A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Ulcerative Colitis Chronic; Ulcerative Colitis; Crohn's Disease; Inflammatory Bowel Diseases

Treatments: Drug: Mirikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04844606

16633

I6T-MC-AMAZ (Other Identifier)

ISA-1 UC (Other Identifier)

ISA-2 CD (Other Identifier)

2020-005311-49 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits.

Enrollment: 150 estimated patients

Sex: All

Ages: 2 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants from originating studies (I6T-MC-AMBA [NCT05784246], I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130]) , I6T-MC-AMAY [NCT05509777]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
• Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
• Female participants must agree to contraception requirements.

Exclusion criteria

• Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.
• Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.
• Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
• Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.
• Participants must not have adenomatous polyps that have not been removed.
• Participants must not be pregnant or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 7 patient groups

Mirikizumab Dose 1 for UC

Experimental group

Description:

Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.

Treatment:

Drug: Mirikizumab

Drug: Mirikizumab

Mirikizumab Dose 2 for UC

Experimental group

Description:

Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Treatment:

Drug: Mirikizumab

Drug: Mirikizumab

Mirikizumab Dose 3 for UC

Experimental group

Description:

Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Treatment:

Drug: Mirikizumab

Drug: Mirikizumab

Mirikizumab Dose 4 for CD

Experimental group

Description:

Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Treatment:

Drug: Mirikizumab

Drug: Mirikizumab

Mirikizumab Dose 5 for CD

Experimental group

Description:

Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Treatment:

Drug: Mirikizumab

Drug: Mirikizumab

Mirikizumab Dose 6 for CD

Experimental group

Description:

Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Treatment:

Drug: Mirikizumab

Drug: Mirikizumab

Mirikizumab Dose 7 for UC or CD

Experimental group

Description:

Intravenous (IV) rescue dosing, if response is lost.

Treatment:

Drug: Mirikizumab

Drug: Mirikizumab