A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis (SHINE-2)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: Mirikizumab IV; Drug: Mirikizumab SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT05784246

2022-502183-20-00 (Other Identifier)

I6T-MC-AMBA (Other Identifier)

16634

Details and patient eligibility

About

The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

Full description

Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females weighing >10 kg and ≥2 and <18 years old
• Have moderate to severe UC
• Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, or Janus Kinase (JAK)-Inhibitor treatment
• Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report

Exclusion criteria

• Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis
• Have immune deficiency syndrome
• Previous bowel resection or intestinal surgery
• Evidence of toxic megacolon
• History or current evidence of cancer of the gastrointestinal tract

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Mirikizumab Weight-Based Group 1

Experimental group

Description:

Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).

Treatment:

Drug: Mirikizumab SC

Drug: Mirikizumab IV

Mirikizumab Weight-Based Group 2

Experimental group

Description:

Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.

Treatment:

Drug: Mirikizumab SC

Drug: Mirikizumab IV

Mirikizumab Weight-Based Group 3

Experimental group

Description:

Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.

Treatment:

Drug: Mirikizumab SC

Drug: Mirikizumab IV