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