Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn’s Disease and Obesity or Overweight: Phase 3b Study (COMMIT-CD)

2024-520210-21-00 Protocol I6T-MC-AMCE Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 19 Sep 2025 · Status Ongoing, recruiting · 15 EU/EEA countries · 98 sites · Protocol I6T-MC-AMCE

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 299
Countries 15
Sites 98

Crohn’s Disease

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, endoscopic remission, and weight reduction.

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
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
2024-520210-21-00
WHO UTN
U1111-1319-3171
ClinicalTrials.gov
NCT06937099

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Pharmacogenetic, Pharmacodynamic, Efficacy, Therapy

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, endoscopic remission, and weight reduction.

Conditions and MedDRA coding

Crohn’s Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Have had a diagnosis of Crohn’s disease (CD) or perianal fistulizing CD established at least 3 months prior to enrollment with tests confirming the diagnosis.
  2. Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
  3. SES-CD score of at least 6 or 4 (isolated ileal)
  4. Participants with a history of CD involving only or predominantly the colon for greater than or equal to 8 years with a surveillance colonoscopy within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.
  5. Be obese with a body mass index (BMI) of 30 or higher or be overweight with a BMI between 27 and 30 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.
  6. Have tried and not responded well to at least one conventional CD medication (like oral such as corticosteroids or azathioprine) and also not respond well to advanced CD therapies (like biologics or JAK inhibitors).

Exclusion criteria 8

  1. Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
  2. Have more than 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum.
  3. Have a stoma, ileoanal pouch, or ostomy.
  4. Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.
  5. Have Type 1 diabetes or Type 2 diabetes treated with insulin.
  6. Have had severe low blood sugar or unawareness of low blood sugar in the past 6 months.
  7. Have had more than 5% body weight change in the past 3 months.
  8. Have a current or recent serious infection.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Percentage of participants who simultaneously achieve clinical remission by Crohn’s Disease Activity Index (CDAI), endoscopic remission, and at least 10% weight reduction.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 9

Tirzepatide

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
742.5 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

Tirzepatide

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
742.5 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

Tirzepatide

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
742.5 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

Tirzepatide

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
742.5 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

Tirzepatide

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
742.5 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

Tirzepatide

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
742.5 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

Mirikizumab

PRD10082852 · Product

Active substance
Mirikizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
900 mg milligram(s)
Max total dose
17400 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

Mirikizumab

PRD10725963 · Product

Active substance
Mirikizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
900 mg milligram(s)
Max total dose
17400 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

Mirikizumab

PRD10082863 · Product

Active substance
Mirikizumab
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS USE
Max daily dose
900 mg milligram(s)
Max total dose
17400 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

to match Tirzepatide

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.

137 Total trials 45 Recruiting 84 Ended
Commercial
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 20

OrganisationCity, countryDuties
Icon Development Solutions LLC
ORG-100012400
 Whitesboro, United States Laboratory analysis
Alimentiv Inc.
ORG-100006515
 London, Canada Laboratory analysis
Iqvia Rds Inc.
ORG-100043858
 Durham, United States Data management
Clinical Trial Media Inc.
ORG-100046339
 Hauppauge, United States Other
Tier 1 Impact Pbc Inc.
ORG-100050163
 Covington, United States Other
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Iqvia Rds Inc.
ORG-100043858
 Durham, United States Data management
Cleveland Clinic Foundation
ORG-100028017
 Cleveland, United States Other
The Hibbert Co.
ORG-100047639
 Trenton, United States Other
Lionbridge AG
ORL-000012316
 Basel, Switzerland Other
WCG Clinical Inc.
ORL-000007439
 Indianapolis, United States Other
Veeva Systems Inc.
ORG-100006053
 Pleasanton, United States Data management
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Bioagilytix Labs LLC
ORG-100013030
 Durham, United States Laboratory analysis
Labcorp Central Laboratory Services Sàrl
ORL-000005229
 Geneva, Switzerland Laboratory analysis
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
Bioclinica Inc.
ORG-100033079
 Philadelphia, United States Laboratory analysis
Iterative Health, Inc
ORL-000014354
 Cambridge, United States Other

Locations

15 EU/EEA countries · 98 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruiting 5 3
Belgium Ongoing, recruiting 7 6
Bulgaria Authorised, recruiting 3 3
Czechia Ongoing, recruiting 18 6
Denmark Ongoing, recruiting 11 6
France Ongoing, recruiting 19 11
Germany Ongoing, recruiting 13 6
Greece Ongoing, recruiting 13 5
Hungary Ongoing, recruiting 7 4
Italy Ongoing, recruiting 12 10
Netherlands Ongoing, recruiting 9 5
Poland Ongoing, recruiting 23 12
Romania Ongoing, recruiting 6 6
Slovakia Ongoing, recruiting 10 4
Spain Ongoing, recruiting 15 11
Rest of world
Turkey, Israel, Canada, Mexico, United States, Brazil
 — 128 —

Investigational sites

Austria

3 sites · Ongoing, recruiting
Medical University Of Vienna
Department of Internal Medicine III, Division of Gastroenterology and Hepatology, Waehringer Guertel 18-20, Alsergrund, Vienna
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

Belgium

6 sites · Ongoing, recruiting
UZ Leuven
Gastroenterology - Inflammatory Bowel Disease, Herestraat 49, 3000, Leuven
Algemeen Ziekenhuis Groeninge
gastroenterology, President Kennedylaan 4, 8500, Kortrijk
Azorg
Gastroenterology, Moorselbaan 164, 9300, Aalst
Hopital Erasme
Clinical Research - Gastroenterology Department, Lennikse Baan 808, 1070, Anderlecht
CHC MontLegia
Gastroenterology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Centre hospitalier universitaire de Liege
Gastroenterology Department, Avenue De L'Hopital 1, 4000, Liege

Bulgaria

3 sites · Authorised, recruiting
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Gastroenterology, Bulevard Gen. Stoletov No 67a, 1233, Sofia
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
First Internal Department, Ulitsa Otets Paisiy 72, 5100, Gorna Oryahovitsa
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Gastroenterology, Oborishte Distr., Ul.Byalo More 8, Sofia

Czechia

6 sites · Ongoing, recruiting
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
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
SurGal Clinic s.r.o.
NA, Drobneho 307/38, Cerna Pole, Brno-Sever
Gastroenterologie s.r.o.
NA, Manesova 646/16, 500 02, Hradec Kralove

Denmark

6 sites · Ongoing, recruiting
Rigshospitalet
Department of Digestive Diseases, Transplantation and General Surgery, Inge Lehmanns Vej 7, 2100, Copenhagen Oe
Lillebaelt Hospital
Department of Internal Medicine, Section of Gastroenterology, Beriderbakken 4, 7100, Vejle
Herlev Hospital
Department of Gastroenterology and Hepatology, Borgmester IB Juuls Vej 71, 2730, Herlev
Aarhus University Hospital
Department of Hepatology and Gastroenterology, Palle Juul Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
Department of Medical Gastroenterology, J.B. Winsloews Vej 4, 5000, Odense C
Aalborg University Hospital
Department of Medical Gastroenterology, Hospitalsbyen 1, 9260, Gistrup

France

11 sites · Ongoing, recruiting
Bicetre Hospital
Hépato-gastroentérologie, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Centre Hospitalier Universitaire De Saint Etienne
Service Gastro entérologie, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Hopital Saint Antoine
Gastroenterologie et nutrition, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Centre Hospitalier Departemental Vendee
Gastroenterology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
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
Centre Hospitalier Universitaire De Montpellier
HGEA, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Medico Chirurgical Ambroise Pare Hartmann
Institut des MICI, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Centre Hospitalier Universitaire De Nice
Unité de recherche clinique gastroentérologie et nutrition clinique, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Toulouse
GASTROENTEROLOGY, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire Rouen
Gastroentérologie, 1 Rue De Germont, Bp 96031, Rouen Cedex

Germany

6 sites · Ongoing, recruiting
Praxiszentrum für Gastroenterologie und Endoskopie
N/A, Von-Werth-Strasse 5, Grevenbroich, Grevenbroich
Universitaetsklinikum Frankfurt AöR
N/A, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Medizinische Hochschule Hannover
Klinik für Gastroenterologie, Endokrinologie und Hepatologie - CED Ambulanz, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Studiengesellschaft BSF UG (haftungsbeschraenkt)
N/A, Grosse Nikolaistrasse 7, Altstadt, Halle (Saale)
Eugastro GmbH
N/A, Johannisplatz 1, Zentrum Sudost, Leipzig
Klinikum Ernst von Bergmann gGmbH
Department of Gastroenterology, Hepatology, Infectious Diseases and Rheumatology, Charlottenstrasse 72, Noerdliche Innenstadt, Potsdam

Greece

5 sites · Ongoing, recruiting
University General Hospital Of Ioannina
Internal Medicine Sector, Gastroenterology Department, Niarchou Stavrou Avenue, 455 00, Ioannina
University General Hospital Of Heraklion
Department of Gastroenterology, Stavrakia And Voutes, 715 00, Heraklion
Ippokratio General Hospital Of Thessaloniki
2nd Propaedeutic Internal Medicine Clinic, Department of Gastroenterology, Konstadinoupoleos 49, 546 42, Thessaloniki
Thoracic General Hospital Of Athens I Sotiria
3rd Internal Medicine Clinic, Gastroenterology Unit, Messogion Avenue 152, 115 27, Athens
Evangelismos S.A.
Department of Gastroenterology, Ipsiladou 45-47, 106 76, Athens

Hungary

4 sites · Ongoing, recruiting
Clinfan Kft.
Gasztroenterológiai Rendelő, Pollack Mihaly Utca 50, 7100, Szekszard
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

Italy

10 sites · Ongoing, recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
U.O.S.D. Malattie Infiammatorie Croniche Intestinali (M.I.C.I), Via Trabucco 180, 90146, Palermo
IRCCS Humanitas Research Hospital
IBD center, Via Manzoni, 56, Rozzano
National Institute Of Gastroenterology Saverio De Bellis Research Hospital
Gastroenterology, Via Turi 27, 70013, Castellana Grotte
Azienda Socio Sanitaria Territoriale Rhodense
U.O.C. di Gastroenterologia ed Endoscopia Digestiva, Corso Europa 250, 20017, Rho
Ospedale San Raffaele S.r.l.
Gastroenterology and Gastrointestinal Endoscopy, Via Olgettina 60, 20132, Milan
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
SSD Malattie Infiammatorie Croniche Intestinali, Via G. Massarenti 9, 40138, Bologna
Universita Degli Studi Di Padova
Surgery Oncology and Gastroenterology, Via Nicolo' Giustiniani 3, 35128, Padova
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Gastroenterology and Endoscopy Unit, Via Francesco Sforza 35, 20122, Milan
Azienda Ospedaliero Universitaria Pisana
UO Gastroenterologia, Via Paradisa 2, 56124, Pisa
Policlinico universitario Agostino Gemelli IRCCS
Dipartimento di Medicina Interna e Gastroenterologia, Largo Agostino Gemelli 8, 00168, Roma

Netherlands

5 sites · Ongoing, recruiting
Radboud universitair medisch centrum Stichting
Gasteroenterology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Ikazia Ziekenhuis
Gastroenterology - Hepatology, Montessoriweg 1, 3083 AN, Rotterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Gastroenterology and Hepatology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Universitair Medisch Centrum Utrecht
Gastroenterology, Heidelberglaan 100, 3584 CX, Utrecht
Amsterdam UMC
IBD trial Unit, De Boelelaan 1118, PK1 BR114, Amsterdam

Poland

12 sites · Ongoing, recruiting
Twoja Przychodnia Opolskie Centrum Medyczne
NA, ul. Kurpiowska 6/2, 45-819, Opole
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
NA, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Medical Network Sp. z o.o.
NA, Ul. Plowiecka 103, 04-501, Warsaw
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
NA, Ul. Polskiej Organizacji Wojskowej 12 C, 97-300, Piotrkow Trybunalski
Gyncentrum Sp. z o.o.
NA, Rondo Organizacji Narodow Zjednoczonych 1, 00-124, Warsaw
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
NA, Ul. Marcelinska 92, 60-324, Poznan
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
NA, Ul. Marcelinska 42, 60-354, Poznan
Vivamed Sp. z o.o.
NA, Ul. Zamiejska 17, 03-580, Warsaw
Etg Zamosc Sp. z o.o.
NA, Ul. Gesia 3, 22-400, Zamosc
Korczowski Bartosz, Gabinet Lekarski
NA, ul. Litewska 4A/7, 35-302, Rzeszów
Melita Medical Sp. z o.o.
NA, Ul. Strzegomska 2-4, 53-611, Wroclaw
Medrise Sp. z o.o.
NA, Ul. Onyksowa 10, 20-582, Lublin

Romania

6 sites · Ongoing, recruiting
Spitalul Judetean De Urgenta Bacau
Gastroenterology, Strada Haret Spiru 2-4, 600114, Bacau
Spitalul Clinic Judetean De Urgenta Craiova
Gastroenterology, Strada Tabaci Nr 1, 200642, Craiova
Spitalul Clinic Colentina Bucuresti
Gastroenterology, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
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
Spitalul Universitar De Urgenta Bucuresti
Gastroenterology, Splaiul Independentei 169, 050098, Bucharest

Slovakia

4 sites · Ongoing, recruiting
Gastro LM s.r.o.
NA, Jurkovicova 7081/18, 080 01, Presov
F D Roosevelt University General Hospital Of Banska Bystrica
Gastroenterology, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Cliniq s.r.o.
NA, Bezrucova 5, Stare Mesto, Bratislava
Endomed s.r.o.
N/A, Americka Trieda 19, Sidlisko Tahanovce, Kosice

Spain

11 sites · Ongoing, recruiting
Area Sanitaria De Ferrol
GASTROENTEROLOGY DEPARTMENT, Avenida Residencia S/n, 15405, Ferrol
Hospital Universitari Vall D Hebron
Crohn's and Colitis Attention Unit, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Centro Medico Teknon-Grupo Quironsalud
Gastroenterology, Calle Vilana 12, 08022, Barcelona
Hospital Universitario De Cabuenes
Digestive, Calle Prados 395, Cabuenes, Gijon
Hospital General Universitario Gregorio Maranon
Digestive, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario Central De Asturias
Digestive, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario La Paz
Unidad de Enfermedad Inflamatoria Intestinal, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Y Politecnico La Fe
Enfermedad Inflamatoria Intestinal, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario De Navarra
Digestive, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario Virgen De La Macarena
Gastroenterology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital De Galdakao Usansolo
Digestive, Leku Barrio Labeaga 46 A, 48960, Galdakao

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2025-10-21 2026-03-24
Belgium 2025-10-07 2025-11-18
Bulgaria 2025-12-05
Czechia 2025-09-23 2025-11-26
Denmark 2025-10-02 2025-12-03
France 2025-10-21 2025-10-28
Germany 2025-09-30 2026-01-13
Greece 2025-12-10 2025-12-16
Hungary 2025-10-27 2025-11-18
Italy 2025-10-13 2025-11-25
Netherlands 2025-11-17 2025-12-17
Poland 2025-09-19 2025-09-30
Romania 2025-10-08 2025-11-04
Slovakia 2025-09-29 2025-10-16
Spain 2025-10-16 2025-10-22

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 368 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2024-520210-21-00_ GR_Redacted f
Protocol (for publication) D1_Protocol_2024-520210-21-00_GR_Redacted e
Protocol (for publication) D1_Protocol_2024-520210-21-00_Redacted e
Protocol (for publication) D1_Protocol_2024-520210-21-00_Redacted_ f
Protocol (for publication) D4_Patient facing documents_Copyright Statement 1.0
Protocol (for publication) D4_Study Participant Contact Card_GR 2
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 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 template 2
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure_redacted 1
Recruitment arrangements (for publication) K1_Recruitment arrangement_Waiver of the right to appeal_SM-3_CZ 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 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 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 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
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
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Recruitment arrangements (for publication) K1_Recruitment Arrangements_IQVIA Complete Consent Security and Privacy QRG_ENG_Redacted 1.5
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Recruitment arrangements (for publication) K1_Recruitment Arrangements_Netherlands_ 2
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Netherlands_Redacted 3.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Netherlands_TC 2
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Recruitment arrangements (for publication) K1_Recruitment Arrangements_Recruitment and Informed consent procedure_BE 1.0
Recruitment arrangements (for publication) K1_Recruitment materials_Brochure 2.0
Recruitment arrangements (for publication) K1_Recruitment materials_Poster 1.0
Recruitment arrangements (for publication) K1_Recruitment Procedure 1.0
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Recruitment arrangements (for publication) K2_Doctor referral letter 2
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Recruitment arrangements (for publication) K2_List of participating sites 1
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Recruitment arrangements (for publication) K2_Recruitment material_AMCE_Digital_Ad_Copy_Master 5
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Recruitment arrangements (for publication) K2_Recruitment Material_Digital_Ad_Copy_Master 3.0
Recruitment arrangements (for publication) K2_Recruitment material_Digital_Ad_Visuals_Master 5
Recruitment arrangements (for publication) K2_Recruitment Material_Digital_Ad_Visuals_Master 3.0
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Recruitment arrangements (for publication) K2_Recruitment material_IBD Digital Ad Copy Master_ITA 3
Recruitment arrangements (for publication) K2_Recruitment material_IBD Digital Ad Visuals Master_ITA 4
Recruitment arrangements (for publication) K2_Recruitment material_IBD Exclusive Database Messaging Master_ITA 2
Recruitment arrangements (for publication) K2_Recruitment material_IBD Screener Secondary Master _ITA 3
Recruitment arrangements (for publication) K2_Recruitment material_IBD WS Script Secondary Master_ITA 2
Recruitment arrangements (for publication) K2_Recruitment material_IBD_CC_Script_Secondary_Master_Redacted 2
Recruitment arrangements (for publication) K2_Recruitment material_IBD_CC_Script_Secondary_Master_Redacted 2
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 3.0
Recruitment arrangements (for publication) K2_Recruitment Material_IBD_Digital_Ad_Copy_Master 2
Recruitment arrangements (for publication) K2_Recruitment material_IBD_Digital_Ad_Copy_Master 3
Recruitment arrangements (for publication) K2_Recruitment material_IBD_Digital_Ad_Visuals_Master 4.0
Recruitment arrangements (for publication) K2_Recruitment material_IBD_Digital_Ad_Visuals_Master 4
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 2.0
Recruitment arrangements (for publication) K2_Recruitment material_IBD_Exclusive_Database_Messaging_Master 2
Recruitment arrangements (for publication) K2_Recruitment material_IBD_Exclusive_Database_Messaging_Master 2
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Recruitment arrangements (for publication) K2_Recruitment material_IBD_Screener_Secondary_Master 3
Recruitment arrangements (for publication) K2_Recruitment material_IBD_Screener_Secondary_Master 3
Recruitment arrangements (for publication) K2_Recruitment material_IBD_Screener_Secondary_Master 3
Recruitment arrangements (for publication) K2_Recruitment material_IBD_WS_Script_Secondary_Master 2.0
Recruitment arrangements (for publication) K2_Recruitment material_IBD_WS_Script_Secondary_Master 2
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_Patient_Messaging_Master 2.0
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Recruitment arrangements (for publication) K2_Recruitment Material_Poster 1
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Recruitment arrangements (for publication) K2_Recruitment material_Poster_Master_ITA 1
Recruitment arrangements (for publication) K2_Recruitment material_Search_Ads_Master 1
Recruitment arrangements (for publication) K2_Recruitment Material_Search_Ads_Master 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Social_Media_Video_1_Master 1
Recruitment arrangements (for publication) K2_Recruitment Material_Social_Media_Video_1_Master 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Social_Media_Video_2_Master 1
Recruitment arrangements (for publication) K2_Recruitment Material_Social_Media_Video_2_Master 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Video transcript_site MUW_Redacted 4.0
Recruitment arrangements (for publication) K2_Recruitment Poster 1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Contact_CC Script Secondary_IBD_Redacted 4.1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Contact_Exclusive Database Messaging_IBD 2.1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Contact_Patient Messaging_AMCE 2.1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Contact_WS Script Secondary_IBD 4.1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Social Media_Digital Ad Copy_AMCE 5.1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Social Media_Digital Ad Copy_IBD 3.1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Social Media_Digital Ad Visuals_AMCE 4.1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Social Media_Digital Ad Visuals_IBD 4.1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Social Media_Search Ads_AMCE 1.1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Social Media_Video 1_AMCE 1.1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Social Media_Video 2_AMCE 1.1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Website_Landing Page Copy_IBD_Redacted 2.1
Recruitment arrangements (for publication) K3_Recruitment material_HU_Website_Screener_Secondary_IBD 4.1
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
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Recruitment arrangements (for publication) K3_Retention material_ZoomHealth TOS_ENG 1.0
Recruitment arrangements (for publication) K5_Recruitment material Poster 1.1
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_BG_final clean_redacted 4.0
Subject information and informed consent form (for publication) L1 SIS and ICF_Pregnant Partner_BG_en 1.0
Subject information and informed consent form (for publication) L1 SIS and ICF_Pregnant Partner_BGR_BG_final clean_redacted 1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Redacted 2.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_TC_Redacted 2.0
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 Continued Access 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Addendum Genetic_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Addendum Genetic_TC_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Addendum Pregnancy_Redacted 1.0
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 Main_BEDU_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_BEFR_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_ENG_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF Main_Redacted 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum Genetic_IT_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Data Privacy Addendum 1.1
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_DPA_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_IT_Redacted 3
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Redacted 3
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) L1_SIS and ICF_Main ICF_Redacted 2.0
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_Redacted 2
Subject information and informed consent form (for publication) L1_SIS and ICF_PL_Main ICF_redacted 4
Subject information and informed consent form (for publication) L1_SIS and ICF_PL_Main ICF_TC_redacted 4
Subject information and informed consent form (for publication) L1_SIS and ICF_Preganant Partner 1
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_Redacted 1
Subject information and informed consent form (for publication) L2_ Other subject information material_confidentiality sheet 2
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_Mirikizumab 1
Subject information and informed consent form (for publication) L2_ Other subject information material_Subject Instructions for Use_Tirzepatide 1
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_AMCE_Study Participant Contact Card 1
Subject information and informed consent form (for publication) L2_Compensation Information Sheet_Redacted 1
Subject information and informed consent form (for publication) L2_Informed consent and patient recruitment procedure 2
Subject information and informed consent form (for publication) L2_Informed consent and patient recruitment procedure_TC 1
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_Tirzepatid 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 subjec information materials_Mirikizumab_IFU 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 1 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 10 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 11 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 12 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 13 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 14 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 2 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 3 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 4 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 5 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 6 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 7 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 8 Worksheet 1
Subject information and informed consent form (for publication) L2_Other subject information material HBP Module 9 Worksheet 1
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_ e-Consent Participant-Facing Screenshots_BEDU_Redacted 1.4
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_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_ IFU_TIRZEPATIDE 1.0
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Care Partner Guide_GR 1.1
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_Complete Consent Security and Privacy Guide_Redacted 1.5
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
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_CSR_Stool Collection Instructions 1
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_BEFR_Redacted 1.4
Subject information and informed consent form (for publication) L2_Other subject information material_e-Consent Participant-Facing Screenshots_ENG_Redacted 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_HBP participant nutrition-hydration 1
Subject information and informed consent form (for publication) L2_Other subject information material_HBP Protein Brochure 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_ICF_Sponsor_Statement_ENG_Redacted 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_IFU_Mirikizumab_BEDU 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_IFU_Mirikizumab_BEFR 1.0
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 MirrorCling_Master_GR 1.1
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_IQVIA Privacy Policy 1
Subject information and informed consent form (for publication) L2_Other subject information material_Mirikizumab Tirzepatide IFU 1
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_NONSCR 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 1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Emergency Card_Redacted 2
Subject information and informed consent form (for publication) L2_Other subject information material_Patient facing landing page_BEDU_Redacted 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Information Card 2
Subject information and informed consent form (for publication) L2_Other subject information material_Patient landing page_Redacted 1.1
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_BEFR_Redacted 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient-facing landing page_ENG_Redacted 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Polish_ZoomHealth_PrivacyStatement 1
Subject information and informed consent form (for publication) L2_Other subject information material_Polish_ZoomHealth_Screenshots 1
Subject information and informed consent form (for publication) L2_Other subject information material_Polish_ZoomHealth_TermsofService 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_Study Guide_Master_GR 2.1
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_Study Participant Contact Card 1
Subject information and informed consent form (for publication) L2_Other subject information material_Subject Instructions for Use_Mirikizumab 1
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 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_Master_GR 1.1
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
Subject information and informed consent form (for publication) L2_Other subject information_Brochure 2.1
Subject information and informed consent form (for publication) L2_Other subject information_Calendar 1
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_TIRZEPATIDE 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_Study Guide 2
Subject information and informed consent form (for publication) L2_Other_AMCE_Digital_Ad_Copy 5
Subject information and informed consent form (for publication) L2_Other_AMCE_Digital_Ad_Visuals 4
Subject information and informed consent form (for publication) L2_Other_AMCE_Patient_Messaging 2
Subject information and informed consent form (for publication) L2_Other_AMCE_Search_Ads 1
Subject information and informed consent form (for publication) L2_Other_AMCE_Social_Media_Video_1 1
Subject information and informed consent form (for publication) L2_Other_AMCE_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 4
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 3
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 1
Subject information and informed consent form (for publication) L2_Other_PATIENT SCR Stool Collection Instructions 1
Subject information and informed consent form (for publication) L2_Patient Card text 1.0
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
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 material_Brochure_Master_redacted 2
Subject information and informed consent form (for publication) L3_Other subject information material_Calendar_Master_redacted 1
Subject information and informed consent form (for publication) L3_Other subject information material_CT_Thank-You-End-Of-Study_Master_redacted 3
Subject information and informed consent form (for publication) L3_Other subject information material_CT_Thank-You-Participation_Master_redacted 3
Subject information and informed consent form (for publication) L3_Other subject information material_CT_Thank-You-Screening_Master_redacted 3
Subject information and informed consent form (for publication) L3_Other subject information material_CT_Visit-Card-Noname_Master_redacted 3
Subject information and informed consent form (for publication) L3_Other subject information material_DFU_MIRIKIZUMAB_redacted 1
Subject information and informed consent form (for publication) L3_Other subject information material_DFU_TIRZEPATIDE_redacted 1
Subject information and informed consent form (for publication) L3_Other subject information material_InjectionReminder_MirrorCling_Magnet_Master_redacted 1
Subject information and informed consent form (for publication) L3_Other subject information material_Participant Card 1.0
Subject information and informed consent form (for publication) L3_Other subject information material_Poster_Master_redacted 1
Subject information and informed consent form (for publication) L3_Other subject information material_Study-Guide_Master_redacted 2
Subject information and informed consent form (for publication) L3_Retention_HU_eCOA Participant Quick-Start Guide 1.0
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-1-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-10-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-11-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-12-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-13-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-14-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-2-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-3-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-4-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-5-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-6-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-7-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-8-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Module-9-Worksheet_Master_redacted 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Participant-Nutrition-Hydration 1
Subject information and informed consent form (for publication) L4_Other subject information material_HBP_Protein_Brochure_Master 1
Synopsis of the protocol (for publication) D1_Protocol synopsis NL 2024-520210-21-00 f
Synopsis of the protocol (for publication) D1_Protocol synopsis NL 2024-520210-21-00 TC f
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2024-520210-21-00_ GR f
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2024-520210-21-00_ GR_track changes f
Synopsis of the protocol (for publication) D1_Protocol synopsis_2024-520210-21-00_FR f
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2024-520210-21-00_GR e
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2024-520210-21-00_GR_track changes e
Synopsis of the protocol (for publication) D1_Protocol synopsis_2024-520210-21-00_PL f
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2024-520210-21-00_RO f
Synopsis of the protocol (for publication) D1_Protocol Synopsis_AT_2024-520210-21-00 f
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BEDE_2024-520210-21-00 f
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BEDU_2024-520210-21-00 f
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BEFR_2024-520210-21-00 f
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BG_2024-520210-21-00 f
Synopsis of the protocol (for publication) D1_Protocol synopsis_BG_2024-520210-21-00-00_TC f
Synopsis of the protocol (for publication) D1_Protocol Synopsis_CZ_2024-520210-21-00 f
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG_2024-520210-21-00 f
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_2024-520210-21-00 f
Synopsis of the protocol (for publication) D1_Protocol synopsis_HU 2024-520210-21-00 b
Synopsis of the protocol (for publication) D1_Protocol Synopsis_SK_2024-520210-21-00 f
Synopsis of the protocol (for publication) D1_Protocol_synopsis_IT_2024-520210-21-00 f
Synopsis of the protocol (for publication) D1_Protocol_Synopsis_IT_2024-520210-21-00_TC f

Application history

13 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-04-30 Italy Acceptable with conditions
2025-08-25
 2025-08-26
2 NON SUBSTANTIAL MODIFICATION NSM-2 2025-09-05 Acceptable with conditions
2025-08-25
 2025-09-05
3 NON SUBSTANTIAL MODIFICATION NSM-3 2025-09-09 Acceptable with conditions
2025-08-25
 2025-09-09
4 NON SUBSTANTIAL MODIFICATION NSM-4 2025-09-10 Acceptable with conditions
2025-08-25
 2025-09-10
5 NON SUBSTANTIAL MODIFICATION NSM-5 2025-09-12 Acceptable with conditions
2025-08-25
 2025-09-12
6 SUBSTANTIAL MODIFICATION SM-1 2025-09-19 Acceptable with conditions 2025-09-30
7 SUBSTANTIAL MODIFICATION SM-2 2025-10-13 Acceptable with conditions 2025-11-25
8 SUBSTANTIAL MODIFICATION SM-3 2025-12-12 Italy Acceptable
2026-03-02
 2026-03-02
9 NON SUBSTANTIAL MODIFICATION NSM-6 2026-04-07 Acceptable
2026-03-02
 2026-04-07
10 NON SUBSTANTIAL MODIFICATION NSM-7 2026-04-07 Acceptable
2026-03-02
 2026-04-07
11 SUBSTANTIAL MODIFICATION SM-6 2026-04-08 Acceptable 2026-05-21
12 SUBSTANTIAL MODIFICATION SM-7 2026-04-17 Acceptable 2026-05-31
13 SUBSTANTIAL MODIFICATION SM-5 2026-04-24 Acceptable 2026-05-08

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