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

Recruiting in Palo Alto (17 mi)

+39 other locations

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.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment

You must have evidence that your ulcerative colitis is present beyond the rectum.

You have tried other medications for ulcerative colitis, but they did not work well for you or you experienced side effects.

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Exclusion Criteria

Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis

Participants must not have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening endoscopy

Participants must not have had an inadequate response to Interleukin 12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)

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Treatment Details

Interventions

Mirikizumab (Monoclonal Antibodies)

Participant Groups

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 Canada, Japan for the following indications: