letter_ISA1_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Welcome Letter_ISA2_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Welcome Letter_ISA2_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Welcome-Letter-ISA2_IT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Younger kids assent form_ISA 1_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Younger kids assent form_ISA 2_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_IFU_ISA2_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Patient_Home Pregnancy Test Log_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Pregnancy Test Log_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject information_Welcome-Letter-ISA1_IT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject_information_Study Participant Contact Card_DE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Participant-ID-Card_PT | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Documents Not submitted_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Thank-You-Card_PT | 1 |
| Subject information and informed consent form (for publication) | L2_Visit-Guide-ISA4_PT | 1.1 |
| Subject information and informed consent form (for publication) | L2_Welcome-Letter-ISA4_PT | 1 |
| Subject information and informed consent form (for publication) | L3_Patient Card_Huber | 1 |
| Subject information and informed consent form (for publication) | L5_Info Re insurance Conditions for Patient | 1 |
| Subject information and informed consent form (for publication) | P3_ClinCard Cardholder FAQ_FRA | 1.0 |
| Subject information and informed consent form (for publication) | P3_ClinCard Cardholder Msg Templates_FRA | 1.0 |
| Subject information and informed consent form (for publication) | P3_ClinCard Cardholder Website Screenshots_MC_Europe_FRA | 1.0 |
| Subject information and informed consent form (for publication) | P3_ClinCard_Card_Carrier_FRA | 1.0 |
| Subject information and informed consent form (for publication) | P3_ClinCard_Fee_Schedule_FRA | 1.0 |
| Synopsis of the protocol (for publication) | D1_ISA2 Protocol Synopsis_AT 2023-506239-14-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Master Protocol Synopsis_AT 2023-506239-14-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ISA 2 IT 2023-506239-14-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis ISA 3_2023-506239-14-00_ENG_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis ISA 4_2023-506239-14-00_ENG_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ISA1 IT 2023-506239-14-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ISA1_IT_2023-506239-14-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ISA2_IT_2023-506239-14-00_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ISA3_IT_2023-506239-14-00_Redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ISA4_IT_2023-506239-14-00_Redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Master Protocol IT 2023-506239-14-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506239-14-00_f_NL_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-506239-14-00_ISA4_NL_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_ENG_22023-506239-14-00_ISA1_AMAZ_Redacted | e |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_ENG_22023-506239-14-00_ISA2_AMAZ_Redacted | d |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_ENG_22023-506239-14-00_master_AMAZ_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA 1_BE_DE_2023-506239-14-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA 1_BE_DU_2023-506239-14-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA 1_BE_FR_2023-506239-14-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ISA 2_2023-506239-14-00_ES_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA 2_BE_DE_2023-506239-14-00_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA 2_BE_DU_2023-506239-14-00_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA 2_BE_FR_2023-506239-14-00_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA 3_BE_DE_2023-506239-14-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA 3_BE_DU_2023-506239-14-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA 3_BE_FR_2023-506239-14-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ISA 4_ 2023-506239-14-00_ES_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA 4_BE_DE_2023-506239-14-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA 4_BE_DU_2023-506239-14-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA 4_BE_FR_2023-506239-14-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA1_AMAZ_FR_Redacted | D |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA2_AMAZ_FR_Redacted | C |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA3_AMAZ_FR_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ISA4_AMAZ_FR_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Master Protocol_BE_DE_2023-506239-14-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Master Protocol_BE_DU_2023-506239-14-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Master Protocol_BE_FR_2023-506239-14-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Master protocol_IT_2023-506239-14-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Master_2023-506239-14-00_ES_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Master_AMAZ_FR_Redacted | f |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_PL_22023-506239-14-00_ISA1_AMAZ_Redacted | e |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_PL_22023-506239-14-00_ISA2_AMAZ_Redacted | d |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_PL_22023-506239-14-00_ISA3_AMAZ_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_PL_22023-506239-14-00_ISA4_AMAZ_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_protocol synopsis_PL_22023-506239-14-00_master_AMAZ_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsys ISA 4 AT_2023-506239-14-00_Redacted | 1.0 |
Application history
16 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-22 | Italy | Acceptable 2023-10-12
|
2023-10-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-26 | Italy | Acceptable 2024-05-30
|
2024-05-31 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-06-17 | Acceptable 2024-05-30
|
2024-09-15 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-06-17 | Acceptable 2024-05-30
|
2024-08-27 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-06-17 | Acceptable 2024-05-30
|
2024-08-28 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-06-17 | Acceptable 2024-05-30
|
2024-09-05 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-06-17 | 2024-08-27 | ||
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2024-06-17 | Acceptable 2024-05-30
|
2024-09-10 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-01 | Italy | Acceptable 2024-11-19
|
2024-11-21 |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-26 | Italy | Acceptable 2025-09-26
|
2025-09-26 |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2025-10-22 | 2025-12-10 | ||
| 12 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-05 | Acceptable | 2026-02-20 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-16 | Italy | Acceptable | 2026-05-18 |
| 14 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-12 | Acceptable | 2026-04-09 | |
| 15 | SUBSEQUENT ADDITION OF MSC | APP-15 | 2026-03-19 | Acceptable 2023-10-12
|
2026-05-20 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-04-21 | Acceptable | 2026-05-22 |