Ulcerative Colitis
Conditions
Interventions
-Drug: Mirikizumab IV
Administered IV
Other Name: LY3074828
-Drug: Mirikizumab SC
Administered SC
Other Name: LY3074828
Study Arms
-Experimental: Mirikizumab Weight-Based Group 1
Experiment
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males or females weighing >10 kg and >=2 and <18 years old Have moderate to severe UC Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, or Janus Kinase (JAK)-Inhibitor treatment Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report
Exclusion criteria
Exclusion criteria: Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis Have immune deficiency syndrome Previous bowel resection or intestinal surgery Evidence of toxic megacolon History or current evidence of cancer of the gastrointestinal tract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders [ Time Frame: Baseline to Week 52 ] | — |
Countries
Australia, Belgium, Canada, France, Germany, Italy, Japan, Poland, Portugal, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed