A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis
- Conditions
- Ulcerative ColitisUlcerative Colitis Chronic
- Interventions
- Registration Number
- NCT06598943
- Lead Sponsor
- Eli Lilly and Company
- 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo or mirikizumab. Eltrekibart + Placebo Eltrekibart Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab. Eltrekibart + Placebo Mirikizumab Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab. Eltrekibart + Placebo Placebo Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab. Mirikizumab + Placebo Placebo Participants will receive mirikizumab and placebo or mirikizumab. Eltrekibart + Mirikizumab Eltrekibart Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy. Mirikizumab + Placebo Mirikizumab Participants will receive mirikizumab and placebo or mirikizumab. Placebo Mirikizumab Participants will receive placebo or mirikizumab. Eltrekibart + Mirikizumab Mirikizumab Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Clinical Remission Week 12 Percentage of Participants Achieving Clinical Remission
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Clinical Response Week 12 Percentage of Participants Achieving Clinical Response
Percentage of Participants Achieving Endoscopic Improvement Week 12 Percentage of Participants Achieving Endoscopic Improvement
Percentage of Participants Achieving Endoscopic Remission Week 12 Percentage of Participants Achieving Endoscopic Remission
Percentage of Participants Achieving Clinical Remission Week 52 Percentage of Participants Achieving Clinical Remission
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement Week 12 Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement
Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score Baseline, Week 12 Change From Baseline to Week 12 in IBDQ Total Score
Pharmacokinetics (PK): Trough concentrations at Steady State (Ctrough ss) of Eltrekibart Week 12 PK: Ctrough ss of Eltrekibart
PK: Ctrough ss of Mirikizumab Week 12 PK: Ctrough ss of Mirikizumab
Trial Locations
- Locations (173)
Southern California GI and Liver Centers (SCLC)
🇺🇸Coronado, California, United States
Om Research, LLC
🇺🇸Lancaster, California, United States
United Medical Doctors
🇺🇸Los Alamitos, California, United States
Clinnova Research
🇺🇸Orange, California, United States
Prospective Research Innovations
🇺🇸Rancho Cucamonga, California, United States
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, United States
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Well Pharma Medical Research Corp.
🇺🇸Miami, Florida, United States
Digestive Disease Consultants DDCJAX
🇺🇸Orange Park, Florida, United States
Orlando Health Digestive Health Institute
🇺🇸Orlando, Florida, United States
Nodal Medical Center
🇺🇸Tampa, Florida, United States
Research Bay,Inc.
🇺🇸Tampa, Florida, United States
International Center for Research LLC
🇺🇸Tampa, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Avicenna Clinical Research - SW Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
Gastroenterology Associates of Western Michigan, P.L.C.
🇺🇸Wyoming, Michigan, United States
Ellipsis Research Group
🇺🇸Brooklyn, New York, United States
Smart Medical Research - Jackson Heights
🇺🇸Jackson Heights, New York, United States
Pioneer Clinical Research NY
🇺🇸New York, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
DHR Health Gastroenterology - Edinburg
🇺🇸Edinburg, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Intergrity Research
🇺🇸Houston, Texas, United States
Gastroenterology Research of San Antonio
🇺🇸San Antonio, Texas, United States
Tyler Research Institute
🇺🇸Tyler, Texas, United States
Care Access-Ogden
🇺🇸Ogden, Utah, United States
Advanced Research Institute - South Ogden
🇺🇸Ogden, Utah, United States
University of Washington School Medicine
🇺🇸Seattle, Washington, United States
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
🇦🇷Ciudad Autonoma De Buenos Air, Buenos Aires, Argentina
Clínica Privada Independencia
🇦🇷Munro, Buenos Aires, Argentina
CER Instituto Medico
🇦🇷Quilmes, Buenos Aires, Argentina
CIPREC
🇦🇷Caba, Ciudad Autónoma De Buenos Aire, Argentina
Hospital Provincial del Centenario
🇦🇷Rosario, Santa Fe, Argentina
Centro Medico Privado de Reumatologia
🇦🇷SAN M. DE Tucuman, Tucumán, Argentina
Chu Tivoli
🇧🇪La Louviere, Belgium
CHU UCL Namur site Godinne
🇧🇪Yvoir, Belgium
London Health Sciences Centre
🇨🇦London, Ontario, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal
🇨🇦Montreal, Quebec, Canada
Poliklinika Solmed
🇭🇷Zagreb, Grad Zagreb, Croatia
General Hospital Dr Andjelko Visic Bjelovar
🇭🇷Bjelovar, Croatia
Poliklinika Borzan
🇭🇷Osijek, Croatia
Special Hospital Medico
🇭🇷Rijeka, Croatia
Vojenska nemocnice Brno p.o.
🇨🇿Brno, Czechia
Etická komise Nemocnice Slaný
🇨🇿Slany, Czechia
Etická komise Krajské nemocnice T. Bati, a. s.
🇨🇿Zlín, Czechia
Bispebjerg Hospital
🇩🇰Kobenhavn NV, Denmark
CHU De Grenoble Hopital Albert Michallon
🇫🇷Grenoble, Cedex 09, France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
🇫🇷Pierre Benite cedex, Rhone, France
Centre Hospitalier Departemental (CHD) Vendee
🇫🇷La Roche-sur-Yon Cedex 9, France
CHU de Nice Hopital de L'Archet
🇫🇷Nice cedex 3, France
Chu de Rouen Hopital Charles Nicolle
🇫🇷Rouen, France
Universitätsklinikum Ulm
🇩🇪Ulm, Baden-Württemberg, Germany
Universitätsklinikum Augsburg, III. Medizinische Klinik Studienzentrum
🇩🇪Augsburg, Bayern, Germany
Klinikum Rechts der Isar der TU München
🇩🇪München, Bayern, Germany
Universitätsklinikum Brandenburg GmbH
🇩🇪Brandenburg an der Havel, Brandenburg, Germany
Universitätsklinikum Frankfurt Goethe-Universität, Medizinische Klinik 1
🇩🇪Frankfurt am Main, Hessen, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Niedersachsen, Germany
Ospedale S. Paolo
🇮🇹Milano, Italy
Azienda Ospedaliero Universitaria
🇮🇹Modena, Italy
Studiengesellschaft BSF Unternehmergesellschaft
🇩🇪Halle (Saale), Sachsen-Anhalt, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Schleswig-Holstein, Germany
Charité Campus Virchow-Klinikum
🇩🇪Berlin, Germany
HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
🇩🇪Hamburg, Germany
General Hospital of Athens Hippokratio
🇬🇷Athens, Attikí, Greece
Sotiria Thoracic Diseases Hospital of Athens
🇬🇷Athens, Attikí, Greece
Alexandra Hospital
🇬🇷Athens, Attikí, Greece
PAGNI-University General Hospital of Heraklion
🇬🇷Heraklion, Crete, Greece
University Hospital of Ioannina
🇬🇷Ioannina, Greece
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Csongrád, Hungary
Bugát Pál Kórház
🇭🇺Gyongyos, Heves, Hungary
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft
🇭🇺Budapest, Hungary
Óbudai Egészségügyi Centrum
🇭🇺Budapest, Hungary
Semmelweis University
🇭🇺Budapest, Hungary
Fejér Megyei Szent György Egyetemi Oktató Kórház
🇭🇺Szekesfehervar, Hungary
Beaumont Hospital, Dublin
🇮🇪Dublin, Ireland
IRCCS - AOU di Bologna
🇮🇹Bologna, BO, Italy
Università di Cagliari - Presidio Policlinico Monserrato
🇮🇹Monserrato, Cagliari, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, FG, Italy
IRCCS Policlinico San Donato
🇮🇹San Donato Milanese, Milano, Italy
IRCCS Ospedale San Raffaele
🇮🇹Segrate, Milano, Italy
AST Pesaro Urbino - Presidio Ospedaliero Santa Croce
🇮🇹Fano, PU, Italy
Policlinico Universitario Campus Bio-Medico
🇮🇹Rome, Roma, Italy
A.O.U. Policlinico G. Martino
🇮🇹Gazzi - Messina, Italy
Azienda Ospedale Università di Padova
🇮🇹Padova, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Ospedale Sandro Pertini
🇮🇹Roma, Italy
SC Farmacia AO Ordine Mauriziano
🇮🇹Torino, Italy
Hachinohe City Hospital
🇯🇵Hachinohe-shi, Aomori, Japan
National Hospital Organization Hirosaki General Medical Center
🇯🇵Hirosaki, Aomori, Japan
Our Lady of the Snow St. Mary's Hospital
🇯🇵Kurume-shi, Fukuoka-Ken, Japan
Fukuoka University Chikushi Hospital
🇯🇵Chikushino, Fukuoka, Japan
JCHO Kyushu Hospital
🇯🇵Kitakyushu-Shi, Fukuoka, Japan
Hoshi General Hospital Foundation
🇯🇵Koriyama-shi, Fukushima, Japan
Isesaki Municipal Hospital
🇯🇵Isesaki-shi, Gumma, Japan
Hiroshima City North Medical Center Asa Citizens Hospital
🇯🇵Hiroshima-city, Hiroshima, Japan
Hiroshima University Hospital
🇯🇵Hiroshima-shi, Hiroshima, Japan
Sapporo IBD Clinic
🇯🇵Sapporo Shi Chuo Ku, Hokkaido, Japan
Sapporo Higashi Tokushukai Hospital
🇯🇵Sapporo, Hokkaido, Japan
Tokushukai Sapporo Tokushukai Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hyogo College of Medicine
🇯🇵Nishinomiya, Hyogo, Japan
National Hospital Organization Kanazawa Medical Center
🇯🇵Kanazawa, Ishikawa, Japan
Iwate Medical University Hospital
🇯🇵Morioka, Iwate, Japan
JHCO Tokyo Yamate Medical Center
🇯🇵Shinjuku-ku, Jp-13, Japan
Kagoshima IBD Gastroenterology Clinic
🇯🇵Kagoshima City, Kagoshima, Japan
Tokai University Hospital
🇯🇵Isehara, Kanagawa, Japan
Matsushima Hospital
🇯🇵Yokohama, Kanagawa, Japan
Mie University Hospital
🇯🇵Tsu, Mie, Japan
Nara Prefecture General Medical Center
🇯🇵Nara-shi, Nara, Japan
Colentina Clinical Hospital
🇷🇴Bucharest, Romania
Oita Red Cross Hospital
🇯🇵Oita City, Oita-ken, Japan
Infusion Clinic
🇯🇵Osaka-shi, Osaka, Japan
National Hospital Organization Shizuoka Medical Center
🇯🇵Sunto-gun, Shizuoka, Japan
Showa University Koto Toyosu Hospital
🇯🇵Koto-ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital
🇯🇵Minato-Ku, Tokyo, Japan
Kyorin University Hospital
🇯🇵Mitaka, Tokyo, Japan
NTT Medical Center Tokyo
🇯🇵Shinagawa-KU, Tokyo, Japan
Yamanashi Prefectural Central Hospital
🇯🇵Kofu, Yamanashi, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Saiseikai Fukuoka General Hospital
🇯🇵Fukuoak, Japan
Tokyo Metro Bokutoh Hospital
🇯🇵Sumida-ku, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Yonsei University Wonju Severance Christian Hospital
🇰🇷Gangwon-do, Kangwon-do, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Yeungnam Univeristy Medical Center
🇰🇷Daegu, Taegu-Kwangyǒkshi, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Emergency University Hospital
🇷🇴Bucharest, Romania
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Liepaja Regional Hospital
🇱🇻Liepaja, Latvia
Pauls Stradins Clinical Univeristy Hospital
🇱🇻Riga, Latvia
Melita Medical
🇵🇱Wroclaw, Dolnośląskie, Poland
WIP Warsaw IBD Point Profesor Kierkus
🇵🇱Warsaw, Mazowieckie, Poland
ManerMed Sp z o.o. Centrum Medyczne ,Medis
🇵🇱Bydgoszcz, Poland
Centrum Medyczne Kermed Renata Bojata-Bronisz i Ewa Kowalińska Sp.j.
🇵🇱Bydgoszcz, Poland
Centrum Medyczne Plejady Magdalena Celińska-Löwenhoff, Michał Żołnowski sp.k
🇵🇱Krakow, Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz" sp. z o. o.
🇵🇱Krakow, Poland
Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.
🇵🇱Krakow, Poland
Med-GASTR SP. Z O.O., SP.K.
🇵🇱Lodz, Poland
Medrise Sp. z o.o
🇵🇱Lublin, Poland
Twoja Przychodnia Opolskie Centrum Medyczne
🇵🇱Opole, Poland
Twoja Przychodnia Pcm
🇵🇱Poznan, Poland
Endoskopia Sp. z.o.o.
🇵🇱Sopot, Poland
Gastromed Sp. z o.o.
🇵🇱Torun, Poland
NZOZ FOR MED sp. z o.o.
🇵🇱Wadowice, Poland
Centrum Medyczne Oporów
🇵🇱Wroclaw, Poland
VISTAMED
🇵🇱Wroclaw, Poland
Ip Clinic Sp. Z O. O.
🇵🇱Łódź, Poland
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
🇷🇴Cluj-Napoca, Cluj, Romania
Valahia Medical Center SRL
🇷🇴Ploiesti, Prahova, Romania
S.C. Centrul Medical Medicum SRL
🇷🇴Bucuresti, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
🇷🇴Timisoara, Romania
Clinical Hospital Center Zvezdara
🇷🇸Belgrade, Beograd, Serbia
General Hospital "Djordje Joanovic"
🇷🇸Zrenjanin, Vojvodina, Serbia
Clinical Center " Dr Dragisa Misovic Dedinje"
🇷🇸Belgrade, Serbia
Clinical Hospital Center Bezanijska Kosa
🇷🇸Belgrade, Serbia
Clinical Hospital Centre Zemun
🇷🇸Belgrade, Serbia
Military Medical Academy
🇷🇸Beograd, Serbia
Clinical Center of Vojvodina
🇷🇸Novi Sad, Serbia
General Hospital Pancevo
🇷🇸Pancevo, Serbia
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago de Compostela, A Coruña, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
🇪🇸Las Palmas De GC, Las Palmas, Spain
Hospital General Tomelloso
🇪🇸Ciudad Real, Spain
Hospital Universitario Reina Sofia Comite Etico
🇪🇸Cordoba, Spain
Hospital Universitario Juan Ramon Jimenez
🇪🇸Huelva, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
CEIM Hospital Universitario y Politecnico la Fe
🇪🇸Valencia, Spain
Gazi University Medical Faculty Gazi Hospital
🇹🇷Ankara, Turkey
Ege Universitesi Hastanesi
🇹🇷İzmir, Turkey
İnönü Üniversitesi Tıp Fakültesi
🇹🇷Malatya, Turkey
Mersin University Medical Faculty Hospital
🇹🇷Mersin, Turkey