TrialPath
← Back to searchRecruiting

A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis

NCT06598943 · Eli Lilly and Company
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
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
About this study
The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past. * Have experienced a thrombotic event within 24 weeks before baseline. * Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases. * Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study. * Have a history of certain adenomas, dysplasia's, or malignancies.
Study design
Enrollment target: 140 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-10-10
Estimated completion: 2028-09
Last updated: 2026-03-03
Interventions
Drug: EltrekibartDrug: MirikizumabDrug: Placebo
Primary outcomes
  • Percentage of Participants Achieving Clinical Remission (Week 12)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (207)
AZ Gastro Care - ChandlerNot Yet Recruiting
Chandler, Arizona, United States
Applied Research Center of ArkansasRecruiting
Little Rock, Arkansas, United States
Preferred Research PartnersNot Yet Recruiting
Little Rock, Arkansas, United States
Erick Alayo Medical Corp/Gastro SB ClinicRecruiting
Chula Vista, California, United States
Southern California GI and Liver Centers (SCLC)Recruiting
Coronado, California, United States
Valley View ResearchRecruiting
Garden Grove, California, United States
Om Research, LLCRecruiting
Lancaster, California, United States
United Medical DoctorsRecruiting
Los Alamitos, California, United States
Clinnova ResearchRecruiting
Orange, California, United States
Prospective Research InnovationsRecruiting
Rancho Cucamonga, California, United States
Clinical Trials Management Services, LLCRecruiting
Thousand Oaks, California, United States
Om Research LLCRecruiting
Victorville, California, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
Medical Research Center of Connecticut, LLCRecruiting
Hamden, Connecticut, United States
Novum Research, LLCNot Yet Recruiting
Clermont, Florida, United States
I.V.A.M. Clinical & Investigational Center, LLCNot Yet Recruiting
Doral, Florida, United States
Florida Research InstituteNot Yet Recruiting
Lakewood Rch, Florida, United States
Well Pharma Medical Research Corp.Recruiting
Miami, Florida, United States
ReserkaNot Yet Recruiting
Miami, Florida, United States
Digestive Disease Consultants DDCJAXNot Yet Recruiting
Orange Park, Florida, United States
Orlando Health Digestive Health InstituteRecruiting
Orlando, Florida, United States
AdventHealth OrlandoNot Yet Recruiting
Orlando, Florida, United States
Nodal Medical CenterRecruiting
Tampa, Florida, United States
Research Bay,Inc.Recruiting
Tampa, Florida, United States
GCP Clinical Research, LLCRecruiting
Tampa, Florida, United States
International Center for Research LLCRecruiting
Tampa, Florida, United States
Northwestern UniversityNot Yet Recruiting
Chicago, Illinois, United States
Avicenna Clinical Research - SW GastroenterologyRecruiting
Oak Lawn, Illinois, United States
Clinical Trials Management, LLCNot Yet Recruiting
Metairie, Louisiana, United States
Gastroenterology Associates of Western Michigan, P.L.C.Recruiting
Wyoming, Michigan, United States
Ellipsis Research GroupRecruiting
Brooklyn, New York, United States
Smart Medical Research - Jackson HeightsRecruiting
Jackson Heights, New York, United States
Pioneer Clinical Research NYRecruiting
New York, New York, United States
Digestive Disease Medicine of Central New YorkRecruiting
Utica, New York, United States
University of North CarolinaRecruiting
Chapel Hill, North Carolina, United States
GCGA Physicians, LLC dba / Gastro Health ResearchRecruiting
Cincinnati, Ohio, United States
NexGen ResearchNot Yet Recruiting
Lima, Ohio, United States
Inquest Clinical ResearchRecruiting
Baytown, Texas, United States
DHR Health Gastroenterology - EdinburgRecruiting
Edinburg, Texas, United States
Baylor College of MedicineRecruiting
Houston, Texas, United States
Intergrity ResearchRecruiting
Houston, Texas, United States
Gastroenterology Research of San AntonioRecruiting
San Antonio, Texas, United States
Tyler Research InstituteRecruiting
Tyler, Texas, United States
Care Access-OgdenRecruiting
Ogden, Utah, United States
Advanced Research Institute - South OgdenRecruiting
Ogden, Utah, United States
University of Washington School MedicineNot Yet Recruiting
Seattle, Washington, United States
CIPRECRecruiting
CABA, Argentina
Mautalen Salud e Investigacion-Centro de Osteopatías MédicasRecruiting
Ciudad Autonoma de Buenos Air, Argentina
Clínica Privada IndependenciaNot Yet Recruiting
Munro, Argentina
CER Instituto MedicoNot Yet Recruiting
Quilmes, Argentina
Hospital Provincial del CentenarioRecruiting
Rosario, Argentina
Centro Medico Privado de ReumatologiaRecruiting
SAN M. de Tucuman, Argentina
Chu TivoliRecruiting
La Louvière, Belgium
CHU UCL Namur site GodinneRecruiting
Yvoir, Belgium
London Health Sciences CentreNot Yet Recruiting
London, Canada
London Digestive Disease InstituteNot Yet Recruiting
London, Canada
CIUSSS de l'Est-de-l'Île-de-MontréalNot Yet Recruiting
Montreal, Canada
Montreal General HospitalNot Yet Recruiting
Montreal, Canada
Hospital Universitario Mayor MéderiNot Yet Recruiting
Bogotá, Colombia
Comité de Ética en Investigación Biomédica IPS Centro Médico Julián CoronelNot Yet Recruiting
Cali, Colombia
Centro de Inmunología y Genética (CIGE)Not Yet Recruiting
Medellín, Colombia
General Hospital Dr Andjelko Visic BjelovarRecruiting
Bjelovar, Croatia
Poliklinika BorzanRecruiting
Osijek, Croatia
Special Hospital MedicoRecruiting
Rijeka, Croatia
General Hospital Dr. J. BencevicNot Yet Recruiting
Slavonski Brod, Croatia
Poliklinika SolmedRecruiting
Zagreb, Croatia
University Hospital Center ZagrebNot Yet Recruiting
Zagreb, Croatia
SurGal clinic s.r.o.Not Yet Recruiting
Brno, Czechia
Vojenska nemocnice Brno p.o.Recruiting
Brno, Czechia
Etická komise Nemocnice SlanýRecruiting
Slaný, Czechia
Etická komise Krajské nemocnice T. Bati, a. s.Recruiting
Zlín, Czechia
Bispebjerg HospitalNot Yet Recruiting
København NV, Denmark
Henri Mondor HospitalRecruiting
Créteil, France
CHU De Grenoble Hopital Albert MichallonRecruiting
Grenoble, France
Centre Hospitalier Departemental (CHD) VendeeRecruiting
La Roche-sur-Yon, France
CHU de Nice Hopital de L'ArchetRecruiting
Nice, France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -Recruiting
Pierre-Bénite, France
Chu de Rouen Hopital Charles NicolleRecruiting
Rouen, France
Universitätsklinikum Augsburg, III. Medizinische Klinik StudienzentrumRecruiting
Augsburg, Germany
Charité Campus Virchow-KlinikumRecruiting
Berlin, Germany
Universitätsklinikum Brandenburg GmbHRecruiting
Brandenburg an der Havel, Germany
MVZ für spezialärztliche Versorgung Dr. Friedrichs GmbHNot Yet Recruiting
Duisburg, Germany
Universitätsklinikum Frankfurt Goethe-Universität, Medizinische Klinik 1Recruiting
Frankfurt am Main, Germany
Interdisziplinäres Crohn Colitis Centrum Rhein-MainNot Yet Recruiting
Frankfurt am Main, Germany
Studiengesellschaft BSF UnternehmergesellschaftRecruiting
Halle, Germany
HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche DarmerkrankungenNot Yet Recruiting
Hamburg, Germany
Medizinische Hochschule HannoverRecruiting
Hanover, Germany
Universitätsklinikum Schleswig-HolsteinRecruiting
Kiel, Germany
Klinikum Rechts der Isar der TU MünchenRecruiting
München, Germany
Magen-Darm-Zentrum RemscheidRecruiting
Remscheid, Germany
Universitätsklinikum UlmNot Yet Recruiting
Ulm, Germany
General Hospital of Athens 'Evangelismos'Recruiting
Athens, Greece
General Hospital of Athens HippokratioRecruiting
Athens, Greece
Sotiria Thoracic Diseases Hospital of AthensRecruiting
Athens, Greece
Alexandra HospitalRecruiting
Athens, Greece
PAGNI-University General Hospital of HeraklionRecruiting
Heraklion, Greece
University Hospital of IoanninaRecruiting
Ioannina, Greece
General Oncology Hospital of Kifissia "Agioi Anargiroi"Not Yet Recruiting
Nea Kifissia, Greece
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi KftRecruiting
Budapest, Hungary
Óbudai Egészségügyi CentrumRecruiting
Budapest, Hungary
Semmelweis UniversityRecruiting
Budapest, Hungary
Bugát Pál KórházNot Yet Recruiting
Gyöngyös, Hungary
Clinexpert Gyöngyös Kft.Not Yet Recruiting
Gyöngyös, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai KözpontNot Yet Recruiting
Szeged, Hungary
Fejér Megyei Szent György Egyetemi Oktató KórházRecruiting
Székesfehérvár, Hungary
Beaumont Hospital, DublinRecruiting
Dublin, Ireland
IRCCS - AOU di BolognaRecruiting
Bologna, Italy
Fondazione PoliambulanzaNot Yet Recruiting
Brescia, Italy
AST Pesaro Urbino - Presidio Ospedaliero Santa CroceRecruiting
Fano, Italy
Azienda Ospedaliera Universitaria CareggiNot Yet Recruiting
Florence, Italy
A.O.U. Policlinico G. MartinoRecruiting
Gazzi - Messina, Italy
Ospedale S. PaoloRecruiting
Milan, Italy
Azienda Ospedaliero UniversitariaNot Yet Recruiting
Modena, Italy
Università di Cagliari - Presidio Policlinico MonserratoRecruiting
Monserrato, Italy
Azienda Ospedale Università di PadovaRecruiting
Padova, Italy
Fondazione IRCCS Policlinico San MatteoRecruiting
Pavia, Italy
Policlinico Tor VergataRecruiting
Roma, Italy
Ospedale Sandro PertiniNot Yet Recruiting
Roma, Italy
Policlinico Universitario Campus Bio-MedicoRecruiting
Rome, Italy
Istituto Clinico HumanitasNot Yet Recruiting
Rozzano, Italy
IRCCS Policlinico San DonatoRecruiting
San Donato Milanese, Italy
IRCCS Ospedale Casa Sollievo della SofferenzaRecruiting
San Giovanni Rotondo, Italy
IRCCS Ospedale San RaffaeleRecruiting
Segrate, Italy
A.O.U. Citta' della Salute e della Scienza di TorinoRecruiting
Torino, Italy
SC Farmacia AO Ordine MaurizianoRecruiting
Torino, Italy
Chiba University HospitalNot Yet Recruiting
Chiba, Japan
Fukuoka University Chikushi HospitalRecruiting
Chikushino-shi, Japan
Saiseikai Fukuoka General HospitalNot Yet Recruiting
Fukuoak, Japan
Hachinohe City HospitalNot Yet Recruiting
Hachinohe-shi, Japan
National Hospital Organization Hirosaki General Medical CenterNot Yet Recruiting
Hirosaki, Japan
Hiroshima City North Medical Center Asa Citizens HospitalRecruiting
Hiroshima, Japan
Hiroshima University HospitalNot Yet Recruiting
Hiroshima, Japan
Tokai University HospitalNot Yet Recruiting
Isehara, Japan
Isesaki Municipal HospitalNot Yet Recruiting
Isesaki-shi, Japan
Kagoshima IBD Gastroenterology ClinicRecruiting
Kagoshima, Japan
National Hospital Organization Kanazawa Medical CenterNot Yet Recruiting
Kanazawa, Japan
Tsujinaka Hospital KashiwanohaRecruiting
Kashiwa, Japan
JCHO Kyushu HospitalNot Yet Recruiting
Kitakyushu-Shi, Japan
Yamanashi Prefectural Central HospitalNot Yet Recruiting
Kofu, Japan
Hoshi General Hospital FoundationNot Yet Recruiting
Koriyama-shi, Japan
Showa University Koto Toyosu HospitalNot Yet Recruiting
Kōtoku, Japan
Our Lady of the Snow St. Mary's HospitalNot Yet Recruiting
Kurume-shi, Japan
Kitasato University Kitasato Institute HospitalRecruiting
Minatoku, Japan
Kyorin University HospitalRecruiting
Mitaka, Japan
Iwate Medical University HospitalRecruiting
Morioka, Japan
Nara Prefecture General Medical CenterRecruiting
Nara, Japan
Hyogo College of MedicineRecruiting
Nishinomiya, Japan
Infusion ClinicRecruiting
Osaka, Japan
Oita Red Cross HospitalNot Yet Recruiting
Ōita, Japan
Sapporo Higashi Tokushukai HospitalRecruiting
Sapporo, Japan
Tokushukai Sapporo Tokushukai HospitalRecruiting
Sapporo, Japan
Sapporo IBD ClinicRecruiting
Sapporo Shi Chuo Ku, Japan
NTT Medical Center TokyoNot Yet Recruiting
Shinagawa-KU, Japan
JHCO Tokyo Yamate Medical CenterNot Yet Recruiting
Shinjuku-ku, Japan
Tokyo Metro Bokutoh HospitalNot Yet Recruiting
Sumida-ku, Japan
National Hospital Organization Shizuoka Medical CenterRecruiting
Sunto-gun, Japan
Toyama University HospitalRecruiting
Toyama, Japan
Mie University HospitalRecruiting
Tsu, Japan
Matsushima HospitalNot Yet Recruiting
Yokohama, Japan
Liepaja Regional HospitalRecruiting
Liepāja, Latvia
Pauls Stradins Clinical Univeristy HospitalRecruiting
Riga, Latvia
ManerMed Sp z o.o. Centrum Medyczne ,MedisRecruiting
Bydgoszcz, Poland
Centrum Medyczne Kermed Renata Bojata-Bronisz i Ewa Kowalińska Sp.j.Recruiting
Bydgoszcz, Poland
Centrum Medyczne Plejady Magdalena Celińska-Löwenhoff, Michał Żołnowski sp.kRecruiting
Krakow, Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz" sp. z o. o.Recruiting
Krakow, Poland
Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.Recruiting
Krakow, Poland
Ip Clinic Sp. Z O. O.Recruiting
Lodz, Poland
Med-GASTR SP. Z O.O., SP.K.Recruiting
Lodz, Poland
Medrise Sp. z o.oRecruiting
Lublin, Poland
Twoja Przychodnia Opolskie Centrum MedyczneRecruiting
Opole, Poland
Twoja Przychodnia PcmRecruiting
Poznan, Poland
Endoskopia Sp. z.o.o.Recruiting
Sopot, Poland
Gastromed Sp. z o.o.Recruiting
Torun, Poland
H-T. Centrum Medyczne-EndoterapiaNot Yet Recruiting
Tychy, Poland
NZOZ FOR MED sp. z o.o.Recruiting
Wadowice, Poland
WIP Warsaw IBD Point Profesor KierkusRecruiting
Warsaw, Poland
Centrum Medyczne OporówRecruiting
Wroclaw, Poland
VISTAMEDRecruiting
Wroclaw, Poland
Melita MedicalRecruiting
Wroclaw, Poland
Dr.Carol Davila Emergency University Central Military HospitalNot Yet Recruiting
Bucharest, Romania
S.C. Centrul Medical Medicum SRLRecruiting
Bucharest, Romania
Colentina Clinical HospitalRecruiting
Bucharest, Romania
Emergency University HospitalRecruiting
Bucharest, Romania
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian FodorRecruiting
Cluj-Napoca, Romania
Valahia Medical Center SRLRecruiting
Ploieşti, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.LRecruiting
Timișoara, Romania
Clinical Center " Dr Dragisa Misovic Dedinje"Recruiting
Belgrade, Serbia
Clinical Hospital Center Bezanijska KosaRecruiting
Belgrade, Serbia
Clinical Hospital Center ZvezdaraRecruiting
Belgrade, Serbia
Clinical Hospital Centre ZemunNot Yet Recruiting
Belgrade, Serbia
Military Medical AcademyNot Yet Recruiting
Belgrade, Serbia
Clinical Center of VojvodinaRecruiting
Novi Sad, Serbia
General Hospital PancevoRecruiting
Pančevo, Serbia
General Hospital "Djordje Joanovic"Recruiting
Zrenjanin, Serbia
Centro Medico Teknon - DIGESTIVORecruiting
Barcelona, Spain
Hospital General TomellosoRecruiting
Ciudad Real, Spain
Hospital Universitario Reina Sofia Comite EticoRecruiting
Córdoba, Spain
Hospital Universitario Juan Ramon JimenezRecruiting
Huelva, Spain
Hospital Universitario de Gran Canaria Doctor NegrínRecruiting
Las Palmas de GC, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Clínico Universitario de Santiago de CompostelaRecruiting
Santiago de Compostela, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
CEIM Hospital Universitario y Politecnico la FeRecruiting
Valencia, Spain
Gazi University Medical Faculty Gazi HospitalNot Yet Recruiting
Ankara, Turkey (Türkiye)
Ege Universitesi HastanesiNot Yet Recruiting
Izmir, Turkey (Türkiye)
İnönü Üniversitesi Tıp FakültesiNot Yet Recruiting
Malatya, Turkey (Türkiye)
Mersin University Medical Faculty HospitalNot Yet Recruiting
Mersin, Turkey (Türkiye)
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis · TrialPath