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Monoclonal Antibodies

Mirikizumab for Colitis (SHINE-1 Trial)

Phase 2

Waitlist Available

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 predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Colitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pharmacokinetics (PK): Clearance of Mirikizumab

Secondary study objectives

Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52

Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12

Change From Baseline in Body Weight

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirikizumab

2020