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

Study Purpose

The purpose of this study is to evaluate the effect, 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

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 prior or current CD medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or IV corticosteroids or have received biologic therapy/JAK inhibitor for the treatment of CD and have a documented history of inadequate response, loss of response (LOR), or intolerance to the biologic therapy/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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05509777
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Study Website: View Trial Website
Additional Details

Participants screened and assigned to mirikizumab from MACARONI-23 will participate in this ISA study.

Arms & Interventions

Arms

Experimental: Mirikizumab Dose 1

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

Experimental: Mirikizumab Dose 2

Maintenance Dose: 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.

Experimental: Mirikizumab Dose 3

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

Interventions

Drug: - Mirikizumab

Administered IV or SC

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

ClinicalTrials.gov@lilly.com

1-317-615-4559

For additional contact information, you can also visit the trial on clinicaltrials.gov.