Mirikizumab for Crohn's Disease
(VIVID-1 Trial)

Recruiting in Palo Alto (17 mi)

+836 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Inclusion 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.

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Exclusion Criteria

Have a stoma, ileoanal pouch or ostomy

You have been diagnosed with ulcerative colitis, a type of inflammatory bowel disease, or a condition called short bowel syndrome.

Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery

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Treatment Details

Interventions

Mirikizumab (Monoclonal Antibodies)

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: 300 mg Mirikizumab (Adolescents)Experimental Treatment1 Intervention

Participants received open label 900 mg Mirikizumab IV for 3 doses, then 300 mg SC Q4W

Group II: 300 mg MirikizumabExperimental Treatment1 Intervention

Participants received 900 milligrams (mg) Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W

Group III: 90 mg UstekinumabActive Control1 Intervention

Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC every 8 weeks (Q8W)

Group IV: PlaceboPlacebo Group1 Intervention

Participants received Placebo intravenously (IV) or subcutaneously (SC) every 4 weeks (Q4W). Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study. Nonresponse is defined as failing to achieve at least a 30% decrease in stool frequency (SF) and/or abdominal pain (AP) and be no worse than baseline.

Mirikizumab is already approved in Canada, Japan for the following indications: