A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
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
2 other identifiers
interventional
140
21 countries
207
Brief Summary
The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2024
Typical duration for phase_2
207 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
April 20, 2026
April 1, 2026
3.1 years
September 13, 2024
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Clinical Remission
Percentage of Participants Achieving Clinical Remission
Week 12
Secondary Outcomes (8)
Percentage of Participants Achieving Clinical Response
Week 12
Percentage of Participants Achieving Endoscopic Improvement
Week 12
Percentage of Participants Achieving Endoscopic Remission
Week 12
Percentage of Participants Achieving Clinical Remission
Week 52
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement
Week 12
- +3 more secondary outcomes
Study Arms (4)
Eltrekibart + Placebo
EXPERIMENTALParticipants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Mirikizumab + Placebo
EXPERIMENTALParticipants will receive mirikizumab and placebo or mirikizumab.
Eltrekibart + Mirikizumab
EXPERIMENTALParticipants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
Placebo
EXPERIMENTALParticipants will receive placebo or mirikizumab.
Interventions
Administered
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (207)
AZ Gastro Care - Chandler
Chandler, Arizona, 85225, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72205, United States
Preferred Research Partners
Little Rock, Arkansas, 72211, United States
Erick Alayo Medical Corp/Gastro SB Clinic
Chula Vista, California, 91910, United States
Southern California GI and Liver Centers (SCLC)
Coronado, California, 92118, United States
Valley View Research
Garden Grove, California, 92845, United States
Om Research, LLC
Lancaster, California, 93534, United States
United Medical Doctors
Los Alamitos, California, 90720-3433, United States
Clinnova Research
Orange, California, 92868-4402, United States
Prospective Research Innovations
Rancho Cucamonga, California, 91730-4850, United States
Clinical Trials Management Services, LLC
Thousand Oaks, California, 91360, United States
Om Research LLC
Victorville, California, 92395, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907-6262, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518-3602, United States
Novum Research, LLC
Clermont, Florida, 34711, United States
I.V.A.M. Clinical & Investigational Center, LLC
Doral, Florida, 33126, United States
Florida Research Institute
Lakewood Rch, Florida, 34211, United States
Well Pharma Medical Research Corp.
Miami, Florida, 33173, United States
Reserka
Miami, Florida, 33176, United States
Digestive Disease Consultants DDCJAX
Orange Park, Florida, 32073-4752, United States
Orlando Health Digestive Health Institute
Orlando, Florida, 32803-1248, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Nodal Medical Center
Tampa, Florida, 33607, United States
Research Bay,Inc.
Tampa, Florida, 33607, United States
GCP Clinical Research, LLC
Tampa, Florida, 33609, United States
International Center for Research LLC
Tampa, Florida, 33614, United States
Northwestern University
Chicago, Illinois, 60611, United States
Avicenna Clinical Research - SW Gastroenterology
Oak Lawn, Illinois, 60453-3754, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 49519, United States
Ellipsis Research Group
Brooklyn, New York, 11215, United States
Smart Medical Research - Jackson Heights
Jackson Heights, New York, 11372, United States
Pioneer Clinical Research NY
New York, New York, 10012-3645, United States
Digestive Disease Medicine of Central New York
Utica, New York, 13502, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
GCGA Physicians, LLC dba / Gastro Health Research
Cincinnati, Ohio, 45219, United States
NexGen Research
Lima, Ohio, 45801, United States
Inquest Clinical Research
Baytown, Texas, 77521, United States
DHR Health Gastroenterology - Edinburg
Edinburg, Texas, 78539, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Intergrity Research
Houston, Texas, 77043, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229, United States
Tyler Research Institute
Tyler, Texas, 75701, United States
Care Access-Ogden
Ogden, Utah, 84403, United States
Advanced Research Institute - South Ogden
Ogden, Utah, 84405, United States
University of Washington School Medicine
Seattle, Washington, 98195, United States
CIPREC
CABA, C1061AAS, Argentina
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
Ciudad Autonoma de Buenos Air, C1128AAF, Argentina
Clínica Privada Independencia
Munro, 1605, Argentina
CER Instituto Medico
Quilmes, B1878DVB, Argentina
Hospital Provincial del Centenario
Rosario, S2002KDS, Argentina
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, T4000AXL, Argentina
Chu Tivoli
La Louvière, 7100, Belgium
CHU UCL Namur site Godinne
Yvoir, 5530, Belgium
London Health Sciences Centre
London, N6A 5W9, Canada
London Digestive Disease Institute
London, N6K 1M6, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal
Montreal, H1T 2M4, Canada
Montreal General Hospital
Montreal, H3G 1A4, Canada
Hospital Universitario Mayor Méderi
Bogotá, 111411, Colombia
Comité de Ética en Investigación Biomédica IPS Centro Médico Julián Coronel
Cali, 750035, Colombia
Centro de Inmunología y Genética (CIGE)
Medellín, 5001000, Colombia
General Hospital Dr Andjelko Visic Bjelovar
Bjelovar, 43000, Croatia
Poliklinika Borzan
Osijek, 31000, Croatia
Special Hospital Medico
Rijeka, 51000, Croatia
General Hospital Dr. J. Bencevic
Slavonski Brod, 35 000, Croatia
Poliklinika Solmed
Zagreb, 10000, Croatia
University Hospital Center Zagreb
Zagreb, 10000, Croatia
SurGal clinic s.r.o.
Brno, 60200, Czechia
Vojenska nemocnice Brno p.o.
Brno, 615 00, Czechia
Etická komise Nemocnice Slaný
Slaný, 27401, Czechia
Etická komise Krajské nemocnice T. Bati, a. s.
Zlín, 762 75, Czechia
Bispebjerg Hospital
København NV, 2400, Denmark
Henri Mondor Hospital
Créteil, 94010, France
CHU De Grenoble Hopital Albert Michallon
Grenoble, 38043, France
Centre Hospitalier Departemental (CHD) Vendee
La Roche-sur-Yon, 85925, France
CHU de Nice Hopital de L'Archet
Nice, 06202, France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
Pierre-Bénite, 69495, France
Chu de Rouen Hopital Charles Nicolle
Rouen, 76031, France
Universitätsklinikum Augsburg, III. Medizinische Klinik Studienzentrum
Augsburg, 86156, Germany
Charité Campus Virchow-Klinikum
Berlin, 13353, Germany
Universitätsklinikum Brandenburg GmbH
Brandenburg an der Havel, 14770, Germany
MVZ für spezialärztliche Versorgung Dr. Friedrichs GmbH
Duisburg, 47055, Germany
Universitätsklinikum Frankfurt Goethe-Universität, Medizinische Klinik 1
Frankfurt am Main, 60590, Germany
Interdisziplinäres Crohn Colitis Centrum Rhein-Main
Frankfurt am Main, 60594, Germany
Studiengesellschaft BSF Unternehmergesellschaft
Halle, 06108, Germany
HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
Hamburg, 20251, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Klinikum Rechts der Isar der TU München
München, 81675, Germany
Magen-Darm-Zentrum Remscheid
Remscheid, 42859, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
General Hospital of Athens 'Evangelismos'
Athens, 10676, Greece
General Hospital of Athens Hippokratio
Athens, 115 27, Greece
Sotiria Thoracic Diseases Hospital of Athens
Athens, 11527, Greece
Alexandra Hospital
Athens, 11528, Greece
PAGNI-University General Hospital of Heraklion
Heraklion, 71500, Greece
University Hospital of Ioannina
Ioannina, 45500, Greece
General Oncology Hospital of Kifissia "Agioi Anargiroi"
Nea Kifissia, 14564, Greece
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft
Budapest, 1033, Hungary
Óbudai Egészségügyi Centrum
Budapest, 1036, Hungary
Semmelweis University
Budapest, 1088, Hungary
Bugát Pál Kórház
Gyöngyös, 3200, Hungary
Clinexpert Gyöngyös Kft.
Gyöngyös, 3200, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, 6725, Hungary
Fejér Megyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, 8000, Hungary
Beaumont Hospital, Dublin
Dublin, D9, Ireland
IRCCS - AOU di Bologna
Bologna, 40138, Italy
Fondazione Poliambulanza
Brescia, 25124, Italy
AST Pesaro Urbino - Presidio Ospedaliero Santa Croce
Fano, 61032, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
A.O.U. Policlinico G. Martino
Gazzi - Messina, 98125, Italy
Ospedale S. Paolo
Milan, 20142, Italy
Azienda Ospedaliero Universitaria
Modena, 41124, Italy
Università di Cagliari - Presidio Policlinico Monserrato
Monserrato, 09042, Italy
Azienda Ospedale Università di Padova
Padova, 35128, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Policlinico Tor Vergata
Roma, 00133, Italy
Ospedale Sandro Pertini
Roma, 157, Italy
Policlinico Universitario Campus Bio-Medico
Rome, 00128, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
IRCCS Policlinico San Donato
San Donato Milanese, 20097, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
IRCCS Ospedale San Raffaele
Segrate, 20132, Italy
A.O.U. Citta' della Salute e della Scienza di Torino
Torino, 10126, Italy
SC Farmacia AO Ordine Mauriziano
Torino, 10128, Italy
Chiba University Hospital
Chiba, 260-8677, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502, Japan
Saiseikai Fukuoka General Hospital
Fukuoak, 810-0001, Japan
Hachinohe City Hospital
Hachinohe-shi, 031-8555, Japan
National Hospital Organization Hirosaki General Medical Center
Hirosaki, 036-8545, Japan
Hiroshima City North Medical Center Asa Citizens Hospital
Hiroshima, 731-0293, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Tokai University Hospital
Isehara, 259-1193, Japan
Isesaki Municipal Hospital
Isesaki-shi, 372-0817, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, 892-0843, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, 920-8650, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, 277-0871, Japan
JCHO Kyushu Hospital
Kitakyushu-Shi, 806 8501, Japan
Yamanashi Prefectural Central Hospital
Kofu, 400-8506, Japan
Hoshi General Hospital Foundation
Koriyama-shi, 963-8801, Japan
Showa University Koto Toyosu Hospital
Kōtoku, 135 8577, Japan
Our Lady of the Snow St. Mary's Hospital
Kurume-shi, 830 8543, Japan
Kitasato University Kitasato Institute Hospital
Minatoku, 108 8642, Japan
Kyorin University Hospital
Mitaka, 181-8611, Japan
Iwate Medical University Hospital
Morioka, 020-8505, Japan
Nara Prefecture General Medical Center
Nara, 630-8054, Japan
Hyogo College of Medicine
Nishinomiya, 663-8501, Japan
Infusion Clinic
Osaka, 530-0011, Japan
Oita Red Cross Hospital
Ōita, 870-0033, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033, Japan
Tokushukai Sapporo Tokushukai Hospital
Sapporo, 40041, Japan
Sapporo IBD Clinic
Sapporo Shi Chuo Ku, 064-0919, Japan
NTT Medical Center Tokyo
Shinagawa-KU, 141-8625, Japan
JHCO Tokyo Yamate Medical Center
Shinjuku-ku, 169-0073, Japan
Tokyo Metro Bokutoh Hospital
Sumida-ku, 130-8575, Japan
National Hospital Organization Shizuoka Medical Center
Sunto-gun, 411-8611, Japan
Toyama University Hospital
Toyama, 930-0194, Japan
Mie University Hospital
Tsu, 514-8507, Japan
Matsushima Hospital
Yokohama, 220 0041, Japan
Liepaja Regional Hospital
Liepāja, LV-3414, Latvia
Pauls Stradins Clinical Univeristy Hospital
Riga, LV-1002, Latvia
ManerMed Sp z o.o. Centrum Medyczne ,Medis
Bydgoszcz, 85-229, Poland
Centrum Medyczne Kermed Renata Bojata-Bronisz i Ewa Kowalińska Sp.j.
Bydgoszcz, 85-231, Poland
Centrum Medyczne Plejady Magdalena Celińska-Löwenhoff, Michał Żołnowski sp.k
Krakow, 30-363, Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz" sp. z o. o.
Krakow, 31-011, Poland
Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.
Krakow, 31-506, Poland
Ip Clinic Sp. Z O. O.
Lodz, 90-752, Poland
Med-GASTR SP. Z O.O., SP.K.
Lodz, 91 034, Poland
Medrise Sp. z o.o
Lublin, 20-582, Poland
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, 45 819, Poland
Twoja Przychodnia Pcm
Poznan, 60-324, Poland
Endoskopia Sp. z.o.o.
Sopot, 81-756, Poland
Gastromed Sp. z o.o.
Torun, 87-100, Poland
H-T. Centrum Medyczne-Endoterapia
Tychy, 43-100, Poland
NZOZ FOR MED sp. z o.o.
Wadowice, 34-100, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501, Poland
Centrum Medyczne Oporów
Wroclaw, 52-416, Poland
VISTAMED
Wroclaw, 53-149, Poland
Melita Medical
Wroclaw, 53-611, Poland
Dr.Carol Davila Emergency University Central Military Hospital
Bucharest, 010825, Romania
S.C. Centrul Medical Medicum SRL
Bucharest, 012015, Romania
Colentina Clinical Hospital
Bucharest, 020125, Romania
Emergency University Hospital
Bucharest, 50098, Romania
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
Cluj-Napoca, 400162, Romania
Valahia Medical Center SRL
Ploieşti, 100032, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, 300002, Romania
Clinical Center " Dr Dragisa Misovic Dedinje"
Belgrade, 11000, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11000, Serbia
Clinical Hospital Center Zvezdara
Belgrade, 11000, Serbia
Clinical Hospital Centre Zemun
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11000, Serbia
Clinical Center of Vojvodina
Novi Sad, 21000, Serbia
General Hospital Pancevo
Pančevo, 26101, Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, 23000, Serbia
Centro Medico Teknon - DIGESTIVO
Barcelona, 8022, Spain
Hospital General Tomelloso
Ciudad Real, 13700, Spain
Hospital Universitario Reina Sofia Comite Etico
Córdoba, 14004, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de GC, 35019, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
CEIM Hospital Universitario y Politecnico la Fe
Valencia, 46026, Spain
Gazi University Medical Faculty Gazi Hospital
Ankara, 6560, Turkey (Türkiye)
Ege Universitesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
İnönü Üniversitesi Tıp Fakültesi
Malatya, 44280, Turkey (Türkiye)
Mersin University Medical Faculty Hospital
Mersin, 33169, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2024
First Posted
September 19, 2024
Study Start
October 10, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
September 1, 2028
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.