A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-1)

Lilly

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Mirikizumab; Drug: Ustekinumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03926130

2018-004614-18 (EudraCT Number)

16590

I6T-MC-AMAM (Other Identifier)

Details and patient eligibility

About

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

Enrollment: 1,158 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of CD for at least 3 months prior to baseline
• Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
• Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
• If female, subject must meet the contraception recommendations

Exclusion criteria

• Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or 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
• Have a stoma, ileoanal pouch or ostomy
• Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
• Have ever received any monoclonal antibodies binding IL-23

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,158 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Placebo

300 mg Mirikizumab

Experimental group

Description:

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

Treatment:

Drug: Mirikizumab

Drug: Mirikizumab

90 mg Ustekinumab

Active Comparator group

Description:

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

Treatment:

Drug: Ustekinumab

Drug: Ustekinumab

300 mg Mirikizumab (Adolescents)

Experimental group

Description:

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

Treatment:

Drug: Mirikizumab

Drug: Mirikizumab