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Mirikizumab for Ulcerative Colitis (LUCENT 2 Trial)
Phase 3
Waitlist Available
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 predose: weeks 0, 4, 12, 24 and 40
Awards & highlights
LUCENT 2 Trial Summary
This trial will test if a drug called mirikizumab can help people with Crohn's disease who have already responded to another drug.
Who is the study for?
This trial is for adults with moderate to severe ulcerative colitis who responded well to Mirikizumab in a previous study. They must be able to perform required assessments, including endoscopy and daily diary entries, and women must adhere to contraception requirements. Those with Crohn's disease or recent bowel surgery are excluded.Check my eligibility
What is being tested?
The trial tests the long-term effectiveness of Mirikizumab as maintenance therapy for ulcerative colitis. Participants will receive either subcutaneous (SC) or intravenous (IV) forms of Mirikizumab or a placebo, following their initial response in an earlier phase of research.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, increased risk of infection due to immune system suppression, headaches, nausea, and possibly other symptoms not yet identified.
LUCENT 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose: weeks 0, 4, 12, 24 and 40
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose: weeks 0, 4, 12, 24 and 40
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants in Clinical Remission at Week 40
Secondary outcome measures
Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)
Change From Baseline to Week 40 in Fecal Calprotectin
Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
+7 moreLUCENT 2 Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Open Label Maintenance: Delayed Responders - 200 mg Miri SCExperimental Treatment1 Intervention
Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40.
Group II: Maintenance Period: PBO IR - PBO SCExperimental Treatment1 Intervention
Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Group III: Maintenance Period: Miri IR - 200 Milligram (mg) Miri SCExperimental Treatment1 Intervention
Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Group IV: Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IVExperimental Treatment1 Intervention
Participants who received PBO SC or 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.
Group V: Extended Induction: Induction Nonresponders - 300mg Miri IVExperimental Treatment1 Intervention
Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.
Group VI: Maintenance Period: Miri Induction Responder (IR) - Placebo (PBO) Subcutaneous (SC)Placebo Group1 Intervention
Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo SC
2015
Completed Phase 4
~5410
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,199,752 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
2,989 Patients Enrolled for Ulcerative Colitis
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,075 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
2,839 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with Crohn's disease or a similar condition during the AMAN study.I have had abnormal growths or cancer in my digestive system during study AMAN.I have been diagnosed with a significant infection like hepatitis or HIV/AIDS.I had or might need surgery for ulcerative colitis during the AMAN study.
Research Study Groups:
This trial has the following groups:- Group 1: Extended Induction: Induction Nonresponders - 300mg Miri IV
- Group 2: Maintenance Period: PBO IR - PBO SC
- Group 3: Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV
- Group 4: Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
- Group 5: Maintenance Period: Miri Induction Responder (IR) - Placebo (PBO) Subcutaneous (SC)
- Group 6: Open Label Maintenance: Delayed Responders - 200 mg Miri SC
Awards:
This trial has 1 awards, including:- 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.
Are there other similar drugs to Mirikizumab that have been studied?
"Currently, there are 7 trials in operations studying Mirikizumab. 6 of those active trials are in Phase 3. While the many studies for Mirikizumab are based in Warszawa, New South Wales, there are 2942 locations running studies for this treatment."
Answered by AI
Has this research been conducted before?
"There are seven ongoing studies for Mirikizumab in 40 countries and 656 cities. The first trial was completed in 2018 by 1281 participants. It reached the Phase 3 drug approval stage and was sponsored by Eli Lilly and Company. A total of 18303 trials have been completed since then."
Answered by AI
How can I get involved in this research project?
"Eligible patients for this study must be aged 18-80 and currently have a diagnosis of colitis. Furthermore, participants must be able and willing to complete scheduled assessment, which include endoscopy and daily diary entry. 1177 individuals are needed for the study in total."
Answered by AI
Does your research include geriatric patients?
"Patients must be between 18-80 years old in order to participate, as per the eligibility requirements."
Answered by AI
Are there any dangers associated with Mirikizumab?
"Mirikizumab's safety is estimated to be a 3. This is based on the fact that it is in Phase 3 clinical trials, meaning not only does some data support its efficacy, but there are multiple rounds of data supporting its safety."
Answered by AI
Are patients currently being enrolled in this trial?
"The most recent information on clinicaltrials.gov suggests that this particular study is not looking for more participants at this time. The trial was first posted on October 19th, 2018 and the last update was September 9th, 2022. There are 431 other studies you may be eligible for if you check the website."
Answered by AI
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