← Back to Search

Monoclonal Antibodies

Mirikizumab for Crohn's Disease (VIVID-2 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
Must not have
Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study
Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

Summary

This trial will evaluate the effectiveness of mirikizumab in treating Crohn's disease.

Who is the study for?
This trial is for people who have Crohn's disease and completed previous studies (NCT02891226 or NCT03926130). Women must follow contraception rules. People with new risks like cancer, known allergies to mirikizumab, severe reactions in past trials, pregnancy, certain infections like hepatitis or HIV/AIDS can't join.Check my eligibility
What is being tested?
The study tests the long-term effects and safety of a drug called Mirikizumab on individuals with Crohn's disease. It aims to see how well it works over an extended period following earlier trials.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to long-term use of Mirikizumab as part of assessing its safety profile.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have significant infections like hepatitis B/C, HIV/AIDS, or active TB.
Select...
I am not allergic to mirikizumab or similar medications.
Select...
I haven't developed any new conditions that would make joining this trial unsafe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

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 Achieving Clinical Remission
Percentage of Participants Achieving Endoscopic Response
Secondary outcome measures
Change from Baseline in C-Reactive Protein
Change from Baseline in Fecal Calprotectin
Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Mirikizumab SCExperimental Treatment1 Intervention
Mirikizumab given subcutaneously (SC).
Group II: Mirikizumab IV and SCExperimental Treatment1 Intervention
Mirikizumab given intravenously (IV) and SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirikizumab
2020
Completed Phase 3
~4790

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Crohn's Disease include biologic therapies that target specific components of the immune system to reduce inflammation. Mirikizumab, an IL-23 inhibitor, works by blocking the action of interleukin-23, a cytokine involved in the inflammatory process of Crohn's Disease. This helps to reduce inflammation and maintain remission. Other common treatments include anti-TNF agents like infliximab and adalimumab, which inhibit tumor necrosis factor-alpha (TNF-α), another key cytokine in inflammation, and integrin inhibitors like vedolizumab, which prevent immune cells from migrating to the gut. These treatments are crucial for Crohn's Disease patients as they help manage symptoms, reduce flare-ups, and improve quality of life by targeting the underlying inflammatory pathways.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,217,332 Total Patients Enrolled
Study DirectorEli Lilly and Company
8 Previous Clinical Trials
2,426 Total Patients Enrolled

Media Library

Mirikizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04232553 — Phase 3
Crohn's Disease Research Study Groups: Mirikizumab IV and SC, Mirikizumab SC
Crohn's Disease Clinical Trial 2023: Mirikizumab Highlights & Side Effects. Trial Name: NCT04232553 — Phase 3
Mirikizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04232553 — Phase 3
~72 spots leftby Jan 2025