A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease
Eli Lilly and Company
Summary
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.
Eligibility
- Age range
- 2–19 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants from originating studies (I6T-MC-AMBA \[NCT05784246\], I6T-MC-AMBU \[NCT04004611\], I6T-MC-AMAM \[NCT03926130\]) , I6T-MC-AMAY \[NCT05509777\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab * Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment. * Female participants must agree to contraception requirements. Exclusion Criteria: * Participants must not have developed a serious adverse event (SAE) or…
Interventions
- DrugMirikizumab
Administered SC
- DrugMirikizumab
Administered IV
Locations (66)
- UCSF Medical Center at Mission BaySan Francisco, California
- Connecticut Children's Medical CenterHartford, Connecticut
- Emory University School of MedicineAtlanta, Georgia
- Children's Center for Digestive Health Care, LLCAtlanta, Georgia
- Boston Children's HospitalBoston, Massachusetts
- Massachusetts General HospitalWaltham, Massachusetts