Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruitment ended
Participants planned
1,471
Countries
13
Sites
65
Moderately to Severely Active Ulcerative Colitis
To evaluate the efficacy and safety of guselkumab in 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] - Digestive System Diseases [C06]
- Trial duration
- 19 Oct 2019 → ongoing
- Decision date (initial)
- 2024-07-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504718-31-00
- EudraCT number
- 2018-004002-25
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacoeconomic, Pharmacogenomic, Pharmacokinetic, Dose response, Pharmacodynamic, Safety, Efficacy
To evaluate the efficacy and safety of guselkumab in moderately to
severely active UC.
Conditions and MedDRA coding
Moderately to Severely Active Ulcerative Colitis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Male or female, 18 years of age or older
- 2. Documented diagnosis of UC at least 3 months before screening
- 3. Moderately to severely active UC as defined by baseline modified Mayo score
- 4. History of inadequate response to or failure to tolerate conventional or advanced therapy as defined in the protocol
- 5. Screening laboratory test results within the study protocol defined parameters
Exclusion criteria 8
- 1. Severe extensive colitis as defined in the study protocol
- 2. UC limited to the rectum only
- 3. Presence of a stoma
- 4. Presence or history of a fistula
- 5. Presence of symptomatic colonic or small bowel obstruction
- 6. History of extensive colonic resection
- 7. History of colonic mucosal dysplasia
- 8. Indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Clinical Response at Induction Week 12
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
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
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
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 13
| Organisation | City, country | Duties |
|---|---|---|
| Eresearchtechnology Inc. ORG-100013039
|
Pittsburgh, United States | E-data capture |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
| Tata Consultancy Services Limited ORG-100044792
|
Thane, India | Data management |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Other |
| Kcas LLC ORG-100043073
|
Olathe, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Interactive response technologies (IRT) |
| Labcorp Development (Asia) Pte Ltd ORG-100050418
|
Singapore, Singapore | Other, Laboratory analysis |
| Imperial Clinical Research Services International Limited ORG-100037442
|
Shepperton, United Kingdom | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other, Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Code 13, Other, Code 8 |
| Synexus Clinical Research Limited ORL-000008077
|
Chorley, Lancashire, United Kingdom | Code 2 |
| Katholieke Universiteit te Leuven ORG-100012246
|
Leuven, Belgium | Laboratory analysis |
Locations
13 EU/EEA countries · 65 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 8 | 2 |
| Bulgaria | Ongoing, recruitment ended | 7 | 3 |
| Czechia | Ongoing, recruitment ended | 36 | 8 |
| France | Ongoing, recruitment ended | 65 | 10 |
| Germany | Ongoing, recruitment ended | 28 | 4 |
| Hungary | Ongoing, recruitment ended | 42 | 6 |
| Italy | Ongoing, recruitment ended | 42 | 5 |
| Latvia | Ongoing, recruitment ended | 8 | 3 |
| Poland | Ongoing, recruitment ended | 188 | 15 |
| Portugal | Ended | 6 | 1 |
| Slovakia | Ongoing, recruitment ended | 14 | 3 |
| Spain | Ongoing, recruitment ended | 9 | 3 |
| Sweden | Ongoing, recruitment ended | 7 | 2 |
| Rest of world
Jordan, Israel, Australia, Taiwan, Turkey, Russian Federation, Argentina, Brazil, Japan, United Kingdom, Malaysia, Korea, Republic of, Canada, Serbia, United States, New Zealand, China, Ukraine
|
— | 1,011 | — |
Investigational sites
Het Ziekenhuisnetwerk Antwerpen
Gastroenterology, Lange Bremstraat 70, 2170, Antwerp
Algemeen Ziekenhuis Delta
CTC MDL, Brugsesteenweg 90, 8800, Roeselare
Second Multiprofile Hospital For Active Treatment Sofia EAD
Department of Gastroenterology, Internal Diseases Clinic, Bulevard Hristo Botev 120, 1202, Sofia
Diagnostics And Consultation Center Convex Ltd.
NA, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
Acibadem City Clinic University Hospital EOOD
Gastroenterology Clinic, Bulevard Tsarigradsko Shose 66a, 1784, Sofia
Nemocnice Ceske Budejovice a.s.
Gastroenterologicke oddeleni, B. Nemcove 585/54, 370 01, Ceske Budejovice
Artroscan s.r.o.
Gastroenterologicka ambulance, Trebovicka 5114/106, 722 00, Trebovice
Axon Clinical s.r.o.
NA, Ostrovskeho 253/3, Smichov, Prague 5
Nemocnice Strakonice a.s.
Interni oddeleni, Radomyslska 336, 386 01, Strakonice I
Synexus Czech s.r.o.
Klinika Praha, Karlovo Namesti 2097/10, Nove Mesto, Prague
Endohope Havirov s.r.o.
Gastroenterologie, Dlouha Trida 1134/83, Podlesí, Havirov
Iscare a.s.
Klinicke a vyzkumne centrum pro strevni zanety (IBD), Ceskomoravska 2510/19, Liben, Prague
Gastroenterologie s.r.o.
NA, Manesova 646/16, 500 02, Hradec Kralove
Centre Hospitalier Universitaire De Toulouse
Gastroenterology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Lille
Service des Maladies de l'Appareil Digestif, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Hospices Civils De Lyon
Gastroenterology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Hopital Beaujon
Gastroenterology, 100 Boulevard Du General Leclerc, 92110, Clichy
Les Hopitaux Universitaires De Strasbourg
Hepato-gastroenterology and Nutrition, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire De Caen Normandie
Hepato-gastroenterology and Nutrition, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Saint Etienne
Hepato-gastroenterology and Digestive Oncology, 25 Boulevard Pasteur, 42100, Saint-Etienne
Centre Hospitalier Universitaire De Nice
Hepato-gastroenterology and Nutrition, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Bordeaux
Hepato-gastroenterology and Nutrition, Avenue De Magellan, 33600, Pessac
CHRU De Nancy
Hepato-gastroenterology, Co N°34, 29 Avenue Du Mal De Lattre De Tassigny, Nancy Cedex
Praxisgemeinschaft Jerichow
(not applicable), Johannes-Lange-Str. 20, 39319, Jerichow
Universitaetsklinikum Ulm AöR
Klinik fuer Innere Medizin I, Albert-Einstein-Allee 23, Eselsberg, Ulm
Studiengesellschaft BSF UG (haftungsbeschraenkt)
(not applicable), Grosse Nikolaistrasse 7, Altstadt, Halle (Saale)
Medizinische Hochschule Hannover
Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
SYNEXUS Magyarorszag Kft.
N/A, Becsi Ut 61, 1036, Budapest III
Vasutegeszseguegyi Nonprofit Koezhasznu Kft.
N/A, Erzsebet Utca 11-13, 4025, Debrecen
Central Hospital Of Northern Pest Military Hospital
N/A, Podmaniczky Utca 109, 1062, Budapest VI
Gyoengyosi Bugat Pal Koerhaz
N/A, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
Semmelweis University
I. sz. Sebészeti Klinika, Ulloi Ut 78/b, 1082, Budapest
Semmelweis University
Belgyogyaszati es Hematologiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
UOC Gastroenterologia ed Endoscopia, Via Francesco Sforza 28, 20122, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Medicina Interna e Gastroenterologia Complesso Integrato Columbus, Largo Francesco Vito 1, 00168, Rome
Casa Sollievo Della Sofferenza
Unità Operativa Complessa di Endoscopia Digestiva, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Malattie Infiammatorie Croniche Intestinali, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera di Padova
Dipartimento Scienze Chirurgiche e Gastroenterologiche UOC Gastroenterologia, Via Nicolo' Giustiniani 2, 35128, Padova
Digestive Diseases Centre Gastro SIA
Gastroenterology, Gailezera Iela 1, 1079, Riga
Pauls Stradins Clinical University Hospital
Gastroenterology department, Pilsonu Iela 13, 1002, Riga
Pauls Stradins Clinical University Hospital
Gastroenterology, Pilsonu Iela 13, 1002, Riga
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
NA, U2 U3 U4 U5, Ul. Tadeusza Szafrana 5d, Cracow
Promed P.Lach R.Glowacki Sp. j.
NA, Ul. Olszanska 5g, 31-513, Cracow
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
NA, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Manermed Sp. z o.o.
Centrum Medyczne Medis, Ul. Garbary 5/l4, 85-229, Bydgoszcz
Gastromed Sp. z o.o.
NA, Ul. Grudziadzka 11/13-14, 87-100, Torun
Gastromed Kralisz Romatowski Stachurska Sp. j.
NA, Ul. Wiosenna 12/1, 15-322, Bialystok
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia NCHZL, Ul. Woloska 137, 02-507, Warsaw
Centrum Medyczne Medyk Sp. z o.o.
NA, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Scanmed S.A.
Gastromed ZOZ, Ul. Onyksowa 10, 20-582, Lublin
Medical Network Sp. z o.o.
WIP Warsaw IBD Point Profesor Kierkus, Ul. Plowiecka 103, 04-501, Warsaw
Endoskopia Sp. z o.o.
NA, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Klinika Gastroenterologii i Chorob Wewnetrznych, Ulica Szaserow 128, 04-141, Warsaw
Medicome Sp. z o.o.
NA, Plac Tadeusza Kosciuszki 12, 32-600, Oswiecim
Melita Medical Sp. z o.o.
NA, Ul. Strzegomska 2-4, 53-611, Wroclaw
Pro Life Medica Sp. z o.o.
ETG Zamosc, Ul. Gesia 3, 22-400, Zamosc
Unidade Local De Saude De Santo Antonio E.P.E.
Gastroenterology, Largo Professor Abel Salazar, 4050-011, Porto
F D Roosevelt University General Hospital Of Banska Bystrica
Gastroenterology, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Cliniq s.r.o.
Gastroenterology, Bezrucova 5, Stare Mesto, Bratislava
Endomed s.r.o.
Gastroenterology, Americka Trieda 17, Poliklinika Tahanovce, Kosice
Hospital Germans Trias I Pujol
Gastroenterology Service, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Virgen De Valme
Gastroenterology Service, Avenida Bellavista S/n, 41014, Sevilla
Hospital Universitari De Girona Doctor Josep Trueta
Gastroenterology Service, Avinguda De Franca S/n, 17007, Girona
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 | 2021-03-15 | 2021-03-15 | 2022-04-12 | ||
| Bulgaria | 2020-10-20 | 2020-10-20 | 2022-04-26 | ||
| Czechia | 2020-10-01 | 2020-10-01 | 2022-04-14 | ||
| France | 2020-09-03 | 2020-09-03 | 2022-03-31 | ||
| Germany | 2020-08-24 | 2020-08-24 | 2022-03-28 | ||
| Hungary | 2020-06-29 | 2020-06-29 | 2022-04-28 | ||
| Italy | 2020-10-19 | 2020-10-19 | 2022-03-31 | ||
| Latvia | 2021-11-10 | 2021-11-10 | 2022-04-29 | ||
| Poland | 2019-10-19 | 2019-10-19 | 2022-04-29 | ||
| Portugal | 2020-07-07 | 2025-12-10 | 2020-07-07 | 2022-03-21 | |
| Slovakia | 2021-09-20 | 2021-09-20 | 2022-04-21 | ||
| Spain | 2020-08-18 | 2020-08-18 | 2022-04-13 | ||
| Sweden | 2021-01-26 | 2021-01-26 | 2022-04-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 146 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_REDACTED Protocol_2023-504718-31 | Am4 |
| Protocol (for publication) | D4_REDACTED PF AHA booklet diary PART I_multilingual | 2 |
| Protocol (for publication) | D4_REDACTED PF AHA booklet diary PART II_multilingual | 2 |
| Protocol (for publication) | D4_REDACTED_PF C-SSRS_multilingual | 1 |
| Protocol (for publication) | D4_REDACTED_PF IBDQ_multilingual | 7 |
| Protocol (for publication) | D4_REDACTED_PF_EQ-5D-5L_multilingual | 1.1 |
| Protocol (for publication) | D4_REDACTED_PF_Mayo Diary LTE_multilingual | 1 |
| Protocol (for publication) | D4_REDACTED_PF_PGIC-UC_multilingual | 1 |
| Protocol (for publication) | D4_REDACTED_PF_PGIS-UC_multilingual | 1 |
| Protocol (for publication) | D4_REDACTED_PF_PROMIS-29_multilingual | 2.1 |
| Protocol (for publication) | D4_REDACTED_PF_PROMIS-Fatigue_multilingual | 1 |
| Protocol (for publication) | D4_REDACTED_PF_WPAI-GH_multilingual | 2 |
| Recruitment arrangements (for publication) | K1_Placeholder Recruitment Arrangements_BE_Eng_CNTO1959UCO3001 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arragements_BG_EN_CNTO1959UCO3001 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arragements_CZ_ENG_CNTO1959UCO3001 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arragements_IT_ENG_CNTO1959UCO3001 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arragements_LV_eng_CNTO1959UCO3001 | 1 |
| Recruitment arrangements (for publication) | K1_PLACEHOLDER_Recruitment Arrangements_FR_EN_CNTO1959UCO3001 | 1 |
| Recruitment arrangements (for publication) | K1_PLACEHOLDER_Recruitment Arrangements_HU_EN_CNTO1959UCO3001 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_SE_eng_CNTO1959UCO3001 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER_K1_Recruitment Arragements_PL_ENG_CNTO1959UCO3001 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER_K1_Recruitment Arragements_SK_eng_CNTO1959UCO3001 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER_K1_Recruitment Arrangements _PT_ENG_CNTO1959UCO3001 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER_K1_Recruitment Arrangements_ES_ENG_2023-504718-31 | 1 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_GER_EN_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF 12 Month Post Birth Child follow up_DE_ger_2023-504718-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF 12 Months Infant follow-up_CZ_cze_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF 12 Months Infant follow-up_SK_slo_2023-504718-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Add 1 to ICF 7_CZ_CZE_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Add 2 to ICF 7_CZ_CZE_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Add 3 to ICF-CZ-07_CZ_cze_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 3 _DE_ger_2023-504718-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_ES_SPA_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum_PT_POR_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical Addendum 4_DE_GER_2023-504718-31 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical ICF _PL_POL_CNTO1959UCO3001 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical ICF Addendum 1_CoT_DE_UKR_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical ICF Addendum 1_DE_GER_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical ICF Addendum 1_DE_UKR_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical ICF Addendum 2_CoT_DE_UKR_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical ICF COVID Addendum_CoT_DE_UKR_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical ICF COVID Addendum_DE_GER_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical ICF COVID Addendum_DE_UKR_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical Informed Consent_CoT_DE_UKR_CNTO1959UCO3001 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical Informed Consent_DE_GER_CNTO1959UCO3001 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical Informed Consent_DE_UKR_CNTO1959UCO3001 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PL_UKR_2023-504718-31 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Country 12 months follow up of infant _ BG_bul_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Country 12 months follow up of infant _ BG_eng_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Country Clinical _BG_eng_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Genetic ICF _PL_POL_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum 1_BE_dut_2023-504718-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Addendum 1_BE_eng_2023-504718-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Dut_CNTO1959UCO3001 | 8.3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_CZ_CZE_CNTO1959UCO3001 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_FR_UK_CNTO1959UCO3001 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_IT_ITA_CNTO1959UCO3001 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_LV_lv_CNTO1959UCO3001 | 13 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_LV_ru_CNTO1959UCO3001 | 11 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_SE_SWE_CNTO1959UCO3001 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Addendum 2_ES_SPA_2023-504718-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Addendum_1_ES_SPA_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_ES_SPA_2023-504718-31 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master_PT_POR_CNTO1959UCO3001 | 12 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OGR_LV_lv_CNTO1959UCO3001 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OGR_LV_ru_CNTO1959UCO3001 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Genetics_FR_FR_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Research_CZ_CZE_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Research_SE_SWE_CNTO1959UCO3001 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_BE_Dut_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_ES_SPA_2023-504718-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_IT_ITA_CNTO1959UCO3001 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_PT_POR_CNTO1959UCO3001 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Samples Informed Consent_CoT_DE_UKR_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Samples Informed Consent_DE_GER_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Samples Informed Consent_DE_UKR_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Patient Travel Reimbursement_IT_ITA_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Post Birth Child FU_LV-lv_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF PP_LV_lv_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF PP_LV_ru_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy 12 months FU of infant_ES_SPA_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy 12 months FU of infant_PL_POL_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnancy 12 months FU of infant_PT_POR_2023-504718-31 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant ICF _PL_POL_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner Informed Consent_DE_GER_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_CZ_CZE_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_SPA_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_FR_FR_CNTO1959UCO3001 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_PT_POR_CNTO1959UCO3001 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_SE_swe_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Patient_ES_SPA_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Patient_PT_POR_CNTO1959UCO3001 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Language_CZ_CZE_CNTO1959UCO3001 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal ICF _PL_POL_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_SPA_2023-504718-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_PT_POR_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_12 Month Post Birth Child follow up_FR_FRE_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_12 Month Post Birth Child follow up_HU_HUN_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Country Clinical_BG_bul_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Country Optional Sample_BG_bul_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Country Pregnant Partner_BG_bul_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Covid-19_HU_HUN_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main with single cell analysis_HU_HUN_CNTO1959UCO3001 | 6 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main without single cell analysis_HU_HUN_CNTO1959UCO3001 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Main_FR_FRE_2023-504718-31 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Master Pregnant Partner_BG_eng_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Optional Sample Master_BG_eng_CNTO1959UCO3001 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Optional Sample_HU_HUN_CNTO1959UCO3001 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant Partner_HU_HUN_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Privacy child exposed to IP_IT_ITA_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Separate Genomic_HU_HUN_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Withdrawal of consent_IT_ITA_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and Main Clinical ICF_SK_sk_CNTO1959UCO3001 | 13 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and Optional Sample ICF_SK_sk_CNTO1959UCO3001 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and Pregnant Partner ICF_SK_sk_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card LV_lv_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BE_Dut_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_BG_bul_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_CZ_CZE_2023-504718-31 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DE_ger_2023-504718-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_FRE_2023-504718-31 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_FR_UK_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_HU_HUN_2023-504718-31 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_IT_ITA_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_LV_ru_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_POL_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_PL_UKR_2023-504718-31 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PT_POR_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card_SE_SWE_2023-504718-31 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_SK_sk_CNTO1959UCO3001 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_SIS and ICF Clinical ICF Addendum 2_DE_GER_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_SIS and ICF Clinical ICF Addendum 2_DE_UKR_CNTO1959UCO3001 | 2 |
| Subject information and informed consent form (for publication) | REDACTED-_L1_SIS and ICF_Addendum_HU_HUN_CNTO1959UCO3001 | 1 |
| Synopsis of the protocol (for publication) | D1_REDACTED Protocol synopsis CZ 2023-504718-31 | Am4 |
| Synopsis of the protocol (for publication) | D1_REDACTED Protocol Synopsis SE 2023-504718-31 | Am4 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis BE_Dut_2023-504718-31 | Am4 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis BE_Fre_2023-504718-31 | Am4 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis BE_Ger_2023-504718-31 | Am4 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis BG_2023-504718-31 | Am4 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis IT 2023-504718-31 | AM4 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_ES_2023-504718-31 | Am4 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol synopsis_FR_2023-504718-31 | Am 4 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_HU_2023-504718-31 | Am4 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_PL_2023-504718-31 | Am4 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_PT_2023-504718-31 | Am4 |
| Synopsis of the protocol (for publication) | D1_REDACTED_Protocol Synopsis_SK_2023-504718-31 | Am4 |
Application history
32 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-29 | Germany | Acceptable 2024-07-10
|
2024-07-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-19 | Acceptable | 2024-10-16 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-08 | Germany | Acceptable 2025-03-03
|
2025-03-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-18 | Acceptable | 2025-04-28 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-14 | Acceptable | 2025-05-19 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-20 | Germany | 2025-05-20 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-06 | 2025-06-06 | ||
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-03 | Acceptable | 2025-08-12 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-03 | Acceptable | 2025-07-10 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-03 | Acceptable | 2025-07-24 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-07-03 | Germany | Acceptable | 2025-08-12 |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-07-03 | Acceptable | 2025-08-13 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-07-03 | Acceptable | 2025-08-27 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-07-03 | Acceptable | 2025-09-01 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-07-03 | Acceptable | 2025-08-18 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-07-03 | Acceptable | 2025-07-28 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-07-03 | Acceptable | 2025-09-18 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-15 | 2025-07-03 | Acceptable | 2025-07-14 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-16 | 2025-08-29 | Acceptable | 2025-09-30 | |
| 20 | SUBSTANTIAL MODIFICATION | SM-17 | 2025-10-23 | Germany | Acceptable 2026-01-13
|
2026-01-13 |
| 21 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-21 | Germany | Acceptable 2026-01-13
|
2026-01-21 |
| 22 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-03-03 | Germany | Acceptable 2026-01-13
|
2026-03-03 |
| 23 | SUBSTANTIAL MODIFICATION | SM-18 | 2026-03-30 | Acceptable | 2026-05-05 | |
| 24 | SUBSTANTIAL MODIFICATION | SM-20 | 2026-03-31 | Acceptable | 2026-04-02 | |
| 25 | SUBSTANTIAL MODIFICATION | SM-27 | 2026-04-01 | Acceptable | 2026-04-13 | |
| 26 | SUBSTANTIAL MODIFICATION | SM-21 | 2026-04-07 | Acceptable | 2026-05-12 | |
| 27 | SUBSTANTIAL MODIFICATION | SM-22 | 2026-04-07 | Germany | Acceptable | 2026-04-21 |
| 28 | SUBSTANTIAL MODIFICATION | SM-23 | 2026-04-07 | Acceptable | 2026-05-18 | |
| 29 | SUBSTANTIAL MODIFICATION | SM-24 | 2026-04-07 | Acceptable | 2026-05-26 | |
| 30 | SUBSTANTIAL MODIFICATION | SM-25 | 2026-04-07 | Acceptable | 2026-05-20 | |
| 31 | SUBSTANTIAL MODIFICATION | SM-28 | 2026-04-07 | Acceptable | 2026-05-13 | |
| 32 | SUBSTANTIAL MODIFICATION | SM-29 | 2026-04-09 | Acceptable | 2026-05-15 |