Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
342
Countries
15
Sites
97
Obesity or Overweight
To evaluate if concomitant administration of mirikizumab and tirzepatide at the MTD (up to 15 mg) is superior to mirikizumab and placebo in simultaneously achieving clinical remission and weight reduction.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 19 Sep 2025 → ongoing
- Decision date (initial)
- 2025-08-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520209-38-00
- WHO UTN
- U1111-1319-3150
- ClinicalTrials.gov
- NCT06937086
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
To evaluate if concomitant administration of mirikizumab and tirzepatide at the MTD (up to 15 mg) is superior to mirikizumab and placebo in simultaneously achieving clinical remission and weight reduction.
Conditions and MedDRA coding
Obesity or Overweight
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Have been diagnosed with ulcerative colitis (UC) for at least 3 months before the start of the study, with tests confirming the diagnosis.
- Have moderately to severely active UC, with specific scores from medical tests confirming this within 21 days before the study starts.
- Have had a colonoscopy within the past year showing no signs of colorectal dysplasia or cancer, if you’ve had UC for 8 years or more.
- Be obese with a body mass index (BMI) of 30 or higher.
- Be obese, with a body mass index (BMI) of 30 or higher or be overweight with a BMI less than 30 but greater or equal to 27 and have at least one of the following conditions related to weight: high blood pressure, type 2 diabetes, abnormal cholesterol levels, sleep apnea (a condition where you stop breathing for short periods during sleep) or heart disease.
- Have tried and not responded well to at least one conventional UC medication (like oral corticosteroids or azathioprine) and/or also not responded well to advanced UC therapies (like biologics or JAK inhibitors).
Exclusion criteria 7
- Have Crohn's disease, Unclassified inflammatory bowel disease (IBD) or Primary sclerosing cholangitis (a liver disease).
- Have had or will need surgery on your intestines or abdomen.
- Have conditions like toxic megacolon, or narrowing in your intestines or colon.
- Have Type 1 diabetes or Type 2 diabetes treated with insulin.
- Have had severe low blood sugar or unawareness of low blood sugar in the past 6 months.
- Have had more than 5% body weight change in the past 3 months.
- Have a current or recent serious infection.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
PRD10082852 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 900 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10082863 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 900 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12126816 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 690 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12126813 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 690 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12126817 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 690 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12126812 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 690 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12126815 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 690 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12126814 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 690 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
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 21
| Organisation | City, country | Duties |
|---|---|---|
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | Data management |
| Tier 1 Impact Pbc Inc. ORG-100050163
|
Covington, United States | Other |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| SiteRx (Middleware) ORL-000014351
|
New York, United States | Other |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | Data management |
| Professional Case Management Clinical Trials LLC ORG-100044408
|
Denver, United States | Other |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifisia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
| The Hibbert Co. ORG-100047639
|
Trenton, United States | Other |
| Alimentiv Inc. ORG-100006515
|
London, Canada | Laboratory analysis |
| Iterative Health, Inc ORL-000014349
|
Cambridge, United States | Other |
| WCG (Investigator Space) ORL-000014345
|
Indianapolis, United States | Other |
| Clario ORL-000001148
|
Philadelphia, United States | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Lionbridge AG ORL-000012316
|
Basel, Switzerland | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Data management |
| Clinical Trial Media Inc. ORG-100046339
|
Hauppauge, United States | Other |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
Locations
15 EU/EEA countries · 97 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruiting | 15 | 3 |
| Belgium | Ongoing, recruiting | 8 | 6 |
| Bulgaria | Ongoing, recruiting | 3 | 3 |
| Czechia | Ongoing, recruiting | 17 | 6 |
| Denmark | Ongoing, recruiting | 10 | 6 |
| France | Ongoing, recruiting | 17 | 10 |
| Germany | Ongoing, recruiting | 12 | 6 |
| Greece | Ongoing, recruiting | 14 | 5 |
| Hungary | Ongoing, recruiting | 10 | 4 |
| Italy | Ongoing, recruiting | 13 | 10 |
| Netherlands | Ongoing, recruiting | 9 | 5 |
| Poland | Ongoing, recruiting | 34 | 12 |
| Romania | Ongoing, recruiting | 6 | 6 |
| Slovakia | Ongoing, recruiting | 8 | 4 |
| Spain | Authorised, recruiting | 16 | 11 |
| Rest of world
Brazil, Mexico, United States, Israel, Canada, Turkey, United Kingdom
|
— | 150 | — |
Investigational sites
Medical University of Graz
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Auenbruggerplatz 15, 8036, Graz
Medizinische Universitaet Innsbruck
Internal Medicine 1, Anichstrasse 35, 6020, Innsbruck
Medical University Of Vienna
Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Waehringer Guertel 18-20, Alsergrund, Vienna
AZORG Campus Aalst-Moorselbaan
Gastroenterology, 164 Moorselbaan,, Aalst, Oost-Vlaanderen
AZ Groeninge Campus Kennedylaan
gastroenterology, 4 President Kennedylaan, Kortrijk,, West-Vlaanderen
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Gastroenterology Department, 1 Avenue de l'Hopital,, B 35, Liège
Université Libre de Bruxelles - Hôpital Erasme
Clinical Research - Gastroenterology Department, 808 Route de Lennik, Brussels,, Région de Bruxelles-Capitale
UZ Leuven
Gastroenterology - Inflammatory Bowel Disease, Herestraat 49, 3000, Leuven
CHC MontLegia
Gastroenterology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
First Internal Department, Ulitsa Otets Paisiy 72, 5100, Gorna Oryahovitsa
Diagnostics And Consultation Center Convex Ltd.
Gastroenterologist, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Gastroenterology, Bulevard Gen. Stoletov No 67a, 1233, Sofia
SurGal Clinic s.r.o.
NA, Drobneho 307/38, Cerna Pole, Brno-Sever
Iscare a.s.
Klinické a výzkumné centrum pro střevní záněty, Ceskomoravska 2510/19, Liben, Prague
ResTrial GastroEndo s.r.o.
Gastroenterologie, Sofijske Namesti 3404/3, Modrany, Prague
EndoArt s.r.o.
NA, Hladnovska 1255/23, 710 00, Slezska Ostrava
Krajska zdravotni a.s.
Oddělení gastroenterologie, Socialni Pece 3316/12a, Severni Terasa, Usti Nad Labem
Gastroenterologie s.r.o.
NA, Manesova 646/16, 500 02, Hradec Kralove
Rigshospitalet
Department of Digestive Diseases, Transplantation and General Surgery, Inge Lehmanns Vej 7, 2100, Copenhagen Oe
Aarhus University Hospital
Department of Hepatology and Gastroenterology, Palle Juul Jensens Boulevard 99, 8200, Aarhus N
Lillebaelt Hospital
Department of Internal Medicine, Section of Gastroenterology, Beriderbakken 4, 7100, Vejle
Odense University Hospital
Department of Medical Gastroenterology, J. B. Winsloews Vej 4, 5000, Odense C
Herlev Hospital
Mave, - tarm og leversygdomme, Borgmester IB Juuls Vej 71, 2730, Herlev
Aalborg University Hospital
Department of Medical Gastroenterology, Hospitalsbyen 1, 9260, Gistrup
Hopital Saint Antoine
Gastroenterologie et nutrition, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Centre Hospitalier Universitaire De Saint Etienne
Service Gastro entérologie, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Bicetre Hospital
Hépato-gastroentérologie, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Centre Medico Chirurgical Ambroise Pare Hartmann
Institut des MICI, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Centre Hospitalier Universitaire De Toulouse
GASTROENTEROLOGY, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Nice
Unité de recherche clinique gastroentérologie et nutrition clinique, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Departemental Vendee
Gastroenterology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Universitaire De Montpellier
HGEA, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Clinique Des Cedres.
MICI Institut Privé, 21 Rue Albert Londres, 38130, Echirolles
Clinique Pasteur
Gastro-hepato-entérologie, 45 Avenue De Lombez, Cs 27617, Toulouse Cedex 3
Universitaetsklinikum Frankfurt AöR
N/A, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Klinikum Ernst von Bergmann gGmbH
Department of Gastroenterology, Hepatology, Infectious Diseases and Rheumatology, Charlottenstrasse 72, Noerdliche Innenstadt, Potsdam
Praxiszentrum für Gastroenterologie
N/A, Von-Werth-Strasse 5, Grevenbroich, Grevenbroich
Studiengesellschaft BSF UG (haftungsbeschraenkt)
N/A, Grosse Nikolaistrasse 7, Altstadt, Halle (Saale)
Medizinische Hochschule Hannover
Klinik für Gastroenterologie, Endokrinologie und Hepatologie - CED Ambulanz, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Eugastro GmbH
N/A, Johannisplatz 1, Zentrum Sudost, Leipzig
Evangelismos S.A.
Department of Gastroenterology, Ipsiladou 45-47, 106 76, Athens
Ippokratio General Hospital Of Thessaloniki
2nd Propaedeutic Internal Medicine Clinic, Department of Gastroenterology, Konstadinoupoleos 49, 546 42, Thessaloniki
University General Hospital Of Heraklion
Department of Gastroenterology, Stavrakia And Voutes, 715 00, Heraklion
Thoracic General Hospital Of Athens I Sotiria
3rd Internal Medicine Clinic, Gastroenterology Unit, Messogion Avenue 152, 115 27, Athens
University General Hospital Of Ioannina
Internal Medicine Sector, Gastroenterology Department, Niarchou Stavrou Avenue, 455 00, Ioannina
University Of Szeged
Szent-Györgyi Albert Klinikai Központ, Belgyógyászati Klinika, Kalvaria Sugarut 57, 6725, Szeged
Semmelweis University
Sebészeti, Transzplantációs és Gasztroenterológiai Klinika, Ulloi Ut 78, 1082, Budapest
Semmelweis Egyetem
Belgyógyászati és Hematológiai Klinika, Szentkirályi u. 46., 1088, Budapest
Clinfan Kft.
Gasztroenterológiai Rendelő, Pollack Mihaly Utca 50, 7100, Szekszard
Azienda Ospedaliero Universitaria Pisana
UO Gastroenterologia, Via Paradisa 2, 56124, Pisa
Universita Degli Studi Di Padova
Surgery Oncology and Gastroenterology, Via Nicolo' Giustiniani 3, 35128, Padova
Azienda Socio Sanitaria Territoriale Rhodense
U.O.C. di Gastroenterologia ed Endoscopia Digestiva, Corso Europa 250, 20017, Rho
Humanitas Mirasole S.p.A.
IBD center, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
U.O.S.D. Malattie Infiammatorie Croniche Intestinali (M.I.C.I), Via Trabucco 180, 90146, Palermo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dipartimento di Medicina Interna e Gastroenterologia, Largo Agostino Gemelli 8, 00168, Rome
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Gastroenterology and Endoscopy Unit, Via Francesco Sforza 35, 20122, Milan
AOU Bologna Policlinico di Sant’Orsola
SSD Malattie Infiammatorie Croniche Intestinali, Via Massarenti, 9, Bologna
Ospedale San Raffaele S.r.l.
Gastroenterology and Gastrointestinal Endoscopy, Via Olgettina 60, 20132, Milan
National Institute Of Gastroenterology Saverio De Bellis Research Hospital
Gastroenterology, Via Turi 27, 70013, Castellana Grotte
Universitair Medisch Centrum Utrecht
Gastro Enterology, Heidelberglaan 100, 3584 CX, Utrecht
Radboud universitair medisch centrum Stichting
Gasteroenterology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Ikazia Ziekenhuis
Gastroenterology - Hepatology, Montessoriweg 1, 3083 AN, Rotterdam
Amsterdam UMC
IBD trial Unit, De Boelelaan 1118, PK1 BR114, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Gastroenterology and Hepatology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
N/A, Ul. Polskiej Organizacji Wojskowej 12 C, 97-300, Piotrkow Trybunalski
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
N/A, Ul. Marcelinska 92, 60-324, Poznan
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
N/A, Ul. Marcelinska 42, 60-354, Poznan
Etg Zamosc Sp. z o.o.
N/A, Ul. Gesia 3, 22-400, Zamosc
Korczowski Bartosz, Gabinet Lekarski
NA, ul. Litewska 4A/7, 35-302, Rzeszow
Gyncentrum Sp. z o.o.
N/A, Ul. Tadeusza Kosciuszki 229, 40-600, Katowice
Twoja Przychodnia Opolskie Centrum Medyczne
N/A, ul. Kurpiowska, 6/2, Opole
Medical Network Sp. z o.o.
N/A, Ul. Plowiecka 103, 04-501, Warsaw
Gyncentrum Sp. z o.o.
N/A, Rondo Organizacji Narodow Zjednoczonych 1, 00-124, Warsaw
Melita Medical Sp. z o.o.
N/A, Ul. Strzegomska 2-4, 53-611, Wroclaw
Vivamed Sp. z o.o.
N/A, Ul. Zamiejska 17, 03-580, Warsaw
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
N/A, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Spitalul Clinic Colentina Bucuresti
Gastroenterology, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Spitalul Universitar De Urgenta Bucuresti
Gastroenterology, Splaiul Independentei 169, 050098, Bucharest
Spitalul Clinic Judetean De Urgenta Craiova
Gastroenterology, Strada Tabaci Nr 1, 200642, Craiova
Spitalul Judetean De Urgenta Bacau
Gastroenterology, Strada Haret Spiru 2-4, 600114, Bacau
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Gastroenterology, Bulevardul Tomis Nr 145, 900591, Constanta
Centrul De Gastroenterologie Dr. Goldis S.R.L.
Gastroenterology, Strada Blaga Lucian Nr 4, 300002, Timisoara
F D Roosevelt University General Hospital Of Banska Bystrica
gastroenterologická ambulancia, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Endomed s.r.o.
NA, Americka Trieda 17, Poliklinika Tahanovce, Kosice
Cliniq s.r.o.
Gastroenterology Department, Bezrucova 5, Stare Mesto, Bratislava
Gastro LM s.r.o.
NA, Jurkovicova 7081/18, 080 01, Presov
Hospital Universitari Vall D Hebron
Digestive system; Crohn's and Colitis Attention Unit, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital De Galdakao Usansolo
Digestive system, Leku Barrio Labeaga 46 A, 48960, Galdakao
Hospital Universitario La Paz
Digestive system, Paseo De La Castellana 261, 28046, Madrid
Hospital General Universitario Gregorio Maranon
Digestive system, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario De Navarra
Digestive system, Irunlarrea Kalea 3, 31008, Pamplona
Area Sanitaria De Ferrol
GASTROENTEROLOGY DEPARTMENT, Avenida Residencia S/n, 15405, Ferrol
Hospital Universitario Central De Asturias
Digestive system, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario De Cabuenes
Digestive system, Calle Prados 395, Cabuenes, Gijon
Centro Medico Teknon-Grupo Quironsalud
Digestive system; gastroenterology, Calle Vilana 12, 08022, Barcelona
Hospital Universitario Y Politecnico La Fe
Digestive system; gastroenterology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Virgen De La Macarena
Gastroenterology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2025-10-16 | ||||
| Belgium | 2025-10-14 | 2026-03-05 | |||
| Bulgaria | 2025-12-08 | 2026-05-28 | |||
| Czechia | 2025-09-23 | 2025-10-13 | |||
| Denmark | 2025-10-02 | 2025-10-29 | |||
| France | 2025-10-21 | 2025-10-30 | |||
| Germany | 2025-09-22 | 2025-12-17 | |||
| Greece | 2025-12-10 | 2025-12-16 | |||
| Hungary | 2025-10-27 | 2025-11-19 | |||
| Italy | 2025-10-09 | 2025-11-04 | |||
| Netherlands | 2025-11-17 | 2026-04-07 | |||
| Poland | 2025-09-19 | 2025-09-29 | |||
| Romania | 2025-10-09 | 2025-11-05 | |||
| Slovakia | 2025-09-23 | 2025-10-03 | |||
| Spain | 2025-10-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 369 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1__Protocol_2024-520209-38-00_GR_Redacted | f |
| Protocol (for publication) | D1_Protocol 2024-520209-38-00_redacted | d |
| Protocol (for publication) | D1_Protocol_2024-520209-38-00_GR_Redacted | d |
| Protocol (for publication) | D1_Protocol_2024-520209-38-00_Redacted | f |
| Protocol (for publication) | D4_Patient Facing Documents_Copyright Template | 1.0 |
| Recruitment arrangements (for publication) | 1_Recruitment and Informed consent procedure_GR | 1 |
| Recruitment arrangements (for publication) | K1_Appreciation Items | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Allocation | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and consenting procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement statement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_BG | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Complete Consent Security and Privacy Quick Reference Guide_Redacted | 1.5 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_eConsent Submission Letter EN | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Getting Started Patient facing landing page_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_IQVIA Complete Consent Security and Privacy QRG_Redacted_BEDU | 1.5 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_IQVIA Complete Consent Security and Privacy QRG_Redacted_BEFR | 1.5 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_IQVIA Complete Consent Security and Privacy QRG_Redacted_EN | 1.5 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Netherlands | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Netherlands_ | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Netherlands_Redacted | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Netherlands_TC | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Participant Facing Screenshots_Redacted | 1.4 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_PL | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangement_Waiver_of_the_right_to_appeal_SM-3_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Doctor referral letter | 2 |
| Recruitment arrangements (for publication) | K2_List of participating sites | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment arrangments_Informed consent and patient recruitment procedure_PL | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment arrangments_Informed consent and patient recruitment procedure_PL_TC | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Brochure_Clean | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_AMCD Brochure Master BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AMCD_IBD_Digital_Ad_Visuals_Master | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AMCD_IBD_Screener_Secondary_Master | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AMCD_IBD_WS_Script_Secondary_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AMCD_Search_Ads_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_AMCD_Social_Media_Video_2 | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_BG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_GR | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_Digital Ad Copy Master | 5 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_Digital Ad Visuals Master | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_IBD_CC_Script_Secondary_Master_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_IBD_Digital_Ad_copy_Master | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_IBD_Digital_Ad_Visuals_Master | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_IBD_Exclusive_Database_Messaging_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_IBD_Screener_Secondary_Master | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital campaign_IBD_WS_Script_Secondary_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_Patient Messaging Master_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_Search Ads Master1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_Social Media Video script 1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_Social Media Video script 2 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital_Ad_Copy_Master | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital_Ad_Visuals_Master | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital_Ad_Visuals_Master | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Doctor Referral Letter | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr Referral Letter | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer master BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_BG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_GR | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Doctor Referral Letter | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_CC_Script_Secondary_Master_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_CC_Script_Secondary_Master_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_IBD_Digital_Ad_Copy_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_Digital_Ad_Visuals_Master | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_Exclusive_Database_Messaging_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_Screener_Secondary_Master | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_WS_Script_Secondary_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient_Messaging_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster Master BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_BG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_GR | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Search_Ads_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social_Media_Video_1_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social_Media_Video_2_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_AMCD_Digital_Ad_Copy_Master | 5.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_AMCD_Digital_Ad_Visuals_Master | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_AMCD_IBD_Digital_Ad_Copy_Master | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_AMCD_IBD_Exclusive_Database_Messaging_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_AMCD_Patient_Messaging_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_AMCD_Social_Media_Video_1_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Digital_Ad_Copy_Master | 5.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_IBD_CC_Script_Secondary_Master_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_IBD_Digital_Ad_Copy_Master | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_IBD_Digital_Ad_Visuals_Master | 4.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_IBD_Exclusive_Database_Messaging_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_IBD_Landing_Page_Copy_Master_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_IBD_Screener_Secondary_Master | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_IBD_WS_Script_Secondary_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Patient_Messaging_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Search_Ads_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Social_Media_Video_1_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Social_Media_Video_2_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Poster | 1 |
| Recruitment arrangements (for publication) | K3_Other subject information material_Flyer_Master_PL | 1.0 |
| Recruitment arrangements (for publication) | K3_Other subject information material_Letter Doctor Referral_PL | 2.0 |
| Recruitment arrangements (for publication) | K3_Other subject information material_Poster_Master_PL | 1.0 |
| Recruitment arrangements (for publication) | K3_Other subject information material_Trial-Brochure_PL | 1.0 |
| Recruitment arrangements (for publication) | K3_Retention material_ZoomHealth Privacy Statement_ENG | 1.0 |
| Recruitment arrangements (for publication) | K3_Retention material_ZoomHealth Screenshots_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K3_Retention material_ZoomHealth Screenshots_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K3_Retention material_ZoomHealth TOS_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K3_Retention material_ZoomHealth TOS_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K3_Retention material_ZoomHealth TOS_ENG | 1.0 |
| Recruitment arrangements (for publication) | K4_Recruitment material Flyer | 1.1 |
| Recruitment arrangements (for publication) | K5_Recruitment material Poster | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_GR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_GR_track changes | 2 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Pregnant Partner_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data protection addendum | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main - Redacted | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partners_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant_partner_participant | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Continued Access | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Continued Access_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data Privacy Addendum ICF_CZ | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Addendum_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_CZ_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ENG_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BG_en_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BGR_final_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Informed Consent Form_BG_en | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner Informed Consent Form_BGR_final_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_Main_ICF_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_confidentiality sheet | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_IFU_MIRIKIZUMAB | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_ZoomHealth documentation | 1 |
| Subject information and informed consent form (for publication) | L2_Instruction for use_Mirikizumab | 1.0 |
| Subject information and informed consent form (for publication) | L2_Instruction for use_Mirikizumab | 1 |
| Subject information and informed consent form (for publication) | L2_Instruction for use_Tirzepatide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Instruction for use_Tirzepatide | 1 |
| Subject information and informed consent form (for publication) | L2_List of ssICF contact details_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material IQVIA Complete Consent - Participant-Facing Screenshots | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material IQVIA Getting Started Patient-facing landing page | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Leaflet on trial subject rights | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Participant Emergency Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ IFU_MIRIKIZUMAB | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ IFU_TIRZEPATIDE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Atom5TM eCOA Platform_Participant Quick Start Guide_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CIS_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Information Sheet_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Confidentiality Company Information Notice_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality notice | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice_Netherlands_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_ConneX Travel Contact Card_GR_Redacted | 10 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_ConneX Travel Reference Guide for Participants_GR_Redacted | 10 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_CT_Thank You End Of Study_Master_GR | 3.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_CT_Thank You Participation_Master_GR | 3.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_CT_Thank You Screening_Master_GR | 3.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_CT_Visit Card Noname_Master_GR | 3.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_e-Consent Participant-Facing Screenshots_Redacted_BEDU | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_e-Consent Participant-Facing Screenshots_Redacted_BEFR | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_e-Consent Participant-Facing Screenshots_Redacted_EN | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_econsent submission letter | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Getting Started Patient facing landing page_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 1 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 10 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 11 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 12 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 13 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 14 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 2 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 3 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 4 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 5 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 6 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 7 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 8 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Module 9 Worksheet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Participant Nutrition Hydration_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_HBP_Protein_Brochure_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 1 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 10 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 11 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 12 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 13 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 14 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 2 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 3 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 4 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 5 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 6 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 7 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 8 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB Module 9 Worksheet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HPB participant nutrition-hydration | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_ICF_Sponsor_Statement_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU Mirikizumab | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU Tzp | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_TIRZEPATIDE | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_Tirzepatide_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_Tirzepatide_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Injection reminder magnet | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Injection Reminder Magnet_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Injection Reminder MirrorCling_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Instruction for use_MIRIKIZUMAB__PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Instruction for use_TIRZEPATIDE__PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA Complete Consent Participant-Facing Screenshots_BEDU | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA Complete Consent Participant-Facing Screenshots_BEFR | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA Complete Consent Participant-Facing Screenshots_EN | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA eConsent Privacy Policy_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA eConsent Privacy Policy_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA eConsent Privacy Policy_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Letter Participant Welcome_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Mirikizumab IFU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Mirikizumab IFU_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Mirikizumab IFU_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_MIRIKIZUMAB_IFU_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_NON-SCR Stool Collection Instructions | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Non-scr stool collection instructions_ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Facing Screenshots_Redacted | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Patient Stool Collection Instructions_non SCR_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Patient Stool Collection Instructions_SCR_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient-facing landing page_ENG | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient-facing landing page_Redacted_BEDU | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient-facing landing page_Redacted_BEFR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient-facing landing page_Redacted_ENG | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Privacy Policy | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Privacy Policy eConsent_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Scr Stool collection instructions | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_SCR Stool Collection Instructions _V1_28May25 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Security and Privacy Quick Reference Guide_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study guide | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study Guide_Master_GR | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Instructions for Use_Mirikizumab | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Instructions for Use_Tirzepatide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Tirzepatide IFU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_TIRZEPATIDE_IFU_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit calendar | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Visit Calendar_Master_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit card | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_PrivacyStatement | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_PrivacyStatement | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Screenshots | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Screenshots | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_TermsofService | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Clinical Trial Ancillary Supply List_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information_IFU_MIRIKIZUMAB | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_IFU_TIRZEPATID | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Injection Reminder Magnet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Injection Reminder MirrorCling | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Letter Participant Welcome | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Study-Guide_Master | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Thank You End Of Study | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Thank You Participation | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Thank You Screening | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Visit Calendar | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Visit Card Noname | 3 |
| Subject information and informed consent form (for publication) | L2_Other_AMCD_Digital_Ad_Copy | 2 |
| Subject information and informed consent form (for publication) | L2_Other_AMCD_Digital_Ad_Visuals | 2 |
| Subject information and informed consent form (for publication) | L2_Other_AMCD_Patient_Messaging | 2 |
| Subject information and informed consent form (for publication) | L2_Other_AMCD_Search_Ads | 1 |
| Subject information and informed consent form (for publication) | L2_Other_AMCD_Social_Media_Video_1 | 1 |
| Subject information and informed consent form (for publication) | L2_Other_AMCD_Social_Media_Video_2 | 1 |
| Subject information and informed consent form (for publication) | L2_Other_IBD_CC_Script_Secondary_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other_IBD_Digital_Ad_Copy | 2 |
| Subject information and informed consent form (for publication) | L2_Other_IBD_Digital_Ad_Visuals | 2 |
| Subject information and informed consent form (for publication) | L2_Other_IBD_Exclusive_Database_Messaging | 2 |
| Subject information and informed consent form (for publication) | L2_Other_IBD_Landing_Page_Copy_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other_IBD_Screener_Secondary | 1 |
| Subject information and informed consent form (for publication) | L2_Other_IBD_WS_Script_Secondary | 1 |
| Subject information and informed consent form (for publication) | L2_Other_PATIENT non-SCR Stool Collection Instructions_V01 Global | 1 |
| Subject information and informed consent form (for publication) | L2_Other_PATIENT SCR Stool Collection Instructions_V01 Global | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Card text | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Documents Not submitted_PL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Study Participant Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_Study Participant Contact Card_GR | 2 |
| Subject information and informed consent form (for publication) | L3_Info Re insurance Conditions for Patient_PL | 1.0 |
| Subject information and informed consent form (for publication) | L3_Other subject information material Instructions For Use - Mirikizumab | 1.0 |
| Subject information and informed consent form (for publication) | L3_Other subject information material Instructions For Use - Tirzepatide | 1.0 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-01_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-02_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-03CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-04_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-05_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-06_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-07_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-08_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-09_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-10_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-11_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-12_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-13_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information_HBP_Module-14_CZ | 1 |
| Subject information and informed consent form (for publication) | L3_Other_Atom5 eCOA Platform_Participant Quick Start Guide_Paper | 1 |
| Subject information and informed consent form (for publication) | L3_Patient card_master | 1.0 |
| Subject information and informed consent form (for publication) | L3_Retention_EN_Zoom Telehealth_Privacy Statement | 1.0 |
| Subject information and informed consent form (for publication) | L3_Retention_EN_Zoom Telehealth_Screenshots | 1.0 |
| Subject information and informed consent form (for publication) | L3_Retention_EN_Zoom Telehealth_Terms of Service | 1.0 |
| Subject information and informed consent form (for publication) | L3_Retention_HU_eCOA Participant Quick-Start Guide | 2 |
| Synopsis of the protocol (for publication) | D1__Protocol Synopsis_2024-520209-38-00_GR | e |
| Synopsis of the protocol (for publication) | D1_Protocol Amendment A Synopsis_SK_2024-520209-38-00 | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-520209-38-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SK_2024-520209-38-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-520209-38-00_FR | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-520209-38-00_GR | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-520209-38-00_GR_track changes | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-520209-38-00_RO | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_AT_DE_2024-520209-38-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDE_2024-520209-38-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDU_2024-520209-38-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEFR_2024-520209-38-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BG_2024-520209-38-00_17Apr2025 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BG_2024-520209-38-00_e_04Nov2025_TC | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2024-520209-38-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2024-520209-38-00 | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GER_2024-520209-38-00 | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU 2024-520209-38-00 | a |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_2024-520209-38-00_CZ | e |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_2024-520209-38-00_PL | e |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_IT_2024-520209-38-00 | e |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-30 | Italy | Acceptable with conditions 2025-08-25
|
2025-08-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-02 | Acceptable with conditions 2025-08-25
|
2025-09-02 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-03 | Acceptable with conditions 2025-08-25
|
2025-09-03 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-08 | Acceptable with conditions 2025-08-25
|
2025-09-08 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-09-11 | Acceptable with conditions 2025-08-25
|
2025-09-11 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-09-11 | Acceptable with conditions 2025-08-25
|
2025-09-11 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-09-12 | Italy | Acceptable with conditions 2025-08-25
|
2025-09-12 |
| 8 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-19 | Acceptable with conditions | 2025-10-14 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-10 | Acceptable with conditions | 2025-12-10 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-17 | Italy | Acceptable with conditions 2026-04-13
|
2026-04-13 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-04-21 | Acceptable with conditions 2026-04-13
|
2026-04-21 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-04-24 | Acceptable with conditions | 2026-05-08 |