A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease (AMAY)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: Mirikizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05509777

I6T-MC-AMAY (Other Identifier)

2022-000811-29 (EudraCT Number)

I6T-MC-PIBD (Other Identifier)

MACARONI-23 (Other Identifier)

PLATFORMPBCRD3001 (Other Identifier)

16632

Details and patient eligibility

About

Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.

Study periods for the intervention-specific appendix (ISA) will be as follows:

• A 12-week induction period
• A maintenance period from Week 12 to Week 52, and
• A safety follow-up period up to 16 weeks.

The study will last about 74 weeks and may include up to 19 visits.

Full description

Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.

Enrollment: 90 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
• Participants must have moderately to severely active CD (as defined by a baseline PCDAI score >30).
• Participants must have endoscopy with evidence of active CD defined as as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) during screening into this study.
• Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.

Exclusion criteria

• Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
• Participants must not have an abscess.
• Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 3 patient groups

Mirikizumab Dose 1

Experimental group

Description:

Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (\>) 40 kilograms (kg).

Treatment:

Drug: Mirikizumab

Mirikizumab Dose 2

Experimental group

Description:

Mirikizumab administered IV or SC in participants that weigh \>20 kg to less than or equal to (≤) 40 kg. Dosing is based on assessments of the participant's weight and appropriate weight class.

Treatment:

Drug: Mirikizumab

Mirikizumab Dose 3

Experimental group

Description:

Mirikizumab administered IV or SC in participants that weigh greater than or equal to (≥)10 kg to less than or equal to ≤20 kg. Dosing is based on assessments of the participant's weight and appropriate weight class.

Treatment:

Drug: Mirikizumab