Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
173
Countries
9
Sites
64
Moderately to Severely Active Ulcerative Colitis
To assess the improvement in bowel urgency severity at Week 12.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 6 Sep 2023 → 27 Apr 2026
- Decision date (initial)
- 2023-07-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502393-16-00
- WHO UTN
- U1111-1285-7055
- ClinicalTrials.gov
- NCT05767021
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy, Pharmacokinetic
To assess the improvement in bowel urgency severity at Week 12.
Conditions and MedDRA coding
Moderately to Severely Active Ulcerative Colitis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Have an established diagnosis of UC for ≥3 months
- Have confirmed diagnosis of moderately for severely active UC
- Have current bowel urgency
- Have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic/Janus Kinase (JAK) inhibitor/sphingosine-1-phosphate (S1P) receptor modulator therapy for UC
Exclusion criteria 7
- Have Crohn's disease (CD)
- Have inflammatory bowel disease-unclassified, formerly known as indeterminate colitis, or
- Have ulcerative proctitis, disease limited to the rectum, that is, distal to the recto-sigmoid junction, which lies approximately 10 to 15 centimeter (cm) from anal verge
- Have an inherited immunodeficiency syndrome or a monogenic cause of UC-like colonic inflammation
- Have any history or current evidence of cancer of the gastrointestinal tract
- Have active tuberculosis
- Have HIV infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline in bowel urgency severity (UNRS) score at Week 12.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10082863 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION OR INFUSION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10082852 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION OR INFUSION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Acelabio (US) Inc. ORG-100045270
|
San Diego, United States | Other |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Icon (Lr) Limited ORG-100042612
|
Dublin 18, Ireland | Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Other |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Code 10, Code 11, Code 12, Code 13, Other, Code 2, Code 5, Data management, Code 9 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other, Data management |
Locations
9 EU/EEA countries · 64 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 17 | 4 |
| Belgium | Ended | 3 | 2 |
| Czechia | Ended | 10 | 6 |
| France | Ended | 15 | 13 |
| Germany | Ended | 4 | 5 |
| Hungary | Ended | 8 | 8 |
| Italy | Ended | 12 | 7 |
| Poland | Ended | 40 | 15 |
| Slovakia | Ended | 7 | 4 |
| Rest of world
Canada, United Kingdom, United States
|
— | 57 | — |
Investigational sites
Medical University Of Vienna
Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Waehringer Guertel 18-20, Alsergrund, Vienna
Krankenhaus Barmherzige Schwestern Wien
II Medical Department, Stumpergasse 13, 1060, Wien
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
University Department of Internal Medicine I, Muellner Hauptstrasse 48, 5020, Salzburg
Medizinische Universitaet Innsbruck
University Department of Internal Medicine I, Anichstrasse 35, 6020, Innsbruck
Universitair Ziekenhuis Gent
Gastro-enterology, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Gastro-enterology, Herestraat 49, 3000, Leuven
Vojenska Nemocnice Brno
Interni oddeleni, Zabrdovicka 3, Zabrdovice, Brno-Zidenice
Hepato-Gastroenterologie HK s.r.o.
NA, Trida Edvarda Benese 1549/34, 500 12, Novy Hradec Kralove
University Hospital Ostrava
Interni klinika, 17. Listopadu 1790/5, 708 00, Poruba
GASTRO JeKa s.r.o.
NA, Krejciho Nabr. 914, 339 01, Klatovy IV
SurGal Clinic s.r.o.
NA, Drobneho 307/38, Cerna Pole, Brno-Sever
Preventamed s.r.o.
NA, Domovina 774/2, 779 00, Olomouc
CHRU De Nancy
Gastro-Entérologie, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Hospitalier Universitaire De Nantes
Gastro-Entérologie, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Bordeaux
Hépato Gastroentérologie et nutrition, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Rennes
Maladies de l'appareil digestif, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Nice
Gastro-Entérologie, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Reims
Hépato-Gastroentérologie et de Cancérologie Digestive, Rue Du General Koenig, 51092, Reims Cedex
Hopital Saint Eloi
Hépato-gastro-entérologie, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier De Pau
Hépato-gastroentérologie, 4 Boulevard Hauterive, Cs 17595, Pau Cedex
Clinique Jules Verne
Gastro-entérologie et hépatologie, 2 Route De Paris, 44300, Nantes
Centre Hospitalier Universitaire De Lille
Service des Maladies de l'appareil digestif, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Universitaire De Saint Etienne
Gastro-Entérologie, Avenue Albert Raimond, 42270, Saint-Priest-En-Jarez
Hospices Civils De Lyon
Gastro-Entérologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Besancon University Hospital Center
Gastro-enterologie et endoscopie digestive, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
University Hospital Halle (Saale)
Poliklinik fuer Innere Medizin I, Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
DRK Kliniken Berlin
Klinik fuer Innere Medizin II, Eg., Spandauer Damm 130, Berlin
Hamburgisches Forschungsinstitut fuer chronisch entzuendliche Darmerkrankungen HaFCED e.K.
N/A, Christoph-Probst-Weg 4, Eppendorf, Hamburg
Universitaet Leipzig
Gastroenterologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Gastroenterologische Spezialpraxis
N/A, Ehrenfelsstrasse 47, 10318, Berlin
Javorszky Odon Korhaz
Gasztroenterológia, Argenti Dome Ter 1-3, 2600, Vac
Bekes Megyei Kozponti Korhaz
4. Belgyógyászat-Gasztroenterológia-Hepatológia, Gyulai Ut 18, 5600, Bekescsaba
Semmelweis University
Belgyógyászati és Hematológiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Pannonia Maganorvosi Centrum Kft.
N/A, Pannonia Utca 35-37, 1136, Budapest XIII
Clinfan Kft.
N/A, Pollack Mihaly Utca 50, 7100, Szekszard
Clinexpert Kft.
N/A, Kaszasdulo Utca 5, 1033, Budapest III
University Of Debrecen
Gasztroenterológiai Klinika, Nagyerdei Korut 98, 4032, Debrecen
Bugat Pal Korhaz Kht.
Gasztroenterológia, Dozsa Gyorgy Utca 20-22, 3200, Gyongyos
Humanitas Research Hospital
Malattie Infiammatorie Croniche Intestinali, Via Alessandro Manzoni 56, 20089, Rozzano
Ospedale San Raffaele S.r.l.
UO Gastroenterologia e Endoscopia Digestiva, Via Olgettina 60, 20132, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Medicina Interna e Gastroenterologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Ordine Mauriziano Di Torino
SC Gastroenterologia, Via Ferdinando Magellano 1, 10128, Turin
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
SC Gastroenterologia ed Endoscopia, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliera Policlinico Universitario Tor Vergata
UOC Gastroenterologia, Viale Oxford 81, 00133, Rome
National Institute Of Gastroenterology Saverio De Bellis Research Hospital
UOS Malattie Infiammatorie Croniche Intestinali, Via Turi 27, 70013, Castellana Grotte
Amicare Sp. z o.o. S.K.
Gastroenterology, Ul. Zgierska 249, 91-495, Lodz
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j.
Gastroenterology, Ul. Topolowa 33/7, 31-506, Cracow
Nzoz For Med Sp. z o.o.
Gastroenterology, Ul. Lwowska 93, 34-100, Wadowice
Economicus Sp. z o.o.
NZOZ All Medicus, Ul. Harcerzy Wrzesnia 1939 5, 40-659, Katowice
Centrum Medyczne Oporow
Gastroenterology, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Med-Gastr Sp. z o.o. sp.k.
Gastroenterology, Ul. Mokra 4, 91-034, Lodz
Twoja Przychodnia Opolskie Centrum Medyczne
Gastroenterology, Kurpiowska 6/2, 45-819, Opole
Sonomed Sp. z o.o.
Gastroenterology, Ul. Ks. Bp. Wladyslawa Bandurskiego 98/u12, 71-685, Szczecin
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Gastroenterology, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j.
Gastroenterology, Ul. Dluga 10a/21-26, 28-200, Staszow
Planetmed Sp. z o.o.
Gastroenterology, Ul. Lubinowa 12/8, 52-210, Wroclaw
Mz Badania Slowik Zymla Sp. j.
Gastroenterology, Ul. Ks. Alojzego Kozielka 8, 44-190, Knurow
Futuremeds Sp. z o.o.
Gastroenterology; New address: ul. Legnicka 16, 53-673, Wrocław, Polska, Ul. Swobodna 8 A, 50-088, Wroclaw
Centrum Medyczne Kuba-Med 2 Sp. z o.o.
New Organisation name: Pro Life Medica Sp. z o.o._Site name: ETG Zamość, ul. Gęsia 3, 22-400 Zamość, Ul. Spadek 41, 22-400, Zamosc
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
NZOZ Centrum Medyczne KERmed ul. Królowej Jadwigi 16, 85-231 Bydgoszcz, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
KM Management spol. s r.o.
Gastroenterologicke a hepatologicke centrum, Hodzova 408/46, 949 01, Nitra
Endomed s.r.o.
Gastroenterologicka ambulancia, Americka Trieda 19, Sidlisko Tahanovce, Kosice
Cliniq s.r.o.
Gastroenterologicke centrum, Bezrucova 5, Stare Mesto, Bratislava
Accout Center s.r.o.
Gastroenterologicka ambulancia, Hviezdoslavova 402/19, 936 01, Sahy
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 | 2024-03-11 | 2024-04-17 | 2024-03-14 | 2024-04-17 | |
| Czechia | 2023-09-06 | 2025-05-20 | 2023-09-06 | 2024-05-16 | |
| France | 2023-09-26 | 2026-04-27 | 2023-11-06 | 2024-05-16 | |
| Germany | 2023-12-18 | ||||
| Hungary | 2023-09-11 | 2026-04-27 | 2023-09-11 | 2024-05-16 | |
| Italy | 2023-10-25 | 2025-06-23 | 2023-11-28 | 2024-05-16 | |
| Poland | 2023-09-11 | 2025-08-08 | 2023-09-19 | 2023-12-14 | |
| Slovakia | 2023-09-13 | 2026-02-24 | 2023-09-27 | 2024-05-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 426 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Collection of Race and Ethnicity Justification_2022-502393-16 | 1.0 |
| Protocol (for publication) | D1_Protocol_2022-502393-16_Redacted | Amend A |
| Protocol (for publication) | D4_Patient Facing Material_Abdominal Pain eCOA_UC_AT-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Abdominal Pain eCOA_UC_BE-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Abdominal Pain eCOA_UC_BE-NL_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Abdominal Pain eCOA_UC_DE-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Abdominal Pain eCOA_UC_FR-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Abdominal Pain eCOA_UC_HU-HU_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Abdominal Pain eCOA_UC_IT-IT_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Abdominal Pain eCOA_UC_SK-SK_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Absorbent Product Use_eCOA_AT-DE_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Absorbent Product Use_eCOA_BE-FR_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Absorbent Product Use_eCOA_BE-NL_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Absorbent Product Use_eCOA_DE-DE_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Absorbent Product Use_eCOA_EN-US_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Absorbent Product Use_eCOA_FR-FR_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Absorbent Product Use_eCOA_HU-HU_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Absorbent Product Use_eCOA_IT-IT_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Absorbent Product Use_eCOA_SK-SK_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Bowel Frequency_eCOA_AT-DE_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Bowel Frequency_eCOA_BE-FR_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Bowel Frequency_eCOA_BE-NL_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Bowel Frequency_eCOA_DE-DE_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Bowel Frequency_eCOA_FR-FR_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Bowel Frequency_eCOA_HU-HU_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Bowel Frequency_eCOA_IT-IT_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Bowel Frequency_eCOA_SK-SK_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Daily Diary_eCOA_EN-US_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_DDT_eCOA_AT-DE_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_DDT_eCOA_BE-FR_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_DDT_eCOA_BE-NL_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_DDT_eCOA_DE-DE_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_DDT_eCOA_FR-FR_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_DDT_eCOA_HU-HU_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_DDT_eCOA_IT-IT_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_DDT_eCOA_SK-SK_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Fatigue_eCOA_AT-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Fatigue_eCOA_BE-FR_san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_Fatigue_eCOA_BE-NL_san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_Fatigue_eCOA_DE-DE_san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_Fatigue_eCOA_FR-FR_san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_Fatigue_eCOA_HU-HU_san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_Fatigue_eCOA_IT-IT_san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_Fatigue_eCOA_SK-SK_san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_GAD-7_eCOA_AT-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_GAD-7_eCOA_BE-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_GAD-7_eCOA_BE-NL_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_GAD-7_eCOA_DE-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_GAD-7_eCOA_EN-US_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_GAD-7_eCOA_FR-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_GAD-7_eCOA_HU-HU_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_GAD-7_eCOA_IT-IT_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_GAD-7_eCOA_SK-SK_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_IBDQ_eCOA_AT-DE_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_IBDQ_eCOA_BE-FR_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_IBDQ_eCOA_BE-NL_Redsan | 5 |
| Protocol (for publication) | D4_Patient Facing Material_IBDQ_eCOA_DE-DE_Redsan | 7 |
| Protocol (for publication) | D4_Patient Facing Material_IBDQ_eCOA_EN-US_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_IBDQ_eCOA_FR-FR_Redsan | 11 |
| Protocol (for publication) | D4_Patient Facing Material_IBDQ_eCOA_HU-HU_Redsan | 3 |
| Protocol (for publication) | D4_Patient Facing Material_IBDQ_eCOA_IT-IT_red-san | 9 |
| Protocol (for publication) | D4_Patient Facing Material_IBDQ_eCOA_SK-SK_red-san | 6 |
| Protocol (for publication) | D4_Patient Facing Material_NoStools_eCOA_AT-DE_san | 3 |
| Protocol (for publication) | D4_Patient Facing Material_NoStools_eCOA_BE-FR_san | 3 |
| Protocol (for publication) | D4_Patient Facing Material_NoStools_eCOA_BE-NL_san | 3 |
| Protocol (for publication) | D4_Patient Facing Material_NoStools_eCOA_DE-DE_san | 3 |
| Protocol (for publication) | D4_Patient Facing Material_NoStools_eCOA_EN-US_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_NoStools_eCOA_FR-FR_san | 3 |
| Protocol (for publication) | D4_Patient Facing Material_NoStools_eCOA_HU-HU_san | 3 |
| Protocol (for publication) | D4_Patient Facing Material_NoStools_eCOA_IT-IT_san | 3 |
| Protocol (for publication) | D4_Patient Facing Material_NoStools_eCOA_SK-SK_san | 3 |
| Protocol (for publication) | D4_Patient Facing Material_NS_eCOA_AT-DE_San | 1 |
| Protocol (for publication) | D4_Patient Facing Material_NS_eCOA_BE-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_NS_eCOA_BE-NL_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_NS_eCOA_DE-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_NS_eCOA_FR-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_NS_eCOA_HU-HU_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_NS_eCOA_IT-IT_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_NS_eCOA_SK-SK_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_PGI-C_eCOA_AT-DE_san | 1.1 |
| Protocol (for publication) | D4_Patient Facing Material_PGI-C_eCOA_BE-FR_san | 1.1 |
| Protocol (for publication) | D4_Patient Facing Material_PGI-C_eCOA_BE-NL_san | 1.1 |
| Protocol (for publication) | D4_Patient Facing Material_PGI-C_eCOA_DE-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_PGI-C_eCOA_EN-US_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_PGI-C_eCOA_FR-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_PGI-C_eCOA_HU-HU_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_PGI-C_eCOA_IT-IT_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_PGI-C_eCOA_SK-SK_san | 1.1 |
| Protocol (for publication) | D4_Patient Facing Material_PGR-S_UC_eCOA_AT-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_PGR-S_UC_eCOA_BE-FR_san | 1.1 |
| Protocol (for publication) | D4_Patient Facing Material_PGR-S_UC_eCOA_BE-NL_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_PGR-S_UC_eCOA_DE-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_PGR-S_UC_eCOA_FR-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_PGR-S_UC_eCOA_HU-HU_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_PGR-S_UC_eCOA_IT-IT_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_PGR-S_UC_eCOA_SK-SK_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_QIDS-SR16_eCOA_AT-DE_Redsan | 8 |
| Protocol (for publication) | D4_Patient Facing Material_QIDS-SR16_eCOA_BE-FR_red-san | 8 |
| Protocol (for publication) | D4_Patient Facing Material_QIDS-SR16_eCOA_BE-NL_Redsan | 8 |
| Protocol (for publication) | D4_Patient Facing Material_QIDS-SR16_eCOA_DE-DE_Redsan | 8 |
| Protocol (for publication) | D4_Patient Facing Material_QIDS-SR16_eCOA_EN-US_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_QIDS-SR16_eCOA_FR-FR_Redsan | 8 |
| Protocol (for publication) | D4_Patient Facing Material_QIDS-SR16_eCOA_HU-HU_Redsan | 8 |
| Protocol (for publication) | D4_Patient Facing Material_QIDS-SR16_eCOA_IT-IT_red-san | 8 |
| Protocol (for publication) | D4_Patient Facing Material_QIDS-SR16_eCOA_SK-SK_red-san | 8 |
| Protocol (for publication) | D4_Patient Facing Material_RB_eCOA_AT-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_RB_eCOA_BE-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_RB_eCOA_BE-NL_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_RB_eCOA_DE-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_RB_eCOA_FR-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_RB_eCOA_HU-HU_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_RB_eCOA_IT-IT_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_RB_eCOA_SK-SK_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Female_eCOA_AT-DE_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Female_eCOA_BE-FR_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Female_eCOA_BE-NL_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Female_eCOA_DE-DE_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Female_eCOA_EN-US_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Female_eCOA_FR-FR_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Female_eCOA_HU-HU_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Female_eCOA_IT-IT_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Female_eCOA_SK-SK_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Male_eCOA_AT-DE_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Male_eCOA_BE-FR_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Male_eCOA_BE-NL_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Male_eCOA_DE-DE_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Male_eCOA_EN-US_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Male_eCOA_FR-FR_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Male_eCOA_HU-HU_Redsan | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Male_eCOA_IT-IT_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SAA_Male_eCOA_SK-SK_red-san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SConsistency_eCOA_AT-DE_Redsan | 2 |
| Protocol (for publication) | D4_Patient Facing Material_SConsistency_eCOA_BE-FR_red-san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_SConsistency_eCOA_BE-NL_Redsan | 2 |
| Protocol (for publication) | D4_Patient Facing Material_SConsistency_eCOA_DE-DE_Redsan | 2 |
| Protocol (for publication) | D4_Patient Facing Material_SConsistency_eCOA_FR-FR_Redsan | 2 |
| Protocol (for publication) | D4_Patient Facing Material_SConsistency_eCOA_HU-HU_Redsan | 2 |
| Protocol (for publication) | D4_Patient Facing Material_SConsistency_eCOA_IT-IT_red-san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_SConsistency_eCOA_SK-SK_red-san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_SFrequency_eCOA_AT-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SFrequency_eCOA_BE-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SFrequency_eCOA_BE-NL_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SFrequency_eCOA_DE-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SFrequency_eCOA_FR-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SFrequency_eCOA_HU-HU_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SFrequency_eCOA_IT-IT_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_SFrequency_eCOA_SK-SK_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Stool_eCOA_AT-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Stool_eCOA_BE-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Stool_eCOA_BE-NL_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Stool_eCOA_DE-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Stool_eCOA_FR-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Stool_eCOA_HU-HU_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Stool_eCOA_IT-IT_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Stool_eCOA_SK-SK_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Urgency NRS_eCOA_AT-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Urgency NRS_eCOA_BE-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Urgency NRS_eCOA_BE-NL_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Urgency NRS_eCOA_DE-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Urgency NRS_eCOA_FR-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Urgency NRS_eCOA_HU-HU_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Urgency NRS_eCOA_IT-IT_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_Urgency NRS_eCOA_SK-SK_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_WIS_eCOA_DE-DE_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_WIS_eCOA_EN-US_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_WIS_eCOA_FR-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_WIS_eCOA_HU-HU_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_WIS_eCOA_IT-IT_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_WIS_eCOA_SK-SK_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_WIS_eCOA-AT-DE_San | 1 |
| Protocol (for publication) | D4_Patient Facing Material_WIS_eCOA-BE-FR_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_WIS_eCOA-BE-NL_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_WPAI-UC_eCOA_DE-DE_san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_WPAI-UC_eCOA_EN-US_san | 1 |
| Protocol (for publication) | D4_Patient Facing Material_WPAI-UC_eCOA_FR-FR_san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_WPAI-UC_eCOA_HU-HU_san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_WPAI-UC_eCOA_IT-IT_san | 2 |
| Protocol (for publication) | D4_Patient Facing Material_WPAI-UC_eCOA_SK-SK_san | 2 |
| Protocol (for publication) | D4_Patient Facing Materials_WPAI-UC_eCOA_AT-DE_san | 2 |
| Protocol (for publication) | D4_Patient Facing Materials_WPAI-UC_eCOA_BE-FR_san | 2 |
| Protocol (for publication) | D4_Patient Facing Materials_WPAI-UC_eCOA_BE-NL_san | 2 |
| Protocol (for publication) | Instructions for PRO items_Adult_v1_eCOA Ready_German-DE_24Jan2023_san | 1 |
| Protocol (for publication) | Instructions for PRO items_Adult_v1_eCOA Ready_Italian-IT_24Jan2023_san | 1 |
| Recruitment arrangements (for publication) | K1_Digital Waiting Room Ad | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements omission justification_Hungary_san | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_San | ITA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | Final |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_TC_san | 2.0 |
| Recruitment arrangements (for publication) | K2_Digital Waiting Room Ad_San | V01 ITA(it |
| Recruitment arrangements (for publication) | K2_Dr-to-Patient Letter_San | V01 ITA(it |
| Recruitment arrangements (for publication) | K2_Patient Brochure_San | V01 ITA(it |
| Recruitment arrangements (for publication) | K2_Physician Referral Letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material URGE Digital Waiting Room Ad_san | V01SVK(sk) |
| Recruitment arrangements (for publication) | K2_Recruitment material URGE Dr to Patient Letter_san | 1SVK(sk)01 |
| Recruitment arrangements (for publication) | K2_Recruitment material URGE Patient Brochure_san | V01SVK(sk) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Waiting Room Ad_san | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Doctor to Patient Letter_san | V01POL(pl) |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_san | V01POL(pl |
| Recruitment arrangements (for publication) | K3_Patient Brochure | 1 |
| Recruitment arrangements (for publication) | Recruitment and Consent | 2 |
| Recruitment arrangements (for publication) | Recruitment and ICF Procedure_cs_san | 1 |
| Recruitment arrangements (for publication) | Recruitment Tools_Digital Waiting Room Ad | V01FRAfr |
| Recruitment arrangements (for publication) | Recruitment Tools_Dr-to-Patient Letter | V01FRAfr01 |
| Recruitment arrangements (for publication) | Recruitment Tools_Patient Brochure | V01FRAfr |
| Recruitment arrangements (for publication) | Recruitment Tools_Physician Referral Brochure | V01FRAfr |
| Recruitment arrangements (for publication) | Recruitment Tools_Physician Referral Letter A4 | V01FRAfr01 |
| Subject information and informed consent form (for publication) | Abdominal Pain_UC_eCOA _cs_san | 1 |
| Subject information and informed consent form (for publication) | Absorbent Product Use for Bowel Urgency_v1_eCOA Ready_Czech-CZ_24Jan2023_san | 1 |
| Subject information and informed consent form (for publication) | Bowel Urgency Frequency_v1_eCOA Ready_Czech-CZ_07Dec2022_san | 1 |
| Subject information and informed consent form (for publication) | ClinCard Cardholder FAQ_cs_san | CZE v 10.0 |
| Subject information and informed consent form (for publication) | ClinCard Cardholder Msg Templates_cs_san | CZE v 10.0 |
| Subject information and informed consent form (for publication) | ClinCard_Card_cs_san | CZE v 10.0 |
| Subject information and informed consent form (for publication) | ClinCard_Fee_Schedule_cs_san | CZE v 10.0 |
| Subject information and informed consent form (for publication) | ClinCard_Generic_Image_cs_san | CZE v 10.0 |
| Subject information and informed consent form (for publication) | ConneX Travel Contact Card_cs_san | CZE v 10.0 |
| Subject information and informed consent form (for publication) | ConneX Travel Reference Guide for Participants_cs_san | CZE v 10.0 |
| Subject information and informed consent form (for publication) | Cont Access ICF_cs_red and san | V2.0CZE1.0 |
| Subject information and informed consent form (for publication) | Cover Lettre _SM_12Oct2023_Czech Republic | 2 |
| Subject information and informed consent form (for publication) | Czech Republic PFS QR video link_cs_san | CZE |
| Subject information and informed consent form (for publication) | Defecation Deferral Time_v1_eCOA Ready_Czech-CZ_9Jan2023_san | 1 |
| Subject information and informed consent form (for publication) | Definition of Stool_v1_eCOA Ready_Czech-CZ_29Jan2023_san | 1 |
| Subject information and informed consent form (for publication) | Digital Waiting Room Ad_cs_san | V01CZE(cs) |
| Subject information and informed consent form (for publication) | Dr to Patient Letter_cs_san | 01CZEcs01 |
| Subject information and informed consent form (for publication) | eDiary and ePRO Overview Storyboard_cs_san | V01CZE(cs) |
| Subject information and informed consent form (for publication) | Fatigue_v2_eCOA Ready_Czech-CZ_29Jan2023_san | 2 |
| Subject information and informed consent form (for publication) | GAD-7_v1_eCOA Ready_Czech-CZ_26Jan2023_san | 1 |
| Subject information and informed consent form (for publication) | HAQ-DI_ePRO | 1.0ces-CZ1 |
| Subject information and informed consent form (for publication) | IBDQ_v2_eCOA Ready_Czech-CZ_03Feb2023_san | 2 |
| Subject information and informed consent form (for publication) | Informed Consent Form_Continued Access_Red | V1.0FRA2.0 |
| Subject information and informed consent form (for publication) | Informed Consent Form_Main _Add n1_San | 1.0FRA1.0 |
| Subject information and informed consent form (for publication) | Informed Consent Form_Main_Red | V2.0FRA1.0 |
| Subject information and informed consent form (for publication) | Informed Consent Form_PP | V1.0FRA1.0 |
| Subject information and informed consent form (for publication) | Instructions for PRO items_Adult_v1_eCOA Ready_Czech-CZ_24Jan2023_san | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_SoC_cs_san | V2.0CZE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Continued Access_red-san | V2.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Continued Access_TC_red-san | V2.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Data Privacy Addendum_red-san | V1.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_hu_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_hu_TC | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_red-san | V2.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_TC_red-san | V2.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_san | V1.0SVK2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_TC_san | V1.0SVK2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF SoC_IT_San | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF SOC_san | V1.0SVK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Main_redacted | V2.0POL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access Addendum_Red-San | V2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Continued Access_redacted | V2.0POL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Adult_Red-San | V2.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Participant_San | V1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_redacted | 1.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_San | V2.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC ICF_PL_san | v1.0POL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Summary of Changes_ICF_hu_san | V1.0HUN2.0 |
| Subject information and informed consent form (for publication) | L10_Hungary PFS QR video link_en | 1 |
| Subject information and informed consent form (for publication) | L11_How to Inject Video_Script_hu | 1 |
| Subject information and informed consent form (for publication) | L12_How to Inject Video_OnScreen_hu | 1 |
| Subject information and informed consent form (for publication) | L13_ePFS CT IFU_hu | 1.0 |
| Subject information and informed consent form (for publication) | L14_ClinCard_Card_Carrier_hu_Redacted | 1 |
| Subject information and informed consent form (for publication) | L15_ClinCard Cardholder FAQ_hu | 10.0 |
| Subject information and informed consent form (for publication) | L16_ClinCard Cardholder Msg Templates_hu | 10.0 |
| Subject information and informed consent form (for publication) | L17_ClinCard_Fee_Schedule_hu | 1 |
| Subject information and informed consent form (for publication) | L18_ClinCard_Generic_Image | 10.0 |
| Subject information and informed consent form (for publication) | L19_ConneX Travel Contact Card_hu_Redacted | 10.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_Red-San | V1.0 ITA |
| Subject information and informed consent form (for publication) | L2_Instructions for use prefilled syringes_Italian_San | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Abdominal Pain_eCOA_UC_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Absorbent Product Use_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bowel Frequency_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard FAQ_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Image_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard Msg Templates_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Card_Carrier_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ClinCard_Fee Schedule_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Contact Card_red-san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ConneX Travel Ref Guide_red-san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_DDT_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Fatigue_eCOA_SK-SK_red-san | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GAD-7_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IBDQ_eCOA_SK-SK_red-san | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Instructions for use_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Instructions_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_NoStools_eCOA_SK-SK_red-san | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_NS_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Brochure_red-san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant ID Card_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PFS QR video link_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGI-C_eCOA_SK-SK_red-san | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PGR-S_UC_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_QIDS-SR16_eCOA_SK-SK_red-san | TS8.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_RB_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SAA_Female_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SAA_Male_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SConsistency_eCOA_SK-SK_red-san | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SFrequency_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Stool_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Drug Self-Administration Log_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Drug Self-Administration Training Log_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Urgency NRS_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_WIS_eCOA_SK-SK_red-san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_WPAI-UC_eCOA_SK-SK_red-san | 2.0 |
| Subject information and informed consent form (for publication) | L2_Participant Guide_Italian_Red-San | 1.0 |
| Subject information and informed consent form (for publication) | L2_Participant ID Card_Italian_San | V01 ITA |
| Subject information and informed consent form (for publication) | L2_Patient Study Drug Self-Administration Log_Italian_San | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Study Drug Self-Administration Training Log_Italian_San | 1 |
| Subject information and informed consent form (for publication) | L2_Patient__Greenphire_ClinCard Card Carrier_redacted | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient__Greenphire_ClinCard Cardholder FAQ_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient__Greenphire_ClinCard Cardholder Msg Template_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient__Greenphire_ClinCard Fee Schedule_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient__Greenphire_ClinCard Generic Image_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient__Greenphire_ConneX Travel Contact Card_redacted | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient__Greenphire_ConneX Travel Contact Card_san | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient__Greenphire_ConneX Travel Reference Guide for participants_redacted | 10.0 |
| Subject information and informed consent form (for publication) | L2_Patient_eCOA Participant Guide_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_eDiary and ePRO Overview Storyboard_san | V01POL(pl) |
| Subject information and informed consent form (for publication) | L2_Patient_ID Card_san | 01 |
| Subject information and informed consent form (for publication) | L2_Patient_IFU prefilled syringe_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Patient Study Guide_san | V01POL(pl) |
| Subject information and informed consent form (for publication) | L2_Patient_PFS How to Inject Video_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient_Stool Collection Guide Screening Period_san | V01POL(pl) |
| Subject information and informed consent form (for publication) | L2_Patient_Stool Collection Guide Study Treatment Period_san | V01POL(pl) |
| Subject information and informed consent form (for publication) | L2_Patient_Study Drug Self-Administration Log_san | 1 |
| Subject information and informed consent form (for publication) | L2_Patient_Study Drug Self-Administration Training Log_san | 1 |
| Subject information and informed consent form (for publication) | L2_PFS QR video link_Italian_San | NA |
| Subject information and informed consent form (for publication) | L2_SIS Mandatory Genetic_hu | 1 |
| Subject information and informed consent form (for publication) | L20_ConneX Travel Reference Guide_hu_Redacted | 10.0 |
| Subject information and informed consent form (for publication) | L21_I6T-MC-AMBZ_List of submitted documents_en | 2 |
| Subject information and informed consent form (for publication) | L21_I6T-MC-AMBZ_List of submitted documents_hu | 2 |
| Subject information and informed consent form (for publication) | L22_List of submitted documents_hu_en | 1 |
| Subject information and informed consent form (for publication) | L3_ICF Mandatory Genetic_hu | 1 |
| Subject information and informed consent form (for publication) | L3_Stool Collection Guide Screening Period | 1 |
| Subject information and informed consent form (for publication) | L4_SIS and ICF Continued Access_hu_Redacted | 2 |
| Subject information and informed consent form (for publication) | L4_Stool Collection Guide Study Treatment Period | 1 |
| Subject information and informed consent form (for publication) | L5_eDiary and ePRO Overview Storyboard | 1 |
| Subject information and informed consent form (for publication) | L5_SIS and ICF Pregnant Partner_hu_Redacted | 1 |
| Subject information and informed consent form (for publication) | L6_Participant ID Card_hu_Redacted | 1 |
| Subject information and informed consent form (for publication) | L6_Patient Study Guide | 1 |
| Subject information and informed consent form (for publication) | L7_ Participant Guide_hu | 1.0 |
| Subject information and informed consent form (for publication) | L7_Instructions for PRO items | 1 |
| Subject information and informed consent form (for publication) | L8_ Study Drug Self Administration Log_hu | 1 |
| Subject information and informed consent form (for publication) | L9_Study Drug Self Administration Training_hu | 1 |
| Subject information and informed consent form (for publication) | List of documents for Part II_cs | NA |
| Subject information and informed consent form (for publication) | Main GDPR ICF_cs_san | CZE1.0 |
| Subject information and informed consent form (for publication) | Main ICF_already included _cs_red and san | V2.0CZE1.0 |
| Subject information and informed consent form (for publication) | Main ICF_cs_red and san | V2.0CZE1.0 |
| Subject information and informed consent form (for publication) | Miri PFS How to Inject Video_2_cs_san | 1.0 |
| Subject information and informed consent form (for publication) | Miri PFS How to Inject Video_cs_san | 1.0 |
| Subject information and informed consent form (for publication) | Nocturnal Stools_v1_eCOA Ready_Czech-CZ_29Jan2023_san | 1 |
| Subject information and informed consent form (for publication) | Normal no of stools_v3_eCOA Ready_Czech-CZ_07Dec2022_san | 3 |
| Subject information and informed consent form (for publication) | Participant Diary | 1.0CZE(cs) |
| Subject information and informed consent form (for publication) | Participant Guide_cs_san | 1.0 |
| Subject information and informed consent form (for publication) | Participant ID Card_cs_san | V01CZE(cs) |
| Subject information and informed consent form (for publication) | Patient Brochure_cs_san | V01CZE(cs) |
| Subject information and informed consent form (for publication) | Patient Study Drug Self Administration Log_cs_san | 1 |
| Subject information and informed consent form (for publication) | Patient Study Drug Self Administration Training Log_cs_san | 1 |
| Subject information and informed consent form (for publication) | Patient Study Guide_cs_san | V01CZE(cs) |
| Subject information and informed consent form (for publication) | Patient_ eCOA Guide | v1.0 |
| Subject information and informed consent form (for publication) | Patient_ GreenPhire Direct Deposit FAQ | v10.0 |
| Subject information and informed consent form (for publication) | Patient_ GreenPhire Direct Deposit msg templates | v10.0 |
| Subject information and informed consent form (for publication) | Patient_eDiary and ePRO Overview Storyboard | V01FRAfr |
| Subject information and informed consent form (for publication) | Patient_GreenPhire ConneX Contact Card_Red | v10.0 |
| Subject information and informed consent form (for publication) | Patient_GreenPhire ConneX Travel Guide_Red | v10.0 |
| Subject information and informed consent form (for publication) | Patient_ID Card | V01FRA(fr) |
| Subject information and informed consent form (for publication) | Patient_Instruction for use_Red | v1 |
| Subject information and informed consent form (for publication) | Patient_Instructionnal Video Link_Red | 1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Abdominal Pain | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Absorbent Product Use for Bowel Urgency | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Bowel Urgency Frequency | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Defecation Deferral Time | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Definition of Stool | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Fatigue | v2 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_GAD-7 | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_IBDQ | v11 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Instructions for PRO items | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Nocturnal Stools | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Normal no of stools | v3 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_PGI-C | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_PGR-S | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_QIDS-SR16 | TS8.0 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Rectal Bleeding | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Sexual Activity Avoidance_Female | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Sexual Activity Avoidance_Male | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Stool Consistency_ | v2 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Stool Frequency | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Urgency NRS | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_Wexner Incontinence Score | v1 |
| Subject information and informed consent form (for publication) | Patient_Questionnaire_WPAI-UC | v2.0 |
| Subject information and informed consent form (for publication) | Patient_Stool Collection Guide Screening Period | V01FRAfr |
| Subject information and informed consent form (for publication) | Patient_Stool Collection Guide Study Treatment Period | V01FRAfr |
| Subject information and informed consent form (for publication) | Patient_Study Drug Self-Administration Log_Red | v1 |
| Subject information and informed consent form (for publication) | Patient_Study Drug Self-Administration Training Log_Red | v1 |
| Subject information and informed consent form (for publication) | Patient_Study Guide | V01FRAfr |
| Subject information and informed consent form (for publication) | PGI-C_v1_eCOA Ready_Czech-CZ_26Jan2023_san | 1 |
| Subject information and informed consent form (for publication) | PGR-S_UC_v1_eCOA Ready_Czech-CZ_06Feb2023_san | 1 |
| Subject information and informed consent form (for publication) | PP GDPR ICF_cs_san | CZE1.0 |
| Subject information and informed consent form (for publication) | PP ICF_cs_san | V1.0CZE1.0 |
| Subject information and informed consent form (for publication) | PROMIS_ePRO_cs | 1.1_4a |
| Subject information and informed consent form (for publication) | QIDS-SR16_TS8 0_eCOA Ready_Czech-CZ_26Jan2023_san | 8 |
| Subject information and informed consent form (for publication) | Rectal Bleeding_v1_eCOA Ready_Czech-CZ_29Jan2023_san | 1 |
| Subject information and informed consent form (for publication) | Reimbursement and Reminder ICF_ cs_san | V1.0CZE1.0 |
| Subject information and informed consent form (for publication) | Sexual Activity Avoidance_Female_Version_v1_eCOA Ready_Czech-CZ_24Jan2023_san | 1 |
| Subject information and informed consent form (for publication) | Sexual Activity Avoidance_Male_Version_v1_eCOA Ready_Czech-CZ_07Dec2022_san | 1 |
| Subject information and informed consent form (for publication) | SF36_ePRO_CZ | 1.1 |
| Subject information and informed consent form (for publication) | SGA_ePRO_cs | 03 |
| Subject information and informed consent form (for publication) | Skindex_ePRO_cs | 2.0_ces-CZ |
| Subject information and informed consent form (for publication) | Stool Collection Guide_ Study Treatment Period_cs_san | V01CZE(cs) |
| Subject information and informed consent form (for publication) | Stool Collection Guide_Screening Period_cs_san | V01CZE |
| Subject information and informed consent form (for publication) | Stool Consistency_v2_eCOA Ready_Czech-CZ_07Dec2022_san | 2 |
| Subject information and informed consent form (for publication) | Stool Frequency_v1_eCOA Ready_Czech-CZ_29Jan2023_san | 1 |
| Subject information and informed consent form (for publication) | UC ePFS CT IFU_Trans_Paper_cs_san | 1 |
| Subject information and informed consent form (for publication) | Urgency_v1_eCOA Ready_Czech-CZ_29Jan2023_san | 1 |
| Subject information and informed consent form (for publication) | Wexner Incontinence Score_v1_eCOA Ready_Czech-CZ_9Jan2023_san | 1 |
| Subject information and informed consent form (for publication) | WPAI-UC_v2 0_eCOA Ready_Paper_Czech CZ_26Jan2023_san | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT-DE_2022-502393-16_Redacted | A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE-DE_2022-502393-16_Redacted | A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE-FR_2022-502393-16_Redacted | A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE-NL_2022-502393-16_Redacted | A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_2022-502393-16_Redacted | A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_DE_2022-502393-16_Redacted | A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_2022-502393-16_Redacted | A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2022-502393-16_Redacted | A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_HU_2022-502393-16_Redacted | A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2022-502393-16_Redacted | A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2022-502393-16_Redacted | A |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SK_2022-502393-16_Redacted | A |
Application history
22 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-24 | Slovakia | Acceptable 2023-07-17
|
2023-07-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-08-10 | Acceptable 2023-07-17
|
2023-08-10 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-25 | Slovakia | Acceptable 2024-01-10
|
2024-01-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-04-25 | Slovakia | Acceptable 2024-07-01
|
2024-07-02 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2024-10-17 | Slovakia | Acceptable 2024-07-01
|
2024-10-17 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-12-12 | Acceptable | 2025-01-09 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-12-12 | Acceptable | 2025-02-05 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-12-12 | Acceptable | 2025-03-13 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-12-13 | Acceptable | 2025-02-27 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-12-13 | Acceptable | 2025-03-27 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-17 | Slovakia | Acceptable | 2025-03-04 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-12 | 2025-04-17 | Acceptable | 2025-04-17 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-13 | 2025-04-22 | Acceptable | 2025-04-22 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-14 | 2025-04-24 | Acceptable | 2025-04-24 | |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-15 | 2025-04-25 | Slovakia | Acceptable | 2025-04-25 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-16 | 2025-05-07 | Acceptable | 2025-05-07 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-07-04 | Acceptable | 2025-07-17 | |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-17 | 2025-08-08 | Acceptable | 2025-08-08 | |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-18 | 2025-09-22 | Acceptable | 2025-09-22 | |
| 20 | NON SUBSTANTIAL MODIFICATION | NSM-19 | 2025-10-16 | Acceptable | 2025-10-16 | |
| 21 | NON SUBSTANTIAL MODIFICATION | NSM-20 | 2025-12-10 | Slovakia | Acceptable | 2025-12-10 |
| 22 | SUBSTANTIAL MODIFICATION | SM-14 | 2026-04-10 | Slovakia | Acceptable | 2026-05-26 |