A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT-URGE)

May 20, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
172

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent - Gastro IBD
      • Leuven, Belgium, 3000
        • UZ Leuven - E507 Studies IBD tav Tine Hermans
  • Czechia
      • Brno, Czechia, 602 00
        • SurGal Clinic s.r.o.
      • Olomouc, Czechia, 779 00
        • PreventaMed, s.r.o.
    • Czech Republic
      • Brno, Czech Republic, Czechia, 63600
        • Vojenska nemocnice Brno, Interni oddeleni
      • Klatovy, Czech Republic, Czechia, 33901
        • GastroJeka s.r.o
      • Ostrava, Czech Republic, Czechia, 708 52
        • FN Ostrava, Interní Klinika
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Czechia, 50012
        • Hepato-gastroenterologie HK, s.r.o.
    • Olomouc Region
      • Olomouc, Olomouc Region, Czechia, 779 00
        • MUDr. Gregar, s.r.o.
  • France
      • Besançon, France, 25000
        • CHU Besançon
      • Lille, France, 59037
        • CHU de LILLE - Bureau des ARCs Gastro - HPDD
      • Montpellier, France, 34295
        • Hôpital Saint-Eloi Pôle Digestif ,APEMAD - Recherche clinique
      • Nantes, France, 44093
        • CHU Nantes
      • Nantes, France, 44300
        • Clinique Jules Verne
      • Nice, France, 06-202
        • Unité de Recherche Clinique (4èmeB)
      • Reims, France, 51092
        • CHU de Reims - Hôpital Robert Debré
      • Saint-Etienne, France, 42055
        • CHU de Saint-Etienne
      • Vandœuvre-lès-Nancy, France, 54511
        • CHRU Nancy Brabois
    • France
      • Lyon - Pierre Benite, France, France, 69495
        • Hospices Civils de Lyon - Hôpital Lyon Sud - ARC HGE bâtiment 3I
    • Gironde
      • Pessac, Gironde, France, 33604
        • CHU Bordeaux - Hôpital Haut-Lévêque
    • Ille Et Vilaine
      • Rennes, Ille Et Vilaine, France, 35000
        • CHU Rennes - Hôpital Pontchaillou
    • Pyrénées-Atlantiques
      • Pau, Pyrénées-Atlantiques, France, 64046
        • Centre Hospitalier de Pau
  • Germany
      • Berlin, Germany, 10118
        • Praxis Dr. M. Mross - Gastroenterologie
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin Westend, Gastroenterologie, Studienbüro
      • Leipzig, Germany, 04 103
        • Universitätsklinikum Leipzig, Med. Klinik II
  • Hungary
      • Budapest, Hungary, 1136
        • Pannonia Maganorvosi Centrum
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
      • Budapest, Hungary, 1033
        • Clinepert kft
      • Szekszárd, Hungary, 7100
        • Clinfan Ltd. Gastroenterology Clinic
    • Heves County
      • Gyöngyös, Heves County, Hungary, 3200
        • Bugat Pal Korhaz
  • Italy
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Castellana Grotte, Italy, 70013
        • IRCCS Saverio de Bellis, National Institute of Gastroenterology
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
      • Milan, Italy, 20132
        • Irccs Ospedale San Raffaele, Gastroenterologia/Ibd Unit, Settore G Piano -1
      • Roma, Italy, 00 168
        • Fondazione Policlinico Agostino Gemelli IRCCS_ CEMAD
      • Roma, Italy, 00133
        • Uoc Gastroenterologia - Policlinico Tor Vergata
      • Rozzano, Italy, 20089
        • IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
      • Torino, Italy, 10128
        • A.O.Ordine Mauriziano, SC Gastroenterologia, ambulatorio endoscopia digestiva
  • Poland
      • Bydgoszcz, Poland, 85 231
        • NZOZ Centrum Medyczne KERmed
      • Bydgoszcz, Poland, 85-079
        • Vitamed Galaj i Cichomski sp.j.
      • Krakow, Poland, 30 363
        • Centrum Medyczne Plejady
      • Krakow, Poland, 31 501
        • Krakowskie Centrum Medyczne Sp. z o.o
      • Krakow, Poland, 31-506
        • Topolowa Medicenter Ryszawa & Wspólnicy Sp.j.
      • Lodz, Poland, 90-752
        • IP Clinic
      • Lodz, Poland, 91 034
        • Med-GASTR SP. Z O.O., SP.K.
      • Lodz, Poland, 91 495
        • AmiCare Sp. z o.o. Sp. k.
      • Lodz, Poland, 93-357
        • Bonifraterskie Centrum Medyczne sp. z o.o
      • Nowy Targ, Poland, 34-400
        • Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
      • Opole, Poland, 45 819
        • Twoja Przychodnia Opolskie Centrum Medyczne
      • Staszów, Poland, 28 200
        • Nowe Zdrowie-Ck, Kiełtucki I Wspólnicy Sp. J.
      • Swidnica, Poland, 58 100
        • DC-MED Sp. z o.o. s.k.
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Szczecin, Poland, 71-685
        • Sonomed Sp. z o.o.
      • Wadowice, Poland, 34-100
        • NZOZ FOR MED sp. z o.o.
      • Wroclaw, Poland, 52416
        • Centrum Medyczne Oporow
      • Wroclaw, Poland, 52-210
        • PlanetMed Sp.z o.o.
      • Wroclaw, Poland, 50088
        • FutureMeds sp. z o. o.
      • Zamość, Poland, 22 400
        • Centrum Medyczne Kuba Med 2 Sp. z o.o. ETG Zamosc
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-529
        • SOLUMED Centrum Medyczne
    • Silesian Voivodeship
      • Knurów, Silesian Voivodeship, Poland, 44 190
        • MZ Badania Słowik Zymła Sp.j.
    • Subcarpathian
      • Rzeszów, Subcarpathian, Poland, 35-326
        • Centrum Medyczne Medyk
  • Slovakia
    • Slovak Republic
      • Banská Bystrica, Slovak Republic, Slovakia, 975 17
        • Fakultná nemocnica s poliklinikou F. D. Roosevelta Banská Bystrica gastroenterologická ambulancia, II. Interná klinika SZU
      • Bardejov, Slovak Republic, Slovakia, 08501
        • Alian s.r.o.
      • Bratislava, Slovak Republic, Slovakia, 81109
        • CLINIQ, s.r.o
      • Košice, Slovak Republic, Slovakia, 040 13
        • GASTRO AMBULANCIA, poliklinika Ťahanovce
      • Nitra, Slovak Republic, Slovakia, 950 01
        • Fakultna nemocnica Nitra, Interna klinika
      • Nitra Stare Mesto, Slovak Republic, Slovakia, 949 01
        • KM Management, spol. s.r.o
      • Šahy, Slovak Republic, Slovakia, 93601
        • Accout Center s.r.o.
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust
    • Great Britain
      • Bury, Great Britain, United Kingdom, BL9 7TD
        • Fairfield General Hospital
    • Waltham Forest
      • Waltham, Waltham Forest, United Kingdom, E11 1NR
        • Clinical Research Unit, Royal Liverpool University Hospital
  • United States
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Dedicated Clinical Research
      • Sun City, Arizona, United States, 85351
        • Arizona Digestive Health - Sun City
    • California
      • Lancaster, California, United States, 93534
        • Om Research, LLC
      • Northridge, California, United States, 91324
        • California Medical Research Associates, Inc.
      • San Diego, California, United States, 92103
        • Clinical Applications Laboratories, Inc.
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut, LLC
    • Florida
      • Clearwater, Florida, United States, 33762
        • Central Florida Gastro Research
      • Jacksonville, Florida, United States, 32256
        • Encore Borland-Groover Clinical Research
      • Miami, Florida, United States, 33134
        • Research Associates of South Florida
      • Miami, Florida, United States, 33176
        • Advanced Research Associates, LLC
      • Tampa, Florida, United States, 33609
        • GCP Clinical Research, LLC
      • Tampa, Florida, United States, 33614
        • International Center for Research LLC
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta Center for Gastroenterology, P.C.
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Research Group, PLLC
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health University Hospital
      • New Albany, Indiana, United States, 47150
        • Gastroenterology Health Partners
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center, Digestive Health
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • GI Alliance/ Metairie
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
    • Michigan
      • Chesterfield, Michigan, United States, 48038
        • Clinical Research Institute of Michigan, LLC
      • Wyoming, Michigan, United States, 49529
        • West Michigan Clinical Research Center
    • New York
      • Brooklyn, New York, United States, 11235
        • NY Scientific
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Digestive Health Partners - Research Department
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterolgy & Hepatology
      • Wilmington, North Carolina, United States, 28401
        • Innovo Research:Wilmington Health
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Optimed Research, LTD
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Central Sooner Research
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • University Gastroenterology
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Gastro One
      • Kingsport, Tennessee, United States, 37663
        • Tri-Cities Gastroenterology
    • Texas
      • Houston, Texas, United States, 77074
        • Clinical Trial Network
      • Houston, Texas, United States, 77084
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77079
        • Houston Endoscopy And Research Center, LLC
      • Katy, Texas, United States, 77494
        • Citrine Institute for Research and Wellness
      • McAllen, Texas, United States, 78503
        • AngioCardiac Care of Texas, PA
      • Pasadena, Texas, United States, 77505
        • Digestive System Healthcare
      • Pearland, Texas, United States, 77584
        • LinQ Research, LLC
      • San Antonio, Texas, United States, 78229
        • Southern Star Research Institute, LLC
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Research of San Antonio
      • Sugar Land, Texas, United States, 77479
        • Gastroenterology Associates of Texas - Denise Rodriguez
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute, LLC
      • Webster, Texas, United States, 77598
        • GI Alliance Research Webster
    • Utah
      • Ogden, Utah, United States, 84403
        • Care Access Research - Ogden
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research
    • Washington
      • Bellevue, Washington, United States, 98004
        • Washington Gastroenterology
      • Tacoma, Washington, United States, 98405
        • Washington Gastroenterology dba GI Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 300 mg Mirikizumab
Participants received 300 milligram (mg) mirikizumab every 4 weeks (Q4W) at week 0, 4, and 8 administered intravenously (IV).
Drug: Mirikizumab
Administered IV
Other Names:
  • LY3074828
Drug: Mirikizumab
Administered Subcutaneously (SC)
Other Names:
  • LY3074828

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Bowel Urgency Severity Urgency Numeric Rating Scale (UNRS)
Time Frame: Baseline, Week 12

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Bowel Urgency Frequency (BUF)
Time Frame: Baseline, Week 12
BUF is participant reported single item measure of the number of urgent bowel movements reported in the past 24 hours.
Baseline, Week 12
Percentage of Participants Achieving Clinically Meaningful Improvement in BUF
Time Frame: Baseline to Week 12
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.
Baseline to Week 12
Percentage of Participants With Stool Deferral Time (SDT) Intervals at Week 12
Time Frame: 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.
Week 12
Percentage of Participants Achieving Clinically Meaningful Improvement of SDT
Time Frame: Week 12
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.
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
Time Frame: Week 12

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

  1. Rectal Bleeding (RB) sub score (range 0-3, higher is worse) = 0, and
  2. 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.
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
Time Frame: Week 12

Clinical response based on MMS is defined as:

  1. A change in the MMS of ≤ -2 points and ≤ -30% change from baseline, and
  2. 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.
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
Time Frame: Baseline to Week 12

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.
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
Time Frame: Baseline, Week 12

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.
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
Time Frame: 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.
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)
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
Time Frame: 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.
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)
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18551
  • I6T-MC-AMBZ (Other Identifier: Eli Lilly and Company)
  • 2022-502393-16-00 (Other Identifier: EU Clinical Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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