Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
302
Countries
11
Sites
44
Geographic Atrophy
Long-term safety and tolerability after an intravitreal injection of JNJ-81201887 administered in parent clinical studies.
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 27 Feb 2025 → ongoing
- Decision date (initial)
- 2024-11-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Janssen Research & Development, LLC
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
Long-term safety and tolerability after an intravitreal injection of JNJ-81201887 administered in parent clinical studies.
Conditions and MedDRA coding
Geographic Atrophy
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-500746-16-00 | A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) | Janssen - Cilag International |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 1. Study participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study.
- 2. Must sign an ICF indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. The ICF may be signed by an impartial witness and/or legally designated representative depending on national/local regulations.
Exclusion criteria 1
- NA, LTE study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Ocular and systemic treatment-emergent adverse events.
- Clinical laboratory and safety assessments.
- Retinal imaging (FAF, SD-OCT, and CFP) and eye examinations.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD10027736 · Product
- Active substance
- Adeno-Associated Virus Serotype 2 Encoding Soluble CD59
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 0 ml millilitre(s)
- Max total dose
- 0 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10041843 · Product
- Active substance
- Adeno-Associated Virus Serotype 2 Encoding Soluble CD59
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 0 ml millilitre(s)
- Max total dose
- 0 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Prednison acis 5 mg, Tabletten
PRD889556 · Product
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- 49572.00.00
- MA holder
- ACIS ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- over encapsulation
Prednison acis 20 mg, Tabletten
PRD889557 · Product
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- 46168.00.00
- MA holder
- ACIS ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- over encapsulation
Kenacort-A 40, suspensie voor injectie 40 mg/ml
PRD338432 · Product
- Active substance
- Triamcinolone Acetonide
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- OCULAR USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB08 — TRIAMCINOLONE
- Marketing authorisation
- RVG 05341
- MA holder
- BRISTOL-MYERS SQUIBB B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary re-packaging and re-labelling
Placebo 1
Placebo to match Prednisone 20mg, 5mg
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
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Drug Development Inc. ORG-100051241
|
Princeton, United States | Laboratory analysis |
| Boston Image Reading Center LLC ORG-100046514
|
Boston, United States | Other |
| Optymedge LLC ORG-100045359
|
Rockville, United States | Other |
| Labconnect LLC ORG-100042800
|
Johnson City, United States | Laboratory analysis |
| Fisher Clinical Services Inc. ORG-100014726
|
Allentown, United States | Other |
Locations
11 EU/EEA countries · 44 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 3 | 3 |
| Czechia | Ongoing, recruiting | 10 | 2 |
| Denmark | Ongoing, recruiting | 6 | 1 |
| Germany | Ongoing, recruiting | 22 | 8 |
| Hungary | Ongoing, recruiting | 6 | 3 |
| Italy | Ongoing, recruiting | 10 | 6 |
| Netherlands | Ongoing, recruiting | 2 | 2 |
| Poland | Ongoing, recruiting | 9 | 2 |
| Portugal | Ongoing, recruiting | 6 | 3 |
| Spain | Ongoing, recruiting | 45 | 13 |
| Sweden | Ongoing, recruiting | 1 | 1 |
| Rest of world
Switzerland, Canada, Turkey, United Kingdom, United States, Australia
|
— | 182 | — |
Investigational sites
Ziekenhuis Oost Limburg
Department of Ophthalmology, Synaps Park 1, 3600, Genk
Universiteit Gent
Department of Ophthalmology, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Department of Ophthalmology, Herestraat 49, 3000, Leuven
Fakultni Nemocnice Kralovske Vinohrady
Vitreoretinální oddělení a makulární centrum, Srobarova 1150/50, Vinohrady, Prague
Axon Clinical s.r.o.
NA, Ostrovskeho 253/3, Smichov, Prague 5
Rigshospitalet
HovedOrtoCentret – Afdeling for Øjensygdomme, Afsnit 37, Valdemar Hansens Vej 1-23, 2600, Glostrup
Medizinische Hochschule Hannover
NA, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Muenster AöR
Klinik fuer Augenheilkunde, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitätsklinikum Bonn AöR
NA, Ernst-Abbe-Str. 2, Germany, Bonn
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
NA, Bremserstrasse 79, Friesenheim, Ludwigshafen Am Rhein
Universitaetsmedizin Goettingen
NA, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaet Leipzig
NA, Liebigstrasse 12, Zentrum-Suedost, Leipzig
Augenzentrum Am St Franziskus-Hospital Muenster
Augenzentrum am St Franziskus-Hospital Münster, Hohenzollernring 74, Herz-Jesu, Munster
Universitaetsklinikum Tuebingen AöR
NA, Elfriede-Aulhorn-Strasse 7, Nordstadt, Tuebingen
Zala Varmegyei Szent Rafael Korhaz
NA, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg
Central Hospital Of Northern Pest Military Hospital
Szemészeti Osztály, Podmaniczky Utca 109, 1062, Budapest VI
Nozologen Kft.
NA, Varady Antal Utca 10 Fszt. 5, 7621, Pecs
ASST Fatebenefratelli Sacco
Clinica Oculistica, Via Giovanni Battista Grassi 74, 20157, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Unità Operativa Complessa Oculistica, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
U.O.C. Clinica Oculistica, Via Santa Maria Di Costantinopoli 104, 80138, Naples
Ospedale San Raffaele S.r.l.
Unità di Oculistica, Via Olgettina 60, 20132, Milan
University Hospital Of Ferrara
Unità Operativa Complessa di clinical oculistica, Cona, Via Aldo Moro 8, Ferrara
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Malattie Apparato Visivo, Via Francesco Sforza 28, 20122, Milan
Stichting Radboud universitair medisch centrum
Department of Ophthalmology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
The Rotterdam Eye Hospital
NA, Schiedamse Vest 180, 3011 BH, Rotterdam
Warszawski Szpital Okulistyczny Sp. z o.o.
NA, Ul. Wolska 165/u7, 01-258, Warsaw
Oftalmika Sp. z o.o.
NA, Ul. Modrzewiowa 15, 85-631, Bydgoszcz
Unidade Local De Saude De Coimbra E.P.E.
Oftalmologia, Praceta Professor Mota Pinto, 3004-561, Coimbra
Unidade Local de Saude de Sao Joao E.P.E.
Oftalmologia, Alameda Professor Hernani Monteiro, 4200-319, Porto
Rufino Silva & Joao Figueira Espaco Medico De Coimbra Lda.
Oftalmologia, Rua Camara Pestana 37, 3030-163, Coimbra
Hospital Universitari General De Catalunya
Servicio de Oftalmologia, Carrer Pedro I Pons 1, 08195, Sant Cugat Del Valles
Hospital Clinico Universitario Lozano Blesa
Servicio de Oftalmologia, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario Fundacion Jimenez Diaz
Servicio de Oftalmologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
University Hospital Virgen Del Rocio S.L.
Servicio de Oftalmologia, Avenida De Manuel Siurot S/n, 41013, Sevilla
Clinica Baviera S.A.
Servicio de Oftalmologia, Paseo De La Castellana 20, 28046, Madrid
Hospital Universitario 12 De Octubre
Servicio de oftalmologia, Bloque D, Avenida De Cordoba Sn, Madrid
Centro De Oftalmologia Barraquer S.A.
NA, Calle Muntaner 314, 08021, Barcelona
Hospital Universitario Puerta De Hierro De Majadahonda
Servicio de Oftalmologia, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Clinica Universidad De Navarra
Servicio de Oftalmologia, Pio XII Etorbidea 36, 31008, Pamplona
Centro Medico Teknon-Grupo Quironsalud
NA, Calle Vilana 12, 08022, Barcelona
Oftalmologia Vistahermosa S.L.
NA, Avenida De La Ilustracion 1, Poligono Industrial De Burjassot, Burjassot
Clinica De Oftalmologia De Cordoba S.L.
NA, Avenida De La Arruzafa 9, 14012, Cordoba
Institut Catala De Retina S.L.
NA, Calle De La Pau Alcover 67, 08017, Barcelona
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 | 2025-06-24 | 2025-06-24 | |||
| Czechia | 2025-05-21 | 2025-05-21 | |||
| Denmark | 2025-06-03 | 2025-06-03 | |||
| Germany | 2025-03-24 | 2025-03-24 | |||
| Hungary | 2025-07-16 | 2025-07-16 | |||
| Italy | 2025-04-09 | 2025-04-09 | |||
| Netherlands | 2025-04-10 | 2025-04-10 | |||
| Poland | 2025-03-18 | 2025-03-18 | |||
| Portugal | 2025-07-21 | 2025-07-21 | |||
| Spain | 2025-02-27 | 2025-02-27 | |||
| Sweden | 2025-10-07 | 2025-10-07 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-IT-0001
- Member state
- Italy
- Publication date
- 2025-09-12
- Type
- 1
- Reason
- 6
- Reverted date
- 2025-09-12
- Immediate action required
- Yes
- Notes
- Reverted (2025-09-12)
- Justification
- Dear Applicant,
Considering the expiration of the three-year mandate of the members of the National Ethics Committee (CEN) for clinical trials relating to advanced therapies (“ATMP”) and of the National Ethics Committee (CEN) for clinical trials in the pediatric field, appointed by Decree of the Minister of Health - 2 March 2022;
Considering the fact that, due to the expiration of the mandate of the members of the aforementioned National Ethics Committee (CEN), for the procedure in subject the assessment of the aspects relating to Part II of the evaluation report pursuant to art. 7 of the aforementioned Regulation (EU) No. 536/2014 has not been carried out, and as a result there is no conclusion of Part II for the EU CT 2022-500747-21-00 procedure (AIFA authorization provision n° 0107337);
In compliance with CHAPTER XIII (SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS) of Regulation 536/2014 with specific reference to Article 77 (Corrective measures to be taken by Member States):
1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a) revoke the authorisation of a clinical trial;
(b) suspend a clinical trial;
(c) require the sponsor to modify any aspect of the clinical trial.
A corrective measure is applied suspending the trial. This corrective measure is only applicable to Italy.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 78 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | REDACTED_D1_Protocol_2022-500747-21 | Amd 4 |
| Protocol (for publication) | REDACTED_D4_PF_FRII_MULTILINGUAL | 1 |
| Protocol (for publication) | REDACTED_D4_PF_NEI-VFQ-25_MULTILUNGUAL | 1 |
| Protocol (for publication) | REDACTED_D4_PF_PGIC_MULTILINGUAL | 1 |
| Protocol (for publication) | REDACTED_D4_PF_PGIS_MULTILINGUAL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Placeholder_HU_ENG_2022-500747-21 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _IT_ITA_2022-500747-21 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _PL_POL_2022-500747-21 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _PT_ENG_2022-500747-21 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements _SE_Swe_2022-500747-21 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_BE_Eng_2022-500747-21 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_CZ_ENG_2022-500747-21 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_DE_ENG_2022-500747-21 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_DK_eng_2022-500747-21 | 2 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_ES_ENG_2022-500747-21 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment arrangements_NL_Eng_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF _Imaging Addendum_PL_POL_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Certification ICF_SE_swe_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_ES_SPA_2022-500747-21 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Images_ES_SPA_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Dut_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Fre_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_NL_Dut_2022-500747-21 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Non interventional imaging_IT_ITA_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Non Interventional_PT_POR_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Pregnancy_IT_ITA_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_CZ_CZE_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_DK_dan_2022-500747-21 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_IT_ITA_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_PL_POL_2022-500747-21 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_PT_POR_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_CZ_CZE_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Patient Travel Reimbursement_IT_ita_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Photography_BE_Dut_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Photography_BE_Fre_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Photography_NL_Dut_2022-500747-21 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_BE_Dut_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_BE_Fre_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_CZ_CZE_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_DK_dan_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_SPA_2022-500747-21 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PL_POL_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PT_POR_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Appendix for Child_IT_ITA_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Appendix Master_IT_ITA_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Appendix Non interventional imag_IT_ITA_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Appendix Pregnant Partner_IT_ITA_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Language_CZ_CZE_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Reduced Follow Up ICF_PT_POR_2022-500747-21 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Test examination_CZ_CZE_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_ICF Imaging Certification_DE_GER_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Imaging_HU_HUN_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master ICF_SE_swe_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master_HU_HUN_2022-500747-21 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner ICF_DE_GER_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_HU_HUN_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_NL_Dut_2022-500474-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and Master ICF_DE_GER_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_CZ_CZE_2022-500747-21 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DE_GER_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_HU_HUN_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_IT_ITA_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_POL_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PT_POR_2022-500747-21 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_SE_swe_2022-500747-21 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Prednisone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Triamcinolone | 1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Dut_2022-500747-21 | Amd4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Fre_2022-500747-21 | Amd4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_BE_Ger_2022-500747-21 | Amd4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_CZ_CZE_2022-500747-21 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_SPA_2022-500747-21 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_HU_HUN_2022-500747-21 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_IT_ITA_2022-500747-21 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_NL_Dut_2022-500747-21 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PL_pol_2022-500747-21 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PT_POR_2022-500747-21 | Am4 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_SE_Swe_2022-500747-21 | Am4 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-23 | Netherlands | Acceptable with conditions 2024-11-18
|
2024-11-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-11 | Netherlands | Acceptable with conditions 2024-11-18
|
2024-12-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-19 | Netherlands | Acceptable 2025-04-11
|
2025-04-11 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-29 | Netherlands | Acceptable 2025-04-11
|
2025-04-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-27 | Acceptable | 2025-06-04 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-28 | Acceptable | 2025-07-09 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-29 | Acceptable | 2025-06-27 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-05-29 | Acceptable | 2025-06-12 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-06-11 | Acceptable | 2025-07-24 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-10 | Acceptable | 2025-08-25 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-07-11 | Acceptable | 2025-08-19 | |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-13 | Netherlands | Acceptable | 2026-02-13 |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-04-21 | Acceptable | 2026-06-11 |