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Monoclonal Antibodies

Mirikizumab for Pediatric Crohn's Disease (AMAY Trial)

Phase 3

Recruiting

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 week 52

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will evaluate an experimental drug to treat Crohn's disease in children. Participants will randomly be assigned to receive the drug or another intervention. The study will last 74 weeks with up to 19 visits.

Who is the study for?

This trial is for pediatric patients with moderately to severely active Crohn's Disease, confirmed by specific medical criteria. They should have tried at least one treatment without success or could not tolerate it. Kids who've had recent bowel surgery or have complications like strictures that might need surgery can't join.

What is being tested?

The study tests Mirikizumab's effectiveness and safety in children with Crohn's Disease over approximately 74 weeks, including a 12-week induction phase and up to Week 52 maintenance period, followed by a safety follow-up. Participants are randomly assigned to receive either Mirikizumab or another intervention.

What are the potential side effects?

While the exact side effects for this age group aren't listed, similar drugs often cause immune system reactions, injection site discomfort, digestive issues, headaches, and potential increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52

Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52

Secondary study objectives

Percentage of Participants Achieving Clinical Remission by CDAI

Percentage of Participants Achieving Clinical Remission by PCDAI

Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52

+5 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Mirikizumab Dose 3Experimental Treatment1 Intervention

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.

Group II: Mirikizumab Dose 2Experimental Treatment1 Intervention

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.

Group III: Mirikizumab Dose 1Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirikizumab

2020

Completed Phase 3

~6070

Do I qualify?Apply below to find out