Clinical trial • Phase II • Gastroenterology

MIRIKIZUMAB for Ulcerative colitis

Phase II trial of MIRIKIZUMAB for Ulcerative colitis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Ulcerative colitis
Trial Stage
Phase II
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
24-11-2025
First CTIS Authorization Date
18-03-2026

Trial design

Randomised, mirikizumab monotherapy (active comparator); placebos (placebo to mirikizumab; placebo to match ly) are used. dose and schedule not specified in the ctis record.-controlled Phase II trial in Austria, Germany, Hungary and others.

Randomised
Yes
Comparator
Mirikizumab monotherapy (active comparator); placebos (Placebo to Mirikizumab; Placebo to match LY) are used. Dose and schedule not specified in the CTIS record.
Target Sample Size
177

Eligibility

Recruits 177 adults.

Inclusion criteria

  • {"criterion_text":"- Have had an established diagnosis of UC of ≥3 months in before baseline"}
  • {"criterion_text":"- Have moderately to severely active UC"}
  • {"criterion_text":"- Have evidence of UC extending proximal to the rectum"}
  • {"criterion_text":"- Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization."}
  • {"criterion_text":"- Are up-to-date on colorectal cancer surveillance"}
  • {"criterion_text":"- Have an inadequate response to, loss of response to, or intolerance to Conventional therapy, Immunomodulators, Advanced therapy"}

Exclusion criteria

  • {"criterion_text":"- Have a current diagnosis of Crohn’s disease, IBD unclassified or primary sclerosing cholangitis"}
  • {"criterion_text":"- Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation."}
  • {"criterion_text":"- Have had or will need bowel resection or intestinal or intra-abdominal surgery"}
  • {"criterion_text":"- Are likely to require surgery for the treatment of UC during the study"}
  • {"criterion_text":"- Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The proportion of participants who achieve clinical remission with mMS at Week 12","definition_or_measurement_approach":""}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
177
Recruitment Window Months
35
Consent Approach
Informed consent obtained from adult participants. Site-specific Subject Information Sheet (SIS) and Informed Consent Forms (ICF) are provided, with country/language-specific versions available (documents include language/local variants: German (de-AUT/DE), Spanish, Polish (PL), Dutch (NL), Hungarian (HU), Italian (IT), Romanian (RO) and English). Optional consent addendum for genetic research is included (document 'L1_SIS and ICF_Addendum ICF_Optional Genetic'). Consent is provided by the participant (no paediatric/assent provisions are specified in the record).

Methods

  • Digital campaigns: social media video scripts, search ads, digital ad visuals and copy, digital screener and digital recruitment ads (documents: titles include 'Digital Campaign', 'Digital_Ad_Master', 'Social_Media_Video_Script', 'Digital_Ad_Visuals_Master'). Country-localised digital materials are present (e.g. Italy, Netherlands, Poland, Hungary references in document titles).
  • Printed materials: Flyers, Posters, Brochures (K2_Recruitment material_Flyer/Master, Poster, Brochure) targeted to patients with moderately to severely active ulcerative colitis.
  • Healthcare professional recruitment: Doctor-to-patient letters and doctor-to-doctor referral letters (documents titled 'Letter-Doctor-to-Patient', 'Doctor to Doctor referral letter').
  • Patient-facing materials: Patient cards / Study participant contact cards and brochures provided at sites.
  • Country-localised recruitment packages: K1/K2 recruitment arrangements and country-specific packs (files labelled with country codes or language indicators: e.g. _HU_, _NL_, _PL_, de-AUT, etc.).

Geography

Total Number Of Sites
45
Total Number Of Participants
75

Austria

Earliest CTIS Part Ii Submission Date
06-03-2026
Latest Decision Or Authorization Date
22-03-2026
Processing Time Days
16
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Medical University Of Vienna
Department Name
Abteilung für Gastroenterologie und Hepatologie Loc. 1
Principal Investigator Name
Walter Reinisch
Principal Investigator Email
walter.reinisch@meduniwien.ac.at
Contact Person Name
Walter Reinisch
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Innere Medizin I Loc. 1
Principal Investigator Name
Sonja Heeren
Principal Investigator Email
s.heeren@salk.at
Contact Person Name
Sonja Heeren
Contact Person Email
s.heeren@salk.at

Germany

Earliest CTIS Part Ii Submission Date
18-02-2026
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
28
Number Of Sites
4
Number Of Participants
5

Sites

Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Department of Internal Medicine I
Principal Investigator Name
Arne Kandulski
Principal Investigator Email
arne.kandulski@ukr.de
Contact Person Name
Arne Kandulski
Contact Person Email
arne.kandulski@ukr.de
Site Name
Studienzentrum MVZ Dachau
Principal Investigator Name
Wilfred Landry
Principal Investigator Email
landry@dachau-med.de
Contact Person Name
Wilfred Landry
Contact Person Email
landry@dachau-med.de
Site Name
Charité Universitaetsmedizin Berlin - Campus Mitte
Department Name
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie CCM/CVK
Principal Investigator Name
Christoph Jochum
Principal Investigator Email
christoph.jochum@charite.de
Contact Person Name
Christoph Jochum
Contact Person Email
christoph.jochum@charite.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Department of Internal Medicine I
Principal Investigator Name
Jochen Klaus
Principal Investigator Email
jochen.klaus@uniklinik-ulm.de
Contact Person Name
Jochen Klaus
Contact Person Email
jochen.klaus@uniklinik-ulm.de

Hungary

Earliest CTIS Part Ii Submission Date
29-01-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
57
Number Of Sites
8
Number Of Participants
14

Sites

Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
4. Belgyógyászat Gasztroenterológia
Principal Investigator Name
Márta Varga
Principal Investigator Email
drvargamarta@gmail.com
Contact Person Name
Márta Varga
Contact Person Email
drvargamarta@gmail.com
Site Name
Semmelweis University
Department Name
Belgyogyaszati es Hematologai Klinika
Principal Investigator Name
Zsolt Tulassay
Principal Investigator Email
tulassay.zsolt@semmelweis.hu
Contact Person Name
Zsolt Tulassay
Contact Person Email
tulassay.zsolt@semmelweis.hu
Site Name
Clinexpert Gyoengyoes Kft.
Principal Investigator Name
Gyula Horvát
Principal Investigator Email
horvatgyula@gmail.com
Contact Person Name
Gyula Horvát
Contact Person Email
horvatgyula@gmail.com
Site Name
Javorszky Oedoen Korhaz
Department Name
Gastroenterology
Principal Investigator Name
Tibor Szalóki
Principal Investigator Email
szalokitdr@javorszky.hu
Contact Person Name
Tibor Szalóki
Contact Person Email
szalokitdr@javorszky.hu
Site Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
Department Name
Gastroenterology
Principal Investigator Name
András Káfony
Principal Investigator Email
kafony@gmail.com
Contact Person Name
András Káfony
Contact Person Email
kafony@gmail.com
Site Name
Pannonia Maganorvosi Centrum Kft.
Principal Investigator Name
Róbert Schnabel
Principal Investigator Email
schnabelrobert@hotmail.com
Contact Person Name
Róbert Schnabel
Contact Person Email
schnabelrobert@hotmail.com
Site Name
Obudai Egeszseguegyi Centrum Kft.
Principal Investigator Name
Gábor Tamás Tóth
Principal Investigator Email
medicatorbt@gmail.com
Contact Person Name
Gábor Tamás Tóth
Contact Person Email
medicatorbt@gmail.com
Site Name
Clinexpert Gyoengyoes Kft. (second listing)

Italy

Earliest CTIS Part Ii Submission Date
26-02-2026
Latest Decision Or Authorization Date
24-03-2026
Processing Time Days
26
Number Of Sites
5
Number Of Participants
8

Sites

Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
SC Epatologia e Gastroenterologia
Principal Investigator Name
Marcello Vangeli
Principal Investigator Email
marcello.vangeli@ospedaleniguarda.it
Contact Person Name
Marcello Vangeli
Site Name
Humanitas Mirasole S.p.A.
Department Name
Gastroenterology and Gastrointestinal Endoscopy
Principal Investigator Name
Alessandro Armuzzi
Principal Investigator Email
clinicaltrialsibd@humanitas.it
Contact Person Name
Alessandro Armuzzi
Contact Person Email
clinicaltrialsibd@humanitas.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Gastroenterology and Endoscopy
Principal Investigator Name
Flavio Caprioli
Principal Investigator Email
flavio.caprioli@unimi.it
Contact Person Name
Flavio Caprioli
Contact Person Email
flavio.caprioli@unimi.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Gastroenterology and Gastrointestinal Endoscopy
Principal Investigator Name
Silvio Danese
Principal Investigator Email
ibd.trials@hsr.it
Contact Person Name
Silvio Danese
Contact Person Email
ibd.trials@hsr.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Dipartimento di Medicina Interna e Gastroenterologia
Principal Investigator Name
Franco Scaldaferri
Principal Investigator Email
franco.scaldaferri@policlinicogemelli.it
Contact Person Name
Franco Scaldaferri

Romania

Earliest CTIS Part Ii Submission Date
12-02-2026
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
39
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Memorial Healthcare International S.R.L.
Department Name
Gastroenterology
Principal Investigator Name
Ion-Eugeniu Craciun
Principal Investigator Email
eugencraciun@yahoo.com
Contact Person Name
Ion-Eugeniu Craciun
Contact Person Email
eugencraciun@yahoo.com
Site Name
Spital Judetean De Urgenta Satu Mare
Department Name
Gastroenterology
Principal Investigator Name
Bogdan Pintea
Principal Investigator Email
Dr.bogdan.pintea@gmail.com
Contact Person Name
Bogdan Pintea
Contact Person Email
Dr.bogdan.pintea@gmail.com
Site Name
Delta Health Care S.R.L.
Department Name
Gastroenterology
Principal Investigator Name
Camelia Chioncel
Principal Investigator Email
cameliachioncel@yahoo.com
Contact Person Name
Camelia Chioncel
Contact Person Email
cameliachioncel@yahoo.com
Site Name
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Department Name
Gastroenterology
Principal Investigator Name
Eugen Dumitru
Principal Investigator Email
eugen.dumitru@yahoo.com
Contact Person Name
Eugen Dumitru
Contact Person Email
eugen.dumitru@yahoo.com
Site Name
Centrul De Gastroenterologie Dr. Goldis S.R.L.
Department Name
Gastroenterology
Principal Investigator Name
Eugen Goldis
Principal Investigator Email
goldisadi@yahoo.com
Contact Person Name
Eugen Goldis
Contact Person Email
goldisadi@yahoo.com
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
Gastroenterology
Principal Investigator Name
Bogdan Mateescu
Principal Investigator Email
bogmateescu@gmail.com
Contact Person Name
Bogdan Mateescu
Contact Person Email
bogmateescu@gmail.com
Site Name
Delta Health Care S.R.L. (additional listing)

Spain

Earliest CTIS Part Ii Submission Date
17-12-2025
Latest Decision Or Authorization Date
20-03-2026
Processing Time Days
93
Number Of Sites
5
Number Of Participants
4

Sites

Site Name
Centro Medico Teknon-Grupo Quironsalud
Department Name
Gastroenterología
Principal Investigator Name
Miquel Sans Cuffi
Principal Investigator Email
miquelsanscuffi@gmail.com
Contact Person Name
Miquel Sans Cuffi
Contact Person Email
miquelsanscuffi@gmail.com
Site Name
Hospital Universitario Nuestra Senora De Candelaria
Department Name
Gastroenterología
Principal Investigator Name
Alejandro Hernandez Camba
Principal Investigator Email
dr.alejandrohc@gmail.com
Contact Person Name
Alejandro Hernandez Camba
Contact Person Email
dr.alejandrohc@gmail.com
Site Name
Hospital Universitario De Cabuenes
Department Name
Digestivo
Principal Investigator Name
Pilar Varela Trastoy
Principal Investigator Email
trastoy@hotmail.com
Contact Person Name
Pilar Varela Trastoy
Contact Person Email
trastoy@hotmail.com
Site Name
Hospital Universitario De Fuenlabrada
Department Name
Digestivo
Principal Investigator Name
Fernando Bermejo San José
Principal Investigator Email
fernando.bermejo@salud.madrid.org
Contact Person Name
Fernando Bermejo San José
Site Name
Hospital Universitario La Paz
Department Name
Unidad de Enfermedad Inflamatoria Intestinal
Principal Investigator Name
Maria Dolores Martin Arranz
Principal Investigator Email
martinarranz.lapaz@gmail.com
Contact Person Name
Maria Dolores Martin Arranz
Contact Person Email
martinarranz.lapaz@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
7
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Gastroenterology
Principal Investigator Name
Marjolijn Duijvestein
Principal Investigator Email
marjolijn.duijvestein@radboudumc.nl
Contact Person Name
Marjolijn Duijvestein
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
Department of Gastroenterology and Hepatology
Principal Investigator Name
Robert Laheij
Principal Investigator Email
r.laheij@etz.nl
Contact Person Name
Robert Laheij
Contact Person Email
r.laheij@etz.nl

Poland

Earliest CTIS Part Ii Submission Date
24-02-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
76
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Department Name
TBC
Principal Investigator Name
Beata Gawdis-Wojnarska
Principal Investigator Email
gawdis@twojaprzychodnia.com
Contact Person Name
Beata Gawdis-Wojnarska
Contact Person Email
gawdis@twojaprzychodnia.com
Site Name
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
Department Name
TBC
Principal Investigator Name
Piotr Eder
Principal Investigator Email
piotreder@ump.edu.pl
Contact Person Name
Piotr Eder
Contact Person Email
piotreder@ump.edu.pl
Site Name
Pratia S.A.
Department Name
TBC
Principal Investigator Name
Magdalena Andrzejewska
Principal Investigator Email
magdalena.andrzejewska@pratia.com
Contact Person Name
Magdalena Andrzejewska
Site Name
Gyncentrum Sp. z o.o.
Department Name
TBC
Principal Investigator Name
Marek Olakowski
Principal Investigator Email
m.olakowski@holsaclinical.com
Contact Person Name
Marek Olakowski
Contact Person Email
m.olakowski@holsaclinical.com
Site Name
Etg Zamosc Sp. z o.o.
Department Name
TBC
Principal Investigator Name
Katarzyna Wójcik
Principal Investigator Email
k.wojcik@etg-network.com
Contact Person Name
Katarzyna Wójcik
Contact Person Email
k.wojcik@etg-network.com
Site Name
Sonomed Sp. z o.o.
Department Name
TBC
Principal Investigator Name
Anna Wiechowska-Kozłowska
Principal Investigator Email
anna.kozlowska@sonomedszczecin.pl
Contact Person Name
Anna Wiechowska-Kozłowska
Site Name
Medical Network Sp. z o.o.
Department Name
TBC
Principal Investigator Name
Jaroslaw Kierkuś
Principal Investigator Email
j.kierkus@med-net.pl
Contact Person Name
Jaroslaw Kierkuś
Contact Person Email
j.kierkus@med-net.pl
Site Name
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
Department Name
TBC
Principal Investigator Name
Katarzyna Ostrowska
Principal Investigator Email
gastrolog1@ir-med.pl
Contact Person Name
Katarzyna Ostrowska
Contact Person Email
gastrolog1@ir-med.pl
Site Name
Wsd Medi Clinical Sp. z o.o.
Department Name
TBC
Principal Investigator Name
Michał Krogulecki
Principal Investigator Email
michalkrogulecki@medi-clinical.pl
Contact Person Name
Michał Krogulecki

Denmark

Earliest CTIS Part Ii Submission Date
20-03-2026
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
35
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Odense University Hospital
Department Name
Medical Gastroenterology
Principal Investigator Name
Mark Ainsworth
Principal Investigator Email
mark.ainsworth@rsyd.dk
Contact Person Name
Mark Ainsworth
Contact Person Email
mark.ainsworth@rsyd.dk
Site Name
Herlev and Gentofte Hospital
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Jakob Seidelin
Principal Investigator Email
jakob.benedict.seidelin@regionh.dk
Contact Person Name
Jakob Seidelin
Site Name
Aalborg University Hospital
Department Name
Medical Gastroenterology
Principal Investigator Name
Jan Fallingborg
Principal Investigator Email
jaf@rn.dk
Contact Person Name
Jan Fallingborg
Contact Person Email
jaf@rn.dk

Sponsor

Primary sponsor

Full Name
Eli Lilly & Co.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Alimentiv Inc.
Responsibilities
4
Name
Icon Development Solutions LLC
Responsibilities
4
Name
Bioagilytix Labs LLC
Responsibilities
4
Name
Q2 Solutions LLC
Responsibilities
4

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"6","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"The Hibbert Co.","duties_or_roles":"15: Procurement and shipping of appreciation items, printing and shipping of R&R materials","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"2","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Florence","duties_or_roles":"15: Site document management","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Fisher Clinical Services, by Thermo Fisher Scientific","duties_or_roles":"15: Clinical Trial Material Warehousing and Distribution Operations","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Propharma Group LLC","duties_or_roles":"2","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Yprime","duties_or_roles":"7","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"15: Patient reimboursement and travel services","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"OneStudy Team","duties_or_roles":"2","organisation_type":"Health care"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Q2 Solutions (alternate listing)","duties_or_roles":"4","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"15: Adjudication","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Mirikizumab
Active Substance
MIRIKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE | INTRAVENOUS
Route
SUBCUTANEOUS / INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
200 mg (subcutaneous) / 300 mg (intravenous)
Investigational Product Name
LY4268989 (MORF-057)
Active Substance
(S)-3-((S)-2-(5-(2-(DIMETHYLAMINO)ETHYL)-2 OXO-4-(TRIFLUOROMETHYL)PYRIDIN-1(2H)-YL)-4-METHYLPENTANAMIDO)-3-(4-FLUORO-2',4',5,6'-TETRAMETHYL-[1,1'-BIPHENYL]-3-YL)PROPANOIC ACID (synonyms: MORF-057, LY4268989)
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Investigational Product Name
Placebo to Mirikizumab
Modality
Other
Investigational Product Name
Placebo to match LY
Modality
Other
Combination Treatment
Yes

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