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Monoclonal Antibodies

Mirikizumab for Pediatric Ulcerative Colitis (SHINE-2 Trial)

Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial studies if a drug is safe & effective in treating UC in children.

Who is the study for?
This trial is for children and teens aged 2 to less than 18, weighing over 10 kg, with moderate to severe ulcerative colitis (UC) that's lasted at least 3 months. They should have tried other treatments like corticosteroids or biologics without success. It's not for those with Crohn's disease, certain other bowel conditions, a history of significant bowel surgery, toxic megacolon, or gastrointestinal cancer.
What is being tested?
The study tests Mirikizumab given by IV (intravenous) or SC (subcutaneous injection) in young patients with UC. The goal is to see how well it works (efficacy), how the body processes it (pharmacokinetics), and its safety profile.
What are the potential side effects?
Possible side effects of Mirikizumab may include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, abdominal pain and potential allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Mirikizumab Weight-Based Group 3Experimental Treatment2 Interventions
Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
Group II: Mirikizumab Weight-Based Group 2Experimental Treatment2 Interventions
Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
Group III: Mirikizumab Weight-Based Group 1Experimental Treatment2 Interventions
Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,324 Total Patients Enrolled
11 Trials studying Colitis
4,427 Patients Enrolled for Colitis
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,781 Total Patients Enrolled
9 Trials studying Colitis
4,177 Patients Enrolled for Colitis

Media Library

Mirikizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05784246 — Phase 3
Colitis Research Study Groups: Mirikizumab Weight-Based Group 1, Mirikizumab Weight-Based Group 2, Mirikizumab Weight-Based Group 3
Colitis Clinical Trial 2023: Mirikizumab Highlights & Side Effects. Trial Name: NCT05784246 — Phase 3
Mirikizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05784246 — Phase 3
~35 spots leftby Jul 2026
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