A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC) (SHINE-1 Trial)

Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Prior Safety Data

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?This trial tested mirikizumab, a medication that targets the immune system, in children with Ulcerative Colitis. It aimed to see how the body processes and removes the drug, and to check its safety and effectiveness over several months. Mirikizumab has shown promise in treating ulcerative colitis.

Eligibility Criteria

Treatment Details

9Treatment groups

Experimental Treatment

Group I: Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SCExperimental Treatment1 Intervention

Participants (\>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.

Group II: Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/100 mg Miri SCExperimental Treatment1 Intervention

Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (\>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.

Group III: Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/ 50 mg Miri SCExperimental Treatment1 Intervention

Participants (≤40 kg) who were non responders to miri at Week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.

Group IV: Open Label Maintenance Period: 50 mg Miri subcutaneous (SC)Experimental Treatment1 Intervention

Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.

Group V: Open Label Maintenance Period: 200 mg Miri SCExperimental Treatment1 Intervention

Participants (\>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.

Group VI: Open Label Maintenance Period: 100 mg Miri SCExperimental Treatment1 Intervention

Participants (\>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.

Group VII: Open Label Induction Period: 300 mg Miri IVExperimental Treatment1 Intervention

Participants (\>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.

Group VIII: Open Label Induction Period: 10 mg/kg Miri IVExperimental Treatment1 Intervention

Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.

Group IX: Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV)Experimental Treatment1 Intervention

Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks.

Mirikizumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Omvoh for: