Evidence map›Paper›PMID 42112567›Full record

Trial reportJournal of Crohn's & colitis2026

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.

Silvio Danese, Axel Dignass, David Laharie, Jimmy K Limdi, Radoslaw Kempinski, James D Lewis, Ziad Younes, Erica Cohen, Karla Alaka, William J Eastman and 4 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Journal of Crohn's & colitis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05767021 (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), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05767021 phase3completednot on this map

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

TypeinterventionalSponsorEli Lilly and CompanyRan2023 to 2026Enrolled172ConditionsUlcerative Colitis, Ulcerative Colitis ChronicArmsMirikizumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Silvio DaneseIRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.ORCID 0000-0001-7341-1351
Axel DignassAgaplesion Markus Hospital, Goethe University, Frankfurt/Main, Germany.ORCID 0000-0002-9724-054X
David LaharieCHU de Bordeaux, Centre Medico-Chirurgical Magellan, Hôpital Haut-Lévêque, Gastroenterology Department, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France.
Jimmy K LimdiNorthern Care Alliance NHS Foundation Trust and University of Manchester, Manchester, United Kingdom.
Radoslaw KempinskiWrocław Medical University, Wrocław, Poland.
James D LewisUniversity of Pennsylvania, Philadelphia, PA, United States.
Ziad YounesGastroenterology Center of the MidSouth PC, Germantown, TN, United States.
Erica CohenCapital Digestive Care, Chevy Chase, MD, United States.
Karla AlakaEli Lilly and Company, Indianapolis, IN, United States.
William J EastmanEli Lilly and Company, Indianapolis, IN, United States.
Tian TianEli Lilly and Company, Indianapolis, IN, United States.
Isabel RedondoEli Lilly and Company, Indianapolis, IN, United States.
David T RubinUniversity of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL, United States.
Marla DubinskyIcahn School of Medicine at Mount Sinai, Icahn School of Medicine, New York, NY, United States.

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

introductionLUCENT-URGE (NCT05767021) was a Phase 3b, multicenter, open-label, single-arm study investigating bowel urgency (BU) in patients with moderately-to-severely active ulcerative colitis (UC) and BU at baseline, treated with mirikizumab.

methodsPatients without prior mirikizumab exposure received intravenous mirikizumab 300 mg at weeks (W)0, 4, and 8, followed by subcutaneous mirikizumab 200 mg at W12, 16, 20, and 24. The primary objective was improvement in the validated BU severity measure (Urgency Numeric Rating Scale [UNRS]) at W12. Secondary objectives included improvement in BU at W28, novel measures of stool deferral time (SDT), bowel urgency frequency (BUF), and associations between BU measures. UNRS, BUF, and SDT were collected using a daily diary; the shortest weekly SDT was used for analysis. Baseline observation carried forward was used as the response for the corresponding visit for all missing observations. Missing continuous data were treated as having no change from baseline.

resultsAll three BU measures at W12 were sustained or improved through W28. With mirikizumab treatment, 52.2% improved BU severity, 55.1% improved BUF, and 40.7% improved shortest weekly SDT. Patients with shortest weekly SDT ≥ 15 min or no urgency increased from 4.1% at baseline to 29.7% at W28. At W12, 36 (20.9%) achieved clinical remission and 54 (31.4%) achieved endoscopic remission, improving to 62 (36.1%) and 76 (44.2%) at W28, respectively. The safety profile was generally consistent with the known profile.

conclusionIn the first comprehensive approach assessing complex BU symptoms in UC, mirikizumab was associated with improvements in several BU and clinically related measures through W28. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov, NCT05767021.

Indexed as

Antibodies, Monoclonal, HumanizedColitis, UlcerativeGastrointestinal AgentsAdultFemaleHumansInjections, SubcutaneousMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal Agentsmirikizumabbowel urgencyIL-23mirikizumabulcerative colitis

Identifiers

PMID42112567
PMCPMC13158796

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.