Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
317
Countries
9
Sites
33
Moderate to Severly Active Ulcerative Colitis
To evaluate the efficacy, including clinical remission, of guselkumab SC induction compared to placebo in participants with moderately to severely active UC
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 21 Feb 2023 → ongoing
- Decision date (initial)
- 2024-06-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Janssen Research & Development
External identifiers
- EU CT number
- 2023-504719-34-00
- EudraCT number
- 2022-000365-41
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Pharmacokinetic, Pharmacodynamic, Efficacy, Therapy, Dose response, Safety
To evaluate the efficacy, including clinical remission, of guselkumab SC
induction compared to placebo in participants with moderately to
severely active UC
Conditions and MedDRA coding
Moderate to Severly Active Ulcerative Colitis
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
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Documented diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline.
- Moderately to severely active UC as assessed by the modified mayo score
- Demonstraed inadequate response to or intolerance of conventional (ie, 6-MP, AZA, or corticosteroids) or advanced therapy (ADT; ie, TNFα antagonists, vedolizumab, ozanimod, or approved JAK inhibitors).
Exclusion criteria 5
- 1.Has severe extensive colitis as defined in the protocol
- 2.Extent of inflammatory disease limited to the rectum
- 3.Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease (CD)
- 4.Has a history of, or ongoing, chronic or recurrent infectious disease
- 5.Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 weeks prior to first dose of study intervention)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Clinical remission (at week 12)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10890564 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 248 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
PRD2827309 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- INJECTION/INFUSION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 248 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
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
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 7
| Organisation | City, country | Duties |
|---|---|---|
| Alimentiv Inc. ORG-100006515
|
London, Canada | Other, Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other, E-data capture |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 8, Ireland | Code 13, Data management |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other, Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Other, Interactive response technologies (IRT) |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other, E-data capture |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Other |
Locations
9 EU/EEA countries · 33 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 2 | 1 |
| Bulgaria | Ongoing, recruitment ended | 3 | 2 |
| Czechia | Ongoing, recruitment ended | 12 | 3 |
| France | Ongoing, recruitment ended | 12 | 5 |
| Germany | Ongoing, recruitment ended | 5 | 2 |
| Hungary | Ongoing, recruitment ended | 8 | 3 |
| Poland | Ongoing, recruitment ended | 93 | 13 |
| Slovakia | Ended | 2 | 2 |
| Spain | Ongoing, recruitment ended | 6 | 2 |
| Rest of world
Korea, Republic of, Taiwan, Brazil, Israel, Jordan, Mexico, India, Argentina, China, Australia, Canada, Japan, Turkey, Malaysia, New Zealand, United States
|
— | 174 | — |
Investigational sites
Diagnostics And Consultation Center Convex Ltd.
n/a, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
Medical center Asclepion humane medicine researches EOOD
n/a, Ulitsa Damyan Gruev 8a, 1303, Sofia
Nemocnice Ceske Budejovice a.s.
Gastroenterologické oddělení, B. Nemcove 585/54, 370 01, Ceske Budejovice
Axon Clinical s.r.o.
n/a, Ostrovskeho 253/3, Smichov, Prague 5
Gastroenterologie s.r.o.
n/a, Manesova 646/16, 500 02, Hradec Kralove
CHRU De Nancy
Hepato Gastroenterology Department, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Nouvelles Cliniques Nimoises
Hepato Gastroenterology Department, 3 Rue Jean Bouin, 30000, Nimes
Centre Hospitalier Universitaire De Toulouse
Hepato Gastroenterology Department, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Medico Chirurgical Ambroise Pare Hartmann
Institut des MICI, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Centre Hospitalier Universitaire De Bordeaux
Hepato Gastroenterology Department, Avenue De Magellan, 33600, Pessac
Medizinisches Versorgungszentrum (MVZ) Dachau
Medizinisches Versorgungszentrum (MVZ) Dachau, Muenchner Str. 64, 85221, Dachau
Medizinische Hochschule Hannover
Klinik fur Gastroenterologie, Hepatologie und Endokrinologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Semmelweis University
Gasztroenterológia, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Semmelweis University
Gasztroenterológia, Ulloi Ut 78, 1082, Budapest
Vasutegeszseguegyi Nonprofit Koezhasznu Kft.
Gasztroenterológia, Erzsebet Utca 11-13, 4025, Debrecen
Bodyclinic Sp. z o.o. sp.k.
Bodyclinic Sp. z o.o. Sp. k., Ul. Ulica Jozefa Sierakowskiego 4/u3, 03-712, Warsaw
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia - SCM, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Centrum Medyczne Medyk Sp. z o.o. S.K.
Centrum Medyczne Medyk, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Gastromed Sp. z o.o.
Gastromed Sp. z o.o., Ul. Grudziadzka 11/13-14, 87-100, Torun
Medical Network Sp. z o.o.
Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus, Ul. Plowiecka 103, 04-501, Warsaw
Promed P.Lach R.Glowacki Sp. j.
Centrum Medyczne PROMED, Ul. Olszanska 5g, 31-513, Cracow
Vistamed & Vertigo Sp. z o.o.
Vistamed & Vertigo Sp. z o.o., Ul Raclawicka 105 1b, 53-149, Wroclaw
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Centrum Medyczne Plejady, U2 U3 U4 U5, Ul. Tadeusza Szafrana 5d, Cracow
Gastromed Kralisz Romatowski Stachurska Sp. j.
Gastromed Kralisz Romatowski Stachurska Sp. j., Ul. Wiosenna 12/1, 15-322, Bialystok
Centrum Medyczne Lukamed Sp. z o.o.
Centrum Medyczne LukaMed, Ul. Mickiewicza 39, 89-600, Chojnice
Pro Life Medica Sp. z o.o.
Pro Life Medica Sp z o o ETG Zamosc, Ul. Gesia 3, 22-400, Zamosc
Melita Medical Sp. z o.o.
Centrum Medyczne MELITA MEDICAL, Ul. Strzegomska 2-4, 53-611, Wroclaw
Centrum Medyczne Lukamed Sp. z o.o.
Centrum Medyczne LukaMed, Ul. Mickiewicza 39, 89-600, Chojnice
Endomed s.r.o.
Gastroenterologicka ambulancia, Americka Trieda 17, Poliklinika Tahanovce, Kosice
Cliniq s.r.o.
Gastroenterologicka ambulancia, Bezrucova 5, Stare Mesto, Bratislava
Hospital Universitario Virgen De La Macarena
Gastroenterology Service, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Marina Baixa De La Vila Joiosa
Gastroenterology Service, Avenida Alcalde En Jaume Botella Mayor 7, 03570, Villajoyosa
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 | 2023-05-09 | 2023-05-09 | 2023-08-22 | ||
| Bulgaria | 2023-03-10 | 2023-03-10 | 2023-08-23 | ||
| Czechia | 2023-03-15 | 2023-03-15 | 2023-08-23 | ||
| France | 2023-04-24 | 2023-04-24 | 2023-08-04 | ||
| Germany | 2023-05-09 | 2023-05-09 | 2023-08-10 | ||
| Hungary | 2023-04-12 | 2023-04-12 | 2023-07-13 | ||
| Poland | 2023-02-21 | 2023-02-21 | 2023-08-23 | ||
| Slovakia | 2023-06-05 | 2025-02-04 | 2023-06-05 | 2023-07-11 | |
| Spain | 2023-03-06 | 2023-03-06 | 2023-07-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 86 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_REDACTED_Protocol 2023-504719-34 | Am4-EEA1 |
| Protocol (for publication) | D4_REDACTED PF Subject Diary_multilingual | 3 |
| Protocol (for publication) | D4_REDACTED_PF C-SSRS-BLS_multilingual | NA |
| Protocol (for publication) | D4_REDACTED_PF C-SSRS-SLV_multilingual | NA |
| Protocol (for publication) | D4_REDACTED_PF IBDQ_multilingual | NA |
| Protocol (for publication) | D4_REDACTED_PF Mayo Diary_multilingual | NA |
| Protocol (for publication) | D4_REDACTED_PF PROMIS-29_multilingual | 2.1 |
| Protocol (for publication) | D4_REDACTED_PF UC-PRO-SS_multilingual | 7 |
| Protocol (for publication) | REDACTED_D4_PF Subject Diary p week 96_multicountry_ENG_2023-504719-34 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Subject Diary post week 96_BE_Dut_2023-504719-34 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Subject Diary post week 96_BE_Fre_2023-504719-34 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Subject Diary post week 96_CZ_cze_2023-504719-34 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Subject Diary post Week 96_FR_FRE_2023-504719-34 | 1 |
| Protocol (for publication) | REDACTED_D4_PF Subject Diary post Week 96_HU_HUN_ 2023-504719-34 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Dosing diary after W96_DE_GER_2023-504719-34 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Dosing Diary after week 96_BG_bul_2023-504719-34 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Dosing Subj Diary after W96_ES_SPA_ 2023-504719-34 | 1 |
| Protocol (for publication) | REDACTED_D4_PF_Subject Diary post Week 96_SK_slo_2023-504719-34 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arragements_BG_EN_CNTO1959UCO3004 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arragements_CZ_ENG_CNTO1959UCO3004 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arragements_ES_EN_CNTO1959UCO3004 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arragements_PL_EN_CNTO1959UCO3004 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arragements_SK_EN_CNTO1959UCO3004 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements _FR_eng_2023-504719-34 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_HU_ENG_CNTO1959UCO3004 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Placeholder_Recruitment Arragements_DE_ENG_CNTO1959UCO3004 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements-Placeholder_BE_en_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED _L1_SIS and ICF Clinical_AA5-SK10002_SK_slo_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF 12 Month post birth ICF child follow up_FR_FRE_2023-504719-34 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF 12 months infant follow-up _BG_BUL_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF 12 months infant follow-up _BG_ENG_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF 12 Months Infant follow-up_CZ_cze_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF 12 months infant follow-up_PL_POL_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF 12 Months Post-Birth Child FU_HU_HUN_ 2023-504719-34 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 2_PL_POL_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum Master_ES_SPA_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_PL_POL_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical Addendum 2_ES_SPA_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_AA5-SK10003_SK_slo_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Future Research_CZ_CZE_CNTO1959UCO3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF GDPR_SK_sk_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | Redacted_L1_SIS and ICF Main _HU_HUN_CNTO1959UCO3004 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum 2_DE_GER_2023-504719-34 | 1.0 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_fr_CNTO1959UCO3004 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_nl_CNTO1959UCO3004 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_CZ_cze_2023-504719-34 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_PL_pol_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_ES_ES_CNTO1959UCO3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF PP_SK_sk_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | Redacted_L1_SIS and ICF Pregnant partner _HU_HUN_CNTO1959UCO3004 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_BE_Dut_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_BE_Fre_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_CZ_CZE_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_ES_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PL_pol_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Language to ICF_CZ_CZE_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Separate Future_SK_sk_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Clinical informed consent_DE_GER_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Country-spec Clinical ICF_BG_bul_CNTO1959UCO3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Country-spec Clinical ICF_BG_eng_2023-504719-34 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Country-spec Pregnant Partner ICF_BG_bul_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_FR_fre_2023-504719-34 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Clinical Addendum_DE_GER_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Pregnant Partner ICF_BG_eng_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Opt future research informed consent_DE_GER_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant partner informed consent_DE_GER_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_FR_fre_2023-504719-34 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BE_fr_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BE_nl_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BG_bul_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_CZ_CZE_CNTO1959UCO3004 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DE_GER_2023-504719-34 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_fre_2023-504719-34 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_HU_HUN_2023-504719-34 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_pol_CNTO1959UCO3004 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_SK_sk_CNTO1959UCO3004 | 2 |
| Synopsis of the protocol (for publication) | D1_REDACTED Protocol Synopsis CZ 2023-504719-34 | Am3-EEA-1 |
| Synopsis of the protocol (for publication) | D1_REDACTED Protocol synopsis ES 2023-504719-34 | Amd3 EEA-1 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis BE_de_2023-504719-34 | Am3 EEA-1 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis BE_fr_2023-504719-34 | Am3 EEA-1 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis BE_nl_2023-504719-34 | Am3 EEA-1 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis HU_2023-504719-34 | Am4-EEA1 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_FR_2023-504719-34 | Am3-EEA1 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_PL_pol_2023-504719-34 | Am3 EEA-1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BG_bul_2023-504719-34 | Am4-EEA1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_SK_slo_2023-504719-34 | Amd3 EEA-1 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-14 | Germany | Acceptable 2024-06-18
|
2024-06-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-29 | Germany | Acceptable 2025-02-17
|
2025-02-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-09 | Germany | Acceptable 2025-02-17
|
2025-04-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-14 | Acceptable | 2025-05-21 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-08 | Germany | Acceptable 2025-09-08
|
2025-09-08 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-22 | Germany | Acceptable 2025-12-21
|
2025-12-22 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-13 | Germany | Acceptable 2025-12-21
|
2026-01-13 |