Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruitment ended
Participants planned
1,401
Countries
13
Sites
54
Moderately to Severely Active Crohn's Disease
Phase 2: - To evaluate the clinical efficacy of guselkumab in participants with Crohn's disease - To evaluate the safety of guselkumab Phase 3: - To evaluate the clinical and endoscopic efficacy of guselkumab in participants with Crohn's disease - To evaluate the safety of guselkumab
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 26 Jul 2018 → ongoing
- Decision date (initial)
- 2024-08-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Janssen Research & Development
External identifiers
- EU CT number
- 2023-504736-18-00
- EudraCT number
- 2017-002195-13
- ClinicalTrials.gov
- NCT03466411
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacodynamic, Pharmacoeconomic, Safety, Pharmacogenomic, Dose response, Pharmacokinetic
Phase 2:
- To evaluate the clinical efficacy of guselkumab in participants with Crohn's disease
- To evaluate the safety of guselkumab
Phase 3:
- To evaluate the clinical and endoscopic efficacy of guselkumab in participants with Crohn's disease
- To evaluate the safety of guselkumab
Conditions and MedDRA coding
Moderately to Severely Active Crohn's Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10011401 | Crohn's disease | 100000004856 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- - Have Crohn's disease (CD) or fistulizing Crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
- - Have moderate to severe CD as assessed by CDAI, stool frequency (SF), and abdominal pain (AP) scores, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
- - Have screening laboratory test results within the protocol specified parameters
- - A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
- - Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD
Exclusion criteria 5
- - Current diagnosis of ulcerative colitis or indeterminate colitis
- - Has complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
- - Unstable doses of concomitant Crohn's disease therapy
- - Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol
- - Any medical contraindications preventing study participation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Phase 2: Change from Baseline in the Crohn's Disease Activity Index (CDAI) Score at Week 12
- Phase 3: Global co-primary endpoints: - clinical response at Week 12 and clinical remission at Week 48 - clinical response at Week 12 and endoscopic response at Week 48. Regional co-primary endpoints: - clinical remission at Week 12 - endoscopic response at Week 12
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10890564 · Product
- Active substance
- Guselkumab
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 252 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
- 252 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
STELARA 90 mg solution for injection in pre-filled syringe
PRD3349059 · Product
- Active substance
- Ustekinumab
- 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
- 252 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC05 — -
- Marketing authorisation
- EU/1/08/494/004
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Differences between the clinical and the commercial product are shelf-life and specifications. Clinical trial specific packaging and labeling.
STELARA 130 mg concentrate for solution for infusion
PRD4498328 · Product
- Active substance
- Ustekinumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 00 mg/kg milligram(s)/kilogram
- Max total dose
- 00 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AC05 — -
- Marketing authorisation
- EU/1/08/494/005
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Differences between the clinical and the commercial product are shelf-life and specifications. Clinical trial specific packaging and labeling.
Placebo 2
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Kcas LLC ORG-100043073
|
Olathe, United States | Other, Laboratory analysis |
| Eresearchtechnology Inc. ORG-100013039
|
Pittsburgh, United States | Other, E-data capture |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Other, E-data capture |
| Parexel International Corp. ORG-100007310
|
Durham, United States | On site monitoring, Code 2, Interactive response technologies (IRT), Code 5, Data management, E-data capture, Code 8, Code 9 |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other, E-data capture |
Locations
13 EU/EEA countries · 54 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 5 | 1 |
| Croatia | Ended | 6 | 1 |
| Czechia | Ongoing, recruitment ended | 16 | 5 |
| France | Ongoing, recruitment ended | 31 | 5 |
| Germany | Ongoing, recruitment ended | 30 | 5 |
| Hungary | Ongoing, recruitment ended | 20 | 2 |
| Italy | Ongoing, recruitment ended | 15 | 1 |
| Latvia | Ongoing, recruitment ended | 10 | 2 |
| Netherlands | Ongoing, recruitment ended | 13 | 2 |
| Poland | Ongoing, recruitment ended | 295 | 23 |
| Portugal | Ongoing, recruitment ended | 4 | 3 |
| Slovakia | Ongoing, recruitment ended | 17 | 2 |
| Spain | Ongoing, recruitment ended | 12 | 2 |
| Rest of world
Turkey, Georgia, Tunisia, Lebanon, India, Taiwan, Canada, Saudi Arabia, Korea, Democratic People's Republic of, North Macedonia, New Zealand, United Kingdom, Ukraine, United States, Japan, Bosnia and Herzegovina, Colombia, Israel, Jordan, China, Australia, Belarus, Serbia, Russian Federation, Brazil
|
— | 927 | — |
Investigational sites
Poliklinika Solmed d.o.o.
HR10009: Gastroenterology, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Synexus Czech s.r.o.
CZ10008, Karlovo Namesti 2097/10, Nove Mesto, Prague
NH Hospital a.s.
CZ10006:Chirurgicke oddeleni, K Nemocnici 1106/14, 268 01, Horovice
Hepato-Gastroenterologie HK s.r.o.
CZ10003, Trida Edvarda Benese 1549/34, 500 12, Hradec Kralove
Iscare a.s.
CZ10004:IBD a gastroenterologie, Ceskomoravska 2510/19, Liben, Prague
Nemocnice Ceske Budejovice a.s.
CZ10009: Gastroenterologicke oddeleni, B. Nemcove 585/54, 370 01, Ceske Budejovice
Assistance Publique Hopitaux De Paris
10025: Hepato-Gastro-Enterologie, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Hospices Civils De Lyon
10011: Hépato-Gastroentérologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
CHRU De Nancy
10021: Service d'Hépato- Gastroentérologie, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
CHU Besancon
10006: Hépato-gastroentérologie, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Universitaire Reims
10004: Gastroenterology, Rue Du General Koenig, 51092, Reims Cedex
Medizinische Hochschule Hannover
DE10016: Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Charite Universitaetsmedizin Berlin KöR
DE10018: Interdisziplinaeres Stoffwechselzentrum, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Augsburg
DE10032: Klinikum Augsburg - III. Med. Klinik, Stenglinstrasse 2, Kriegshaber, Augsburg
Universitaetsklinikum Ulm AöR
DE10010: Gastroenterologie, Endokrinologie, Albert-Einstein-Allee 23, Eselsberg, Ulm
Eugastro GmbH
DE10027: Gastroenterologie, Johannisplatz 1, Zentrum Sudost, Leipzig
Bekes Varmegyei Koezponti Korhaz
HU10006; III. sz. Belgyógyászat, Gyulai Ut 18, 5600, Bekescsaba
Semmelweis University
HU10005; II. Belgyógyászati Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Casa Sollievo Della Sofferenza
IT10024: Gastroenterologia e Endoscopia Digestiva, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Pauls Stradins Clinical University Hospital
10002: Internal Medicine, Pilsonu Iela 13, 1002, Riga
Pauls Stradins Clinical University Hospital
10003: Gastroenterology Department No.10, Pilsonu Iela 13, 1002, Riga
Stichting Amsterdam UMC
NL10004: Gastroenterology, De Boelelaan 1117, 1081 HV, Amsterdam
Stichting Zuyderland Medisch Centrum
NL10001: Gastroenterology, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen
EMC Instytut Medyczny S.A.
PL10053:EuroMediCare Szpital Specjalistyczny z Przychodnia, Ul. Pilczycka 144/148, 54-144, Wroclaw
Promed P.Lach R.Glowacki Sp. j.
PL10002:Centrum Medyczne Promed, Ul. Olszanska 5g, 31-513, Cracow
Vivamed Sp. z o.o.
PL10013:Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz, Ul. Zamiejska 17, 03-580, Warsaw
Gastromed Sp. z o.o.
PL10025:Torunskie Centrum Gastrologiczne "Gastromed", Ul. Grudziadzka 11/13-14, 87-100, Torun
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
PL10047:Twoja Przychodnia PCM, Ul. Marcelinska 92, 60-324, Poznan
Endoskopia Sp. z o.o.
PL10009: Gastroenterology, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Synexus Polska Sp. z o.o.
PL10037:Oddzial w Czestochowie, Aleja Najswietszej Maryi Panny 15, 42-202, Czestochowa
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
PL10031:Niepubliczny Zakład Opieki Zdrowotnej CENTRUM MEDYCZNE KERMED, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Centrum Medyczne Medyk Sp. z o.o.
PL10018:Centrum Medyczne MEDYK, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Medical Network Sp. z o.o.
PL10042: Medical Network Sp. z o. o. WIP Warsaw IBD Point Profesor Kierkus, Ul. Plowiecka 103, 04-501, Warsaw
Pro Life Medica Sp. z o.o.
PL10017:ETG Zamość, Ul. Gesia 3, 22-400, Zamosc
Synexus Polska Sp. z o.o.
PL10036:Oddzial w Gdansku, Ul. Maurycego Beniowskiego 23, 80-382, Gdansk
Melita Medical Sp. z o.o.
PL10005:Centrum Medyczne Melita Medical, Ul. Strzegomska 2-4, 53-611, Wroclaw
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.
PL10033:Gastroenterology, Ul. Barska 13, 87-800, Wloclawek
H-T.Centrum Medyczne Sp. z o.o. sp.k.
PL10015:H-T. CENTRUM MEDYCZNE - ENDOTERAPIA (Endoscopy performed at Aleja Bielska 105), Aleja Bielska 103a, 43-100, Tychy
Scanmed S.A.
PL10011: Gastromed Zaklad Opieki Zdrowotnej, Ul. Onyksowa 10, 20-582, Lublin
Vistamed & Vertigo Sp. z o.o.
PL10021:VISTAMED, Ul Raclawicka 105 1b, 53-149, Wroclaw
Wojewodzki Szpital Specjalistyczny W Olsztynie
PL10010:Oddzial Gastroenterologii, Ul. Zolnierska 18, 10-561, Olsztyn
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
PL10020:Twoja Przychodnia SCM, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Synexus Polska Sp. z o.o.
PL10035:Oddzial w Poznaniu, Ul. Glogowska 31/33, 60-702, Poznan
Medicome Sp. z o.o.
PL10030:Gastroenterology, Plac Tadeusza Kosciuszki 12, 32-600, Oswiecim
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
PL10026:Centrum Medyczne Plejady, Ul. Tadeusza Szafrana 5d / U2-U5, 30-363, Cracow
Synexus Polska Sp. z o.o.
PL10041:Oddzial w Katowicach, Ul. Konckiego 3, 40-040, Katowice
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
10005:Gastroenterologia, Rua Doutor Candido Pinho, 4520-211, Santa Maria Da Feira
Unidade Local de Saude do Algarve E.P.E.
10011:Enterelogia, Sitio Do Poco Seco, 8500-338, Portimao
Unidade Local De Saude De Santo Antonio E.P.E.
10004:Gastroenterologia, Largo Professor Abel Salazar, 4050-011, Porto
F D Roosevelt University General Hospital Of Banska Bystrica
SK10001: II. Interna klinika, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Gastro I s.r.o.
SK10002: Gastroenterologicka ambulacia, Puskinova 18, 080 01, Presov
Area Sanitaria De Ferrol
ES1008; Digestivo, Avenida Residencia S/n, 15405, Ferrol
Hospital Universitario De Torrejon
ES10010; Gastroenterologia, Calle De Mateo Inurria 1, 28850, Torrejon De Ardoz
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 | 2018-07-26 | 2018-12-17 | 2022-06-21 | ||
| Croatia | 2018-10-10 | 2025-10-28 | 2021-03-29 | 2022-07-05 | |
| Czechia | 2018-08-29 | 2019-03-05 | 2022-09-29 | ||
| France | 2018-09-21 | 2019-01-22 | 2022-09-30 | ||
| Germany | 2018-09-04 | 2019-01-07 | 2022-09-12 | ||
| Hungary | 2020-07-16 | 2020-09-28 | 2022-09-07 | ||
| Italy | 2018-11-26 | 2019-03-20 | 2022-07-14 | ||
| Latvia | 2019-01-16 | 2019-02-04 | 2022-08-17 | ||
| Netherlands | 2019-02-07 | 2020-02-27 | 2022-07-19 | ||
| Poland | 2018-08-27 | 2018-09-29 | 2022-09-30 | ||
| Portugal | 2019-05-16 | 2020-10-20 | 2022-09-30 | ||
| Slovakia | 2018-10-04 | 2018-12-27 | 2022-09-27 | ||
| Spain | 2018-11-15 | 2019-01-24 | 2022-09-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 287 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Amendment Main English CNTO1959CRD3001 Public | 5.1 |
| Protocol (for publication) | D4_BEL Subject Diary AHA Diary Screening Visit Week 48 to 252 Dutch CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_BEL Subject Diary AHA Diary Screening Visit week 48 to 252 French CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_BEL Subject Diary Study Participant Diary Screening Visit to Week 48 Dutch CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Diary Study Participant Diary Week 48 to 144 Dutch CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Diary Study Participant Diary Week 48 to 144 French CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Diary Study Participant Diary Week 48 to 252 Dutch CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Diary Study Participant Diary Week 48 to 252 French CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire Assessment of Injection Site Pain Dutch CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire Assessment of Injection Site Pain French CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire Injection Assessment Dutch CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire Injection Assessment French CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire PGIC Dutch CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire PGIC French CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire PGIS Dutch CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire PGIS French CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire WPAI-CD Dutch CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_BEL Subject Questionnaire WPAI-CD French CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_CZE Subject Diary AHA Diary Screening Visit week 48 to 252 Czech CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_CZE Subject Diary Study Participant Diary Screening to Week 48 Czech CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_CZE Subject Diary Study Participant Diary Week 48 to 144 Czech CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_CZE Subject Diary Study Participant Diary Week 48 to 252 Czech CNTO1959CRD3001 | 2.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire Assessment of Injection Site Pain Czech CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire eCOA PGIC Czech CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire eCOA PGIS Czech CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire eCOA WPAI-CD Czech CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_CZE Subject Questionnaire Injection Assessment Czech CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Diary AHA Diary Screening Visit week 48 to 252 German CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_DEU Subject Diary AHA Diary Screening week 48 to 252 Ukrainian CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_DEU Subject Diary Study Participant Diary Screening to Week 48 German CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_DEU Subject Diary Study Participant Diary Week 48 to 144 German CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Diary Study Participant Diary Week 48 to 252 German CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_DEU Subject Diary Study Participant Diary Week 48 to 252 Ukrainian CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_DEU Subject Questionnaire Assessment of Injection Site Pain German CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Questionnaire Injection Assessment German CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Questionnaire PGIC German CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Questionnaire PGIC Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Questionnaire PGIS German CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Questionnaire PGIS Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Questionnaire WPAI-CD German CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_DEU Subject Questionnaire WPAI-CD Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_ESP Subject Diary Study Participant Diary Week 48 to 144 Spanish CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_ESP Subject Diary AHA Diary Screening Visit week 48 to 252 Spanish CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_ESP Subject Diary Study Participant Diary Week 48 to 252 Spanish CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire PGIC Spanish CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire Assessment of Injection Site Pain Spanish CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire Injection Assessment Spanish CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire PGIS Spanish CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_ESP Subject Questionnaire WPAI-CD Spanish CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_FRA Study Participant Diary Week 48 to 252 French CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_FRA Subject Diary AHA Diary Screening Visit week 48 to 252 French CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_FRA Subject Diary AHA Diary Screening Visit week 48 to 252 Russian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_FRA Subject Diary Injection Assessment French CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_FRA Subject Diary Study Participant Diary Screening to Week 48 French CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_FRA Subject Diary Study Participant Diary Week 48 to 144 French CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire Assessment of Injection Site Pain French CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire Assessment of Injection Site Pain Russian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire Injection Assessment Russian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire PGIC French CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire PGIC Russian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire PGIS French CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire PGIS Russian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire WPAI-CD French CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_FRA Subject Questionnaire WPAI-CD Russian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_HRV Study Participant Diary Week 48 to 252 Croatian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_HRV Subject Diary Study Participant Diary Week 48 to 252 Ukrainian CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_HRV Subject Diary AHA Diary week 48 to 252 Croatian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Diary AHA Diary week 48 to 252 Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Diary Study Participant Diary Week 48 to 144 Croatian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Diary Study Participant Diary Week 48 to 252 Croatian CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_HRV Subject Diary Study Participant Screening Visit to Week 48 Croatian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Questionnaire Assessment of Injection Site Pain Croatian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Questionnaire PGIC Croatian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Questionnaire PGIC Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Questionnaire PGIS Croatian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Questionnaire PGIS Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Questionnaire WPAI-CD Croatian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_HRV Subject Questionnaire WPAI-CD Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_HUN Subject Questionnaire PGIC Hungarian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_HUN Subject Questionnaire PGIS Hungarian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_HUN Subject Questionnaire WPAI-CD Hungarian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_ITA Subject Diary AHA Diary screening visit week 48 to 252 Italian CNTO1959CRD3001 Public | 6.0 |
| Protocol (for publication) | D4_ITA Subject Diary Study Participant Diary Week 48 to 252 Italian CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_ITA Subject Diary Study Participant screening visit to week 48 Italian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_ITA Subject Questionnaire WPAI-CD Italian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_ITA Subject Questionnaire Assessment of Injection Site Pain Italian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_ITA Subject Questionnaire Injection Assessment Italian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_ITA Subject Questionnaire PGIC Italian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_ITA Subject Questionnaire PGIS Italian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_LVA Study Participant Diary Week 48 to 252 Latvian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Study Participant Diary Week 48 to 252 Russian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Subject Diary AHA Diary Screening Visit 48 to 252 Latvian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_LVA Subject Diary AHA Diary Screening Visit 48 to 252 Russian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_LVA Subject Diary Study Participant Diary Screening to Week 48 Latvian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Subject Diary Study Participant Diary Screening to Week 48 Russian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Subject Diary Study Participant Diary Week 48 to 144 Latvian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Subject Diary Study Participant Diary Week 48 to 144 Russian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Subject Questionnaire Assessment of Injection Site Pain Latvian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Subject Questionnaire Assessment of Injection Site Pain Russian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Subject Questionnaire Injection Assessment Latvian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_LVA Subject Questionnaire Injection Assessment Russian CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_LVA Subject Questionnaire PGIC Latvian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Subject Questionnaire PGIC Russian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Subject Questionnaire PGIS Latvian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Subject Questionnaire PGIS Russian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Subject Questionnaire WPAI-CD Latvian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_LVA Subject Questionnaire WPAI-CD Russian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_NLD Subject Diary AHA Diary Screening Visit week 48 to 252 Dutch CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_NLD Subject Diary Study Participant Diary Screening to Week 48 Dutch CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_NLD Subject Diary Study Participant Diary Week 48 to 144 Dutch CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_NLD Subject Diary Study Participant Diary Week 48 to 252 Dutch CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_NLD Subject Questionnaire WPAI-CD Dutch CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_POL Subject Diary AHA Diary screening visit week 48 to 252 Polish CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_POL Subject Diary Study Participant Diary Screening to Week 48 Polish CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_POL Subject Diary Study Participant Diary Week 48 to 144 Polish CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_POL Subject Diary Study Participant Diary Week 48 to 252 Polish CNTO1959CRD3001 Public | 2.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire Assessment of Injection Site Pain Polish CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire Injection Assessment Polish CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire PGIC Polish CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire PGIS Polish CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_POL Subject Questionnaire WPAI-CD Polish CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_PRT Subject Diary AHA Diary screening visit week 48 to 252 Portuguese CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_PRT Subject Diary Study Participant Diary Screening to Week 48 Portuguese CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_PRT Subject Diary Study Participant Diary Week 48 to 252 Portuguese CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_PRT Subject Questionnaire PGIC Portuguese CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_PRT Subject Questionnaire PGIS Portuguese CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_PRT Subject Questionnaire WPAI-CD Portuguese CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_Study Participant Diary Week 48 to 252 Russian CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_Subject Diary Study Participant Diary Week 48 to 144 English CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_Subject Diary AHA Diary Screening Visit week 48 to 252 English CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_Subject Diary Study Participant Diary Screening to Week 48 English CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_Subject Diary Study Participant Diary Week 48 to 252 English CNTO1959CRD3001 | 2.0 |
| Protocol (for publication) | D4_Subject Questionnaire Assessment of Injection Site Pain English CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_Subject Questionnaire Injection Assessment English CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_Subject Questionnaire PGIC English CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_Subject Questionnaire PGIS English CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_Subject Questionnaire Regulatory Filenote English CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_Subject Questionnaire WPAI-CD English CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_SVK Subject Diary AHA Diary Screening visit week 48 to 252 Slovak CNTO1959CRD3001 Public | 1.0 |
| Protocol (for publication) | D4_SVK Subject Diary Study Participant Diary Screening to Week 48 Slovak CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_SVK Subject Diary Study Participant Diary Week 48 to 144 Slovak CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_SVK Subject Diary Study Participant Diary Week 48 to 252 Slovak CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_SVK Subject Materials Assessment of Injection Site Pain Slovak CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_SVK Subject Questionnaire eCOA PGIC Slovak CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_SVK Subject Questionnaire eCOA PGIS Slovak CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_SVK Subject Questionnaire eCOA WPAI-CD Slovak CNTO1959CRD3001 | 1.0 |
| Protocol (for publication) | D4_SVK Subject Questionnaire Injection Assessment Slovak CNTO1959CRD3001 Public | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitement Arrangement_Regulatory Filenote_CNTO1959CRD3001_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement _Regulatory File Note_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement_Regulatory File Note_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Regulatory Filenote Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements Regulatory Filenote Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Regulatory Filenote_CNTO1959CRD3001 | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Regulatory Filenote_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Regulatory Filenote_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Regulatory Filenote_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Regulatory Filenote_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Regulatory Filenote_Public | NA |
| Recruitment arrangements (for publication) | K1_Regulatory Filenote CNTO1959CRD3001 Public | NA |
| Recruitment arrangements (for publication) | K1_Regulatory Filenote Recruitment Arrangments CNTO1959CRD3001 | NA |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Genetic Research Adult Dutch CNTO1959CRD3001 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Genetic Research Adult English CNTO1959CRD3001 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Genetic Research Adult French CNTO1959CRD3001 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main Dutch CNTO1959CRD3001 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main English CNTO1959CRD3001 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Main French CNTO1959CRD3001 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Pregnant partner Dutch CNTO1959CRD3001 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Pregnant partner English CNTO1959CRD3001 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_BEL Country ICF Pregnant partner French CNTO1959CRD3001 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_BEL Regulatory Filenote CNTO1959CRD3001 Public | NA |
| Subject information and informed consent form (for publication) | L1_CZE_ ICF Addendum Adult COVID-19_ Czech CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE_ ICF Genetic Research Adult _Czech CNTO1959CRD3001 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_CZE_ ICF Main Adult Already enrolled_Czech CNTO1959CRD3001 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_CZE_ ICF Optional Labs Adult Ileocolonoscopy _Czech CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE_ ICF Pregnant Partner_ Czech CNTO1959CRD3001 Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_CZE_ ICF Privacy GDPR_ Czech CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE_ ICF Research Adult Optional Future_Czech CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_CZE_ICF Main Adult _Czech CNTO1959CRD3001 Public | 10.0 |
| Subject information and informed consent form (for publication) | L1_CZE_ICF Main Adult Contact Author_Czech CNTO1959CRD3001 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_CZE_OtherSubject Participation Card _Czech CNTO1959CRD3001Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Addendum German CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Addendum Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Genetic Research German CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Genetic Research Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Information and Contact Authorization Form German CNTO1959CRD3001 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Information and Contact Authorization Form Ukrainian CNTO1959CRD3001 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Main Adult German CNTO1959CRD3001 Public | 10.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Main Adult Ukrainian CNTO1959CRD3001 Public | 10.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Pregnant Form Adult Child Follow-Up German CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Pregnant Partner German CNTO1959CRD3001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_DEU Country ICF Pregnant Partner Ukrainian CNTO1959CRD3001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF - Addendum Spanish CNTO1959CRD3001 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_ESP Country ICF Main Adult Spanish CNTO1959CRD3001 Public | 10.0 |
| Subject information and informed consent form (for publication) | L1_ESP_ICF Other Pregnant partner Spanish_CNTO1959CRD3001_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ESP_ICF Research_Spanish_CNTO1959CRD3001_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_FRA Country ICF - Other 12 Months Post- Birth Child FU French CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_FRA IRB-IEC Filenote CNTO1959CRD3001 Public | NA |
| Subject information and informed consent form (for publication) | L1_FRA IRB-IEC CL Filenote CNTO1959CRD3001 Public | NA |
| Subject information and informed consent form (for publication) | L1_FRA_Contact Authorization Form_French_CNTO1959CRD3001_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_FRA_Country ICF Addendum Covid 19_French_CNTO1959CRD3001_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_FRA_Country ICF Addendum Covid 19_Russian_CNTO1959CRD3001_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_FRA_Country ICF Genetic Research_French_CNTO1959CRD3001_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_FRA_Country ICF Main_French_CNTO1959CRD3001_Public | 10.0 |
| Subject information and informed consent form (for publication) | L1_FRA_Country ICF Main_Russian_CNTO1959CRD3001_Public | 10.0 |
| Subject information and informed consent form (for publication) | L1_FRA_Country ICF Other Complementary _French_CNTO1959CRD3001_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_FRA_Country ICF Other Complementary Russian_CNTO1959CRD3001_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_FRA_Pregnant partner ICF_French_CNTO1959CRD3001_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Addendum Croatian CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Addendum Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Genetic Research Croatian CNTO1959CRD3001 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Genetic Research Ukrainian CNTO1959CRD3001 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Main Croatian CNTO1959CRD3001 Public | 12.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Main Ukrainian CNTO1959CRD3001 Public | 12.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Optional Smart Phone Croatian CNTO1959CRD3001 Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Pregnant Partner Croatian CNTO1959CRD3001 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HRV Country ICF Pregnant Partner Ukrainian CNTO1959CRD3001 Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HRV Subject Participation Card Croatian CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HRV Subject Participation Card Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HUN Country ICF - Addendum Post Birth Follow-up Hungarian CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HUN ICF Main Adult_Hungarian_CNTO1959CRD3001_Public | 7.1 |
| Subject information and informed consent form (for publication) | L1_HUN_ICF Addendum Adult Covid-19_Hungarian_CNTO1959CRD3001_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HUN_ICF Genetic Research Adult PIS_Hungarian_CNTO1959CRD3001_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HUN_ICF Genetic Research Adult_Hungarian_CNTO1959CRD3001_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HUN_ICF Main Adult PIS_Hungarian_CNTO1959CRD3001_Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_HUN_ICF Other Adult Pregnant Partner PIS_Hungarian_CNTO1959CRD3001_ Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HUN_ICF Other Adult Pregnant Partner_Hungarian_CNTO1959CRD3001_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_HUN_ICF Patient ID Card Justification Letter_English_CNTO1959CRD3001_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_HUN_ICF Recruitment_Hungarian_CNTO1959CRD3001_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF - Other Addendum Birth Follow-up Italian CNTO1959CRD3001 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Genetic Research_Italian_CNTO1959CRD3001_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Main_Italian_CNTO1959CRD3001_Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_ITA Country ICF Other Pregnant Partner_Italian_CNTO1959CRD3001_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ITA ICF Assessment Report_Italian_CNTO1959CRD3001_Public | NA |
| Subject information and informed consent form (for publication) | L1_LVA Country ICF - Addendum Child follow up Latvian CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_LVA Country ICF - Addendum Child follow up Russian CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_LVA Country ICF Addendum_Latvian CNTO1959CRD3001_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_LVA Country ICF Addendum_Russian CNTO1959CRD3001_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_LVA Country ICF Genetic Research_Latvian CNTO1959CRD3001_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_LVA Country ICF Genetic Research_Russian CNTO1959CRD3001_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_LVA Country ICF Main_Latvian CNTO1959CRD3001_Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_LVA Country ICF Main_Russian CNTO1959CRD3001_Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_LVA Country ICF Other Pregnant Partner_Latvian CNTO1959CRD3001_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_LVA Country ICF Other Pregnant Partner_Russian CNTO1959CRD3001_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Genetic Research Adult Dutch CNTO1959CRD3001 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Main Dutch CNTO1959CRD3001 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_NLD Country ICF Pregnant partner Dutch CNTO1959CRD3001 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_NLD Regulatory Filenote CNTO1959CRD3001 Public | NA |
| Subject information and informed consent form (for publication) | L1_POL Country ICF - Addendum Child Follow-up Polish CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF - Addendum Child Follow-up Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Addendum Adult COVID-19 Polish CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Addendum Adult COVID-19 Ukrainian CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Genetic Research Adult Polish CNTO1959CRD3001 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Genetic Research Adult Ukrainian CNTO1959CRD3001 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Main Adult Polish CNTO1959CRD3001 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Main Adult Ukrainian CNTO1959CRD3001 Public | 11.0 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Other Adult Pregnant Partner Polish CNTO1959CRD3001 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_POL Country ICF Other Adult Pregnant Partner Ukrainian CNTO1959CRD3001 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_PRT Country ICF Addendum Adult Addendum COVID-19 Portuguese CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_PRT Country ICF Main Galaxi 1 Fase 2 Main ICF Portuguese CNTO1959CRD3001 Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_PRT Country ICF Main current English CNTO1959CRD3001 Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_PRT Country ICF Main Galaxi 2_3 Phase 3 Main Portuguese CNTO1959CRD3001 Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_PRT Country ICF Main suppressed English CNTO1959CRD3001 Public | 8.1 |
| Subject information and informed consent form (for publication) | L1_PRT Country ICF Research Adult Portuguese CNTO1959CRD3001 Public | 1.2 |
| Subject information and informed consent form (for publication) | L1_PRT Country Pregnant Medical Release Form ICF Pregnant Partner Portuguese CNTO1959CRD3001 Public | 1.4 |
| Subject information and informed consent form (for publication) | L1_PRT Country Pregnant Medical Release Form Pregnant Participant Portuguese CNTO1959CRD3001 Public | 1.3 |
| Subject information and informed consent form (for publication) | L1_SVK Country ICF - Pregnant Form Adult Child Follow-Up Slovak CNTO1959CRD3001 Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SVK Country ICF Addendum Adult COVID-19 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SVK Country ICF Caregiver Adult Slovak CNTO1959CRD3001 Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SVK Country ICF Genetic Research Adult_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SVK Country ICF Main Adult Contact Author_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_SVK Country ICF Main Adult_Public | 11.1 |
| Subject information and informed consent form (for publication) | L1_SVK Country ICF Other Adult Pregnant Partner_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_SVK Country ICF Privacy Adult GDPR_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SVK Country ICF Privacy Adult Privacy Rights_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SVK Subject Participation Card_Slovak_CNTO1959CRD3001 | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC CNTO1959CRD3001 | NA |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Czech CNTO1959CRD3001 Public | 5.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Dutch CNTO1959CRD3001 Public | 5.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main English CNTO1959CRD3001 Public | 5.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main French CNTO1959CRD3001 Public | 5.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main German CNTO1959CRD3001 Public | 5.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Hungarian CNTO1959CRD3001 Public | 5.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Italian CNTO1959CRD3001 Public | 5.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Polish CNTO1959CRD3001 Public | 5.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Portuguese CNTO1959CRD3001 Public | 5.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Slovak CNTO1959CRD3001 Public | 5.1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main Spanish CNTO1959CRD3001 Public | 5.1 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-05 | Germany | Acceptable with conditions 2024-08-01
|
2024-08-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-15 | Germany | Acceptable 2025-02-03
|
2025-02-03 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-04-01 | Acceptable 2025-02-03
|
2025-04-01 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-02 | Acceptable | 2025-05-13 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-30 | 2025-07-15 | ||
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-04 | Germany | Acceptable 2026-01-16
|
2026-01-16 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-27 | Germany | Acceptable 2026-01-16
|
2026-02-27 |