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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Other trials in United States

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

Other trials in Poland

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

Other trials in France

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

Other trials in Italy

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

Other trials in Czechia

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

Other trials in Slovakia

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

Other trials in Hungary

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

Other trials in Germany

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

Other trials in United Kingdom

Belgium2 sites

  • Universitair Ziekenhuis Gent - Gastro IBD

    Ghent, 9000

  • UZ Leuven - E507 Studies IBD tav Tine Hermans

    Leuven, 3000

Other trials in Belgium

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.

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 groups in NCT05767021
Study groupRoleWhat they receive
300 mg MirikizumabExperimentalParticipants 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.

  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.

    Measured: Baseline, Week 12

Secondary outcomes (10)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

    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.

    Measured: Week 12

  6. 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:

    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.

    Measured: Week 12

  7. 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

  8. 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

  9. 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.

  10. 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.

  1. First posted14 Mar 2023
  2. Study start17 May 2023
  3. Primary completion9 Aug 2024
  4. Study completion27 Apr 2026

Resources

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)
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
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Poland, France, Italy, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Bowel Urgency Severity Urgency Numeric Rating Scale (UNRS) (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05767021, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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