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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
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 moreLUCENT-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
2,620 Previous Clinical Trials
3,216,439 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
4,006 Patients Enrolled for Ulcerative Colitis
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,585 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
3,856 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active tuberculosis.I am HIV positive.I often feel a sudden need to use the bathroom.I have been diagnosed with ulcerative colitis for over 3 months.I have a type of inflammatory bowel disease that hasn't been specifically classified.I have or had cancer in my digestive system.My ulcerative colitis affects only my rectum.I have a genetic condition that affects my immune system or causes UC-like symptoms.I have Crohn's disease.My ulcerative colitis is moderate to severe.My UC treatment with standard or advanced medications hasn't worked well.
Research Study Groups:
This trial has the following groups:- Group 1: Mirikizumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Mirikizumab been endorsed by the FDA?
"Multiple rounds of safety data have been collected and efficacy is supported by existing clinical evidence, thus we rated mirikizumab's security a 3 on the 1-3 scale."
Answered by AI
How many study locations are carrying out this experiment?
"This study is currently open in 17 different medical centres, with three of them being located in Lancaster, Hialeah and Jacksonville. It is advised to choose the location nearest you to reduce travel needs if participation ensues."
Answered by AI
Is it possible to join this research endeavor at present?
"Clinicaltrials.gov indicates that this research protocol is no longer actively recruiting participants, as the last edit was made on April 10th 2023. Despite concluding recruitment for this trial, there are still 423 other clinical trials open to enrollment at this time."
Answered by AI
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