Crohn's Disease
Conditions
Interventions
Drug: Mirikizumab
Administered IV or SC
Other Name: LY3074828
Study Arms
Experimental: Mirikizumab Dose 1
Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria. Participants must have moderately to severely active CD (as defined by a baseline PCDAI score >30). Participants must have endoscopy with evidence of active CD defined as as SES-CD score >=6 (or >=4 for participants with isolated ileal disease) during screening into this study. Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.
Exclusion criteria
Exclusion criteria: Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery. Participants must not have an abscess. Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 [ Time Frame: Baseline to Week 52 ] Clinical response based on PCDAI, and endoscopic response based on SES-CD. Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 [ Time Frame: Baseline to Week 52 ] Clinical response based on PCDAI, and clinical remission based on PCDAI. | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, France, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Spain, United Kingdom, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed