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

Lilly

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Mirikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04004611

2019-001298-96 (EudraCT Number)

I6T-MC-AMBU (Other Identifier)

17410

Details and patient eligibility

About

This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab. The study lasted about 52 weeks and included up to 18 visits.

Enrollment: 26 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants weighing >10 kg
• Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications
• 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
• Participants must have evidence of UC extending proximal to the rectum
• Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC

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 had surgery to remove part of their colon
• Participants must not have current evidence of toxic megacolon
• 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 9 patient groups

Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV)

Experimental group

Description:

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:

Drug: Mirikizumab

Open Label Induction Period: 10 mg/kg Miri IV

Experimental group

Description:

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

Treatment:

Drug: Mirikizumab

Open Label Induction Period: 300 mg Miri IV

Experimental group

Description:

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

Treatment:

Drug: Mirikizumab

Open Label Maintenance Period: 50 mg Miri subcutaneous (SC)

Experimental group

Description:

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.

Treatment:

Drug: Mirikizumab

Open Label Maintenance Period: 100 mg Miri SC

Experimental group

Description:

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.

Treatment:

Drug: Mirikizumab

Open Label Maintenance Period: 200 mg Miri SC

Experimental group

Description:

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.

Treatment:

Drug: Mirikizumab

Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/ 50 mg Miri SC

Experimental group

Description:

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.

Treatment:

Drug: Mirikizumab

Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/100 mg Miri SC

Experimental group

Description:

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.

Treatment:

Drug: Mirikizumab

Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SC

Experimental group

Description:

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.

Treatment:

Drug: Mirikizumab