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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
Pivotal Trial
Summary
This trial is testing whether mirikizumab is safe and effective for people with moderate to severe Crohn's disease. The drug works by reducing inflammation in the digestive tract, aiming to help those who may not respond well to other treatments. Mirikizumab has shown positive results in previous studies for Crohn's disease.
Eligible Conditions
- Crohn's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
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 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 study objectives
Change from Baseline in C-Reactive Protein
Change from Baseline in Fecal Calprotectin
Change from Baseline in Health Related Quality of Life
+11 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~6070
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,671 Previous Clinical Trials
3,227,864 Total Patients Enrolled
Study DirectorEli Lilly and Company
8 Previous Clinical Trials
2,046 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The text discusses a confirmed diagnosis of moderate to severe CD, as assessed by SF, AP score, and SES-CD.You have tried traditional or biologic therapy for Crohn's disease but did not respond well, experienced side effects, or lost the benefits of treatment.You have been diagnosed with CD (Crohn's disease) for at least 3 months before starting the study.You have been diagnosed with ulcerative colitis, a type of inflammatory bowel disease, or a condition called short bowel syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Mirikizumab
- Group 2: Ustekinumab
- Group 3: Placebo
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.
Crohn's Disease Patient Testimony for trial: Trial Name: NCT03926130 — Phase 3
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