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
Status: Recruiting
Location: See all (202) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Applied Research Center of Arkansas
RECRUITING
Little Rock
Preferred Research Partners
NOT_YET_RECRUITING
Little Rock
Arizona
AZ Gastro Care - Chandler
NOT_YET_RECRUITING
Chandler
California
Erick Alayo Medical Corp/Gastro SB Clinic
NOT_YET_RECRUITING
Chula Vista
Southern California GI and Liver Centers (SCLC)
RECRUITING
Coronado
Valley View Research
NOT_YET_RECRUITING
Garden Grove
Om Research, LLC
RECRUITING
Lancaster
United Medical Doctors
RECRUITING
Los Alamitos
Clinnova Research
RECRUITING
Orange
Prospective Research Innovations
RECRUITING
Rancho Cucamonga
Clinical Trials Management Services, LLC
NOT_YET_RECRUITING
Thousand Oaks
Om Research LLC
NOT_YET_RECRUITING
Victorville
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Connecticut
Medical Research Center of Connecticut, LLC
RECRUITING
Hamden
Florida
Novum Research, LLC
NOT_YET_RECRUITING
Clermont
I.V.A.M. Clinical & Investigational Center, LLC
NOT_YET_RECRUITING
Doral
Florida Research Institute
NOT_YET_RECRUITING
Lakewood Rch
Reserka
NOT_YET_RECRUITING
Miami
Well Pharma Medical Research Corp.
RECRUITING
Miami
Digestive Disease Consultants DDCJAX
NOT_YET_RECRUITING
Orange Park
AdventHealth Orlando
NOT_YET_RECRUITING
Orlando
Orlando Health Digestive Health Institute
RECRUITING
Orlando
GCP Clinical Research, LLC
NOT_YET_RECRUITING
Tampa
International Center for Research LLC
RECRUITING
Tampa
Nodal Medical Center
RECRUITING
Tampa
Research Bay,Inc.
RECRUITING
Tampa
Illinois
Northwestern University
NOT_YET_RECRUITING
Chicago
Avicenna Clinical Research - SW Gastroenterology
RECRUITING
Oak Lawn
Louisiana
Clinical Trials Management, LLC
NOT_YET_RECRUITING
Metairie
Michigan
Gastroenterology Associates of Western Michigan, P.L.C.
RECRUITING
Wyoming
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
New York
Ellipsis Research Group
RECRUITING
Brooklyn
Smart Medical Research - Jackson Heights
RECRUITING
Jackson Heights
Pioneer Clinical Research NY
RECRUITING
New York
Digestive Disease Medicine of Central New York
NOT_YET_RECRUITING
Utica
Ohio
GCGA Physicians, LLC dba / Gastro Health Research
NOT_YET_RECRUITING
Cincinnati
NexGen Research
NOT_YET_RECRUITING
Lima
Texas
Inquest Clinical Research
RECRUITING
Baytown
DHR Health Gastroenterology - Edinburg
RECRUITING
Edinburg
Baylor College of Medicine
NOT_YET_RECRUITING
Houston
Intergrity Research
RECRUITING
Houston
Gastroenterology Research of San Antonio
RECRUITING
San Antonio
Tyler Research Institute
RECRUITING
Tyler
Utah
Advanced Research Institute - South Ogden
RECRUITING
Ogden
Care Access-Ogden
RECRUITING
Ogden
Washington
University of Washington School Medicine
NOT_YET_RECRUITING
Seattle
Other Locations
Argentina
CIPREC
RECRUITING
Caba
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
RECRUITING
Ciudad Autonoma De Buenos Air
Clínica Privada Independencia
NOT_YET_RECRUITING
Munro
CER Instituto Medico
NOT_YET_RECRUITING
Quilmes
Hospital Provincial del Centenario
RECRUITING
Rosario
Centro Medico Privado de Reumatologia
RECRUITING
San M. De Tucuman
Belgium
Chu Tivoli
RECRUITING
La Louvière
CHU UCL Namur site Godinne
RECRUITING
Yvoir
Canada
London Digestive Disease Institute
NOT_YET_RECRUITING
London
London Health Sciences Centre
NOT_YET_RECRUITING
London
CIUSSS de l'Est-de-l'Île-de-Montréal
NOT_YET_RECRUITING
Montreal
Montreal General Hospital
NOT_YET_RECRUITING
Montreal
Colombia
Hospital Universitario Mayor Méderi
NOT_YET_RECRUITING
Bogotá
Centro de Inmunología y Genética (CIGE)
NOT_YET_RECRUITING
Medellín
Comité de Ética en Investigación Biomédica IPS Centro Médico Julián Coronel
NOT_YET_RECRUITING
Santiago De Cali
Croatia
General Hospital Dr Andjelko Visic Bjelovar
RECRUITING
Bjelovar
Poliklinika Borzan
RECRUITING
Osijek
Special Hospital Medico
RECRUITING
Rijeka
General Hospital Dr. J. Bencevic
NOT_YET_RECRUITING
Slavonski Brod
Poliklinika Solmed
RECRUITING
Zagreb
University Hospital Center Zagreb
NOT_YET_RECRUITING
Zagreb
Denmark
Bispebjerg Hospital
NOT_YET_RECRUITING
København Nv
France
Henri Mondor Hospital
NOT_YET_RECRUITING
Créteil
CHU De Grenoble Hopital Albert Michallon
RECRUITING
Grenoble
Centre Hospitalier Departemental (CHD) Vendee
RECRUITING
La Roche-sur-yon
CHU de Nice Hopital de L'Archet
RECRUITING
Nice
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
RECRUITING
Pierre-bénite
Chu de Rouen Hopital Charles Nicolle
RECRUITING
Rouen
Germany
Universitätsklinikum Augsburg, III. Medizinische Klinik Studienzentrum
RECRUITING
Augsburg
Charité Campus Virchow-Klinikum
RECRUITING
Berlin
Universitätsklinikum Brandenburg GmbH
RECRUITING
Brandenburg
MVZ für spezialärztliche Versorgung Dr. Friedrichs GmbH
NOT_YET_RECRUITING
Duisburg
Interdisziplinäres Crohn Colitis Centrum Rhein-Main
NOT_YET_RECRUITING
Frankfurt Am Main
Universitätsklinikum Frankfurt Goethe-Universität, Medizinische Klinik 1
RECRUITING
Frankfurt Am Main
Studiengesellschaft BSF Unternehmergesellschaft
RECRUITING
Halle
HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
NOT_YET_RECRUITING
Hamburg
Medizinische Hochschule Hannover
NOT_YET_RECRUITING
Hanover
Universitätsklinikum Schleswig-Holstein
RECRUITING
Kiel
Klinikum Rechts der Isar der TU München
NOT_YET_RECRUITING
München
Magen-Darm-Zentrum Remscheid
NOT_YET_RECRUITING
Remscheid
Universitätsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Greece
Alexandra Hospital
RECRUITING
Athens
General Hospital of Athens 'Evangelismos'
NOT_YET_RECRUITING
Athens
General Hospital of Athens Hippokratio
RECRUITING
Athens
Sotiria Thoracic Diseases Hospital of Athens
RECRUITING
Athens
PAGNI-University General Hospital of Heraklion
NOT_YET_RECRUITING
Heraklion
University Hospital of Ioannina
RECRUITING
Ioannina
General Oncology Hospital of Kifissia Agioi Anargiroi
NOT_YET_RECRUITING
Nea Kifissia
Hungary
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft
RECRUITING
Budapest
Óbudai Egészségügyi Centrum
RECRUITING
Budapest
Semmelweis University
RECRUITING
Budapest
Bugát Pál Kórház
NOT_YET_RECRUITING
Gyöngyös
Clinexpert Gyöngyös Kft.
NOT_YET_RECRUITING
Gyöngyös
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
NOT_YET_RECRUITING
Szeged
Fejér Megyei Szent György Egyetemi Oktató Kórház
RECRUITING
Székesfehérvár
Ireland
Beaumont Hospital, Dublin
RECRUITING
Dublin
Italy
IRCCS - AOU di Bologna
RECRUITING
Bologna
Fondazione Poliambulanza
NOT_YET_RECRUITING
Brescia
AST Pesaro Urbino - Presidio Ospedaliero Santa Croce
RECRUITING
Fano
Azienda Ospedaliera Universitaria Careggi
NOT_YET_RECRUITING
Florence
A.O.U. Policlinico G. Martino
RECRUITING
Gazzi - Messina
Ospedale S. Paolo
RECRUITING
Milan
Azienda Ospedaliero Universitaria
NOT_YET_RECRUITING
Modena
Università di Cagliari - Presidio Policlinico Monserrato
RECRUITING
Monserrato
Azienda Ospedale Università di Padova
RECRUITING
Padua
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Ospedale Sandro Pertini
NOT_YET_RECRUITING
Roma
Policlinico Tor Vergata
NOT_YET_RECRUITING
Roma
Policlinico Universitario Campus Bio-Medico
RECRUITING
Rome
Istituto Clinico Humanitas
NOT_YET_RECRUITING
Rozzano
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
IRCCS Ospedale Casa Sollievo della Sofferenza
RECRUITING
San Giovanni Rotondo
IRCCS Ospedale San Raffaele
RECRUITING
Segrate
SC Farmacia AO Ordine Mauriziano
RECRUITING
Torino
Japan
Chiba University Hospital
NOT_YET_RECRUITING
Chiba
Fukuoka University Chikushi Hospital
NOT_YET_RECRUITING
Chikushino-shi
Saiseikai Fukuoka General Hospital
NOT_YET_RECRUITING
Fukuoak
Hachinohe City Hospital
NOT_YET_RECRUITING
Hachinohe-shi
National Hospital Organization Hirosaki General Medical Center
NOT_YET_RECRUITING
Hirosaki
Hiroshima City North Medical Center Asa Citizens Hospital
RECRUITING
Hiroshima
Hiroshima University Hospital
NOT_YET_RECRUITING
Hiroshima
Tokai University Hospital
NOT_YET_RECRUITING
Isehara
Isesaki Municipal Hospital
NOT_YET_RECRUITING
Isesaki-shi
Kagoshima IBD Gastroenterology Clinic
NOT_YET_RECRUITING
Kagoshima
National Hospital Organization Kanazawa Medical Center
NOT_YET_RECRUITING
Kanazawa
Tsujinaka Hospital Kashiwanoha
NOT_YET_RECRUITING
Kashiwa
JCHO Kyushu Hospital
NOT_YET_RECRUITING
Kitakyushu-shi
Yamanashi Prefectural Central Hospital
NOT_YET_RECRUITING
Kofu
Hoshi General Hospital Foundation
NOT_YET_RECRUITING
Koriyama-shi
Showa University Koto Toyosu Hospital
NOT_YET_RECRUITING
Kōtoku
Our Lady of the Snow St. Mary's Hospital
NOT_YET_RECRUITING
Kurume-shi
Kitasato University Kitasato Institute Hospital
NOT_YET_RECRUITING
Minatoku
Kyorin University Hospital
RECRUITING
Mitaka
Iwate Medical University Hospital
NOT_YET_RECRUITING
Morioka
Nara Prefecture General Medical Center
RECRUITING
Nara
Hyogo College of Medicine
NOT_YET_RECRUITING
Nishinomiya
Oita Red Cross Hospital
NOT_YET_RECRUITING
Ōita
Infusion Clinic
NOT_YET_RECRUITING
Osaka
Sapporo Higashi Tokushukai Hospital
NOT_YET_RECRUITING
Sapporo
Tokushukai Sapporo Tokushukai Hospital
NOT_YET_RECRUITING
Sapporo
Sapporo IBD Clinic
NOT_YET_RECRUITING
Sapporo Shi Chuo Ku
NTT Medical Center Tokyo
NOT_YET_RECRUITING
Shinagawa-ku
JHCO Tokyo Yamate Medical Center
NOT_YET_RECRUITING
Shinjuku-ku
Tokyo Metro Bokutoh Hospital
NOT_YET_RECRUITING
Sumida-ku
National Hospital Organization Shizuoka Medical Center
NOT_YET_RECRUITING
Sunto-gun
Toyama University Hospital
NOT_YET_RECRUITING
Toyama
Mie University Hospital
NOT_YET_RECRUITING
Tsu
Matsushima Hospital
NOT_YET_RECRUITING
Yokohama
Latvia
Liepaja Regional Hospital
RECRUITING
Liepāja
Pauls Stradins Clinical Univeristy Hospital
RECRUITING
Riga
Poland
Centrum Medyczne Kermed Renata Bojata-Bronisz i Ewa Kowalińska Sp.j.
RECRUITING
Bydgoszcz
ManerMed Sp z o.o. Centrum Medyczne ,Medis
RECRUITING
Bydgoszcz
Centrum Medyczne Plejady Magdalena Celińska-Löwenhoff, Michał Żołnowski sp.k
RECRUITING
Krakow
Centrum Nowoczesnych Terapii Dobry Lekarz sp. z o. o.
RECRUITING
Krakow
Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.
RECRUITING
Krakow
Ip Clinic Sp. Z O. O.
RECRUITING
Lodz
Med-GASTR SP. Z O.O., SP.K.
RECRUITING
Lodz
Medrise Sp. z o.o
RECRUITING
Lublin
Twoja Przychodnia Opolskie Centrum Medyczne
RECRUITING
Opole
Twoja Przychodnia Pcm
RECRUITING
Poznan
Endoskopia Sp. z.o.o.
RECRUITING
Sopot
Gastromed Sp. z o.o.
RECRUITING
Torun
H-T. Centrum Medyczne-Endoterapia
NOT_YET_RECRUITING
Tychy
NZOZ FOR MED sp. z o.o.
RECRUITING
Wadowice
WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
Centrum Medyczne Oporów
RECRUITING
Wroclaw
Melita Medical
RECRUITING
Wroclaw
VISTAMED
RECRUITING
Wroclaw
Romania
Colentina Clinical Hospital
RECRUITING
Bucharest
Dr.Carol Davila Emergency University Central Military Hospital
NOT_YET_RECRUITING
Bucharest
Emergency University Hospital
RECRUITING
Bucharest
S.C. Centrul Medical Medicum SRL
RECRUITING
Bucharest
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
RECRUITING
Cluj-napoca
Valahia Medical Center SRL
RECRUITING
Ploieşti
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
RECRUITING
Timișoara
Serbia
Clinical Center Dr Dragisa Misovic Dedinje
RECRUITING
Belgrade
Clinical Hospital Center Bezanijska Kosa
RECRUITING
Belgrade
Clinical Hospital Center Zvezdara
RECRUITING
Belgrade
Clinical Hospital Centre Zemun
NOT_YET_RECRUITING
Belgrade
Military Medical Academy
NOT_YET_RECRUITING
Belgrade
Clinical Center of Vojvodina
RECRUITING
Novi Sad
General Hospital Pancevo
RECRUITING
Pančevo
General Hospital Djordje Joanovic
RECRUITING
Zrenjanin
Spain
Centro Medico Teknon - DIGESTIVO
NOT_YET_RECRUITING
Barcelona
Hospital General Tomelloso
RECRUITING
Ciudad Real
Hospital Universitario Reina Sofia Comite Etico
RECRUITING
Córdoba
Hospital Universitario Juan Ramon Jimenez
RECRUITING
Huelva
Hospital Universitario de Gran Canaria Doctor Negrín
RECRUITING
Las Palmas De Gc
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Clínico Universitario de Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Macarena
RECRUITING
Seville
CEIM Hospital Universitario y Politecnico la Fe
RECRUITING
Valencia
Turkey
Gazi University Medical Faculty Gazi Hospital
NOT_YET_RECRUITING
Ankara
Ege Universitesi Hastanesi
NOT_YET_RECRUITING
Izmir
İnönü Üniversitesi Tıp Fakültesi
NOT_YET_RECRUITING
Malatya
Mersin University Medical Faculty Hospital
NOT_YET_RECRUITING
Mersin
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2028-09
Participants
Target number of participants: 140
Treatments
Experimental: Eltrekibart + Placebo
Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.
Experimental: Mirikizumab + Placebo
Participants will receive mirikizumab and placebo or mirikizumab.
Experimental: Eltrekibart + Mirikizumab
Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
Experimental: Placebo
Participants will receive placebo or mirikizumab.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company