Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
1,096
Countries
19
Sites
115
Moderately to Severely Active Crohn's Disease
To evaluate the efficacy of JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone)
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 30 Nov 2022 → ongoing
- Decision date (initial)
- 2024-05-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Janssen Research & Development, United States
External identifiers
- EU CT number
- 2023-504741-32-00
- EudraCT number
- 2021-003314-39
- ClinicalTrials.gov
- NCT05242471
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Therapy, Pharmacodynamic, Pharmacokinetic, Pharmacogenomic, Others, Safety, Efficacy
To evaluate the efficacy of JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone)
Conditions and MedDRA coding
Moderately to Severely Active Crohn's Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10017947 | Gastrointestinal disorders | 14 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
- IPD plan description
- Based on the recent system update a final company position is not available yet
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
- Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
- Demonstrated inadequate response, loss of response, or intolerance to at least one advanced therapy (ADT) for IBD that includes biologics as well as oral small molecule therapies with biologic-like effect
- If female and of childbearing potential, must meet the contraception and reproduction requirements
Exclusion criteria 8
- Complications of CD that may be anticipated to require surgery
- Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
- Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
- Has a draining (example, functioning) stoma or ostomy
- Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for greater than or equal to (>=)12 months before the first dose of study intervention
- Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
- Presence on screening ileocolonoscopy of adenomatous colonic polyps, if not removed before study entry, or history of adenomatous colonic polyps that were not removed.
- Has a stool culture or other examination positive for an enteric pathogen, including Clostridioides difficile (formerly known as Clostridium difficile) toxin, within 16 weeks before the first dose of study intervention, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen. Treatment and repeat testing can occur in the current screening period.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Clinical remission and endoscopic response at Week 48 compared with each monotherapy
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11001931 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
PRD11082758 · Product
- Active substance
- Golimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 240 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
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo for Guselkumab, Golimumab and JNJ-78934804
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
- Clinical Registry Group
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- Clinical Registry Group
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Other |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other, E-data capture |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | On site monitoring, Code 12, Code 2, Data management, Code 9 |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other, E-data capture |
| Excelya Greece CRO Single Member S.A. ORG-100009224
|
Vrilissia, Greece | On site monitoring, Other, Code 2 |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Other, E-data capture |
Locations
19 EU/EEA countries · 115 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 4 | 4 |
| Belgium | Ongoing, recruitment ended | 9 | 1 |
| Bulgaria | Ended | 1 | 2 |
| Croatia | Ongoing, recruitment ended | 15 | 1 |
| Czechia | Ongoing, recruitment ended | 12 | 4 |
| Denmark | Ended | 7 | 4 |
| Estonia | Ended | 5 | 3 |
| France | Ongoing, recruitment ended | 83 | 15 |
| Germany | Ongoing, recruitment ended | 113 | 16 |
| Greece | Ongoing, recruitment ended | 12 | 3 |
| Hungary | Ongoing, recruitment ended | 13 | 5 |
| Italy | Ongoing, recruitment ended | 23 | 13 |
| Netherlands | Ongoing, recruitment ended | 23 | 4 |
| Norway | Ongoing, recruitment ended | 13 | 5 |
| Poland | Ongoing, recruitment ended | 69 | 20 |
| Portugal | Ongoing, recruitment ended | 5 | 4 |
| Slovenia | Ongoing, recruitment ended | 4 | 1 |
| Spain | Ongoing, recruitment ended | 15 | 6 |
| Sweden | Ongoing, recruitment ended | 7 | 4 |
| Rest of world
New Zealand, Switzerland, Jordan, Israel, Singapore, Korea, Republic of, Taiwan, India, Brazil, South Africa, United Kingdom, Japan, Canada, United States, Malaysia, Australia
|
— | 663 | — |
Investigational sites
Medical University Of Vienna
AT10004, Gastroenterologie, Hepatologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Klinikum Wels-Grieskirchen GmbH
AT10001, Abteilung für Innere Medizin I, Grieskirchner Strasse 42, 4600, Wels
Krankenhaus Der Barmherzigen Brueder Wien
AT10005, Gastroenterologie und Nephologie, Johannes-Von-Gott-Platz 1, Leopoldstadt, Vienna
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
AT10003, Innere Medizin I, Muellner Hauptstrasse 48, 5020, Salzburg
Vitaz
BE10005: Gastro-entérologie, Moerlandstraat 1, 9100, Sint-Niklaas
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
BG10003: Gastroenterology, Oborishte Distr., Ul.Byalo More 8, Sofia
Diagnostic-Consultative Center Alexandrovska EOOD
BG10002, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya
Vojenska Nemocnice Brno
CZ10004: Interni oddeleni, Zabrdovicka 3, Zabrdovice, Brno-Zidenice
Iscare a.s.
CZ10003: IBD a gastroenterologie, Ceskomoravska 2510/19, Liben, Prague
Fakultni Nemocnice Brno
CZ10002: lnterni gastroenterologicka klinika, Jihlavska 340/20, Bohunice, Brno
Krajska zdravotni a.s.
CZ10001: Gastroenterologie, Socialni Pece 3316/12a, Severni Terasa, Usti Nad Labem
Region Hovedstaden
DK10001:, Borgmester Ib Juuls Vej 1, 2730, Herlev
Bispebjerg Hospital
DK10004:Digestive Disease Center, Research Unit K, Nielsine Nielses vej 11, 2400, Copenhagen NV
Region Midtjylland
DK10005:, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
DK10002:, Sdr. Boulevard 29, 5000, Odense C
East Tallinn Central Hospital
EE10002: Cardiology, Ravi Tn 18, Kesklinna Linnaosa, Tallinn
Tartu University Hospital
EE10001:Gastroenterology, A006, L. Puusepa Tn 8, Tartu Linn
Laane-Tallinna Keskhaigla AS
EE10003:Gastroenterology, Paldiski Mnt 68, 10617, Pohja-Tallinna Linnaosa
Centre Hospitalier De Saint-Brieuc
FR10017: Gastroenterology, 10 Rue Marcel Proust, 22000, Saint-Brieuc
Centre Hospitalier Regional De Marseille
FR10010: Hépato-Gastroentérologie, 265 Chemin Des Bourrely, 13015, Marseille
Centre Medico Chirurgical Ambroise Pare Hartmann
FR10003: Institut des MICI, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Centre Hospitalier Universitaire De Rennes
FR10018: Unité d’Investigation Clinique, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire Grenoble Alpes
FR10008: Hepato-Gastroenterology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Nantes
FR10004: Hépato-Gastroentérologie, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Saint Etienne
FR10015: Hepatologie, Gastroentérologie (HGE) et d'oncologie digestive, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Centre Hospitalier Universitaire De Toulouse
FR10001: Hépato-Gastroentérologie, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Assistance Publique Hopitaux De Paris
FR10016: Hepato-Gastro-Enterologie, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
CHRU De Nancy
FR10014: Service d'Hépato-Gastroentérologie, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Hospices Civils De Lyon
FR10013: Hépato-Gastroentérologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire Amiens Picardie
FR10006: Service Hepato-Gastroenterolog, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire De Nice
FR10012: Gastro-Entérologie, Hépatologie, 151 Route De Saint Antoine, 06200, Nice
Besancon University Hospital Center
FR10019: Hématologie, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Hopital Saint Louis
FR10002: Département de Gastroentérologie, 1 Avenue Claude Vellefaux, 75010, Paris
MVZ Dachau
Endoscopy, Münchner Str. 64, 85221, Dachau
Universitat Heidelberg
II. Medizinische Klinik, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 1, Ulmenweg 18, Innenstadt, Erlangen
Gastroenterologie Opernstraße
Falk - Krause - Kuhn - Langenkamp - Steinbrück, Opernstrasse 9, 2. Etage, Kassel
Rostock University Medical Center
Zentrum für Innere Medizin, Klinik II, Abteilung für Gastroenterologie und Endokrinologie, Ernst-Heydemann-Strasse 6, Hansaviertel, Rostock
Technische Universitaet Dresden
Medizinische Klinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Martin-Luther-Universitaet Halle-Wittenberg
Gastroenterologie, Pneumologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Universitaetsklinikum Essen AöR
Gastroenterologie und Hepatolo, Hufelandstrasse 55, Holsterhausen, Essen
Eugastro GmbH
Gastroenterologie und Hepatologie am Johannisplatz, Johannisplatz 1, Zentrum Sudost, Leipzig
Dr. med. Thomas Brunk Gastroenterologie Berlin
Facharztpraxis für Gastroenterologie Karlshorst, IBD Study Center Karlshorst, Ehrenfelsstrasse 47, 10318, Berlin-Karlshorst
MVZ Gastro Berlin
Gastroenterologie, Innsbrucker Straße 58, 10825, Berlin
Medizinische Hochschule Hannover
Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Evangelisches Krankenhaus Kalk gGmbH
Gastroenterologie, Pulmologie und allgemeine Innere Medizin, Buchforststrasse 2, Kalk, Cologne
MVZ Portal 10
Gastroenterologie, Albersloher Weg 10B, 48155, Munster
Krankenhaus Waldfriede e.V.
Gastroenterologie, Argentinische Allee 40, Zehlendorf, Berlin
Studiengesellschaft BSF UG (haftungsbeschraenkt)
Unternehmergesellschaft (haftungsbeschränkt), Grosse Nikolaistrasse 7, Altstadt, Halle (Saale)
Thoracic General Hospital Of Athens I Sotiria
GR10003: 3rd internal Clinic, Messogion Avenue 152, 115 27, Athens
Hippokration Hospital
GR10004:2nd Internal Clinic of the University of Athens, Vassilissas Sofias Avenue 114, 115 27, Athens
Ippokratio General Hospital Of Thessaloniki
GR10001: B Internal Medicine Clinic, Konstadinoupoleos 49, 546 42, Thessaloniki
Semmelweis University
HU10006, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Gyongyosi Bugat Pal Korhaz
HU10002:Gasztroenterológiai Egység, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
HU10005:Gasztroenterológiai és Belgyógyászati Osztály, Markusovszky Str. 5, 9700, Szombathely
University Of Szeged
HU10001:Gasztroenterológiai Osztály, Kalvaria Sugarut 57, 6725, Szeged
Semmelweis University
HU10003:, Ulloi Ut 78, 1082, Budapest
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
IT10008: Gastroenterologia U, Corso Bramante 88, 10126, Turin
Ospedale San Raffaele S.r.l.
IT10001: Gastroenterologia ed endoscopia digestiva, Via Olgettina 60, 20132, Milan
Humanitas Research Hospital
IT10017: IBD center, Malattie Infiammatorie Croniche Intestinali, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IT10011: UOC Medicina Interna e Gastroenterologia, Largo Agostino Gemelli 8, 00168, Rome
Azienda Ospedaliero-Universitaria Di Cagliari
IT10006: Gastroenterologia, Strada Statale 554 N. 1, 09042, Monserrato
University Hospital Consorziale Policlinico
IT10014: Gastroenterologia Universitaria, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Ospedaliera Per L'Emergenza Cannizzaro
IT10009: UOC chirurgia generale – IBD Unit, Via Messina 829, 95126, Catania
National Institute Of Gastroenterology Saverio De Bellis Research Hospital
IT10002: Gastroenterologia II ed Endoscopia Digestiva - Ambulatorio IBD, Via Turi 27, 70013, Castellana Grotte
Fondazione IRCCS San Gerardo Dei Tintori
IT10013: SC Gastroenterologia, Via Giovanni Battista Pergolesi 33, 20900, Monza
IRCCS Ospedale Sacro Cuore Don Calabria
IT10007: Unità Operativa Complessa di Gastroenterologia ed Endoscopia digestiva - IBD Unit, Via Don Angelo Sempreboni 5, 37024, Negrar
ASST Fatebenefratelli Sacco
IT10015: UOC Gastroenterologia Sacco, Via Giovanni Battista Grassi 74, 20157, Milan
Azienda Ospedaliera Universitaria Gaetano Martino Messina
IT10010: U.O.C. Gastroenterologia e Malattie Intestinali Croniche, Via Consolare Valeria N 1, 98124, Messina
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
IT10004: UOS Dipartimentale di Malattie Infiammatorie Croniche dell'Intestino (MICI), Via Trabucco 180, 90146, Palermo
Universiteit Maastricht
NL10010, Afdeling MDL, P Debyelaan 25, 6229 HX, Maastricht
Amsterdam UMC Stichting
NL10003, Gastroenterology, De Boelelaan 1117, 1081 HV, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
NL10004, Gastroenterology and Hepatology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Universitair Medisch Centrum Utrecht
NL10007, Department of Gastroenterology and Hepatology, Heidelberglaan 100, 3584 CX, Utrecht
Universitetssykehuset Nord-Norge HF
NO10006:Gastroenterology, Sykehusvegen 38, 9019, Tromsoe
Helse Moere Og Romsdal HF
NO10005:, Aasehaugen 1, 6017, Aalesund
Oslo University Hospital HF
NO10002:Gastroenterology, Taarnbygget, Kirkeveien 166, Oslo
Baerum Sykehus
NO10007:, Sogneprest Munthe-Kaas Vei 100, 1346, Gjettum
Akershus University Hospital
NO10001:Gastrolab B202, Sykehusveien 27, 1478, Lorenskog
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.
PL10004: Twoja Przychodnia PCM, Os. Lecha 15a, 61-293, Poznan
Centrum Medyczne Kuba-Med 2 Sp. z o.o.
PL10007: ETG Zamosc, Ul. Spadek 41, 22-400, Zamosc
Rivermed Sp. z o.o.
PL10019: Gabinety Lekarskie RIVERMED, Ul. 28 Czerwca 1956 R. Nr 382/u4, 61-441, Poznan
Gastromed Sp. z o.o.
PL10008: Gastroenterologia, Ul. Grudziadzka 11/13-14, 87-100, Torun
Promed P.Lach R.Glowacki Sp. j.
PL10018: Centrum Medyczne PROMED, Ul. Olszanska 5g, 31-513, Cracow
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
PL10013: Centrum Medyczne Plejady, U2 U3 U4 U5, Ul. Tadeusza Szafrana 5d, Cracow
Medical Network Sp. z o.o.
PL10022: Medical Network Sp. z o. o. WIP Warsaw IBD Point Profesor Kierkus, Ul. Plowiecka 103, 04-501, Warsaw
Centrum Medyczne Medyk Sp. z o.o.
PL10015: Centrum Medyczne Medyk, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Reumed Sp. z o.o.
PL10021: Zespol Poradni Specjalistycznych REUMED ONYKSOWA Filia nr 2, Ul. Onyksowa 10, 20-582, Lublin
Endoskopia Sp. z o.o.
PL10016: Poradnia Gastroenterologiczna, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
NZOZ VIVAMED Jadwiga Miecz
PL10026: Gastroenterologia, ul. Zamiejska 17, 03-580, Warszawa
Melita Medical Sp. z o.o.
PL10024: Centrum Medyczne Melita Medical, Ul. Gen. Romualda Traugutta 1-7, 50-449, Wroclaw
Wojewodzki Szpital Specjalistyczny W Olsztynie
PL10012: Oddzial Gastroenterologiczny, Ul. Zolnierska 18, 10-561, Olsztyn
Sonomed Sp. z o.o.
PL10020: Poradnia Gastroenterologiczna, Ul. Ks. Bp. Wladyslawa Bandurskiego 98/u12, 71-685, Szczecin
Centrum Medyczne Oporow
PL10023: Gastroenterologia, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.
PL10017: Poradnia Gastroenterologiczna, Ul. Barska 13, 87-800, Wloclawek
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
PL10025:Klinika Chorob Wewnetrznych i Gastroenterologii, Ul. Woloska 137, 02-507, Warsaw
Klinika Reuma Park Sp. z o.o. S.K.
PL10010:Centrum Medyczne Reuma Park, Aleja Wilanowska 333, 02-665, Warsaw
Bodyclinic Sp. z o.o. sp.k.
PL10009:Gastroenterologia, Ul. Ulica Jozefa Sierakowskiego 4/u3, 03-712, Warsaw
Manermed Sp. z o.o.
PL10011:Centrum Medyczne "Medis", Ul. Garbary 5/l4, 85-229, Bydgoszcz
Centro Hospitalar De Entre O Douro E Vouga E.P.E.
PT10006, Serviço de Gastrenterologia, Rua Dr Candido De Pinho, 4520-211, Santa Maria Da Feira
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
PT10002, Serviço de Gastrenterologia, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Unidade Local De Saude De Santa Maria E.P.E.
PT10004, Serviço de Gastrenterologia, Avenida Professor Egas Moniz, 1649-035, Lisbon
Centro Hospitalar Universitario Do Algarve E.P.E.
PT10005, Serviço de Gastroenterologia - Exames Especiais, Sitio Do Poco Seco, 8500-338, Portimao
University Medical Center Ljubljana
SI10001, Gastroenterology, Zaloska Cesta 7, 1000, Ljubljana
Hospital Universitario Marques De Valdecilla
ES10005: Aparato Digestivo, Avenida Valdecilla Sn, 39008, Santander
Parc Tauli Hospital Universitari
ES10008: Aparato Digestivo, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Complexo Hospitalario Universitario De Pontevedra
ES10014: Gastroenterologia, Calle Mourente S/n, 36164, Pontevedra
Hospital Universitario De Torrejon
ES10013: Gastroenterologia, Calle De Mateo Inurria 1, 28850, Torrejon De Ardoz
Hospital Universitario De Navarra
ES10006: Gastroenterology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario La Paz
ES10012: Gastroenterologia, Paseo De La Castellana 261, 28046, Madrid
Karolinska University Hospital
SE10001: IBD Gastrointestinal research, Eugeniavagen 3, 171 64, Solna
Linkoping University Hospital Region Ostergotland
SE10003, Byggnad 441, 581 85, Linkoping
Ersta Sjukhus-Ersta Hospital
SE10004: Mag-tarmcentrum, Fjallgatan 44, Sofia, Stockholm
Region Oerebro Laen
SE10002: Enheten för Kliniska Studier, EKS, Sodra Grev Rosengatan, 701 85, Orebro
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 |
|---|---|---|---|---|---|
| Austria | 2023-08-03 | 2023-12-11 | 2024-04-18 | ||
| Belgium | 2023-04-27 | 2024-01-25 | 2024-03-28 | ||
| Bulgaria | 2023-05-05 | 2024-08-01 | 2023-07-14 | 2024-08-01 | |
| Croatia | 2023-05-24 | 2023-06-29 | 2024-04-11 | ||
| Czechia | 2023-02-03 | 2023-02-23 | 2024-04-18 | ||
| Denmark | 2023-04-27 | 2025-01-25 | 2023-09-05 | 2024-04-12 | |
| Estonia | 2023-05-17 | 2024-04-24 | 2024-04-24 | 2024-04-24 | |
| France | 2023-04-14 | 2023-05-03 | 2024-04-18 | ||
| Germany | 2023-03-17 | 2023-03-23 | 2024-04-17 | ||
| Greece | 2023-06-27 | 2023-07-06 | 2023-12-20 | ||
| Hungary | 2022-11-30 | 2023-03-08 | 2024-02-12 | ||
| Italy | 2023-02-16 | 2023-02-21 | 2024-04-18 | ||
| Netherlands | 2023-03-28 | 2023-04-12 | 2024-04-03 | ||
| Norway | 2023-05-31 | 2023-06-08 | 2024-04-17 | ||
| Poland | 2023-03-13 | 2023-03-16 | 2024-04-18 | ||
| Portugal | 2023-11-20 | 2024-03-05 | 2024-04-17 | ||
| Slovenia | 2023-05-15 | 2024-02-05 | 2024-04-09 | ||
| Spain | 2022-12-29 | 2023-02-28 | 2024-02-02 | ||
| Sweden | 2023-04-27 | 2023-08-22 | 2024-04-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 292 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Main 2023-504741-32-00 Public | 4.0 |
| Protocol (for publication) | D1_Protocol Main 2023-504741-32-00 Public Greek | 4.0 |
| Protocol (for publication) | D4_AUT Subject Diary Evening Dairy CDAI German 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_AUT Subject Questionnaire PGIC German 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_AUT Subject Questionnaire PGIS German 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_AUT Subject Questionnaire WPAI-CD German 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_BEL Rating Scale PGIC Dutch 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Diary WPAI Dutch 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Diary WPAI French 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire CDAI Evening Diary Dutch 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire CDAI Evening Diary French 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire PGIC BE-dut Dutch 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire PGIC French 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire PGIS Dutch 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire PGIS French 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire PGIS_BE-fre French 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire CDAI Czech 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire CDAI Evening Diary Czech 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire PGIC Czech 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire PGIC Screen Report Czech 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire PGIS Czech 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire PGIS Screen Report Czech 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire PRO-AE Czech 78934804CRD2001 | 3.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire WPAI-CD Czech 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire WPAI-CD Screen Report Czech 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_DEU Subject Diary CDAI German 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_DEU Subject Materials Other PGIS Screen Report English 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_DEU Subject Materials Other WPAI Screen Report English 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_DEU Subject Questionnaire PGIC German 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_DEU Subject Questionnaire PGIS German 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_DEU Subject Questionnaire WPAI-CD German 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_DNK Subject Questionnaire CDAI Evening Diary Danish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_DNK Subject Questionnaire PGIC Danish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_DNK Subject Questionnaire PGIS Danish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_DNK Subject Questionnaire PRO-AE Danish 78934804CRD2001 | 3.0 |
| Protocol (for publication) | D4_DNK Subject Questionnaire WPAI Danish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire CDAI Evening Dairy Screen Report Spanish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire CDAI Evening Dairy Spanish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire PGIC Screen Report Spanish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire PGIC Spanish 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire PGIS Screen Report Spanish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire PGIS Spanish 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire PRO-AE Spanish 78934804CRD2001 | 3.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire WPAI- CD Spanish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire WPAI-CD Screen Report Spanish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire French CDAI Evening Diary 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire PGIC French 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire PGIS French 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire WPAI-CD French 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_GRC Subject Diary CDAI Greek 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_GRC Subject Questionnaire PGIC Greek 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_GRC Subject Questionnaire PGIC Screen Report Greek 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_GRC Subject Questionnaire PRO-AE Greek 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_GRC Subject Questionnaire WPAI-CD Greek 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_GRC Subject Questionnaire WPAI-CD Greek Screen Report 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HRV Subject Diary CDAI Croatian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HRV Subject Diary CDAI Screen Report Croatian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HRV Subject Materials Other PRO-AE Croatian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HRV Subject Questionnaire PGIC Croatian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HRV Subject Questionnaire PGIC Screen Report Croatian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HRV Subject Questionnaire PGIS Croatian 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_HRV Subject Questionnaire PGIS Screen Report Croatian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HRV Subject Questionnaire WPAI-CD Croatian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HUN Subject Questionnaire CDAI Evening Dairy Screen Report Hungarian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HUN Subject Questionnaire CDAI Hungarian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HUN Subject Questionnaire PGIC Hungarian 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_HUN Subject Questionnaire PGIC Screen Report Hungarian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HUN Subject Questionnaire PGIS Hungarian 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_HUN Subject Questionnaire PGIS Screen Report Hungarian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HUN Subject Questionnaire PRO AE Hungarian 78934804CRD2001 | 3.0 |
| Protocol (for publication) | D4_HUN Subject Questionnaire WPAI-CD Hungarian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_HUN Subject Questionnaire WPAI-CD Screen Report Hungarian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_ITA Subject Diary CDAI Evening Diary Screen Report Italian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_ITA Subject Questionnaire CDAI Italian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_ITA Subject Questionnaire PGIC Italian 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_ITA Subject Questionnaire PGIC Screen Report Italian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_ITA Subject Questionnaire PGIS Italian 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_ITA Subject Questionnaire PGIS Screen Report Italian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_ITA Subject Questionnaire WPAI-CD Screen Report Italian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_NLD Subject Diary CDAI Dutch 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_NLD Subject Questionnaire CDAI Dutch 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_NLD Subject Questionnaire PGIC Dutch 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_NLD Subject Questionnaire PGIC Screen Report Dutch 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_NLD Subject Questionnaire PGIS Dutch 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_NLD Subject Questionnaire PGIS Screen Report Dutch 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_NLD Subject Questionnaire WPAI-CD Dutch 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_NOR Subject Diary CDAI Norwegian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_NOR Subject Materials Other PRO-AE Norwegian 78934804CRD2001 | 3.0 |
| Protocol (for publication) | D4_NOR Subject Questionnaire CDAI Evening Diary Norwegian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_NOR Subject Questionnaire PGIC Norwegian 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_NOR Subject Questionnaire PGIC Screen Report Norwegian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_NOR Subject Questionnaire PGIS Norwegian 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_NOR Subject Questionnaire PGIS Screen Report Norwegian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_NOR Subject Questionnaire WPAI-CD Norwegian 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_NOR Subject Questionnaire WPAI-CD Screen Report Norwegian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_Patient Facing Regulatory Filenote 78934804CRD2001 | NA |
| Protocol (for publication) | D4_POL Subject Materials Other PRO-AE Polish 78934804CRD2001 | 3.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire CDAI Evening Diary Screen Report Polish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire CDAI Polish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire PGIC Polish 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire PGIC Screen Report Polish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire PGIS Polish 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire PGIS Screen Report Polish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire WPAI-CD Polish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire WPAI-CD Screen Report Polish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_PRT Subject Diary CDAI Portuguese 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_PRT Subject Questionnaire PGIC Screen Report Portuguese 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_PRT Subject Questionnaire PGIS Screen Report Portuguese 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_PRT Subject Questionnaire WPAI Screen Report Portuguese 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_SVN Subject Diary CDAI Slovenian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_SVN Subject Materials Other PRO-AE Slovenian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_SVN Subject Questionnaire PGIC Screen Report Slovenian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_SVN Subject Questionnaire PGIC Slovenian 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_SVN Subject Questionnaire PGIS Screen report Slovenian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_SVN Subject Questionnaire PGIS Slovenian 78934804CRD2001 | 2.0 |
| Protocol (for publication) | D4_SVN Subject Questionnaire WPAI-CD Screen Report Slovenian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_SVN Subject Questionnaire WPAI-CD Slovenian 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_SWE Subject Questionnaire CDAI Evening Diary Screen Report Swedish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_SWE Subject Questionnaire PGIC Screen Report Swedish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_SWE Subject Questionnaire PGIS Screen Report Swedish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_SWE Subject Questionnaire WPAI-CD Screen Report Swedish 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_USA Subject Materials Other CDAI Evening Diary English 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_USA Subject Materials Other PGIC Screen Report English 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_USA Subject Materials Other PGIS Screen Report English 78934804CRD2001 | 1.0 |
| Protocol (for publication) | D4_USA Subject Materials Other WPAI Screen Report English 78934804CRD2001 | 1.0 |
| Recruitment arrangements (for publication) | BGR IRB-IEC Filenote 78934804CRD2001 Public | NA |
| Recruitment arrangements (for publication) | CZE IRB-IEC Filenote 78934804CRD2001 Public | NA |
| Recruitment arrangements (for publication) | DEU Recruitment Arrangements Filenote 78934804CRD2001 Public | NA |
| Recruitment arrangements (for publication) | DNK Recruitment Arrangements Filenote 78934804CRD2001 Public | NA |
| Recruitment arrangements (for publication) | ESP IRB-IEC Filenote 78934804CRD2001 Public | NA |
| Recruitment arrangements (for publication) | FRA IRB-IEC Filenote 78934804CRD2001 Public | NA |
| Recruitment arrangements (for publication) | IRB-IEC Filenote 78934804CRD2001 | 1 |
| Recruitment arrangements (for publication) | ITA IRB-IEC Filenote 78934804CRD2001 Public | NA |
| Recruitment arrangements (for publication) | K1_ Recruitment Arrangements IRB-IEC Filenote 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_Filenote - End of Recruitment 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_Filenote Recruitment closed 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC English Filenote 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote English 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote English 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote English 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote English 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote English 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote English 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote English 78934804CRD2001 | 1.0 |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote Recruitment Arrangements 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC FRA Recruitment Procedure Description File note English 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | K1_POL IRB IEC Filenote English 78934804CRD2001 Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements IRB-IEC Filenote 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | NOR Recruitment Arrangements Regulatory Filenote 78934804CRD2001 Public | NA |
| Recruitment arrangements (for publication) | POL IRB-IEC Filenote 78934804CRD2001 Public | NA |
| Recruitment arrangements (for publication) | PRT IRB-IEC Filenote EU-CTR Transition placeholder 78934804CRD2001 | NA |
| Recruitment arrangements (for publication) | SWE IRB-IEC Filenote 78934804CRD2001 Public | NA |
| Subject information and informed consent form (for publication) | AUT Country ICF Addendum Adult German 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | AUT Country ICF Genetic Research Adult German 78934804CRD2001 Public | 1.3 |
| Subject information and informed consent form (for publication) | AUT Country ICF Other Adult Withdrawal German 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | AUT Country ICF Pregnant Partner German 78934804CRD2001 Public | 1.3 |
| Subject information and informed consent form (for publication) | BEL Country ICF Genetic Research Dutch 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | BEL Country ICF Genetic Research English 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | BEL Country ICF Genetic Research French 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | BEL Country ICF Other Pregnant Partner Dutch 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | BEL Country ICF Other Pregnant Partner English 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | BEL Country ICF Other Pregnant Partner French 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | BEL Country ICF Other Withdrawal Dutch 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | BEL Country ICF Other Withdrawal English 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | BEL Country ICF Other Withdrawal French 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | BEL Country Scout ICF addendum Dutch 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | BEL Country Scout ICF addendum English 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | BEL Country Scout ICF addendum French 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | CZE Country ICF Addendum Czech 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | CZE Country ICF Genetic Research Adult Czech 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | CZE Country ICF Other Adult Withdrawal Czech 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | CZE Country ICF Other Czech 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | CZE Country ICF Other Pregnant Partner Czech 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | CZE Country ICF Privacy Czech 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | CZE Country ICF Research Czech 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | DEU Country ICF Addendum Adult German 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | DEU Country ICF Genetic Research Adult German 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | DEU Country ICF Optional Future Research German 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | DEU Country ICF Other Adult Pregnant Partner German 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | DEU Country ICF Other Adult Withdrawal German 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | DNK Country ICF Genetic Research Danish 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | DNK Country ICF Other PP Danish 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | DNK Country ICF Other Withdrawal Danish 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | ESP Country ICF Addendum Spanish 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | ESP Country ICF Genetic Research Spanish 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | ESP Country ICF Other Pregnant Partner Spanish 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | ESP Country ICF Other Withdrawal Spanish 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | FRA Country ICF Genetic Research French 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | FRA Country ICF Other Withdrawal French 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | FRA Country ICF Other Pregnant Partner French 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | GRC Country ICF Addendum Adult English 78934804CRD2001 Public | 1.000 |
| Subject information and informed consent form (for publication) | GRC Country ICF Addendum Adult Greek 78934804CRD2001 Public | 1.000 |
| Subject information and informed consent form (for publication) | GRC Country ICF Genetic Research Adult English 78934804CRD2001 Public | 1.000 |
| Subject information and informed consent form (for publication) | GRC Country ICF Genetic Research Adult Greek 78934804CRD2001 Public | 1.000 |
| Subject information and informed consent form (for publication) | GRC Country ICF Other Adult English 78934804CRD2001 Public | 1.100 |
| Subject information and informed consent form (for publication) | GRC Country ICF Other Adult pregnant partner Greek 78934804CRD2001 Public | 1.100 |
| Subject information and informed consent form (for publication) | GRC Country ICF Other Adult Withdrawal English 78934804CRD2001 Public | 2.000 |
| Subject information and informed consent form (for publication) | GRC Country ICF Other Adult withdrawal Greek 78934804CRD2001 Public | 2.000 |
| Subject information and informed consent form (for publication) | HRV Country ICF Addendum Croatian 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | HRV Country ICF Genetic Research Croatian 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | HRV Country ICF Other Pregnant Partner Croatian 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | HRV Country ICF Other Withdrawal Croatian 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | HRV Country ICF Pregnant Participant Croatian 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | HRV Country ICF Research Croatian 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | HUN Country ICF Genetic Research Optional Genetic ICF Hungarian 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | HUN Country ICF Genetic Research Optional Genetic PIS Hungarian 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | HUN Country ICF Other Pregnant Partner IS Hungarian 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | HUN Country ICF Other Pregnant Partner ICF Hungarian 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | HUN Country ICF Other Withdrawal ICF Hungarian 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | HUN Country ICF Other Withdrawal PIS Hungarian 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | HUN Country ICF Research Optional Research ICF Hungarian 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | HUN Country ICF Research Optional Research PIS Hungarian 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | HUN Subject ID Card Justification letter English 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | HUN Subject Participation Subject ID Card Hungarian 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | ITA Country ICF Genetic Research Italian 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | ITA Country ICF Other Withdrawal Italian 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | ITA Country ICF Other Pregnancy Italian 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | ITA Country IRB-IEC Additional-Amendment Approval Italian 78934804CRD2001 Public | NA |
| Subject information and informed consent form (for publication) | L1_AUT Contact Data Form for site-specific Data English 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_AUT Country ICF Main Adult German 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Dutch 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main English 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main French 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Main Adult Already Enrolled Czech 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CZE Country ICF Main Adult Czech 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_CZE Subject Participation Card Czech 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Extension Adult German 78934804CRD2001 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Main Adult German 78934804CRD2001 Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_DNK Country ICF Main Danish 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Spanish 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF Main French 78934804CRD2001 Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Main Adult English 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Main Adult Greek 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_GRC Country ICF Research Greek 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Main Croatian 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Main Hungarian 78934804CRD2001 Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF Main PIS Hungarian 78934804CRD2001 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main Italian 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Privacy Adult Italian 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Main Dutch 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_NOR Country ICF Genetic Research Norwegian 78934804CRD2001 Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_NOR Country ICF Main Appendix 1 to Main ICF Norwegian 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_NOR Country ICF Main Norwegian 78934804CRD2001 Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_NOR Country ICF Other Pregnant Partner Norwegian 78934804CRD2001 Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_NOR Country ICF Other Withdrawal ICF Norwegian 78934804CRD2001 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Main Polish 78934804CRD2001 Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_PRT Country ICF Main Portuguese 78934804CRD2001 Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_SVN Country ICF Main Slovenian 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_SWE Country ICF Main Appendix 1 Swedish 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_SWE Country ICF Main Appendix 2 Swedish 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_SWE Country ICF Main Appendix 3 Swedish 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_SWE Country ICF Main Appendix 4 Swedish 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_SWE Country ICF Main Swedish 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_ITA Country ICF Other Other information Italian 78934804CRD2001 | 1.0 |
| Subject information and informed consent form (for publication) | NLD Country ICF Genetic Research Dutch 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | NLD Pregnancy ICF Other Dutch 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | NLD Withdrawal ICF Other Dutch 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | NOR Country ICF Addendum Norwegian 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | NOR Country ICF Optional Research Norwegian 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | POL Country ICF Addendum Polish 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | POL Country ICF Genetic Research Polish 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | POL Country ICF Pregnant Partner Polish 78934804CRD2001 Public | 2.1 |
| Subject information and informed consent form (for publication) | POL Country ICF Scout Clinical Polish 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | POL Country ICF Withdrawal Polish 78934804CRD2001 Public | 3.0 |
| Subject information and informed consent form (for publication) | PRT Country ICF Addendum Portuguese 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | PRT Country ICF Genetic Research Portuguese 78934804CRD2001 Public | 4.0 |
| Subject information and informed consent form (for publication) | PRT Country ICF Other Pregnant Partner Portuguese 78934804CRD2001 Public | 3.1 |
| Subject information and informed consent form (for publication) | PRT Country ICF Other Pregnant Study Participant Portuguese 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | PRT Country ICF Other Withdrawal Portuguese 78934804CRD2001 Public | 4.0 |
| Subject information and informed consent form (for publication) | SVN Country ICF Addendum Slovenian 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | SVN Country ICF Genetic Research Slovenian 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | SVN Country ICF Other Pregnant Partner Slovenian 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | SVN Country ICF Other Withdrawal Slovenian 78934804CRD2001 Public | 2.0 |
| Subject information and informed consent form (for publication) | SWE Country ICF Genetic Research Swedish 78934804CRD2001 Public | 1.1 |
| Subject information and informed consent form (for publication) | SWE Country ICF Other Pregnant Partner Swedish 78934804CRD2001 Public | 1.0 |
| Subject information and informed consent form (for publication) | SWE Country ICF Other Withdrawal Swedish 78934804CRD2001 Public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Czech 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Dutch 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main English 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main German 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Greek 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Hungarian 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Italian 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Norwegian 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Polish 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Portuguese 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Slovenian 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Spanish 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Swedish 78934804CRD2001 Public | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-504741-32-00 Public French | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis English 2023-504741-32-00 Regulatory Filenote Public | NA |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-15 | Netherlands | Acceptable 2024-05-22
|
2024-05-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-10 | Acceptable 2024-05-22
|
2024-09-10 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-27 | Netherlands | Acceptable 2025-03-17
|
2025-03-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-22 | Acceptable | 2025-06-06 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-04 | Netherlands | Acceptable 2025-09-08
|
2025-09-08 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-27 | Netherlands | Acceptable 2026-01-14
|
2026-01-14 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-28 | Netherlands | Acceptable 2026-01-14
|
2026-01-28 |