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Monoclonal Antibodies

Mirikizumab for Ulcerative Colitis (LUCENT-URGE Trial)

Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

LUCENT-URGE Trial Summary

This trial will study the effects of mirikizumab on bowel urgency in those with UC, and will last 36 weeks.

Who is the study for?
This trial is for adults with moderately to severely active ulcerative colitis who have had it for at least 3 months. They should be experiencing bowel urgency and not responding well to conventional or certain advanced therapies. People with Crohn's disease, limited rectal disease, gastrointestinal cancer history, tuberculosis, HIV, or specific immunodeficiency syndromes cannot join.Check my eligibility
What is being tested?
The study tests Mirikizumab's effect on bowel urgency in people with moderate to severe ulcerative colitis. It spans over 36 weeks and includes four different periods of assessment to understand how well the treatment works.See study design
What are the potential side effects?
While the specific side effects are not listed here, similar medications often cause immune system reactions, infections risk increase, potential liver issues and may affect blood cells leading to various symptoms.

LUCENT-URGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Bowel Urgency Severity Urgency Numeric Rating Score (UNRS)
Secondary outcome measures
Change from Baseline in Bowel Urgency Frequency
Change from Baseline in Stool Deferral Time
Correlation between Change in UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures, with Change in QoL/Functional Outcome Measures and UC Symptom Measures
+7 more

LUCENT-URGE Trial Design

1Treatment groups
Experimental Treatment
Group I: MirikizumabExperimental Treatment1 Intervention
Participants will receive mirikizumab intravenously (IV) and mirikizumab subcutaneously (SC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirikizumab
2020
Completed Phase 3
~4790

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,624 Previous Clinical Trials
3,216,761 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
4,006 Patients Enrolled for Ulcerative Colitis
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
415,520 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
3,856 Patients Enrolled for Ulcerative Colitis

Media Library

Mirikizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05767021 — Phase 3
Ulcerative Colitis Research Study Groups: Mirikizumab
Ulcerative Colitis Clinical Trial 2023: Mirikizumab Highlights & Side Effects. Trial Name: NCT05767021 — Phase 3
Mirikizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05767021 — Phase 3
~53 spots leftby Dec 2024
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