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NCT06598943PHASE2Recruiting

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

Eli Lilly and Company

Start Date

10/10/2024

Completion Date

9/1/2028

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

Eltrekibart

DRUG

Mirikizumab

DRUG

Placebo

Interested in This Trial?

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Conditions

Ulcerative ColitisUlcerative Colitis Chronic

Locations

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)