← Back to Search

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

Must not have

Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086)

Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose: weeks 0, 4, 12, 24 and 40

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I was diagnosed with Crohn's disease or a similar condition during the AMAN study.

Select...

I have had abnormal growths or cancer in my digestive system during study AMAN.

Select...

I have been diagnosed with a significant infection like hepatitis or HIV/AIDS.

Select...

I had or might need surgery for ulcerative colitis during the AMAN study.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose: weeks 0, 4, 12, 24 and 40 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants in Clinical Remission at Week 40

Secondary study objectives

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 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~5420

0 / 4Eligibility criteria met