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

Last updated: February 26, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Ulcerative Colitis

Ulcers

Crohn's Disease

Treatment

Eltrekibart

Mirikizumab

Placebo

Clinical Study ID

NCT06598943
18751
I7P-MC-DSAG
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

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 oneconventional 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

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 inflammatorygastrointestinal diseases.

  • Have had certain abdominal surgeries within the past 3 months or are likely torequire surgery for UC during the study.

  • Have a history of certain adenomas, dysplasia's, or malignancies.

Study Design

Total Participants: 140
Treatment Group(s): 3
Primary Treatment: Eltrekibart
Phase: 2
Study Start date:
October 10, 2024
Estimated Completion Date:
September 30, 2028

Study 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.

Connect with a study center

  • Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

    Ciudad Autonoma De Buenos Air, Buenos Aires C1128AAF
    Argentina

    Site Not Available

  • Clínica Privada Independencia

    Munro, Buenos Aires 1605
    Argentina

    Site Not Available

  • CER Instituto Medico

    Quilmes, Buenos Aires B1878DVB
    Argentina

    Site Not Available

  • CIPREC

    Caba, Ciudad Autónoma De Buenos Aire C1061AAS
    Argentina

    Site Not Available

  • Hospital Provincial del Centenario

    Rosario, Santa Fe S2002KDS
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia

    SAN M. DE Tucuman, Tucumán T4000AXL
    Argentina

    Site Not Available

  • Chu Tivoli

    La Louviere, 7100
    Belgium

    Site Not Available

  • CHU UCL Namur site Godinne

    Yvoir, 5530
    Belgium

    Site Not Available

  • Poliklinika Borzan

    Osijek, 31000
    Croatia

    Site Not Available

  • Vojenska nemocnice Brno p.o.

    Brno, 615 00
    Czechia

    Site Not Available

  • Etická komise Nemocnice Slaný

    Slany, 27401
    Czechia

    Site Not Available

  • Bispebjerg Hospital

    Kobenhavn NV, 2400
    Denmark

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, Baden-Württemberg 89081
    Germany

    Site Not Available

  • Universitätsklinikum Augsburg, III. Medizinische Klinik Studienzentrum

    Augsburg, Bayern 86156
    Germany

    Site Not Available

  • Klinikum Rechts der Isar der TU München

    München, Bayern 81675
    Germany

    Site Not Available

  • Universitätsklinikum Brandenburg GmbH

    Brandenburg an der Havel, Brandenburg 14770
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt Goethe-Universität, Medizinische Klinik 1

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • Studiengesellschaft BSF Unternehmergesellschaft

    Halle (Saale), Sachsen-Anhalt 06108
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Charité Campus Virchow-Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen

    Hamburg, 20251
    Germany

    Site Not Available

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged, Csongrád 6725
    Hungary

    Site Not Available

  • Bugát Pál Kórház

    Gyongyos, Heves 3200
    Hungary

    Site Not Available

  • Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft

    Budapest, 1033
    Hungary

    Site Not Available

  • Semmelweis University

    Budapest, 1088
    Hungary

    Site Not Available

  • Óbudai Egészségügyi Centrum

    Budapest, 1036
    Hungary

    Site Not Available

  • Fejér Megyei Szent György Egyetemi Oktató Kórház

    Szekesfehervar, 8000
    Hungary

    Site Not Available

  • Beaumont Hospital, Dublin

    Dublin, D9
    Ireland

    Site Not Available

  • Hachinohe City Hospital

    Hachinohe-shi, Aomori 031-8555
    Japan

    Site Not Available

  • National Hospital Organization Hirosaki General Medical Center

    Hirosaki, Aomori 036-8545
    Japan

    Site Not Available

  • Fukuoka University Chikushi Hospital

    Chikushino, Fukuoka 818-8502
    Japan

    Site Not Available

  • JCHO Kyushu Hospital

    Kitakyushu-Shi, Fukuoka 806 8501
    Japan

    Site Not Available

  • Our Lady of the Snow St. Mary's Hospital

    Kurume-shi, Fukuoka-Ken 830 8543
    Japan

    Site Not Available

  • Hoshi General Hospital Foundation

    Koriyama-shi, Fukushima 963-8801
    Japan

    Site Not Available

  • Isesaki Municipal Hospital

    Isesaki-shi, Gumma 372-0817
    Japan

    Site Not Available

  • Hiroshima City North Medical Center Asa Citizens Hospital

    Hiroshima-city, Hiroshima 731-0293
    Japan

    Site Not Available

  • Hiroshima University Hospital

    Hiroshima-shi, Hiroshima 734-8551
    Japan

    Site Not Available

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido 065-0033
    Japan

    Site Not Available

  • Tokushukai Sapporo Tokushukai Hospital

    Sapporo, Hokkaido 40041
    Japan

    Site Not Available

  • Sapporo IBD Clinic

    Sapporo Shi Chuo Ku, Hokkaido 064-0919
    Japan

    Site Not Available

  • Hyogo College of Medicine

    Nishinomiya, Hyogo 663-8501
    Japan

    Site Not Available

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, Ishikawa 920-8650
    Japan

    Site Not Available

  • Iwate Medical University Hospital

    Morioka, Iwate 020-8505
    Japan

    Site Not Available

  • JHCO Tokyo Yamate Medical Center

    Shinjuku-ku, Jp-13 169-0073
    Japan

    Site Not Available

  • Kagoshima IBD Gastroenterology Clinic

    Kagoshima City, Kagoshima 892-0843
    Japan

    Site Not Available

  • Tokai University Hospital

    Isehara, Kanagawa 259-1193
    Japan

    Site Not Available

  • Matsushima Hospital

    Yokohama, Kanagawa 220 0041
    Japan

    Site Not Available

  • Mie University Hospital

    Tsu, Mie 514-8507
    Japan

    Site Not Available

  • Nara Prefecture General Medical Center

    Nara-shi, Nara 630-8054
    Japan

    Site Not Available

  • Oita Red Cross Hospital

    Oita City, Oita-ken 870-0033
    Japan

    Site Not Available

  • Infusion Clinic

    Osaka-shi, Osaka 530-0011
    Japan

    Site Not Available

  • National Hospital Organization Shizuoka Medical Center

    Sunto-gun, Shizuoka 411-8611
    Japan

    Site Not Available

  • Showa University Koto Toyosu Hospital

    Koto-ku, Tokyo 135 8577
    Japan

    Site Not Available

  • Kitasato University Kitasato Institute Hospital

    Minato-Ku, Tokyo 108 8642
    Japan

    Site Not Available

  • Kyorin University Hospital

    Mitaka, Tokyo 181-8611
    Japan

    Site Not Available

  • NTT Medical Center Tokyo

    Shinagawa-KU, Tokyo 141-8625
    Japan

    Site Not Available

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi 400-8506
    Japan

    Site Not Available

  • Chiba University Hospital

    Chiba, 260-8677
    Japan

    Site Not Available

  • Saiseikai Fukuoka General Hospital

    Fukuoak, 810-0001
    Japan

    Site Not Available

  • Tokyo Metro Bokutoh Hospital

    Sumida-ku, 130-8575
    Japan

    Site Not Available

  • Toyama University Hospital

    Toyama, 930-0194
    Japan

    Site Not Available

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon-si, Gyeonggi-do 16247
    Korea, Republic of

    Site Not Available

  • Yonsei University Wonju Severance Christian Hospital

    Gangwon-do, Kangwon-do 26426
    Korea, Republic of

    Site Not Available

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul-teukbyeolsi [Seoul]
    Korea, Republic of

    Site Not Available

  • Hanyang University Seoul Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 04763
    Korea, Republic of

    Site Not Available

  • Yeungnam Univeristy Medical Center

    Daegu, Taegu-Kwangyǒkshi 42415
    Korea, Republic of

    Site Not Available

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Liepaja Regional Hospital

    Liepaja, LV-3414
    Latvia

    Site Not Available

  • Pauls Stradins Clinical Univeristy Hospital

    Riga, LV-1002
    Latvia

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, Mazowieckie 04-501
    Poland

    Site Not Available

  • Centrum Medyczne Kermed Renata Bojata-Bronisz i Ewa Kowalińska Sp.j.

    Bydgoszcz, 85-231
    Poland

    Site Not Available

  • ManerMed Sp z o.o. Centrum Medyczne ,Medis

    Bydgoszcz, 85-229
    Poland

    Site Not Available

  • Centrum Medyczne Plejady Magdalena Celińska-Löwenhoff, Michał Żołnowski sp.k

    Krakow, 30-363
    Poland

    Site Not Available

  • Centrum Nowoczesnych Terapii "Dobry Lekarz" sp. z o. o.

    Krakow, 31-011
    Poland

    Site Not Available

  • Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.

    Krakow, 31-506
    Poland

    Site Not Available

  • Medrise Sp. z o.o

    Lublin, 20-582
    Poland

    Site Not Available

  • Twoja Przychodnia Opolskie Centrum Medyczne

    Opole, 45 819
    Poland

    Site Not Available

  • Twoja Przychodnia Pcm

    Poznan, 60-324
    Poland

    Site Not Available

  • Endoskopia Sp. z.o.o.

    Sopot, 81-756
    Poland

    Site Not Available

  • Gastromed Sp. z o.o.

    Torun, 87-100
    Poland

    Site Not Available

  • NZOZ FOR MED sp. z o.o.

    Wadowice, 34-100
    Poland

    Site Not Available

  • Centrum Medyczne Oporów

    Wroclaw, 52-416
    Poland

    Site Not Available

  • VISTAMED

    Wroclaw, 53-149
    Poland

    Site Not Available

  • Ip Clinic Sp. Z O. O.

    Łódź, 90-752
    Poland

    Site Not Available

  • Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor

    Cluj-Napoca, Cluj 400162
    Romania

    Site Not Available

  • Valahia Medical Center SRL

    Ploiesti, Prahova 100032
    Romania

    Site Not Available

  • Colentina Clinical Hospital

    Bucharest, 020125
    Romania

    Site Not Available

  • Emergency University Hospital

    Bucharest, 50098
    Romania

    Site Not Available

  • S.C. Centrul Medical Medicum SRL

    Bucuresti, 012015
    Romania

    Site Not Available

  • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

    Timisoara, 300002
    Romania

    Site Not Available

  • Clinical Hospital Center Zvezdara

    Belgrade, Beograd 11000
    Serbia

    Site Not Available

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña 15706
    Spain

    Site Not Available

  • Hospital General Tomelloso

    Ciudad Real, 13700
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia Comite Etico

    Cordoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • CEIM Hospital Universitario y Politecnico la Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Southern California GI and Liver Centers (SCLC)

    Coronado, California 92118
    United States

    Site Not Available

  • Southern California Research Center, Inc.

    Coronado, California 92118-1943
    United States

    Site Not Available

  • Om Research, LLC

    Lancaster, California 93534
    United States

    Site Not Available

  • United Medical Doctors

    Los Alamitos, California 90720-3433
    United States

    Active - Recruiting

  • Clinnova Research

    Orange, California 92868-4402
    United States

    Active - Recruiting

  • Prospective Research Innovations

    Rancho Cucamonga, California 91730-4850
    United States

    Active - Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907-6262
    United States

    Active - Recruiting

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut 06518-3602
    United States

    Site Not Available

  • Digestive Disease Consultants DDCJAX

    Orange Park, Florida 32073-4752
    United States

    Site Not Available

  • Orlando Health Digestive Health Institute

    Orlando, Florida 32803-1248
    United States

    Site Not Available

  • International Center for Research LLC

    Tampa, Florida 33614
    United States

    Site Not Available

  • Nodal Medical Center

    Tampa, Florida 33607
    United States

    Site Not Available

  • Research Bay,Inc.

    Tampa, Florida 33607
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Avicenna Clinical Research - SW Gastroenterology

    Oak Lawn, Illinois 60453-3754
    United States

    Active - Recruiting

  • Gastroenterology Associates of Western Michigan, P.L.C.

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Ellipsis Research Group

    Brooklyn, New York 11215
    United States

    Site Not Available

  • Smart Medical Research - Jackson Heights

    Jackson Heights, New York 11372
    United States

    Site Not Available

  • Pioneer Clinical Research NY

    New York, New York 10012-3645
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Inquest Clinical Research

    Baytown, Texas 77521
    United States

    Site Not Available

  • DHR Health Gastroenterology - Edinburg

    Edinburg, Texas 78539
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Intergrity Research

    Houston, Texas 77043
    United States

    Site Not Available

  • Gastroenterology Research of San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Tyler Research Institute

    Tyler, Texas 75701
    United States

    Site Not Available

  • Advanced Research Institute - South Ogden

    Ogden, Utah 84405
    United States

    Active - Recruiting

  • Care Access-Ogden

    Ogden, Utah 84403
    United States

    Active - Recruiting

  • University of Washington School Medicine

    Seattle, Washington 98195
    United States

    Site Not Available

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