RecruitingPhase 3NCT05784246
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis
Sponsor
Eli Lilly and Company
Enrollment
60 participants
Start Date
Nov 22, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
Eligibility
Min Age: 2 YearsMax Age: 17 Years
Inclusion Criteria4
- Males or females weighing ≥10 kg and ≥2 and \<18 years old at the time of consent for screening.
- Have moderate to severe UC.
- Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) 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 Criteria5
- 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.
Interventions
DRUGMirikizumab IV
Administered IV
DRUGMirikizumab SC
Administered SC
Locations(34)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05784246
Related Trials
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
NCT060713121 location
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
NCT0609512849 locations
A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
NCT0658132891 locations
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
NCT0381634552 locations
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
NCT06880744270 locations