Ulcerative ColitisPhase 3LUCENT-URGENCT05767021
A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study testing Mirikizumab in people with Ulcerative Colitis and Ulcerative Colitis Chronic, run by Eli Lilly and Company at 120 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Ulcerative Colitis Chronic
- What is being tested?
- Mirikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 120 sitesin 10 countries
- Study dates
- 17 May 2023to 27 Apr 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
120 sites in 10 countries.
120 sites in 10 countries
United States49 sites
Digestive Health Partners - Research Department
Asheville, North Carolina, 28801
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
Washington Gastroenterology
Bellevue, Washington, 98004
NY Scientific
Brooklyn, New York, 11235
Charlotte Gastroenterolgy & Hepatology
Charlotte, North Carolina, 28207
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48038
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Central Florida Gastro Research
Clearwater, Florida, 33762
Optimed Research, LTD
Columbus, Ohio, 43235
Gastro One
Cordova, Tennessee, 38018
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, 30033
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, 06518
Clinical Trial Network
Houston, Texas, 77074
Houston Endoscopy And Research Center, LLC
Houston, Texas, 77079
Biopharma Informatic, LLC
Houston, Texas, 77084
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404
IU Health University Hospital
Indianapolis, Indiana, 46202
Encore Borland-Groover Clinical Research
Jacksonville, Florida, 32256
Citrine Institute for Research and Wellness
Katy, Texas, 77494
Tri-Cities Gastroenterology
Kingsport, Tennessee, 37663
Om Research, LLC
Lancaster, California, 93534
Dedicated Clinical Research
Litchfield Park, Arizona, 85340
AngioCardiac Care of Texas, PA
McAllen, Texas, 78503
GI Alliance/ Metairie
Metairie, Louisiana, 70006
Research Associates of South Florida
Miami, Florida, 33134
Advanced Research Associates, LLC
Miami, Florida, 33176
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130
Delta Research Partners
Monroe, Louisiana, 71201
Gastroenterology Health Partners
New Albany, Indiana, 47150
Central Sooner Research
Norman, Oklahoma, 73071
California Medical Research Associates, Inc.
Northridge, California, 91324
Care Access Research - Ogden
Ogden, Utah, 84403
Digestive System Healthcare
Pasadena, Texas, 77505
LinQ Research, LLC
Pearland, Texas, 77584
University Gastroenterology
Providence, Rhode Island, 02904
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
Southern Star Research Institute, LLC
San Antonio, Texas, 78229
Clinical Applications Laboratories, Inc.
San Diego, California, 92103
Gastroenterology Associates of Texas - Denise Rodriguez
Sugar Land, Texas, 77479
Arizona Digestive Health - Sun City
Sun City, Arizona, 85351
Washington Gastroenterology dba GI Alliance
Tacoma, Washington, 98405
GCP Clinical Research, LLC
Tampa, Florida, 33609
International Center for Research LLC
Tampa, Florida, 33614
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, 66606
Tyler Research Institute, LLC
Tyler, Texas, 75701
GI Alliance Research Webster
Webster, Texas, 77598
Innovo Research:Wilmington Health
Wilmington, North Carolina, 28401
West Michigan Clinical Research Center
Wyoming, Michigan, 49529
Poland23 sites
NZOZ Centrum Medyczne KERmed
Bydgoszcz, 85 231
Vitamed Galaj I Cichomski sp.j.
Bydgoszcz, 85-079
MZ Badania Słowik Zymła Sp.j.
Knurów, Silesian Voivodeship, 44 190
Centrum Medyczne Plejady
Krakow, 30 363
KRAKOWSKIE CENTRUM MEDYCZNE Sp. z o.o
Krakow, 31 501
Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.
Krakow, 31-506
IP Clinic
Lodz, 90-752
Med-GASTR SP. Z O.O., SP.K.
Lodz, 91 034
AmiCare Sp. z o.o. Sp. K.
Lodz, 91 495
Bonifraterskie Centrum Medyczne sp. z o.o
Lodz, 93-357
Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
Nowy Targ, 34-400
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, 45 819
Solumed Centrum Medyczne
Poznan, Greater Poland Voivodeship, 60-529
Centrum Medyczne Medyk
Rzeszów, Subcarpathian, 35-326
Nowe Zdrowie-Ck, Kiełtucki I Wspólnicy Sp. J.
Staszów, 28 200
DC-MED Sp. z o.o. s.k.
Swidnica, 58 100
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434
Sonomed Sp. z o.o.
Szczecin, 71-685
NZOZ FOR MED sp. z o.o.
Wadowice, 34-100
FutureMeds sp. z o. o.
Wroclaw, 50088
PlanetMed Sp.z o.o.
Wroclaw, 52-210
Centrum Medyczne Oporow
Wroclaw, 52416
Centrum Medyczne Kuba Med 2 Sp. z o.o. ETG Zamosc
Zamość, 22 400
France13 sites
Chu Besancon
Besançon, 25000
CHU de LILLE - Bureau des ARCs Gastro - HPDD
Lille, 59037
Hospices Civils de Lyon - Hôpital Lyon Sud - ARC HGE bâtiment 3I
Lyon - Pierre Benite, France, 69495
Hôpital Saint-Eloi Pôle Digestif ,APEMAD - Recherche clinique
Montpellier, 34295
CHU Nantes
Nantes, 44093
Clinique Jules Verne
Nantes, 44300
Unité de Recherche Clinique (4èmeB)
Nice, 06-202
Centre Hospitalier de Pau
Pau, Pyrénées-Atlantiques, 64046
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, Gironde, 33604
Chu de Reims - Hôpital Robert Debré
Reims, 51092
CHU Rennes - Hôpital Pontchaillou
Rennes, Ille Et Vilaine, 35000
CHU de Saint-Etienne
Saint-Etienne, 42055
Chru Nancy Brabois
Vandœuvre-lès-Nancy, 54511
Italy8 sites
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, 25123
IRCCS Saverio de Bellis, National Institute of Gastroenterology
Castellana Grotte, 70013
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, 20122
Irccs Ospedale San Raffaele, Gastroenterologia/Ibd Unit, Settore G Piano -1
Milan, 20132
Fondazione Policlinico Agostino Gemelli IRCCS_ CEMAD
Roma, 00 168
Uoc Gastroenterologia - Policlinico Tor Vergata
Roma, 00133
IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
Rozzano, 20089
A.O.Ordine Mauriziano, SC Gastroenterologia, ambulatorio endoscopia digestiva
Torino, 10128
Czechia7 sites
Vojenska nemocnice Brno, Interni oddeleni
Brno, Czech Republic, 63600
SurGal clinic s.r.o.
Brno, 602 00
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, Hradec Králové, 50012
GastroJeka s.r.o
Klatovy, Czech Republic, 33901
MUDr. Gregar, s.r.o.
Olomouc, Olomouc Region, 779 00
PreventaMed, s.r.o.
Olomouc, 779 00
FN Ostrava, Interní Klinika
Ostrava, Czech Republic, 708 52
Slovakia7 sites
Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica gastroenterologická ambulancia, II. Interná klinika SZU
Banská Bystrica, Slovak Republic, 975 17
ALIAN s.r.o.
Bardejov, Slovak Republic, 08501
CLINIQ, s.r.o
Bratislava, Slovak Republic, 81109
GASTRO AMBULANCIA, poliklinika Ťahanovce
Košice, Slovak Republic, 040 13
Fakultna nemocnica Nitra, Interna klinika
Nitra, Slovak Republic, 950 01
KM Management, spol. s.r.o
Nitra Stare Mesto, Slovak Republic, 949 01
Accout Center s.r.o.
Šahy, Slovak Republic, 93601
Hungary5 sites
Clinepert kft
Budapest, 1033
Semmelweis Egyetem, Belgyógyászati es Hematológiai Klinika
Budapest, 1088
Pannónia Magánorvosi Centrum
Budapest, 1136
Bugat Pal Korhaz
Gyöngyös, Heves County, 3200
Clinfan Ltd. Gastroenterology Clinic
Szekszárd, 7100
Germany3 sites
Praxis Dr. M. Mross - Gastroenterologie
Berlin, 10118
DRK Kliniken Berlin Westend, Gastroenterologie, Studienbüro
Berlin, 14050
Universitätsklinikum Leipzig, Med. Klinik II
Leipzig, 04 103
United Kingdom3 sites
Fairfield General Hospital
Bury, Great Britain, BL9 7TD
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Clinical Research Unit, Royal Liverpool University Hospital
Waltham, Waltham Forest, E11 1NR
Belgium2 sites
Universitair Ziekenhuis Gent - Gastro IBD
Ghent, 9000
UZ Leuven - E507 Studies IBD tav Tine Hermans
Leuven, 3000
About this study
Official title: 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
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.
- Conditions
- Ulcerative Colitis, Ulcerative Colitis Chronic
- Being tested
- Mirikizumab
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirikizumabDrug
Also called LY3074828
Administered IV
MirikizumabDrug
Also called LY3074828
Administered Subcutaneously (SC)
| Study group | Role | What they receive |
|---|---|---|
| 300 mg Mirikizumab | Experimental | Participants received 300 milligram (mg) mirikizumab every 4 weeks (Q4W) at week 0, 4, and 8 administered intravenously (IV). Receives: Drug: Mirikizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12
Secondary outcomes (10)
Change From Baseline in Bowel Urgency Frequency (BUF)
BUF is participant reported single item measure of the number of urgent bowel movements reported in the past 24 hours.
Measured: Baseline, Week 12
Percentage of Participants Achieving Clinically Meaningful Improvement in BUF
This outcome measures the percentage of participants who experience a clinically meaningful reduction in the frequency of bowel urgency episodes from baseline to the 12 week treatment period. Results for this outcome will be reported during final results posting.
Measured: Baseline to Week 12
Percentage of Participants With Stool Deferral Time (SDT) Intervals at Week 12
The SDT is a participant-reported single item measure of the average duration a patient could delay defecation in the past 24 hours. The shortest weekly SDT is used for analysis of SDT in minutes by taking the shortest response (i.e. minimum value) available over the past 7 days, where no urgency is treated as the largest value. The SDT categories were:<1 min, ≥1 min to <2 min, ≥2 min to <5 min, ≥5 min to <15 min, and ≥15 min or no urgency. No urgency indicates participant's selected "Did not feel urge to have a bowel movement in the past 24 hours" for all available days in 7-day period.
Measured: Week 12
Percentage of Participants Achieving Clinically Meaningful Improvement of SDT
This outcome measures the percentage of participants who demonstrate a clinically meaningful improvement in SDT. Results for this outcome will be reported during final results posting.
Measured: 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
Clinical remission based on MMS is defined as Stool Frequency (SF) sub score (range 0-3, higher is worse) = 0, or SF = 1 with a ≥1- point decrease from baseline, and
- Rectal Bleeding (RB) sub score (range 0-3, higher is worse) = 0, and
- Endoscopic sub score (ES) (range 0-3, higher is worse) = 0 or 1 (excluding friability).
UNRS measures bowel urgency severity (range 0 to 10; Higher scores indicate more severe urgency)
This outcome assesses the proportion of participants who achieved both a clinical response, as defined by an MMS, and an improvement of ≥3 points from baseline in a UNRS score at Week 12.
Measured: Week 12
Percentage of Participants Achieving Both Clinical Response, Based on the Modified Mayo Score (MMS) and a Rounded Urgency Numeric Rating Scale (UNRS) Score ≥3 Points of Improvement From Baseline
Clinical response based on MMS is defined as:
- A change in the MMS of ≤ -2 points and ≤ -30% change from baseline, and
- A change of ≤-1 point in the RB subscore (range 0-3, higher is worse) from baseline or a RB score of 0 or 1.
UNRS measures bowel urgency severity (range 0 to 10; Higher scores indicate more severe urgency)
This outcome measures the percentage of participants achieving both, clinical response, based on the MMS, and a UNRS score of ≥3 points of improvement from baseline at 12 weeks.
Measured: Week 12
Pairwise Correlations Between the Urgency Numeric Rating Scale (UNRS), Baseline in Bowel Urgency Frequency (BUF), Stool Deferral Time (SDT) and Absorbent Product Use (APU) Measures
UNRS measures bowel urgency severity (range 0 to 10; Higher scores indicate more severe urgency).
BUF measures the number of urgent bowel movements reported in the past 24 hours.
SDT measures the average duration a patient could delay defecation in the past 24 hours.
APU is a single item to assess participant's need to wear an adult diaper, pad or protection because of bowel urgency.
This outcome evaluates the pairwise correlations among four bowel urgency-related measures above.
Measured: Baseline to Week 12
Pairwise Correlations Between Change From Baseline in Urgency Numeric Rating Scale (UNRS), Baseline in Bowel Urgency Frequency (BUF), Stool Deferral Time (SDT) and Absorbent Product Use (APU) Measures
UNRS measures bowel urgency severity (range 0 to 10; Higher scores indicate more severe urgency).
BUF measures the number of urgent bowel movements reported in the past 24 hours.
SDT measures the average duration a patient could delay defecation in the past 24 hours.
APU is a single item to assess participant's need to wear an adult diaper, pad or protection because of bowel urgency.
This outcome evaluates the pairwise correlations between the change in correlations among four bowel urgency-related measures above.
Measured: Baseline, Week 12
Correlation Between Urgency Numeric Rating Scale (UNRS), Baseline in Bowel Urgency Frequency (BUF),Stool Deferral Time (SDT) and Absorbent Product Use (APU) Measures,With Quality of Life (QoL)/Functional Outcome Measures and UC Symptom Measures
This outcome evaluates correlations between UNRS, BUF, SDT, APU, and patient-reported outcomes (PROs) related to quality of life (QoL), functional outcomes, and UC symptoms. QoL is assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ), a 32-item patient-completed tool with four domains: bowel (score range 10-70), systemic (5-35), emotional (12-84), and social (5-35). Each item is rated on a 7-point Likert scale (1 = very severe problem,7 = not a problem at all); The total IBDQ score is calculated by summing the scores from all four domains and total score range is 32-224 (Higher = better QoL). Functional outcomes measures: Work Productivity and Activity Impairment (WPAI) questionnaire (four scores derived: absenteeism, presenteeism, productivity loss, activity impairment; each score 0-100%, higher = greater impairment) and Generalized Anxiety Disorder-7 (GAD-7; total score range 0-21, higher = more severe anxiety)... (Continued below due to character constraint)
Measured: Baseline to Week 12 UC symptom measures:Patient Global Rating of Severity (PGR-S)(1-6),Patient Global Impression of Change (PGI-C)(1-7),Mayo SF/RB (0-3),Abdominal pain/fatigue NRS (0-10),nocturnal stool frequency;higher=worse severity for all measures.
Correlation Between Change From Baseline in Urgency Numeric Rating Scale (UNRS), Baseline in Bowel Urgency Frequency (BUF), Stool Deferral Time (SDT) and Absorbent Product Use (APU) Measures, With QoL/Functional Outcome Measures and UC Symptom Measures
This outcome evaluates correlations between change from baseline in UNRS, BUF, SDT, APU, and PROs related to quality of life (QoL), functional outcomes, and UC symptoms. QoL is assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ), a 32-item patient-completed tool with four domains: bowel (score range 10-70), systemic (5-35), emotional (12-84), and social (5-35). Each item is rated on a 7-point Likert scale (1 = very severe problem, 7 = not a problem at all); The total IBDQ score is calculated by summing the scores from all four domains and total score range is 32-224 (Higher = better QoL). Functional outcomes measures: Work Productivity and Activity Impairment (WPAI) questionnaire (four scores derived: absenteeism, presenteeism, productivity loss, activity impairment; each score 0-100%, higher = greater impairment) and Generalized Anxiety Disorder-7 (GAD-7;total score range 0-21, higher = more severe anxiety)... (Continued below due to character constraint)
Measured: Baseline, Week 12 UC symptom measures:Patient Global Rating of Severity (PGR-S)(1-6),Patient Global Impression of Change (PGI-C)(1-7),Mayo SF/RB (0-3),Abdominal pain/fatigue NRS (0-10),nocturnal stool frequency; higher=worse severity for all measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start17 May 2023
- Primary completion9 Aug 2024
- Study completion27 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767021
- Sponsor's protocol ID
- 18551
- Other IDs
- I6T-MC-AMBZ, 2022-502393-16-00
- Acronym
- LUCENT-URGE
- Status last verified
- May 2026
- First submitted
- 8 Feb 2023
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Danese S, Dignass A, Laharie D, Limdi JK, Kempinski R, Lewis JD, Younes Z, Cohen E, Alaka K, Eastman WJ, Tian T, Redondo I, Rubin DT, Dubinsky M. Mirikizumab is associated with rapid and sustained improvements in novel measures of bowel urgency in moderately-to-severely active ulcerative colitis: 28-week results from the LUCENT-URGE trial. J Crohns Colitis. 2026 May 8;20(5):jjag049. doi: 10.1093/ecco-jcc/jjag049.
PubMed 42112567