The VIVID-1 study, a clinical research study, is currently enrolling individuals 18 to 80 years of age who have been diagnosed with Crohn’s disease (CD) for at least 3 months. This study will evaluate whether treatment with mirikizumab (the investigational medication) is superior to placebo as assessed by endoscopic response and clinical remission by PRO at Week 52.
The overall study design includes 28 days for screening, 12 weeks for induction treatment, 40 weeks for maintenance treatment, and up to 16 weeks for the follow-up period.
Qualifying Participant Requirements:
- Be male or female, 18 to 80 years of age, and diagnosed with CD for at least 3 months
- Have moderately to severely active CD as defined by unweighted daily average SF ≥ 4 (loose and watery stools defined as Bristol Stool Scale Category 6 or 7) and/or unweighted daily average AP ≥ 2 at baseline
- Have an inadequate response to, loss of response to, or intolerance to at least 1 of the following medications:
- Corticosteroids (prednisone or budesonide) or immunomodulators (AZA or 6-MP), and must have not failed or demonstrated an intolerance to a biologic medication that is approved for the treatment of CD
- Approved biologic therapy for CD
- Have a centrally read SES-CD score ≥ 7 for patients with ileal-colonic disease or ≥ 4 for patients with isolated ileal disease within 14 days before the first dose of study treatment
- Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry