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Monoclonal Antibodies

Mirikizumab for Crohn's Disease (VIVID-1 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

VIVID-1 Trial Summary

This trial is testing a new drug for Crohn's Disease to see if it is safe and effective.

Eligible Conditions
  • Crohn's Disease

VIVID-1 Trial 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 Response at Week 12 and Clinical Remission at Week 52
Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52
Secondary outcome measures
Change from Baseline in C-Reactive Protein
Change from Baseline in Fecal Calprotectin
Change from Baseline in Health Related Quality of Life
+11 more

VIVID-1 Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: MirikizumabExperimental Treatment1 Intervention
Mirikizumab given intravenously (IV) and subcutaneously (SC). Participants in the open-label adolescent addendum will be given mirikizumab IV and SC.
Group II: UstekinumabActive Control1 Intervention
Ustekinumab given IV and SC.
Group III: PlaceboPlacebo Group1 Intervention
Placebo given IV and 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
2,613 Previous Clinical Trials
3,199,771 Total Patients Enrolled
Study DirectorEli Lilly and Company
8 Previous Clinical Trials
2,046 Total Patients Enrolled

Media Library

Mirikizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03926130 — Phase 3
Crohn's Disease Research Study Groups: Mirikizumab, Ustekinumab, Placebo
Crohn's Disease Clinical Trial 2023: Mirikizumab Highlights & Side Effects. Trial Name: NCT03926130 — Phase 3
Mirikizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03926130 — Phase 3
Crohn's Disease Patient Testimony for trial: Trial Name: NCT03926130 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the patients chosen for this test restricted to a certain age group?

"Eligible candidates for this trial must be over 15 and under 80 years of age."

Answered by AI

What is the efficacy of Mirikizumab in other medical contexts?

"41 clinical trials for Mirikizumab are underway, with 23 of them in Phase 3. Mirikizumab trials are particularly prominent in Gdansk, Pomorskie, but can be found in 4889 other locations."

Answered by AI

How many different medical clinics is this study being run in today?

"This trial is currently being conducted at 100 different locations, which include Jackson, San Antonio, Bellevue, and many other places. If you are considering participating in this study, please choose the location nearest to you to minimize travel time and effort."

Answered by AI

What is the FDA's standing on Mirikizumab?

"Mirikizumab has received a safety score of 3. This is because Phase 3 trials have found some evidence of efficacy and there is supporting safety data from multiple rounds of testing."

Answered by AI

Am I able to enroll in this experiment?

"Crohn's disease patients aged 15 to 80 are welcome to participate in this 1100 person trial. The most crucial aspect is that potential participants must have a confirmed diagnosis of moderate to severe CD. Furthermore, they must have an intolerance, loss of response, or inadequate response to conventional or biologic therapy for CD."

Answered by AI

Are individuals needed for this clinical trial at this time?

"This particular study has completed recruitment and is no longer active. The trial was initially posted on July 23rd, 2019 but was last updated on August 30th, 2022. However, there are currently 256 clinical trials actively seeking patients with Crohn's disease and 41 studies for Mirikizumab that are still open."

Answered by AI

What are the conditions that Mirikizumab is most often used to treat?

"Mirikizumab is most frequently used to regulate adrenal cortex hormones, but can also be prescribed for conditions like severe Crohn's disease, psoriasis, and therapeutic resistance to one or more TNF antagonists."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I've tried a couple of medicines but no help I have also had a illeostomy to remove the Crohn's but it came back.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
2019. "A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03926130.
~201 spots leftby Apr 2025
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