A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT05767021
Last Updated: 2025-10-28
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
172 participants
INTERVENTIONAL
2023-05-17
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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300 mg Mirikizumab
Participants received 300 milligram (mg) mirikizumab every 4 weeks (Q4W) at week 0, 4, and 8 administered intravenously (IV).
Mirikizumab
Administered IV
Mirikizumab
Administered Subcutaneously (SC)
Interventions
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Mirikizumab
Administered IV
Mirikizumab
Administered Subcutaneously (SC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have confirmed diagnosis of moderately for severely active UC
* Have current bowel urgency
* Have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic/Janus Kinase (JAK) inhibitor/sphingosine-1-phosphate (S1P) receptor modulator therapy for UC.
Exclusion Criteria
* Have inflammatory bowel disease-unclassified, formerly known as indeterminate colitis, or
* Have ulcerative proctitis, disease limited to the rectum, that is, distal to the recto-sigmoid junction, which lies approximately 10 to 15 centimeter (cm) from anal verge.
* Have an inherited immunodeficiency syndrome or a monogenic cause of UC-like colonic inflammation
* Have any history or current evidence of cancer of the gastrointestinal tract
* Have active tuberculosis
* Have HIV infection.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Dedicated Clinical Research
Litchfield Park, Arizona, United States
Arizona Digestive Health - Sun City
Sun City, Arizona, United States
Om Research, LLC
Lancaster, California, United States
California Medical Research Associates, Inc.
Northridge, California, United States
Clinical Applications Laboratories, Inc.
San Diego, California, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States
Central Florida Gastro Research
Clearwater, Florida, United States
Encore Borland-Groover Clinical Research
Jacksonville, Florida, United States
Research Associates of South Florida
Miami, Florida, United States
Advanced Research Associates, LLC
Miami, Florida, United States
GCP Clinical Research, LLC
Tampa, Florida, United States
International Center for Research LLC
Tampa, Florida, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, United States
IU Health University Hospital
Indianapolis, Indiana, United States
Gastroenterology Health Partners
New Albany, Indiana, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States
GI Alliance/ Metairie
Metairie, Louisiana, United States
Delta Research Partners
Monroe, Louisiana, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
West Michigan Clinical Research Center
Wyoming, Michigan, United States
NY Scientific
Brooklyn, New York, United States
Digestive Health Partners - Research Department
Asheville, North Carolina, United States
Charlotte Gastroenterolgy & Hepatology
Charlotte, North Carolina, United States
Innovo Research:Wilmington Health
Wilmington, North Carolina, United States
Optimed Research, LTD
Columbus, Ohio, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
University Gastroenterology
Providence, Rhode Island, United States
Gastro One
Cordova, Tennessee, United States
Tri-Cities Gastroenterology
Kingsport, Tennessee, United States
Clinical Trial Network
Houston, Texas, United States
Houston Endoscopy And Research Center, LLC
Houston, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Citrine Institute for Research and Wellness
Katy, Texas, United States
AngioCardiac Care of Texas, PA
McAllen, Texas, United States
Digestive System Healthcare
Pasadena, Texas, United States
LinQ Research, LLC
Pearland, Texas, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Gastroenterology Associates of Texas - Denise Rodriguez
Sugar Land, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
GI Alliance Research Webster
Webster, Texas, United States
Care Access Research - Ogden
Ogden, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Washington Gastroenterology
Bellevue, Washington, United States
Washington Gastroenterology dba GI Alliance
Tacoma, Washington, United States
Universitair Ziekenhuis Gent - Gastro IBD
Ghent, , Belgium
UZ Leuven - E507 Studies IBD tav Tine Hermans
Leuven, , Belgium
Vojenska nemocnice Brno, Interni oddeleni
Brno, Czech Republic, Czechia
GastroJeka s.r.o
Klatovy, Czech Republic, Czechia
FN Ostrava, Interní Klinika
Ostrava, Czech Republic, Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, Hradec Králové, Czechia
MUDr. Gregar, s.r.o.
Olomouc, Olomoucký kraj, Czechia
SurGal clinic s.r.o.
Brno, , Czechia
PreventaMed, s.r.o.
Olomouc, , Czechia
Hospices Civils de Lyon - Hôpital Lyon Sud - ARC HGE bâtiment 3I
Lyon - Pierre Benite, France, France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, Gironde, France
CHU Rennes - Hôpital Pontchaillou
Rennes, Ille Et Vilaine, France
Centre Hospitalier de Pau
Pau, Pyrénées-Atlantiques, France
Chu Besancon
Besançon, , France
CHU de LILLE - Bureau des ARCs Gastro - HPDD
Lille, , France
Hôpital Saint-Eloi Pôle Digestif ,APEMAD - Recherche clinique
Montpellier, , France
CHU Nantes
Nantes, , France
Clinique Jules Verne
Nantes, , France
Unité de Recherche Clinique (4èmeB)
Nice, , France
Chu de Reims - Hôpital Robert Debré
Reims, , France
CHU de Saint-Etienne
Saint-Etienne, , France
Chru Nancy Brabois
Vandœuvre-lès-Nancy, , France
Praxis Dr. M. Mross - Gastroenterologie
Berlin, , Germany
DRK Kliniken Berlin Westend, Gastroenterologie, Studienbüro
Berlin, , Germany
Universitätsklinikum Leipzig, Med. Klinik II
Leipzig, , Germany
Bugat Pal Korhaz
Gyöngyös, Heves County, Hungary
Clinepert kft
Budapest, , Hungary
Semmelweis Egyetem, Belgyógyászati es Hematológiai Klinika
Budapest, , Hungary
Pannónia Magánorvosi Centrum
Budapest, , Hungary
Clinfan Ltd. Gastroenterology Clinic
Szekszárd, , Hungary
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, , Italy
IRCCS Saverio de Bellis, National Institute of Gastroenterology
Castellana Grotte, , Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, , Italy
Irccs Ospedale San Raffaele, Gastroenterologia/Ibd Unit, Settore G Piano -1
Milan, , Italy
Fondazione Policlinico Agostino Gemelli IRCCS_ CEMAD
Roma, , Italy
Uoc Gastroenterologia - Policlinico Tor Vergata
Roma, , Italy
IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
Rozzano, , Italy
A.O.Ordine Mauriziano, SC Gastroenterologia, ambulatorio endoscopia digestiva
Torino, , Italy
Solumed Centrum Medyczne
Poznan, Greater Poland Voivodeship, Poland
MZ Badania Słowik Zymła Sp.j.
Knurów, Silesian Voivodeship, Poland
Centrum Medyczne Medyk
Rzeszów, Subcarpathian, Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz, , Poland
Vitamed Galaj I Cichomski sp.j.
Bydgoszcz, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
KRAKOWSKIE CENTRUM MEDYCZNE Sp. z o.o
Krakow, , Poland
Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.
Krakow, , Poland
IP Clinic
Lodz, , Poland
Med-GASTR SP. Z O.O., SP.K.
Lodz, , Poland
AmiCare Sp. z o.o. Sp. K.
Lodz, , Poland
Bonifraterskie Centrum Medyczne sp. z o.o
Lodz, , Poland
Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
Nowy Targ, , Poland
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, , Poland
Nowe Zdrowie-Ck, Kiełtucki I Wspólnicy Sp. J.
Staszów, , Poland
DC-MED Sp. z o.o. s.k.
Swidnica, , Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, , Poland
Sonomed Sp. z o.o.
Szczecin, , Poland
NZOZ FOR MED sp. z o.o.
Wadowice, , Poland
FutureMeds sp. z o. o.
Wroclaw, , Poland
PlanetMed Sp.z o.o.
Wroclaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Centrum Medyczne Kuba Med 2 Sp. z o.o. ETG Zamosc
Zamość, , Poland
Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica gastroenterologická ambulancia, II. Interná klinika SZU
Banská Bystrica, Slovak Republic, Slovakia
ALIAN s.r.o.
Bardejov, Slovak Republic, Slovakia
CLINIQ, s.r.o
Bratislava, Slovak Republic, Slovakia
GASTRO AMBULANCIA, poliklinika Ťahanovce
Košice, Slovak Republic, Slovakia
Fakultna nemocnica Nitra, Interna klinika
Nitra, Slovak Republic, Slovakia
KM Management, spol. s.r.o
Nitra Stare Mesto, Slovak Republic, Slovakia
Accout Center s.r.o.
Šahy, Slovak Republic, Slovakia
Fairfield General Hospital
Bury, Great Britain, United Kingdom
Clinical Research Unit, Royal Liverpool University Hospital
Waltham, Waltham Forest, United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT-URGE)
Other Identifiers
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I6T-MC-AMBZ
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502393-16-00
Identifier Type: OTHER
Identifier Source: secondary_id
18551
Identifier Type: -
Identifier Source: org_study_id
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