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2023-507853-13-00RecruitingPhase 2

An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination with Mirikizumab for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis

I7P-MC-DSAG - An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination with Mirikizumab for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis

Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Nov 2026

Next steps

Brief summary (registry, in English)

To determine whether eltrekibart alone is superior to placebo in inducing clinical remission in participants with moderately to severely active UC

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
593 (estimated)
First submitted
10 Oct 2024
Start date
25 Feb 2025
Lead sponsor
Eli Lilly & Co.
EU CT number
2023-507853-13-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 593
  • 115 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderately to severely active ulcerative colitis who did not respond well to earlier treatment.

Age
18 years or older
Sex
All sexes
Disease stage
Moderately to severely active ulcerative colitis, diagnosed at least 3 months before the start.
Earlier treatment
Must have had an inadequate response, loss of response or intolerance to at least one conventional medicine (including corticosteroids) or one advanced therapy (including biologics, JAK inhibitors or S1P immunomodulators). Must be on a stable dose of certain oral UC medicines. Must not have had anti-IL-23p19 or anti-IL-12p40 antibodies before.

Main reasons for not taking part

  • Past treatment with anti-IL-23p19 or anti-IL-12p40 antibodies
  • A blood clot (thrombotic event) within 24 weeks before the start
  • Current Crohn's disease or certain other inflammatory bowel diseases
  • Certain abdominal surgeries within the past 3 months, or likely to need surgery for UC during the study
  • History of certain adenomas, dysplasias or cancers

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have received anti-IL-23p19 or anti-IL-12p40 antibodies in the past.
  • Have experienced a thrombotic event within 24 weeks before baseline.
  • Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.

Other illness

  • Have a current diagnosis of Crohn’s Disease or certain other inflammatory gastrointestinal diseases.
  • Have a history of certain adenomas, dysplasia’s, or malignancies.

Who the study is looking for

  • Have had an established diagnosis of UC of ≥3 months in duration before baseline.
  • Have moderately to severely active UC as assessed by the UC disease activity score.
  • Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators).
  • Are on a stable dose of certain oral UC medications (including corticosteroids).
  • Must meet contraception requirements.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (115)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistesLa LouviereBelgiumCompleted
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-NamurYvoirBelgiumCompleted
SurGal Clinic s.r.o.Brno-SeverCzechiaCompleted
Vojenska Nemocnice BrnoBrno-ZideniceCzechiaCompleted
Nemocnice SlanySlanýCzechiaCompleted
Krajska Nemocnice T Bati a.s.ZlinCzechiaCompleted
Universitaetsklinikum AugsburgAugsburgGermanyActive, not recruiting
Charite Universitaetsmedizin Berlin KöRBerlinGermanyActive, not recruiting
Universitaetsklinikum Brandenburg an der Havel GmbHBrandenburg An Der HavelGermanyActive, not recruiting
Medizinisches Versorgungszentrum fuer spezialaerztliche Versorgung Professor Dr. Friedrichs GmbHDuisburgGermanyActive, not recruiting
CED Studien UG (haftungsbeschraenkt)Frankfurt Am MainGermanyActive, not recruiting
Goethe University FrankfurtFrankfurt Am MainGermanyActive, not recruiting
Studiengesellschaft BSF UG (haftungsbeschraenkt)Halle (Saale)GermanyActive, not recruiting
Hamburgisches Forschungsinstitut fuer chronisch entzuendliche Darmerkrankungen HaFCED e.K.HamburgGermanyActive, not recruiting
Medizinische Hochschule HannoverHanoverGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöRKielGermanyActive, not recruiting
Klinikum rechts der Isar der TU Muenchen AöRMunichGermanyActive, not recruiting
Magen-Darm-Zentrum RemscheidRemscheidGermanyActive, not recruiting
Universitaetsklinikum Ulm AoRUlmGermanyActive, not recruiting
Region HovedstadenCopenhagen NvDenmarkWithdrawn
Region HovedstadenHerlevDenmarkWithdrawn
Centro Medico Teknon - Grupo QuironsaludBarcelonaSpainActive, not recruiting
Hospital Universitario Reina SofiaCórdobaSpainActive, not recruiting
Hospital Universitario Juan Ramon JimenezHuelvaSpainActive, not recruiting
El Hospital Universitario De Gran Canaria Dr. NegrinLas Palmas De Gran CanariaSpainActive, not recruiting
Hospital Universitario La PazMadridSpainActive, not recruiting
Complexo Hospitalario Universitario De SantiagoSantiago de CompostelaSpainActive, not recruiting
Hospital Universitario Virgen De La MacarenaSevillaSpainActive, not recruiting
Hospital General De TomellosoTomellosoSpainActive, not recruiting
Hospital Universitario Y Politecnico La FeValenciaSpainActive, not recruiting
Assistance Publique Hopitaux De ParisCreteil CedexFranceActive, not recruiting
Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9FranceActive, not recruiting
Centre Hospitalier Departemental VendeeLa Roche Sur Yon Cedex 9FranceActive, not recruiting
Centre Hospitalier Universitaire de NiceNiceFranceActive, not recruiting
Hospices Civils de LyonPierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire RouenRouen CedexFranceActive, not recruiting
Evangelismos S AAthensGreeceActive, not recruiting
Alexandra HospitalAthensGreeceActive, not recruiting
Thoracic General Hospital of Athens "I Sotiria"AthensGreeceActive, not recruiting
Hippokration HospitalAthensGreeceActive, not recruiting
University General Hospital of HeraklionHeraklionGreeceActive, not recruiting
University General Hospital of IoanninaIoanninaGreeceActive, not recruiting
General Oncological Hospital Of Kifissia Agioi AnargyroiKifissiaGreeceActive, not recruiting
Opca Bolnica Dr. Andelko Visic BjelovarBjelovarCroatiaRecruiting
Poliklinika Solmed d.o.o.Grad ZagrebCroatiaRecruiting
Poliklinika Borzan d.o.o.OsijekCroatiaRecruiting
Specijalna Bolnica MedicoRijekaCroatiaRecruiting
General Hospital Dr. Josip BencevicSlavonski BrodCroatiaRecruiting
University Hospital Centre ZagrebZagrebCroatiaRecruiting
Semmelweis EgyetemBudapestHungarySuspended
Obudai Egeszseguegyi Centrum Kft.Budapest IIIHungarySuspended
Clinexpert Kft.Budapest IIIHungarySuspended
Clinexpert Gyoengyoes Kft.GyongyosHungarySuspended
University of SzegedSzegedHungarySuspended
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato KorhazSzekesfehervarHungarySuspended
Beaumont HospitalDublin 9IrelandActive, not recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'OrsolaBolognaItalyActive, not recruiting
Fondazione PoliambulanzaBresciaItalyActive, not recruiting
Azienda Sanitaria Territoriale Di Pesaro E UrbinoFanoItalyActive, not recruiting
Azienda Ospedaliero-Universitaria CareggiFlorenceItalyActive, not recruiting
Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessinaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale Santi Paolo E CarloMilanItalyActive, not recruiting
Ospedale San Raffaele S.r.l.MilanItalyActive, not recruiting
Azienda Ospedaliero - Universitaria di ModenaModenaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Di CagliariMonserratoItalyActive, not recruiting
Azienda Ospedaliera di PadovaPadovaItalyActive, not recruiting
Fondazione IRCCS Policlinico San MatteoPaviaItalyActive, not recruiting
Azienda Ospedaliera Policlinico Universitario Tor VergataRomeItalyActive, not recruiting
Azienda Ospedaliera S Giovanni AddolorataRomeItalyActive, not recruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRomeItalyActive, not recruiting
Humanitas Mirasole S.p.A.RozzanoItalyActive, not recruiting
Policlinico San Donato S.p.A.San Donato MilaneseItalyActive, not recruiting
Casa Sollievo della SofferenzaSan Giovanni RotondoItalyActive, not recruiting
Azienda Ospedaliera Ordine Mauriziano di TorinoTurinItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurinItalyActive, not recruiting
Liepajas Regionala Slimnica SIALiepajaLatviaCompleted
Pauls Stradins Clinical University HospitalRigaLatviaCompleted
Veselibas Centrs 4 SIARigaLatviaCompleted
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.BydgoszczPolandSuspended
Manermed Sp. z o.o.BydgoszczPolandSuspended
Vitamed Galaj i Cichomski sp.j.BydgoszczPolandSuspended
M2M Med. Sp. z o.o. Sp. j.ChorzowPolandSuspended
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.CracowPolandSuspended
Topolowa Medicenter Ryszawa & Wspolnicy Sp. j.CracowPolandSuspended
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.CracowPolandSuspended
Centrum Medyczne Med-Gastr Sp. z o.o.LodzPolandSuspended
Amicare Sp. z o.o. S.K.LodzPolandSuspended
IP Clinic Sp. z o.o.LodzPolandSuspended
Medrise Sp. z o.o.LublinPolandSuspended
Twoja Przychodnia Opolskie Centrum MedyczneOpolePolandSuspended
Pratia S.A.PoznanPolandSuspended
Twoja Przychodnia PCMPoznanPolandSuspended
Centrum Medyczne Medyk Sp. z o.o. S.K.RzeszowPolandSuspended
Bartosz Korczowski, Gabinet LekarskiRzeszówPolandSuspended
Endoskopia Sp z o.o.SopotPolandSuspended
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.SzczecinPolandSuspended
GASTROMED Sp. z o.o.TorunPolandSuspended
H-T. Centrum Medyczne Sp. z o.o. Sp.k.TychyPolandSuspended
NZOZ FOR MED sp. z o.o.WadowicePolandSuspended
Eb Group Sp. z o.o.WarsawPolandSuspended
Medical Network Sp z o oWarsawPolandSuspended
Medical Concierge Centrum MedyczneWarszawaPolandSuspended
EMC Instytut Medyczny S.A.WroclawPolandSuspended
Melita Medical Sp. z o.o.WroclawPolandSuspended
Centrum Medyczne OporowWroclawPolandSuspended
VISTAMEDWrocławPolandSuspended
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-DworakWrocławPolandSuspended
Pro Life Medica Sp. z o.o.ZamośćPolandSuspended
Spitalul Clinic Colentina BucurestiBucharestRomaniaSuspended
Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'BucharestRomaniaSuspended
Monza-Ares S.R.L.BucharestRomaniaSuspended
Spitalul Universitar de Urgență BucureștiBucharestRomaniaSuspended
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor ClujCluj-NapocaRomaniaSuspended
Valahia Medical S.R.L.PloiestiRomaniaSuspended
Centrul De Gastroenterologie Dr. Goldis S.R.LTimișoaraRomaniaSuspended

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This page is information, not medical advice. Discuss any trial with your doctor.