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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT03926130
• Date of registration: 23/04/2019
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease VIVID-1
• Scientific title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease
• Date of first enrolment: July 23, 2019
• Target sample size: 1158
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03926130
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

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



Age minimum: 15 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Mirikizumab

Drug: Ustekinumab

Drug: Placebo

Primary Outcome(s)

Percentage of Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 [Time Frame: Baseline to Week 52]

Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 [Time Frame: Baseline to Week 52]

Secondary Outcome(s)

Percentage of Participants Achieving Clinical Remission [Time Frame: Week 52]

Percentage of Participants Achieving Endoscopic Response [Time Frame: Week 52]

Change from Baseline in Urgency NRS [Time Frame: Baseline, Week 52]

Percentage of Participants Achieving Endoscopic Remission [Time Frame: Week 12]

Percentage of Participants Achieving Clinical Response at Week 12 and Endoscopic Remission at Week 52 [Time Frame: Baseline to Week 52]

Change from Baseline in Fecal Calprotectin [Time Frame: Baseline, Week 52]

Percentage of Participants with Extraintestinal Manifestations (EIMs) of Crohn's Disease [Time Frame: Week 52]

Percentage of Participants with Fistulae Response [Time Frame: Week 52]

Change from Baseline in Health Related Quality of Life [Time Frame: Baseline, Week 52]

Change from Baseline in Urgency Numeric Rating Score (NRS) [Time Frame: Baseline, Week 12]

Percentage of Participants Achieving Clinical Response at Week 12 and Corticosteroid-free AND either in Clinical Remission or Endoscopic Remission at Week 52 [Time Frame: Baseline to Week 52]

Percentage of Participants Achieving Endoscopic Response [Time Frame: Week 12]

Change from Baseline in C-Reactive Protein [Time Frame: Baseline, Week 52]

Percentage of Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52 [Time Frame: Baseline to Week 52]

Percentage of Participants Achieving Clinical Remission [Time Frame: Week 12]

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Mirikizumab [Time Frame: Baseline through Week 52]

Secondary ID(s)

I6T-MC-AMAM

16590

2018-004614-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors