A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
LUCENT-URGE
A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship With Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab
3 other identifiers
interventional
172
10 countries
120
Brief Summary
A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2023
Typical duration for phase_3
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
March 14, 2023
CompletedStudy Start
First participant enrolled
May 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2024
CompletedResults Posted
Study results publicly available
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedOctober 28, 2025
October 1, 2025
1.2 years
February 8, 2023
August 8, 2025
October 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Bowel Urgency Severity Urgency Numeric Rating Scale (UNRS)
The UNRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicate more severe urgency. Baseline Observation Carried Forward (BOCF) endpoint was defined as the baseline value for participants discontinued during acute phase and defined as the last non-missing observation in the treatment phase for all other randomized participants.
Baseline, Week 12
Secondary Outcomes (10)
Change From Baseline in Bowel Urgency Frequency (BUF)
Baseline, Week 12
Percentage of Participants Achieving Clinically Meaningful Improvement in BUF
Baseline to Week 12
Percentage of Participants With Stool Deferral Time (SDT) Intervals at Week 12
Week 12
Percentage of Participants Achieving Clinically Meaningful Improvement of SDT
Week 12
Percentage of Participants Achieving Both Clinical Remission, Based on the Modified Mayo Score (MMS) and a Rounded Urgency Numeric Rating Scale (UNRS) Score of ≤1
Week 12
- +5 more secondary outcomes
Study Arms (1)
300 mg Mirikizumab
EXPERIMENTALParticipants received 300 milligram (mg) mirikizumab every 4 weeks (Q4W) at week 0, 4, and 8 administered intravenously (IV).
Interventions
Eligibility Criteria
You may qualify if:
- Have an established diagnosis of UC for ≥3 months
- 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.
You may not qualify if:
- Have Crohn's disease (CD)
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (120)
Dedicated Clinical Research
Litchfield Park, Arizona, 85340, United States
Arizona Digestive Health - Sun City
Sun City, Arizona, 85351, United States
Om Research, LLC
Lancaster, California, 93534, United States
California Medical Research Associates, Inc.
Northridge, California, 91324, United States
Clinical Applications Laboratories, Inc.
San Diego, California, 92103, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518, United States
Central Florida Gastro Research
Clearwater, Florida, 33762, United States
Encore Borland-Groover Clinical Research
Jacksonville, Florida, 32256, United States
Research Associates of South Florida
Miami, Florida, 33134, United States
Advanced Research Associates, LLC
Miami, Florida, 33176, United States
GCP Clinical Research, LLC
Tampa, Florida, 33609, United States
International Center for Research LLC
Tampa, Florida, 33614, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033, United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404, United States
IU Health University Hospital
Indianapolis, Indiana, 46202, United States
Gastroenterology Health Partners
New Albany, Indiana, 47150, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 66606, United States
GI Alliance/ Metairie
Metairie, Louisiana, 70006, United States
Delta Research Partners
Monroe, Louisiana, 71201, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48038, United States
West Michigan Clinical Research Center
Wyoming, Michigan, 49529, United States
NY Scientific
Brooklyn, New York, 11235, United States
Digestive Health Partners - Research Department
Asheville, North Carolina, 28801, United States
Charlotte Gastroenterolgy & Hepatology
Charlotte, North Carolina, 28207, United States
Innovo Research:Wilmington Health
Wilmington, North Carolina, 28401, United States
Optimed Research, LTD
Columbus, Ohio, 43235, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130, United States
Central Sooner Research
Norman, Oklahoma, 73071, United States
University Gastroenterology
Providence, Rhode Island, 02904, United States
Gastro One
Cordova, Tennessee, 38018, United States
Tri-Cities Gastroenterology
Kingsport, Tennessee, 37663, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Houston Endoscopy And Research Center, LLC
Houston, Texas, 77079, United States
Biopharma Informatic, LLC
Houston, Texas, 77084, United States
Citrine Institute for Research and Wellness
Katy, Texas, 77494, United States
AngioCardiac Care of Texas, PA
McAllen, Texas, 78503, United States
Digestive System Healthcare
Pasadena, Texas, 77505, United States
LinQ Research, LLC
Pearland, Texas, 77584, United States
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
Gastroenterology Associates of Texas - Denise Rodriguez
Sugar Land, Texas, 77479, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
GI Alliance Research Webster
Webster, Texas, 77598, United States
Care Access Research - Ogden
Ogden, Utah, 84403, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Washington Gastroenterology
Bellevue, Washington, 98004, United States
Washington Gastroenterology dba GI Alliance
Tacoma, Washington, 98405, United States
Universitair Ziekenhuis Gent - Gastro IBD
Ghent, 9000, Belgium
UZ Leuven - E507 Studies IBD tav Tine Hermans
Leuven, 3000, Belgium
Vojenska nemocnice Brno, Interni oddeleni
Brno, Czech Republic, 63600, Czechia
GastroJeka s.r.o
Klatovy, Czech Republic, 33901, Czechia
FN Ostrava, Interní Klinika
Ostrava, Czech Republic, 708 52, Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, Hradec Králové, 50012, Czechia
MUDr. Gregar, s.r.o.
Olomouc, Olomoucký kraj, 779 00, Czechia
SurGal clinic s.r.o.
Brno, 602 00, Czechia
PreventaMed, s.r.o.
Olomouc, 779 00, Czechia
Hospices Civils de Lyon - Hôpital Lyon Sud - ARC HGE bâtiment 3I
Lyon - Pierre Benite, France, 69495, France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, Gironde, 33604, France
CHU Rennes - Hôpital Pontchaillou
Rennes, Ille Et Vilaine, 35000, France
Centre Hospitalier de Pau
Pau, Pyrénées-Atlantiques, 64046, France
Chu Besancon
Besançon, 25000, France
CHU de LILLE - Bureau des ARCs Gastro - HPDD
Lille, 59037, France
Hôpital Saint-Eloi Pôle Digestif ,APEMAD - Recherche clinique
Montpellier, 34295, France
CHU Nantes
Nantes, 44093, France
Clinique Jules Verne
Nantes, 44300, France
Unité de Recherche Clinique (4èmeB)
Nice, 06-202, France
Chu de Reims - Hôpital Robert Debré
Reims, 51092, France
CHU de Saint-Etienne
Saint-Etienne, 42055, France
Chru Nancy Brabois
Vandœuvre-lès-Nancy, 54511, France
Praxis Dr. M. Mross - Gastroenterologie
Berlin, 10118, Germany
DRK Kliniken Berlin Westend, Gastroenterologie, Studienbüro
Berlin, 14050, Germany
Universitätsklinikum Leipzig, Med. Klinik II
Leipzig, 04 103, Germany
Bugat Pal Korhaz
Gyöngyös, Heves County, 3200, Hungary
Clinepert kft
Budapest, 1033, Hungary
Semmelweis Egyetem, Belgyógyászati es Hematológiai Klinika
Budapest, 1088, Hungary
Pannónia Magánorvosi Centrum
Budapest, 1136, Hungary
Clinfan Ltd. Gastroenterology Clinic
Szekszárd, 7100, Hungary
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, 25123, Italy
IRCCS Saverio de Bellis, National Institute of Gastroenterology
Castellana Grotte, 70013, Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Irccs Ospedale San Raffaele, Gastroenterologia/Ibd Unit, Settore G Piano -1
Milan, 20132, Italy
Fondazione Policlinico Agostino Gemelli IRCCS_ CEMAD
Roma, 00 168, Italy
Uoc Gastroenterologia - Policlinico Tor Vergata
Roma, 00133, Italy
IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
Rozzano, 20089, Italy
A.O.Ordine Mauriziano, SC Gastroenterologia, ambulatorio endoscopia digestiva
Torino, 10128, Italy
Solumed Centrum Medyczne
Poznan, Greater Poland Voivodeship, 60-529, Poland
MZ Badania Słowik Zymła Sp.j.
Knurów, Silesian Voivodeship, 44 190, Poland
Centrum Medyczne Medyk
Rzeszów, Subcarpathian, 35-326, Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz, 85 231, Poland
Vitamed Galaj I Cichomski sp.j.
Bydgoszcz, 85-079, Poland
Centrum Medyczne Plejady
Krakow, 30 363, Poland
KRAKOWSKIE CENTRUM MEDYCZNE Sp. z o.o
Krakow, 31 501, Poland
Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.
Krakow, 31-506, Poland
IP Clinic
Lodz, 90-752, Poland
Med-GASTR SP. Z O.O., SP.K.
Lodz, 91 034, Poland
AmiCare Sp. z o.o. Sp. K.
Lodz, 91 495, Poland
Bonifraterskie Centrum Medyczne sp. z o.o
Lodz, 93-357, Poland
Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
Nowy Targ, 34-400, Poland
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, 45 819, Poland
Nowe Zdrowie-Ck, Kiełtucki I Wspólnicy Sp. J.
Staszów, 28 200, Poland
DC-MED Sp. z o.o. s.k.
Swidnica, 58 100, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
Sonomed Sp. z o.o.
Szczecin, 71-685, Poland
NZOZ FOR MED sp. z o.o.
Wadowice, 34-100, Poland
FutureMeds sp. z o. o.
Wroclaw, 50088, Poland
PlanetMed Sp.z o.o.
Wroclaw, 52-210, Poland
Centrum Medyczne Oporow
Wroclaw, 52416, Poland
Centrum Medyczne Kuba Med 2 Sp. z o.o. ETG Zamosc
Zamość, 22 400, Poland
Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica gastroenterologická ambulancia, II. Interná klinika SZU
Banská Bystrica, Slovak Republic, 975 17, Slovakia
ALIAN s.r.o.
Bardejov, Slovak Republic, 08501, Slovakia
CLINIQ, s.r.o
Bratislava, Slovak Republic, 81109, Slovakia
GASTRO AMBULANCIA, poliklinika Ťahanovce
Košice, Slovak Republic, 040 13, Slovakia
Fakultna nemocnica Nitra, Interna klinika
Nitra, Slovak Republic, 950 01, Slovakia
KM Management, spol. s.r.o
Nitra Stare Mesto, Slovak Republic, 949 01, Slovakia
Accout Center s.r.o.
Šahy, Slovak Republic, 93601, Slovakia
Fairfield General Hospital
Bury, Great Britain, BL9 7TD, United Kingdom
Clinical Research Unit, Royal Liverpool University Hospital
Waltham, Waltham Forest, E11 1NR, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2023
First Posted
March 14, 2023
Study Start
May 17, 2023
Primary Completion
August 9, 2024
Study Completion
April 1, 2026
Last Updated
October 28, 2025
Results First Posted
September 30, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.