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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

AMAY 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.Check my eligibility

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.See study design

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.

AMAY Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change from Baseline in C-reactive Protein (CRP)

Change from Baseline in CRP

Change from Baseline in Fecal calprotectin

+11 more

AMAY 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

~4790

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,624 Previous Clinical Trials

3,216,934 Total Patients Enrolled

Study DirectorEli Lilly and Company

1,349 Previous Clinical Trials

415,792 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could individuals aged twenty and above be enrolled in this experiment?

"This clinical trial is recruiting minors between the ages of 2 and 17."

Answered by AI

How many locations are presently hosting this clinical trial?

"Arkansas Children's Hospital Research Institute in Little Rock, University of California San Diego in La Jolla, and Cedars-Sinai Medical Center in Los Angeles are a sample of the 92 sites currently recruiting patients for this trial."

Answered by AI

What risks have been associated with the initial dosage of Mirikizumab?

"Due to clinical evidence of both efficacy and safety, Mirikizumab Dose 1 has been assigned a rating of 3 on the Power scale."

Answered by AI

Does this research still accept subjects for participation?

"This medical trial is no longer recruiting, as indicated by clinicaltrials.gov; first posted on October 24th 2023 and last updated one day short of a year later. While this study has concluded recruitment, there are still 265 other trials seeking participants at present."

Answered by AI

Could I be a qualified candidate for this research project?

"This medical trial is taking applications from 90 individuals between the ages of two and seventeen who have been diagnosed with Crohn's disease. To qualify for participation, patients must meet a set of additional criteria regarding their CD history and endoscopy results. Specifically, they need to demonstrate an inadequate response or intolerance to prior treatments such as immunomodulators, corticosteroids, biologics therapy/JAK inhibitors; in addition to having active colitis, ileitis or ileocolitis (confirmed by clinical evidence) and a PCDAI score higher than 30 alongside a SES-CD score greater than 6 (or 4"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05509777.