A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma

2023-504655-27-00 Protocol AU-011-301 Therapeutic confirmatory (Phase III) Authorised, recruiting

Start 23 Dec 2024 · Status Authorised, recruiting · 12 EU/EEA countries · 30 sites · Protocol AU-011-301

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruiting
Participants planned 267
Countries 12
Sites 30

Primary Indeterminate Lesions or Small Choroidal Melanoma

To determine the efficacy and safety of bel-sar compared to sham control for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).

Key facts

Sponsor
Aura Biosciences Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
23 Dec 2024 → ongoing
Decision date (initial)
2024-05-23
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes
Funding sources
Aura Biosciences, Inc

External identifiers

EU CT number
2023-504655-27-00
WHO UTN
U1111-1292-7769
ClinicalTrials.gov
NCT06007690

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Pharmacokinetic, Safety

To determine the efficacy and safety of bel-sar compared to sham control for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).

Secondary objectives 1

  1. To assess the systemic pharmacokinetics (PK) and immunogenicity of bel-sar with suprachoroidal (SC) administration.

Conditions and MedDRA coding

Primary Indeterminate Lesions or Small Choroidal Melanoma

VersionLevelCodeTermSystem organ class
20.0 HLT 10030052 Ocular melanomas 10029104
21.1 PT 10081431 Uveal melanoma 100000004864
21.0 PT 10025839 Malignant neoplasm of choroid 100000004864
21.1 PT 10008773 Choroid melanoma 100000004864

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM) with documented early growth
  2. Have no evidence of metastatic disease confirmed by imaging
  3. Be treatment naïve for their IL/CM (Note: eligibility for subjects who have received treatment with photodynamic therapy >6 months prior to enrollment should be discussed with the medical monitor for approval prior to enrollment).

Exclusion criteria 3

  1. Any active eye infection or ocular disease in the study eye (other than IL/CM)
  2. Have known contraindications or sensitivities to the study drug or laser
  3. Have a history of any ocular surgery/procedure that could alter the SCS and affect the SC administration of study drug (e.g., scleral buckle, laser retinopexy, macular laser, or panretinal photocoagulation).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Time to reach Tumor Progression (at the Week 65 analysis).

Secondary endpoints 1

  1. Time to reach the Composite Endpoint (at the Week 65 analysis). • Tumor progression or visual acuity failure

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Belzupacap Sarotalocan

PRD10589579 · Product

Active substance
Belzupacap Sarotalocan
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUPRACHOROIDAL
Max daily dose
80 µg microgram(s)
Max total dose
240 µg microgram(s)
Max treatment duration
3 Week(s)
Authorisation status
Not Authorised
MA holder
AURA BIOSCIENCES, INC
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/22/2599

Belzupacap Sarotalocan

PRD10589580 · Product

Active substance
Belzupacap Sarotalocan
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUPRACHOROIDAL
Max daily dose
80 µg microgram(s)
Max total dose
240 µg microgram(s)
Max treatment duration
3 Week(s)
Authorisation status
Not Authorised
MA holder
AURA BIOSCIENCES, INC
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/22/2599

Placebo 1

Placebo (Sham injection) to Belzupacap Sarotalocan solution for sham injection 0.0 mg/mL

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Aura Biosciences Inc.

Sponsor organisation
Aura Biosciences Inc.
Address
80 Guest Street
City
Boston
Postcode
02135-2071
Country
United States

Scientific contact point

Organisation
Aura Biosciences Inc.
Contact name
Aura Clinical

Public contact point

Organisation
Aura Biosciences Inc.
Contact name
Head of Investor Relations and Corporate Communications

Third parties 12

OrganisationCity, countryDuties
Medidata Solutions Inc.
ORG-100016256
 New York, United States Interactive response technologies (IRT), E-data capture
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Longboat Clinical Limited
ORG-100045828
 Limerick, Ireland Other
B2S Life Sciences LLC
ORG-100046553
 Franklin, United States Laboratory analysis
CIRION Biopharma Research Inc.
ORG-100016262
 Laval, Canada Laboratory analysis
Voiant LLC
ORG-100051555
 Waltham, United States Other
Catalent Pharma Solutions LLC
ORG-100011506
 Philadelphia, United States Code 14, Other
United Biosource LLC
ORG-100027856
 Blue Bell, United States Code 8
Eurofins Central Laboratory LLC
ORG-100043608
 Lancaster, United States Laboratory analysis
Optymedge LLC
ORG-100045359
 Milwaukee, United States Other
Catalent Germany Schorndorf GmbH
ORG-100011845
 Schorndorf, Germany Code 14, Other
PPD Development LP
ORG-100011560
 Wilmington, United States On site monitoring, Code 10, Code 12, Code 13, Code 14, Code 2, Code 5, Data management, Code 9

Locations

12 EU/EEA countries · 30 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruitment ended 15 2
Belgium Ongoing, recruitment ended 15 2
Czechia Ongoing, recruitment ended 15 3
Denmark Ended 15 1
France Ongoing, recruitment ended 15 2
Germany Ongoing, recruitment ended 15 7
Greece Ended 3 1
Ireland Ended 2 1
Italy Ongoing, recruitment ended 15 4
Netherlands Ongoing, recruitment ended 15 2
Spain Ongoing, recruitment ended 15 4
Sweden Ended 2 1
Rest of world
Canada, Israel, Australia, New Zealand, United Kingdom, United States
 — 125 —

Investigational sites

Austria

2 sites · Ongoing, recruitment ended
Medical University Of Graz
04002: Universitats-Augenklinik, Neue Stiftingtalstrasse 6, 8010, Graz
Medical University Of Vienna
04001: Augenheilkunde und Optometrie, Waehringer Guertel 18-20, Alsergrund, Vienna

Belgium

2 sites · Ongoing, recruitment ended
Cliniques Universitaires Saint-Luc
Ophthalmology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Leuven
Ophthalmology, Herestraat 49, 3000, Leuven

Czechia

3 sites · Ongoing, recruitment ended
Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha
20304:Ocni klinika, U Vojenske Nemocnice 1200, 169 02, Prague 6
Fakultni Thomayerova nemocnice
20301:Ocni oddeleni, Videnska 800, Krc, Prague 4
Fakultni Nemocnice Plzen
20303:Ocni klinika, Alej Svobody 923/80, 323 00, Plzen 23

Denmark

1 site · Ended
Rigshospitalet
20801: Copenhagen Neuromuscular Center, Inge Lehmanns Vej 7, 2100, Copenhagen Oe

France

2 sites · Ongoing, recruitment ended
Hospices Civils De Lyon
Ophthalmology Department, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Centre Hospitalier Universitaire De Nice
Hopital Pasteur, 30 Voie Romaine, 06000, Nice

Germany

7 sites · Ongoing, recruitment ended
Charite Universitaetsmedizin Berlin KöR
27602:Klinik für Augenheilkunde, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Schleswig-Holstein
27601:Klinik für Augenheilkunde, Ratzeburger Allee 160, 23538, Lübeck
University Hospital Cologne AöR
Zentrum für Augenheilkunde, Kerpener Strasse 62, Lindenthal, Cologne
Klinikum der Universitaet Muenchen AöR
27604: Augenklinik und Poliklinik, Mathildenstrasse 8, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsklinikum Essen AöR
27608: Zentrum für Augenheilkunde, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Tuebingen AöR
27605:Augenklinik, Elfriede-Aulhorn-Strasse 7, Nordstadt, Tuebingen
University Medical Center Hamburg-Eppendorf
27606:Augenheilkunde, Martinistrasse 52, Eppendorf, Hamburg

Greece

1 site · Ended
Mitera S.A.
30001: Ocular Oncology Adult and Children Department, Erythrou Stavrou Str 6, 151 23, Marousi

Ireland

1 site · Ended
Royal Victoria Eye And Ear Hospital
37201: Ophthalmology, Adelaide Road, D02 XK51, Dublin 2

Italy

4 sites · Ongoing, recruitment ended
ASST Fatebenefratelli Sacco
U.O. Clinica Oculistica, Via Giovanni Battista Grassi 74, 20157, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Oncologia Oculare, Largo Francesco Vito 1, 00168, Rome
Careggi University Hospital
Oncologia Oculare Unit, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Chirurgia Oncologica oculare, Via Giacomo Venezian 1, 20133, Milan

Netherlands

2 sites · Ongoing, recruitment ended
Academisch Ziekenhuis Leiden
52801: ophthalmology, Albinusdreef 2, 2333 ZA, Leiden
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
52802: ophthalmology, Dr. Molewaterplein 40, 3015 GD, Rotterdam

Spain

4 sites · Ongoing, recruitment ended
Bellvitge University Hospital
72403: Oftalmología, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Hospital Universitario Y Politecnico La Fe
72401: Oftalmología, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Complexo Hospitalario Universitario De Santiago
72402: Oftalmología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Virgen De La Macarena
72404: Oftalmología, Avenida Del Doctor Fedriani 3, 41009, Sevilla

Sweden

1 site · Ended
St Erik Eye Hospital
75201: Ocular Oncology Service, Eugeniavagen 12, 171 64, Solna

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2025-07-31 2025-09-15 2026-05-14
Belgium 2025-01-13 2026-02-03 2026-05-14
Czechia 2024-12-23 2025-04-30 2026-05-14
France 2025-01-28 2025-01-30 2026-05-14
Germany 2025-02-18 2025-04-23 2026-05-14
Italy 2025-06-30 2025-08-27 2026-05-14
Netherlands 2024-12-30 2025-03-05 2026-05-14
Spain 2025-04-30 2025-05-27 2026-05-14

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 117 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol Main English AU-011-301 Public 5.2
Recruitment arrangements (for publication) K1_AUT Recruitment Brochure German AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_AUT Recruitment Procedure Description English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_AUT Recruitment Procedure Description English TC AU-011-301 2.0
Recruitment arrangements (for publication) K1_BEL Recruitment Brochure Dutch AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_BEL Recruitment Brochure English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_BEL Recruitment Brochure French AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_BEL Recruitment Poster Dutch AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_BEL Recruitment Poster English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_BEL Recruitment Poster French AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_BEL Recruitment Procedure Description English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_CZE Recruitment Brochure Czech AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_CZE Recruitment Poster Czech AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_CZE Recruitment Procedure Description Czech-English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_DEU Recruitment Brochure German AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_DEU Recruitment Poster German AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_DEU Recruitment Procedure Description English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_DNK Recruitment Brochure Danish AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_DNK Recruitment Poster Danish AU-011-301_Public 2.1
Recruitment arrangements (for publication) K1_DNK Recruitment Procedure Description English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_ESP Recruitment Brochure Spanish AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_ESP Recruitment Procedure Description English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_FRA Recruitment Brochure French AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_FRA Recruitment Poster French AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_FRA Recruitment Procedure Description French-English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_GRC Recruitment Brochure Greek AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_GRC Recruitment Poster Greek AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_GRC Recruitment Procedure Description English AU-011-301 Public 3.0
Recruitment arrangements (for publication) K1_IRL Recruitment Brochure English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_IRL Recruitment Brochure Text English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_IRL Recruitment Poster English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_IRL Recruitment Procedure Description English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_ITA Country ICF Procedure English AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_ITA Recruitment Brochure Italian AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_NLD Recruitment Procedure Description English AU-011-301 Public 3.0
Recruitment arrangements (for publication) K1_SWE Recruitment Brochure Swedish AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_SWE Recruitment Poster Swedish AU-011-301 Public 2.0
Recruitment arrangements (for publication) K1_SWE Recruitment Procedure Description Swedish AU-011-301 Public 2.0
Recruitment arrangements (for publication) K2_AUT Recruitment Brochure English TC AU-011-301 2.0
Recruitment arrangements (for publication) K2_AUT Recruitment Poster German AU-011-301 Public 2.0
Recruitment arrangements (for publication) K2_ESP Recruitment Poster Spanish AU-011-301 Public 2.0
Recruitment arrangements (for publication) K2_ITA Recruitment Poster Italian AU-011-301 Public 2.0
Recruitment arrangements (for publication) K2_NLD Recruitment Brochure Dutch AU-011-301 Public 3.0
Recruitment arrangements (for publication) K2_NLD Recruitment Poster Dutch AU-011-301 Public 2.0
Subject information and informed consent form (for publication) 1_ITA Country ICF Data Protection Italian AU-011-301 Public 1.1
Subject information and informed consent form (for publication) L1_AU-011-301_Data Protection_ICF_IT_Italian_clean_Public 3.0
Subject information and informed consent form (for publication) L1_AU-011-301_GDPR-ICF_CZE_Czech_Public 3.0
Subject information and informed consent form (for publication) L1_AU-011-301_GDPR-ICF_CZE_Ukrainian_Public 3.0
Subject information and informed consent form (for publication) L1_AU-011-301_Greenphire DPN_BEL-ENG_Public 2.0
Subject information and informed consent form (for publication) L1_AU-011-301_Greenphire DPN_BEL-FRA_Public 2.0
Subject information and informed consent form (for publication) L1_AU-011-301_Greenphire DPN_BEL-NLD_Public 2.0
Subject information and informed consent form (for publication) L1_AU-011-301_Greenphire-Data-Protection-Notice_Blank-Statement_AT_Public NA
Subject information and informed consent form (for publication) L1_AU-011-301_Greenphire-Data-Protection-Notice_Blank-Statement_DE_Public NA
Subject information and informed consent form (for publication) L1_AU-011-301_Greenphire-Data-Protection-Notice_IT_Italian_Public 2.0
Subject information and informed consent form (for publication) L1_AU-011-301_Greenphire-DPN-EU-EEA-Site-Driven_ES_Note-to-File_Public NA
Subject information and informed consent form (for publication) L1_AU-011-301_Greenphire-DPN-EU-EEA-Site-Driven_FR_French_Public 2.1
Subject information and informed consent form (for publication) L1_AU-011-301_Greenphire-DPN-EU-EEA-Site-Driven_GR_Note-to-File_Public N/A
Subject information and informed consent form (for publication) L1_AU-011-301_Main ICF_BEL_ENG_Clean_Public 4.0
Subject information and informed consent form (for publication) L1_AU-011-301_Main ICF_BEL_FRA_Clean_Public 4.0
Subject information and informed consent form (for publication) L1_AU-011-301_Main ICF_BEL_NDL_Clean_Public 4.0
Subject information and informed consent form (for publication) L1_AU-011-301_Main ICF_DE_German_Clean_Public 4.0
Subject information and informed consent form (for publication) L1_AU-011-301_Main_ICF_IT_Italian_clean_Public 4.0
Subject information and informed consent form (for publication) L1_AU-011-301_Main-ICF_CZE_Ukrainian_Public 4.0
Subject information and informed consent form (for publication) L1_AU-011-301_Main-ICF_ES_Spanish_Clean_Public 4.0
Subject information and informed consent form (for publication) L1_AU-011-301_Partner or Patient Pregnant Data Protection_ICF_IT_Italian_clean_Public 2.0
Subject information and informed consent form (for publication) L1_AU-011-301_PP ICF_BE_Dutch_Clean_Public 2.0
Subject information and informed consent form (for publication) L1_AU-011-301_PP ICF_BE_English_Clean_Public 2.0
Subject information and informed consent form (for publication) L1_AU-011-301_PP ICF_BE_French_Clean_Public 2.0
Subject information and informed consent form (for publication) L1_AU-011-301_PPP-ICF_CZE_Czech_Public 2.0
Subject information and informed consent form (for publication) L1_AU-011-301_PPP-ICF_CZE_Ukrainian_Public 2.0
Subject information and informed consent form (for publication) L1_AU-011-301_Pregnancy ICF_DE_German_Clean_Public 2.0
Subject information and informed consent form (for publication) L1_AU-011-301_Pregnant Medical Release Form_IT_Italian_clean_Public 2.0
Subject information and informed consent form (for publication) L1_AU-011-301_SIS-and-ICF-adults_NL_Dutch_Public 4.0
Subject information and informed consent form (for publication) L1_AU-011-301_SIS-and-ICF-Pregnancy_NL_Dutch_Public 2.0
Subject information and informed consent form (for publication) L1_AUT Country ICF Main Adult German AU-011-301 Public 4.0
Subject information and informed consent form (for publication) L1_AUT Country ICF Other Adult Pregnancy follow-up German AU-011-301 Public 2.0
Subject information and informed consent form (for publication) L1_AUT Subject Materials Other Contact Data German AU-011-301 Public n/a
Subject information and informed consent form (for publication) L1_CZE Country ICF Main Adult Czech AU-011-301 Public 4.0
Subject information and informed consent form (for publication) L1_CZE Subject Participation Card Czech AU-011-301 Public 1.0
Subject information and informed consent form (for publication) L1_DNK Country ICF Main Adult Danish AU-011-301 Public 4.0
Subject information and informed consent form (for publication) L1_DNK Country PP ICF Danish AU-011-301 Public 2.0
Subject information and informed consent form (for publication) L1_FRA Country ICF Main French AU-011-301 Public 4.0
Subject information and informed consent form (for publication) L1_FRA Country ICF Other Pregnant Partner French AU-011-301 Public 2.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Main Adult English AU-011-301 Public 3.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Main Adult Greek AU-011-301 Public 3.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Other Adult Pregnant Participant English AU-011-301 Public 2.0
Subject information and informed consent form (for publication) L1_GRC Country ICF Other Adult Pregnant Participant Greek AU-011-301 Public 2.0
Subject information and informed consent form (for publication) L1_IRL Country ICF Main English AU-011-301 Public 3.1
Subject information and informed consent form (for publication) L1_IRL Country ICF Other Pregnant Partner English AU-011-301 Public 2.1
Subject information and informed consent form (for publication) L1_ITA Country ICF Pregnant Partner Data Protection Italian AU-011-301 Public 1.1
Subject information and informed consent form (for publication) L1_ITA Subject Materials Other GP Letter Italian AU-011-301 Public 1.0
Subject information and informed consent form (for publication) L1_NLD Country ICF Other Pregnant Partner Dutch AU-011-301 Public 1.2
Subject information and informed consent form (for publication) L1_SWE Country ICF Addendum Swedish AU-011-301 Public 2.0
Subject information and informed consent form (for publication) L1_SWE Country ICF Main Swedish AU-011-301 Public 2.0
Subject information and informed consent form (for publication) L1_SWE Country ICF Other Pregnant Partner Swedish AU-011-301 Public 1.1
Subject information and informed consent form (for publication) L2_AU-011-301_Greenphire_Data_Privacy_Notice_Public 2.0
Subject information and informed consent form (for publication) L2_AU-011-301_Greenphire-DPN-EU-EEA_CZE_Czech_Public 2.0
Subject information and informed consent form (for publication) L2_AU-011-301_Greenphire-DPN-EU-EEA_CZE_Ukrainian_Public 2.0
Subject information and informed consent form (for publication) L2_AU-011-301_ICfs_CoT_Public n/a
Subject information and informed consent form (for publication) L2_AUT Country ICF Procedure English AU-011-301 Public 1.0
Subject information and informed consent form (for publication) L2_BEL Country ICF Procedure English AU-011-301 Public 1.0
Subject information and informed consent form (for publication) L2_DEU Country ICF Procedure English AU-011-301 Public 1.0
Subject information and informed consent form (for publication) L2_DNK Country ICF Procedure English AU-011-301 Public 1.2
Subject information and informed consent form (for publication) L2_GRC Country ICF Procedure English AU-011-301 Public 2.0
Subject information and informed consent form (for publication) L2_IRL Country ICF Procedure English AU-011-301 Public 1.0
Subject information and informed consent form (for publication) L2_SWE Country ICF Procedure Swedish AU-011-301 Public 1.0
Subject information and informed consent form (for publication) LL1_AU-011-301_Pregnancy-ICF_ES_Spanish_Clean_Public 2.0
Synopsis of the protocol (for publication) D1_ Aura_AU-011-301_Lay Synopsis _2023-504655-27-00_BEL_DEU_Public 5.0
Synopsis of the protocol (for publication) D1_ Aura_AU-011-301_Lay Synopsis _2023-504655-27-00_CZE_Public 5.0
Synopsis of the protocol (for publication) D1_ Aura_AU-011-301_Lay Synopsis _2023-504655-27-00_ESP_Public 5.0
Synopsis of the protocol (for publication) D1_ Aura_AU-011-301_Lay Synopsis _2023-504655-27-00_FRA_Public 5.0
Synopsis of the protocol (for publication) D1_ Aura_AU-011-301_Lay Synopsis _2023-504655-27-00_ITA_Public 5.0
Synopsis of the protocol (for publication) D1_ Aura_AU-011-301_Lay Synopsis_2023-504655-27-00_DEU_Public 5.0
Synopsis of the protocol (for publication) D1_ Aura_AU-011-301_Lay Synopsis_2023-504655-27-00_FR_BE_Public 5.0
Synopsis of the protocol (for publication) D1_ Aura_AU-011-301_Lay Synopsis_2023-504655-27-00_NL_BE_Public 5.0
Synopsis of the protocol (for publication) D1_Aura_AU-011-301_Lay Synopsis _2023-504655-27-00_NLD_Public 5.0
Synopsis of the protocol (for publication) D1_Aura_AU-011-301_Lay Synopsis_2023-504655-27-00_Public 5.0

Application history

19 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-11-29 Spain Acceptable with conditions
2024-05-20
 2024-05-20
2 NON SUBSTANTIAL MODIFICATION NSM-1 2024-06-14 Spain Acceptable with conditions
2024-05-20
 2024-06-14
3 SUBSTANTIAL MODIFICATION SM-1 2024-07-22 Spain Acceptable with conditions
2024-09-03
 2024-09-04
4 NON SUBSTANTIAL MODIFICATION NSM-2 2024-10-31 Acceptable with conditions
2024-09-03
 2024-10-31
5 NON SUBSTANTIAL MODIFICATION NSM-3 2024-11-08 Spain Acceptable with conditions
2024-09-03
 2024-11-08
6 NON SUBSTANTIAL MODIFICATION NSM-4 2025-02-06 Spain Acceptable with conditions
2024-09-03
 2025-02-06
7 SUBSTANTIAL MODIFICATION SM-2 2025-03-21 Spain Acceptable
2025-06-30
 2025-06-30
8 NON SUBSTANTIAL MODIFICATION NSM-5 2025-07-09 Acceptable
2025-06-30
 2025-07-09
9 SUBSTANTIAL MODIFICATION SM-3 2025-07-21 Acceptable 2025-08-25
10 SUBSTANTIAL MODIFICATION SM-4 2025-07-22 Spain Acceptable 2025-07-30
11 SUBSTANTIAL MODIFICATION SM-5 2025-07-24 Acceptable 2025-09-01
12 SUBSTANTIAL MODIFICATION SM-6 2025-08-13 Acceptable 2025-09-15
13 NON SUBSTANTIAL MODIFICATION NSM-6 2025-11-12 Acceptable 2025-11-12
14 NON SUBSTANTIAL MODIFICATION NSM-7 2025-11-17 Spain Acceptable 2025-11-17
15 NON SUBSTANTIAL MODIFICATION NSM-8 2025-11-20 Spain Acceptable 2025-11-20
16 SUBSTANTIAL MODIFICATION SM-7 2025-11-27 Spain Acceptable
2026-03-19
 2026-03-19
17 NON SUBSTANTIAL MODIFICATION NSM-9 2026-03-31 Spain Acceptable
2026-03-19
 2026-03-31
18 NON SUBSTANTIAL MODIFICATION NSM-10 2026-04-29 Acceptable
2026-03-19
 2026-04-29
19 NON SUBSTANTIAL MODIFICATION NSM-11 2026-05-05 Acceptable
2026-03-19
 2026-05-05