Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
70
Countries
5
Sites
29
J6Z-MC-IIBD - Colitis, Ulcerative Crohn Disease J6Z-MC-CD01 - Crohn Disease
J6Z-MC-IIBD - To evaluate the 12-week efficacy of the study intervention compared with mirikizumab via endoscopic outcomes in adult participants with moderately to severely active UC or CD J6Z-MC-CD01 - To evaluate the 12-week efficacy of the study intervention compared with mirikizumab via endoscopic outcomes in adul…
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]
- Decision date (initial)
- 2026-06-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Efficacy, Safety, Therapy, Pharmacogenetic, Pharmacokinetic
J6Z-MC-IIBD - To evaluate the 12-week efficacy of the study intervention compared with mirikizumab via endoscopic outcomes in adult participants with moderately to severely active UC or CD
J6Z-MC-CD01 - To evaluate the 12-week efficacy of the study intervention compared with mirikizumab via endoscopic outcomes in adult participants with moderately to severely active Crohn’s Disease
Conditions and MedDRA coding
J6Z-MC-IIBD - Colitis, Ulcerative Crohn Disease J6Z-MC-CD01 - Crohn Disease
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-520210-21-00 | I6T-MC-AMCE: A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered with Tirzepatide in Adult Participants with Moderately to Severely Active Crohn’s Disease and Obesity or Overweight | Eli Lilly & Co. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- J6Z-MC-CD01 - Participants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:
- J6Z-MC-CD01 - Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1/glucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1/glucagon (Gcg) RAs, GLP-1/GIP/Gcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening
- J6Z-MC-IIBD - Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn’s Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD. • For UC: • Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2. • For CD: • Have moderately to severely active CD as defined by a Crohn’s disease activity index (CDAI) score ≥ 220 and ≤ 450. Have a centrally read Simple Endoscopic Score for Crohn’s Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization
- J6Z-MC-IIBD - Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD
- J6Z-MC-IIBD - Have screening laboratory test results within the protocol specified parameters
Exclusion criteria 12
- J6Z-MC-IIBD - Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis • For UC - must not have a current diagnosis of CD • For CD - must not have a current diagnosis of UC
- J6Z-MC-IIBD - Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol
- J6Z-MC-IIBD - Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome
- J6Z-MC-IIBD - Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant’s safety or interfere with interpretation of data
- J6Z-MC-IIBD - Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action
- J6Z-MC-IIBD - Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment
- J6Z-MC-IIBD - Must not have received or will need any prohibited medications for UC or CD as specified in the protocol
- J6Z-MC-CD01 - Participants must meet all the exclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:
- J6Z-MC-CD01 - Must not have a hepatic disease
- J6Z-MC-CD01 - Must not have a history of any other bone disease that affects bone metabolism
- J6Z-MC-CD01 - Must not have had any of the following within the past 180 days before screening: acute myocardial infarction cerebrovascular incident hospitalization for unstable angina hospitalization due to congestive heart failure, or coronary revascularization
- J6Z-MC-CD01 - Must not have received or will need any other prohibited medications as specified in the protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- J6Z-MC-CD01 - Percentage of Participants with Crohn’s Disease who Achieve Endoscopic Response
- J6Z-MC-IIBD - The proportion of participants who achieve the following at Week 12 of Study Period 1: UC: endoscopic improvement CD: endoscopic response
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD13419308 · Product
- Active substance
- LY4395089
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11080950 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10082852 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 5700 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
PRD10725963 · Product
- Active substance
- Mirikizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 15
| Organisation | City, country | Duties |
|---|---|---|
| OneStudy Team ORL-000001062
|
Boston, United States | Code 2 |
| Clario ORL-000006643
|
Philadelphia, United States | Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Suvoda ORL-000017965
|
Pennsylvania, United States | Other |
| Icon Development Solutions LLC ORG-100012400
|
Whitesboro, United States | Laboratory analysis |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Alimentiv ORL-000017962
|
London, ON Canada, Canada | Laboratory analysis |
| Clinical Trial Media Inc. ORG-100046339
|
Hauppauge, United States | Code 2 |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| The Hibbert Co. ORG-100047639
|
Trenton, United States | Other |
| Mayo Collaborative Services LLC ORG-100046687
|
Rochester, United States | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Data management |
Locations
5 EU/EEA countries · 29 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 6 | 4 |
| Germany | Authorised, recruitment pending | 7 | 5 |
| Hungary | Authorised, recruitment pending | 6 | 4 |
| Italy | Authorised, recruitment pending | 7 | 6 |
| Poland | Authorised, recruitment pending | 11 | 10 |
| Rest of world
Canada, United States, Israel, Brazil, China
|
— | 33 | — |
Investigational sites
UZ Leuven
Gastroenterology - Inflammatory Bowel Disease, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Gastroenterology, Corneel Heymanslaan 10, 9000, Gent
Az Maria Middelares Gent
Digestief Centrum, Buitenring-Sint-Denijs 30, 9000, Gent
Algemeen Ziekenhuis Delta
Gastroenterology, Deltalaan 1, 8800, Roeselare
St. Marien Und St. Annastiftskrankenhaus
Klinik für Innere Medizin, Salzburger Strasse 15, Gartenstadt, Ludwigshafen Am Rhein
Studienzentrum MVZ Dachau
N/A, Münchner Straße 64, Bayern, Dachau
Universitaetsklinikum Ulm AöR
Department of Internal Medicine I, Albert-Einstein-Allee 23, Eselsberg, Ulm
Studiengesellschaft BSF UG (haftungsbeschraenkt)
N/A, Grosse Nikolaistrasse 7, Altstadt, Halle (Saale)
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie CCM/CVK, Chariteplatz 1, Mitte, Berlin
Obudai Egeszseguegyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
Geomedical Kft.
N/A, Jokai Utca 6, Kerulet, Budapest VI
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Gasztroenterológia, Dozsa Gyorgy Ut 77, 2800, Tatabanya
Semmelweis University
Sebeszeti, Transzplantacios és Gasztroenterologiai Klinika, Ulloi Ut 78, 1082, Budapest
Ospedale San Raffaele S.r.l.
Gastroenterology and Gastrointestinal Endoscopy Building G, Floor -1, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero Universitaria Careggi
SOD Gastroenterology-Ground Floor Room 19, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Humanitas Mirasole S.p.A.
IBD center Loc. 14 Building 4 First floor, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dipartimento di Medicina Interna e Gastroenterologia CEMAD - Ala A, piano 3, Largo Agostino Gemelli 8, 00168, Rome
Fondazione IRCCS San Gerardo Dei Tintori
Gastroenterologia Sector C, floor 11, Via Giovanbattista Pergolesi 33, 20900, Monza
IRCCS Ospedale Sacro Cuore Don Calabria
IBD Unit Loc. 1 Nogarè/Floor -1/room 11, Via Don Angelo Sempreboni 5, 37024, Negrar
Etg Zamosc Sp. z o.o.
NA, Ul. Gesia 3, 22-400, Zamosc
Medrise Sp. z o.o.
NA, Ul. Onyksowa 10, 20-582, Lublin
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
NA, Ul. Juliusza Slowackiego 19, 71-434, Szczecin
Gyncentrum Sp. z o.o.
NA, Ul. Tadeusza Kosciuszki 229, 40-600, Katowice
Lukmed 2 Sp. z o.o.
NA, Ul. Mlynarska 16 B, 08-110, Siedlce
Twoja Przychodnia Poznanskie Centrum Medyczne Sp. z o.o.
NA, Ul. Marcelinska 92, 60-324, Poznan
Wsd Medi Clinical Sp. z o.o.
NA, Aleja Jana Rodowicza Anody 22 Lok U 4, 02-786, Warsaw
Sonomed Sp. z o.o.
NA, Ul. Ks. Bp. Wladyslawa Bandurskiego 98/u12, 71-685, Szczecin
R57 Sp. z o.o.
NA, Ul. Pleszowska 23, 31-228, Cracow
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
NA, ul. Płowiecka 103,, 04-501, Warszawa
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 153 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ISA Protocol 2025-524112-11-00_Redacted | Initial |
| Protocol (for publication) | D1_Protocol Master 2025-524112-11-00_Redacted | Initial |
| Protocol (for publication) | D4_Patient Documents Copyright Statement | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements statement | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements statement | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements statement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Recruitment and Informed Consent Procedure_BE | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Recruitment and Informed Consent Procedure_ITA | 1.1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Brochure_digital | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Brochure_print | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Poster_digital | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Poster_print | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Poster2_print | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Poster3_digital | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Poster3_print | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Poster4_digital | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Poster4_print | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Recruitment Brochure_Digital | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Recruitment brochure_Print | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Recruitment poster_Digital | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Recruitment poster_Print | 1 |
| Recruitment arrangements (for publication) | K2_Informed consent and patient recruitment procedure | 1 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_EP_What-Are-Clinical Trials | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure DG_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure DG_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_BEFR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master_DG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Brochure_Master_DG_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Brochure_Master_PL_Print | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_LT-TrialPage | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_LT-TrialPage_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster Persona2_DG_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster Persona2_Master_PL_Print | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster Persona3_DG_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster Persona3_Master_PL_Print | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster Persona4 DG_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster Persona4_Master_PL_Print | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster_Master_DG_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster_Master_PL_Print | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster-Persona2 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster-Persona2_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster-Persona2-DG_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster-Persona3 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster-Persona3_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster-Persona3-DG_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster-Persona4 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster-Persona4_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CD01_Poster-Persona4-DG_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CTM_Database & Patient_Messaging_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CTM_Digital_Ad_Visuals_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CTM_Digital_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CTM_Search_Ads_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CTM_Social_Media_Video 1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CTM_Social_Media_Video 1_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CTM_Social_Media_Video 2_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_CD01_Database_and_Patient_Messaging_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_IBD_CC_Script_Secondary_Master_Redacted | 1 |
| 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_Screener_Secondary_Master | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_IBD_WS_Script_Secondary_Master | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_ISA-CD01_Digital_Ad_Copy_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_ISA-CD01_Digital_Ad_Visuals_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_ISA-CD01_Search_Ads_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_ISA-CD01_Social_Media_Video_1_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital Campaign_ISA-CD01_Social_Media_Video_2_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_CC_Script_Secondary_Master_PL_Redacted | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_CC_Script_Secondary_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_Digital | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_Digital_Ad_Copy_Master_PL | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_Digital_Ad_Visuals_Master_PL | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_Post-Consent_Patient_Messaging | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_Screener_Secondary | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_Screener_Secondary_Master_PL | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_Visuals | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_WS_Script_Secondary | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IBD_WS_Script_Secondary_Master_PL | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IIBD_LT-TrialPage | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IIBD_LT-TrialPage_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IIBD_LT-TrialPage_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ISA CD01_Database_Patient_Messaging_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ISA CD01_Digital_Ad_Copy_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ISA CD01_Digital_Ad_Visuals_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ISA CD01_Search_Ads_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ISA CD01_Social_Media_Video_1_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ISA CD01_Social_Media_Video_2_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster 2_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster 2_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster 3_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster 3_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster 4_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster 4_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster DG 2_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster DG 2_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster DG 3_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster DG 3_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster DG 4_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster DG 4_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster DG_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster DG_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master_DG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster2_digital | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_ISA (CD01)_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_Main ICF_ISA (CD01)_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Master_IIBD_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Genetica_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CD01 ICF_BEDU_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CD01 ICF_BEFR_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CD01 ICF_ENG_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CD01 Main ICF_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IIBD Main ICF_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA Protocol_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_BEDU_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_BEFR_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ENG_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Master Protocol_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_CD01_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Master ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_FXR IFU_redacted | 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_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_MKZ_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_MKZ_BEFR | 1.0 |
| 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_Patient card | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Compensation Information Sheet_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Compensation Information Sheet_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Compensation Information Sheet_ENG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Patient contact card template | 1 |
| Subject information and informed consent form (for publication) | L3_Recruitment arrangments_Informed consent and patient recruitment procedure_PL | 1 |
| Subject information and informed consent form (for publication) | L4_Info Re insurance Conditions for Patient | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol CD01 Synopsis_BEDE_2025-524112-11-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol CD01 Synopsis_BEDU_2025-524112-11-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol CD01 Synopsis_BEFR_2025-524112-11-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol IIBD Synopsis_BEDE_2025-524112-11-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol IIBD Synopsis_BEDU_2025-524112-11-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol IIBD Synopsis_BEFR_2025-524112-11-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis CD01_2025-524112-11-00_HU_redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IIBD_2025-524112-11-00_HU | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis ISA_2025-524112-11-00_PL_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis Master_2025-524112-11-00_PL | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524112-11-00_ISA_Redacted_ENG | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-524112-11-00_Master_ENG | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis ISA_IT_ 2025-524112-11-00_Redacted | initial |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis Master_IT_2025-524112-11-00 | initial |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-04 | Germany | Acceptable with conditions 2026-06-11
|
2026-06-11 |