Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
648
Countries
14
Sites
115
Ulcerative Colitis
To determine whether eltrekibart alone is superior to placebo in inducing clinical remission in participants with moderately to severely active UC
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
- 25 Feb 2025 → ongoing
- Decision date (initial)
- 2025-02-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Eli Lilly & Co.
External identifiers
- EU CT number
- 2023-507853-13-00
- WHO UTN
- U1111-1297-0784
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Dose response, Safety, Pharmacoeconomic, Efficacy, Pharmacodynamic, Therapy, Pharmacokinetic
To determine whether eltrekibart alone is superior to placebo in inducing clinical remission in participants with moderately to severely active UC
Conditions and MedDRA coding
Ulcerative Colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10045365 | Ulcerative colitis | 10017947 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Have had an established diagnosis of UC of ≥3 months in duration before baseline.
- 2. Have moderately to severely active UC as assessed by the UC disease activity score.
- 3. Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators).
- 4. Are on a stable dose of certain oral UC medications (including corticosteroids).
- 5. Must meet contraception requirements.
Exclusion criteria 5
- 1. Have received anti-IL-23p19 or anti-IL-12p40 antibodies in the past.
- 2. Have experienced a thrombotic event within 24 weeks before baseline.
- 3. Have a current diagnosis of Crohn’s Disease or certain other inflammatory gastrointestinal diseases.
- 4. Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.
- 5. Have a history of certain adenomas, dysplasia’s, or malignancies.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of participants who achieve clinical remission at Week 12
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10980677 · Product
- Active substance
- Humanised IGG4 Kappa Monoclonal Antibody Against CXCL1, CXCL2, CXCL3, CXCL5, CXCL6, CXCL7 and CXCL8
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
PRD10082852 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11080950 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
Placebo for LY3074828 SC Injection, 1mL Prefilled Syringe
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
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 18
| Organisation | City, country | Duties |
|---|---|---|
| Inato ORG-100044345
|
Neuilly Sur Seine Cedex, France | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Pharmaceutical Product Development LLC ORG-100016999
|
Highland Heights, United States | Other, Laboratory analysis |
| Charles River Laboratories Montreal ULC ORG-100041009
|
Senneville, Canada | Other, Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Other, Laboratory analysis |
| Eurofins Pharma Bioanalytics Services US Inc. ORG-100049364
|
Saint Charles, United States | Other, Laboratory analysis |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Other, Laboratory analysis |
| Acelabio (US) Inc. ORG-100045270
|
San Diego, United States | Laboratory analysis |
| PPD Global Ltd. ORG-100007531
|
Marousi, Greece | On site monitoring, Code 12, Code 5 |
| Jumo Health USA Inc. ORG-100044054
|
New Haven, United States | Other |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Other, Laboratory analysis |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| PPD Development LP ORG-100011560
|
Wilmington, United States | On site monitoring, Code 11, Code 12, Code 13, Code 2, Laboratory analysis, Code 5, Data management |
| Pra International ORG-100032850
|
Lenexa, United States | Other, Laboratory analysis |
| Alimentiv B.V. ORG-100030611
|
Amsterdam, Netherlands | Other |
Locations
14 EU/EEA countries · 115 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruiting | 8 | 2 |
| Croatia | Ongoing, recruiting | 28 | 6 |
| Czechia | Temporarily halted | 30 | 4 |
| Denmark | Not authorised | 12 | 2 |
| France | Ongoing, recruiting | 38 | 6 |
| Germany | Ongoing, recruiting | 86 | 13 |
| Greece | Authorised, recruiting | 36 | 7 |
| Hungary | Temporarily halted | 40 | 6 |
| Ireland | Ongoing, recruiting | 16 | 1 |
| Italy | Ongoing, recruiting | 124 | 19 |
| Latvia | Temporarily halted | 10 | 3 |
| Poland | Temporarily halted | 93 | 30 |
| Romania | Temporarily halted | 34 | 7 |
| Spain | Ongoing, recruiting | 50 | 9 |
| Rest of world
Turkey, Mexico, United States, Colombia, Argentina, Korea, Republic of, Japan, Canada, Serbia
|
— | 43 | — |
Investigational sites
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes
Gastro-enterelogy, Avenue Max Buset 34, 7100, La Louviere
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Gastro-enterelogy, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
General Hospital Dr. Josip Bencevic
Internal Medicine, Ulica Dr. Andrije Stampara 42, 35000, Slavonski Brod
University Hospital Centre Zagreb
Gastroenterology and Hepatology, Ulica Mije Kispatica 12, 10000, Zagreb
Poliklinika Borzan d.o.o.
Gastroenterology, Dubrovacka 12, 31000, Osijek
Poliklinika Solmed d.o.o.
Gastroenterology, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Specijalna Bolnica Medico
N/A, Agaticeva 8, 51000, Rijeka
Opca Bolnica Dr. Andelko Visic Bjelovar
Gastroenterology and Pulmology, Antuna Mihanovica 8, 43000, Bjelovar
Nemocnice Slany
Interní klinika Gastroenterologie, Politickych Veznu 576, 274 01, Slany
Vojenska Nemocnice Brno
Interní oddělení, Zabrdovicka 3, Zabrdovice, Brno-Zidenice
Krajska Nemocnice T Bati a.s.
Interní klinika, Havlickovo Nabrezi 600, 760 01, Zlin
SurGal Clinic s.r.o.
Endoskopické centrum, Drobneho 307/38, Cerna Pole, Brno-Sever
Region Hovedstaden
Gastroenterologisk afdeling, Borgmester Ib Juuls Vej 1, 2730, Herlev
Region Hovedstaden
Digestive Disease Center, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Centre Hospitalier Departemental Vendee
Hepato-Gastroenterology Department, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Universitaire De Nice
Gastroenterology Department, 151 Route De Saint Antoine, 06200, Nice
Hospices Civils De Lyon
Gastroenterology Department, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire Rouen
Hepato-Gastroenterology Department, 1 Rue De Germont, Bp 96031, Rouen Cedex
Assistance Publique Hopitaux De Paris
Gastroenterology Department, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Centre Hospitalier Universitaire Grenoble Alpes
Hepato-Gastroenterology Department, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie, Augustenburger Platz 1, Wedding, Berlin
Medizinische Hochschule Hannover
Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Brandenburg an der Havel GmbH
Zentrum für Innere Medizin II Klinik für Gastroenterologie, Hepatologie, Diabetologie und Endoskopie, Hochstrasse 29, Altstadt, Brandenburg An Der Havel
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Allgemeine Innere Medizin I Medizinische Klinik, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsklinikum Augsburg
III. Medizinische Klinik, Stenglinstrasse 2, Kriegshaber, Augsburg
Klinikum rechts der Isar der TU Muenchen AöR
Klinik und Poliklinik für Innere Medizin II, Ismaninger Strasse 22, Au-Haidhausen, Munich
Hamburgisches Forschungsinstitut fuer chronisch entzuendliche Darmerkrankungen HaFCED e.K.
N/A, Christoph-Probst-Weg 4, Eppendorf, Hamburg
Studiengesellschaft BSF UG (haftungsbeschraenkt)
N/A, Grosse Nikolaistrasse 7, Altstadt, Halle (Saale)
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin I, Albert-Einstein-Allee 23, Eselsberg, Ulm
Goethe University Frankfurt
Medizinische Klinik 1, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
CED Studien UG (haftungsbeschraenkt)
Interdisziplinäres Crohn Colitis Centrum Rhein-Main, Schifferstrasse 59, Sachsenhausen, Frankfurt Am Main
Medizinisches Versorgungszentrum fuer spezialaerztliche Versorgung Professor Dr. Friedrichs GmbH
MVZ für spezialärztliche Versorgung Dr. Friedrichs GmbH, Zu Den Rehwiesen 9, Wanheimerort, Duisburg
Magen-Darm-Zentrum Remscheid
n/a, Rosenhügelerstr. 2, 42859, Remscheid,
General Oncological Hospital Of Kifissia Agioi Anargyroi
Endoscopy Unit, Timiou Stavrou And 14 Noufaron, 145 64, Kifissia
Thoracic General Hospital Of Athens I Sotiria
3rd Academic Department of Internal Medicine, Gastroenterology Unit, Messogion Avenue 152, 115 27, Athens
Alexandra Hospital
Hepato-Gastroenterology Department, Vassilissas Sofias Avenue 80, 115 28, Athens
University General Hospital Of Ioannina
Gastroenterology clinic and endoscopic unit, Niarchou Stavrou Avenue, 455 00, Ioannina
University General Hospital Of Heraklion
Gastroenterology Department, Stavrakia And Voutes, 715 00, Heraklion
Hippokration Hospital
Hepatogastroenterology Unit, Vassilissas Sofias Avenue 114, 115 27, Athens
Evangelismos S.A.
Gastroenterology Department, Ipsiladou 45-47, 106 76, Athens
University Of Szeged
Belgyógyászati Klinika, Kalvaria Sugarut 57, 6725, Szeged
Obudai Egeszseguegyi Centrum Kft.
n/a, Lajos Utca 74-76, 1036, Budapest III
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
I.Sz. Belgyógyászati Osztály, Seregelyesi Ut 3, 8000, Szekesfehervar
Clinexpert Kft.
n/a, Kaszasdulo Utca 5, 1033, Budapest III
Clinexpert Gyoengyoes Kft.
N/A, Dozsa Gyorgy Utca 13, 3200, Gyongyos
Semmelweis Egyetem
II.Sz. Belgyógyászati Klinika, Szentkirályi utca 46, 1088, Budapest
Casa Sollievo Della Sofferenza
UOC di Gastroenterologia ed Endoscopia Digestiva, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Azienda Ospedaliera Policlinico Universitario Tor Vergata
U.O.C. Gastroenterologia, Viale Oxford 81, 00133, Rome
Azienda Ospedaliera S Giovanni Addolorata
UOC Gastroenterologia Endoscopia Digestiva, Via Dell' Amba Aradam 9, 00184, Rome
Fondazione Poliambulanza
Gastroenterology and Digestive Endoscopy Unit, Via Leonida Bissolati 57, 25124, Brescia
Fondazione IRCCS Policlinico San Matteo
UOC Gastroenterologia Dipartimento di Medicina Interna e Terapia Medica, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliero Universitaria Di Modena
Struttura Complessa di Gastroenterologia ed Endoscopia Digestiva, Largo Del Pozzo 71, 41124, Modena
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
S.C. Medicina ad indirizzo Epatologico e Gastroenterologico, Via Antonio Di Rudini' 8, 20142, Milan
Humanitas Mirasole S.p.A.
Chronic Infiammatory Bowel Diseases Unit, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero-Universitaria Di Cagliari
Unità di Gastroenterologia Dipartimento di Scienze Mediche e Salute Pubblica, Strada Statale 554 N. 1, 09042, Monserrato
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
S.C. Gastroenterology U., Corso Bramante 88, 10126, Turin
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
UOC Gastroenterologia, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliera Universitaria Gaetano Martino Messina
UOC Gastroenterologia e malattie infiammatorie croniche intestinali, Via Consolare Valeria N 1, 98124, Messina
Azienda Ospedaliera di Padova
UOC Gastroenterologia, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliera Ordine Mauriziano Di Torino
S.C. Gastroenterologia, Via Ferdinando Magellano 1, 10128, Turin
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
SSD Malattie Infiammatorie Croniche Intestinali - Centro di Riferimento per le MICI, Via G. Massarenti 9, 40138, Bologna
Azienda Ospedaliero Universitaria Careggi
SOD Gastroenterology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Sanitaria Territoriale Di Pesaro E Urbino
UOC Gastroenterologia e Endoscopia Digestiva, Viale Vittorio Veneto 2, 61032, Fano
Policlinico San Donato S.p.A.
Unità di Gastroenterologia ed Endoscopia Digestiva, Piazza Edmondo Malan 2, 20097, San Donato Milanese
Ospedale San Raffaele S.r.l.
Gastroenterologia ed Endoscopia digestiva, Via Olgettina 60, 20132, Milan
Liepajas Regionala Slimnica SIA
n/a, Slimnicas Iela 25, 3414, Liepaja
Pauls Stradins Clinical University Hospital
n/a, Pilsonu Iela 13, 1002, Riga
Veselibas Centrs 4 SIA
N/A, Brivibas Iela 180, 1012, Riga
Vistamed
n/a, ul. Racławicka 105/1B, 53-149, Wrocław
Ip Clinic Sp. z o.o.
n/a, Ul. Gen. Lucjana Zeligowskiego 3/5, 90-752, Lodz
Gastromed Sp. z o.o.
n/a, Ul. Grudziadzka 11/13-14, 87-100, Torun
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
n/a, Ul. Tadeusza Szafrana 5d / U2-U5, 30-363, Cracow
Centrum Medyczne Med-Gastr Sp. z o.o.
n/a, Ul. Mokra 4, 91-034, Lodz
Medrise Sp. z o.o.
n/a, Ul. Onyksowa 10, 20-582, Lublin
Endoskopia Sp. z o.o.
n/a, Ul. Boleslawa Chrobrego 6/8, 81-756, Sopot
Centrum Medyczne Oporow
n/a, Ul. Ul. Ludwika Solskiego 4a/1, 52-416, Wroclaw
Manermed Sp. z o.o.
Centrum Medyczne Medis, Ul. Garbary 5/l4, 85-229, Bydgoszcz
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
n/a, Plac Szczepanski 3, 31-011, Cracow
Twoja Przychodnia Opolskie Centrum Medyczne
n/a, ul. Kurpiowska 6/2, 45-819, Opole
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
Centrum Medyczne KERmed, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Nzoz For Med Sp. z o.o.
n/a, Ul. Lwowska 93, 34-100, Wadowice
Medical Network Sp. z o.o.
WIP Warsaw IBD Point Profesor Kierkuś, Ul. Plowiecka 103, 04-501, Warsaw
Twoja Przychodnia PCM
n/a, ul. Marcelińska 92, 60-324, Poznań
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j.
n/a, Ul. Topolowa 33/7, 31-506, Cracow
Melita Medical Sp. z o.o.
Centrum Medyczne Melita Medical, Ul. Strzegomska 2-4, 53-611, Wroclaw
Amicare Sp. z o.o. S.K.
N/A, Ul. Zgierska 249, 91-495, Lodz
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Twoja Przychodnia SCM, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
H-T.Centrum Medyczne Sp. z o.o. sp.k.
H-T. Centrum Medyczne - Endoterapia, Aleja Bielska 103a, 43-100, Tychy
Vitamed Galaj I Cichomski Sp. j.
N/A, Ul. Tadeusza Kosciuszki 35, 85-079, Bydgoszcz
EMC Instytut Medyczny S.A.
EuroMediCare Przychodnia Specjalistyczna we Wrocławiu, Ul. Pilczycka 144/148, 54-144, Wroclaw
Medical Concierge Centrum Medyczne
N/A, ul. Polnej Róży 6/ U2, 02-798, Warszawa
M2M Med. Sp. z o.o. Sp. j.
N/A, Ul. Lwowska 34, 41-500, Chorzow
Pro Life Medica Sp. z o.o.
ETG Zamość, Ul. Gesia 3, 22-400, Zamosc
Eb Group Sp. z o.o.
Centrum Zdrowia MDM, Ul. Inflancka 4a, 00-189, Warsaw
Centrum Medyczne Medyk Sp. z o.o. S.K.
N/A, Al. Tadeusza Rejtana 53, 35-326, Rzeszow
Pratia S.A.
Pratia Poznań, Ul. Gryfinska 1, 60-192, Poznan
Bartosz Korczowski, Gabinet Lekarski
N/A, ul. Litewska 4A/7, 35-302, Rzeszów
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
N/A, ul. Łubinowa 12/7, 52-210, Wrocław
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Sectia Clinica Gastroenterologie, Strada Vulcanescu Mircea 88, 010825, Bucharest
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
Gastroenterology, Strada Croitorilor 19-21, 400162, Cluj-Napoca
Valahia Medical S.R.L.
Gastroenterology, Strada Golesti 7, 100032, Ploiesti
Spitalul Clinic Colentina Bucuresti
Gastroenterology, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Centrul De Gastroenterologie Dr. Goldis S.R.L.
Gastroenterolgy, Strada Blaga Lucian Nr 4, 300002, Timisoara
Spitalul Universitar De Urgenta Bucuresti
Gastroenterology, Splaiul Independentei 169, 050098, Bucharest
Monza-Ares S.R.L.
Gastroenterolgy Department, Strada Bulandra Tony Actor Nr. 27 Sectorul 2, 021967, Bucharest
Hospital Universitario Reina Sofia
Digestive, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Juan Ramon Jimenez
Digestivo, Ronda Exterior Norte S/n, 21005, Huelva
Hospital Universitario Virgen De La Macarena
Gastroenterology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
El Hospital Universitario De Gran Canaria Dr. Negrin
Gastroenterology, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitario Y Politecnico La Fe
Gastroenterology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario La Paz
Gastroenterology, Paseo De La Castellana 261, 28046, Madrid
Complexo Hospitalario Universitario De Santiago
Gastroenterology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital General De Tomelloso
Gastroenterology, Vereda De Socuellamos S/n, 13700, Tomelloso
Centro Medico Teknon-Grupo Quironsalud
Gastroenterology, Calle Vilana 12, 08022, Barcelona
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 | 2025-04-16 | ||||
| Croatia | 2025-03-25 | 2025-06-05 | |||
| Czechia | 2025-05-21 | ||||
| France | 2025-04-24 | 2025-08-22 | |||
| Germany | 2025-03-27 | 2025-07-24 | |||
| Greece | 2025-03-27 | ||||
| Hungary | 2025-04-16 | 2025-04-29 | 2025-08-05 | ||
| Ireland | 2025-07-23 | 2025-10-08 | |||
| Italy | 2025-04-10 | 2025-09-10 | |||
| Latvia | 2025-05-26 | ||||
| Poland | 2025-03-27 | 2025-04-01 | 2025-08-05 | ||
| Romania | 2025-04-11 | 2025-06-03 | 2025-08-05 | ||
| Spain | 2025-02-25 | 2025-06-23 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 6 · Art. 38 CTR
Temporary halt TH-95608
- Halt date
- 2025-08-05
- Planned restart
- 2026-07-31
- Member states concerned
- Romania
- Publication date
- 2025-08-27
- Reason
- Sponsor decision
- Explanation
- Biostatistics confirmed an enrollment limit for eastern european countries to ensure appropriate sample of patients for statistical analysis for Stage 1.
- Follow-up measures
- Screening of subjects in the abovementioned countries will cease. Randomized patients will proceed with study procedures per protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-97056
- Halt date
- 2025-08-05
- Planned restart
- 2026-07-01
- Member states concerned
- Poland
- Publication date
- 2025-09-09
- Reason
- Sponsor decision
- Explanation
- Biostatistics confirmed an enrollment limit for eastern European countries to ensure appropriate sample of patients for statistical analysis for Stage 1.
- Follow-up measures
- Screening of subjects in the abovementioned countries will cease. Randomized patients will proceed with study procedures per protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-115913
- Halt date
- 2025-08-05
- Planned restart
- 2026-07-01
- Member states concerned
- Croatia
- Publication date
- 2026-01-22
- Reason
- Sponsor decision
- Explanation
- Biostatistics confirmed an enrollment limit for Eastern European countries to ensure appropriate sample of patients for statistical analysis for Stage 1.
- Follow-up measures
- Screening of subjects in the abovementioned countries will cease. Randomized patients will proceed with study procedures per protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-95422
- Halt date
- 2025-08-05
- Planned restart
- 2025-11-30
- Member states concerned
- Czechia
- Publication date
- 2025-08-26
- Reason
- Sponsor decision
- Explanation
- Biostatistics confirmed an enrollment limit for eastern european countries to ensure appropriate sample of patients for statistical analysis for Stage 1.
- Follow-up measures
- Screening of subjects in the abovementioned countries will cease. Randomized patients will proceed with study procedures per protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-95421
- Halt date
- 2025-08-05
- Planned restart
- 2025-11-30
- Member states concerned
- Latvia
- Publication date
- 2025-08-26
- Reason
- Sponsor decision
- Explanation
- Biostatistics confirmed an enrollment limit for eastern european countries to ensure appropriate sample of patients for statistical analysis for Stage 1.
- Follow-up measures
- Screening of subjects in the abovementioned countries will cease. Randomized patients will proceed with study procedures per protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-95423
- Halt date
- 2025-08-05
- Planned restart
- 2025-11-30
- Member states concerned
- Hungary
- Publication date
- 2025-08-26
- Reason
- Sponsor decision
- Explanation
- Biostatistics confirmed an enrollment limit for eastern european countries to ensure appropriate sample of patients for statistical analysis for Stage 1.
- Follow-up measures
- Screening of subjects in the abovementioned countries will cease. Randomized patients will proceed with study procedures per protocol.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 318 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Eli Lilly_I7P-MC_DSAG_Protocol Addendum_2023-507853-13-00_GRC_Public | Addendum 4 |
| Protocol (for publication) | D1_Eli Lilly_I7P-MC_DSAG_Protocol Addendum_2023-507853-13-00_Public | Addendum 4 |
| Protocol (for publication) | D1_Eli Lilly_I7P-MC-DSAG_Placebo Justification_2023-507853-13-00_Public | N/A |
| Protocol (for publication) | D1_Eli Lilly_I7P-MC-DSAG_Protocol Amendment_2023-507853-13-00_GRC_Public | a |
| Protocol (for publication) | D1_Eli Lilly_I7P-MC-DSAG_Protocol Amendment_2023-507853-13-00_Public | a |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_All questionnaires-materials_CZE_Public | 1.0 |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_All questionnaires-materials_DEU_Public | 1.0 |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_All questionnaires-materials_ENG_Public | 1.0 |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_All questionnaires-materials_ESP_Public | 1.0 |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_All questionnaires-materials_FRA_Public | 1.0 |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_All questionnaires-materials_GRC_Public | 1.0 |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_All questionnaires-materials_HRV_Public | 1.0 |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_All questionnaires-materials_HUN_Public | 1.0 |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_All questionnaires-materials_ITA_Public | 1.0 |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_All questionnaires-materials_LAT_Public | 1.0 |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_All questionnaires-materials_NLD_Public | 1.0 |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_All questionnaires-materials_ROM_Public | 1.0 |
| Protocol (for publication) | D4_Eli Lilly_I7P-MC-DSAG_Urgency__GRC_NotPublic | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Doctor-to-Doctor-Letter_CZ_Czech_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Doctor-to-Patient-Letter_CZ_Czech_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_KEYWORD-SEARCH_CZ_Czech_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Mandatory-Social-Security-Membership_FR_Public | N/A |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_PP_URLs_CZ_Czech_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Pre-Screening-Questionnaire_UC_SSPS_Public | n/a |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment Arrangements_DE_Public | 1 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment Arrangements_DNK_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment Arrangements_ES_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment Arrangements_HU_Public | n/a |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment Arrangements_IT_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment_Arrangements_RO | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment_Informed_Consent_Procedure_BE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment_Informed-Consent-Procedure_CZ_Public | n/a |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment-Arrangements_FR_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment-Arrangements_GRC_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment-Arrangements_HR_Croatian_Public | 1 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment-Arrangements_IE_Public | n/a |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment-Arrangements_LV_Public | n/a |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Recruitment-Arrangements_PL_Polish_Public | 1.1 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_SOCIAL-MEDIA_CZ_Czech_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Ulcerative-Colitis_Carousel_1080x1080_CZ_Czech_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Ulcerative-Colitis_Flipchart_CZ_Czech_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Ulcerative-Colitis_Patient-Recruitment-Brochure_CZ_Czech_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Ulcerative-Colitis_Social_1080x1080_CZ_Czech_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Ulcerative-Colitis_Social_1200x628_CZ_Czech_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_I7P-MC-DSAG_Ulcerative-Colitis_US_Landing Page_CZ_Czech_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG _GP-Letter_IT_Italian_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Appointment-Card_IE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Carousel_1080x1080_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Carousel_1080x1080_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Carousel_1080x1080_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Carousel_1080x1080_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Carousel_IE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Carousel-1080x1080_LV_Latvian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Carousel-1080x1080_LV_Russian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor to Doctor Letter_BE_Dutch_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor to Doctor Letter_BE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor to Doctor Letter_BE_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor to Doctor Letter_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor to Doctor Letter_HU_Hungarian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor to Doctor Letter_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor to Patient Letter_BE_Dutch_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor to Patient Letter_BE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor to Patient Letter_BE_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor to Patient Letter_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor to Patient Letter_HU_Hungarian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor to Patient Letter_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Doctor Letter_IE_English_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Doctor-Letter_FR_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Doctor-Letter_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Doctor-Letter_HR_Croatian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Doctor-Letter_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Doctor-Letter_RO_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Doctor-Letter_RO_Romanian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Patient-Letter_FR_French_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Patient-Letter_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Patient-Letter_HR_Croatian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Patient-Letter_IE_English_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Patient-Letter_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Patient-Letter_RO_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Doctor-to-Patient-Letter_RO_Romanian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_FR_French_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_HR_Croatian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_HU_Hungarian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_IE_English_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_LV_Latvian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_LV_Russian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_RO_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Flipchart_RO_Romanian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_GP-Letter_IE_English_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Keyword Search_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Keyword-Search_IE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Keyword-Search_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Landing Page_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Landing-Page_IE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Landing-Page_LV_Latvian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Landing-Page_LV_Russian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Landing-Page_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Patient Recruitment Brochure_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Patient Recruitment Brochure_HU_Hungarian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Patient Recruitment Brochure_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Patient-Recruitment-Brochure_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Patient-Recruitment-Brochure_FR_French_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Patient-Recruitment-Brochure_IE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Patient-Recruitment-Brochure_LV_Latvian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Patient-Recruitment-Brochure_LV_Russian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Patient-Recruitment-Brochure_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Patient-Recruitment-Brochure_RO_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Patient-Recruitment-Brochure_RO_Romanian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_PP-KEYWORD-SEARCH_LV_Latvian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_PP-KEYWORD-SEARCH_LV_Russian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_PP-SOCIAL-MEDIA_LV_Latvian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_PP-SOCIAL-MEDIA_LV_Russian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_PP-URLs_LV_Russian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Pre-screening-Questionnaire_IE_Public | n/a |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Recruitment Brochure_GRC_Greek_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Recruitment-Brochure_HR_Croatian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_SM_Doctor-to-Doctor-Letter_LV_Latvian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_SM_Doctor-to-Patient-Letter_LV_Latvian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social Media_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social_1080x1080_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social_1080x1080_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social_1080x1080_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social_1080x1080_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social_1200x628_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social_1200x628_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social_1200x628_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social_1200x628_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social-1080x1080_IE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social-1080x1080_LV_Latvian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social-1080x1080_LV_Russian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social-1200x628_IE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social-1200x628_LV_Latvian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social-1200x628_LV_Russian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social-Media_IE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Social-Media_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_SSPS_LV_Latvian_Public | n/a |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_SSPS_LV_Russian_Public | n/a |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Thank-You-Card_IE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_UC_PP_KEYWORD SEARCH_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_UC_PP_KEYWORD-SEARCH_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_UC_PP_SOCIAL MEDIA_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_UC_PP_SOCIAL-MEDIA_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_UC_PP_URLs_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_UC_PP_URLs_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_UC_SM_Doctor-to-Doctor-Letter_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_UC_SM_Doctor-to-Patient-Letter_ES_Spanish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_UC_SSPS_DE_German_Public | n/a |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_UC_SSPS_ES_Spanish_Public | N/A |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_UC_SSPS_IT_Italian_Public | n/a |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_UC_SSPS_PL_Polish_Public | n/a |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Ulcerative Colitis_Flipchart_BE_Dutch_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Ulcerative Colitis_Flipchart_BE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Ulcerative Colitis_Flipchart_BE_French_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Ulcerative Colitis_Patient Recruitment Brochure_BE_Dutch_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Ulcerative Colitis_Patient Recruitment Brochure_BE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_Ulcerative Colitis_Patient Recruitment Brochure_BE_French_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_URLs_DE_German_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_URLs_IE_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_URLs_PL_Polish_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_US_Landing Page_IT_Italian_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_I7P-MC-DSAG_US_Landing-Page_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_17P-MC-DSAG_Future-Research-ICF_DNK_Danish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_17P-MC-DSAG_Main-ICF-A_DNK_Danish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_17P-MC-DSAG_Main-ICF-B_DNK_Danish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_17P-MC-DSAG_Main-ICF-C_DNK_Danish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_17P-MC-DSAG_Main-ICF-Stage-1_DNK_Danish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_17P-MC-DSAG_Pregnant-Partner-ICF_DNK_Danish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Addendum-ICF-Pharmacogenetic-Sample_RO_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Addendum-ICF-Pharmacogenetic-Sample_RO_Romanian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_GDPR ICF_CZ_Czech_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main ICF_Stage 1_DE_German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main ICF_Stage 1_HU_Hungarian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main ICF_Stage 1_IT_Italian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main ICF-A_DE_German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main ICF-A_HU_Hungarian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main ICF-A_IT_Italian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main ICF-B_DE_German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main ICF-B_HU_Hungarian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main ICF-B_IT_Italian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main ICF-C_DE_German_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main ICF-C_HU_Hungarian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main ICF-C_IT_Italian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main_ICF_A_ES_Spanish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main_ICF_B_ES_Spanish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main_ICF_C_ES_Spanish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main_ICF_Stage-1_ES_Spanish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-A_CZ_Czech_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-A_FR_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-A_GRC_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-A_GRC_Greek_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-A_HR_Croatian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-A_IE_English_Public | 3.2 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-A_LV_Latvian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-A_LV_Russian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-A_PL_Polish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-A_RO_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-A_RO_Romanian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-B_CZ_Czech_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-B_FR_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-B_GRC_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-B_GRC_Greek_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-B_HR_Croatian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-B_IE_English_Public | 3.2 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-B_LV_Latvian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-B_LV_Russian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-B_PL_Polish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-B_RO_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-B_RO_Romanian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-C_CZ_Czech_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-C_FR_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-C_GRC_English_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-C_GRC_Greek_Public | 3.1 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-C_HR_Croatian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-C_IE_English_Public | 3.2 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-C_LV_Latvian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-C_LV_Russian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-C_PL_Polish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-C_RO_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-C_RO_Romanian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-Stage 1_LV_Latvian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-Stage 1_RO_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-Stage 1_RO_Romanian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-Stage-1_CZ_Czech_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-Stage-1_FR_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-Stage-1_GRC_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-Stage-1_GRC_Greek_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-Stage-1_LV_Russian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-Stage-1_PL_Polish_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-ICF-Stage1_HR_Croatian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Main-Stage-1-ICF_IE_English_Public | 3.2 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Optional Genetic Research ICF_CZ_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Optional_Pharmacogenetic_Testing_ICF_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pharmacogenetic ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pharmacogenetic Testing ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pharmacogenetic-ICF_GRC_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pharmacogenetic-ICF_GRC_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pharmacogenetic-ICF_HR_Croatian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pharmacogenetic-Testing-ICF_LVA_Latvian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pharmacogenetic-Testing-ICF_LVA_Russian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pharmacogenetics-Addendum_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pre-ICF Telephone Data Consent_DE_German_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pre-ICF-Telephone-Data-Consent_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnancy ICF_DE_German_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnancy-and-Newborn_ICF_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnancy-ICF_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnant Partner Participant ICF_HU_Hungarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnant Partner Participant_ICF_CZ_Czech_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnant Subject ICF_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnant_Partner_ICF_RO_English | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnant_Partner_ICF_RO_Romanian | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnant-Partner-Participant-ICF_IE_English_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnant-Partner-Participant-ICF_PL_Polish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnant-Partner-Participant-Infant-ICF_GRC_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnant-Partner-Participant-Infant-ICF_GRC_Greek_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnant-Partner-Patient-ICF_LVA_Latvian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnant-Partner-Patient-ICF_LVA_Russian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Pregnant-Partner-Subject-ICF_HR_Croatian_Public | 1 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Privacy Addendum ICF_IT_Italian_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Scout Clinical Pre-ICF Telephone Data Consent_IT_Italian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Scout-Clinical-Pre-ICF-Telephone-Data Consent_IE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Scout-Clinical-Pre-ICF-Telephone-Data-Consent_ES_Spanish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Scout-Clinical-Pre-ICF-Telephone-Data-Consent_LVA_Latvian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Scout-Clinical-Pre-ICF-Telephone-Data-Consent_LVA_Russian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7P-MC-DSAG_Scout-Clinical-Pre-ICF-Telephone-Data-Consent_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Addendum ICF Pharmacogenetic Sample_BE_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Addendum ICF Pharmacogenetic Sample_BE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Addendum ICF Pharmacogenetic Sample_BE_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Addendum-ICF-Pharmacogenetic-Sample_IE-English_Public | 1.1 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Main ICF A_BE_Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Main ICF A_BE_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Main ICF A_BE_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Main ICF B_BE_Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Main ICF B_BE_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Main ICF B_BE_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Main ICF C_BE_Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Main ICF C_BE_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Main ICF C_BE_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Main ICF Stage 1_BE_Dutch_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Main ICF Stage 1_BE_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Main ICF Stage 1_BE_French_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Pharmacogenetic ICF_HU_Hungarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Pharmacogenetic-Testing-ICF_PL_Polish_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Pregnant Partner_BE_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Pregnant Partner_BE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Pregnant Partner_BE_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_I7PMC-DSAG_Sponsor-Statement_Main-ICF_BE_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_ I7P-MC-DSAG_Scout-Pre-ICF-Notice _GRC_Greek_Public | 1.1 |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Patient Card_HU_Hungarian_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Patient-Card_IE_English_Public | 1.0.0 |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Pre-ICF Telephone Data Consent_HU_Hungarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Pre-ICF-Telephone-Data-Consent_RO_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Pre-ICF-Telephone-Data-Consent_RO_Romanian_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Reloadable-ScoutPass-Brochure_IE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Reloadable-ScoutPass-Mailer_IE_English_Public | n/a |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Scout Pre-Consent_HR_Croatian_Public | 1.1 |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Scout_SFD_UserGuide_DE_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Scout-Email-Communication_IE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Study information_HU_Public | n/a |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Study-Brochure_IE_English_Public | 1.0 |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_Taxable-Payments-Letter-Template_IE_English_Public | 3.0 |
| Subject information and informed consent form (for publication) | L2_I7P-MC-DSAG_TRIALMAX-APP-Quick-Reference-Guide_IE_English_NotPublic | 2 |
| Synopsis of the protocol (for publication) | D1_ Eli Lilly_I7P-MC-DSAG_Protocol synopsis_2023-507853-13-00_CZE_Public | a |
| Synopsis of the protocol (for publication) | D1_ Eli Lilly_I7P-MC-DSAG_Protocol synopsis_2023-507853-13-00_GRC_Public | a |
| Synopsis of the protocol (for publication) | D1_ Eli Lilly_I7P-MC-DSAG_Protocol synopsis_2023-507853-13-00_HRV_Public | a |
| Synopsis of the protocol (for publication) | D1_ Eli Lilly_I7P-MC-DSAG_Protocol synopsis_2023-507853-13-00_ITA_Public | a |
| Synopsis of the protocol (for publication) | D1_ Eli Lilly_I7P-MC-DSAG_Protocol synopsis_2023-507853-13-00_POL_Public | a |
| Synopsis of the protocol (for publication) | D1_ Eli Lilly_I7P-MC-DSAG_Protocol synopsis_2023-507853-13-00_ROM_Public | a |
| Synopsis of the protocol (for publication) | D1_Eli Lilly_I7P-MC-DSAG_Protocol synopsis_2023-507853-13-00_DEU_Public | a |
| Synopsis of the protocol (for publication) | D1_Eli Lilly_I7P-MC-DSAG_Protocol synopsis_2023-507853-13-00_ENG_Public | a |
| Synopsis of the protocol (for publication) | D1_Eli Lilly_I7P-MC-DSAG_Protocol synopsis_2023-507853-13-00_ESP_Public | a |
| Synopsis of the protocol (for publication) | D1_Eli Lilly_I7P-MC-DSAG_Protocol synopsis_2023-507853-13-00_FRA_Public | a |
| Synopsis of the protocol (for publication) | D1_Eli Lilly_I7P-MC-DSAG_Protocol synopsis_2023-507853-13-00_HUN_Public | a |
| Synopsis of the protocol (for publication) | D1_Eli Lilly_I7P-MC-DSAG_Protocol synopsis_2023-507853-13-00_NLD_Public | a |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-10 | Hungary | Acceptable 2025-02-10
|
2025-02-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-25 | Hungary | Acceptable 2025-07-04
|
2025-07-04 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-23 | Acceptable 2025-07-04
|
2025-07-23 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-05 | Acceptable | 2025-09-22 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-18 | Acceptable | 2025-09-25 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-26 | Acceptable | 2025-09-25 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-29 | Hungary | Acceptable | 2025-09-29 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-11 | Hungary | Acceptable | 2025-11-11 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-04-01 | Hungary | Acceptable | 2026-04-01 |