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NCT Number: NCT05509777

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

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.

Recruiting

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AKH - Medizinische Universtität Wien, Vienna, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0.
  • 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.

Treatment and study plan

Mirikizumab

Drug

Administered IV or SC

Other names: LY3074828

Primary outcomes

  1. 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

    Time frame: Baseline to Week 52

    Clinical response based on PCDAI, and endoscopic response based on SES-CD.

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

    Time frame: Baseline to Week 52

    Clinical response based on PCDAI, and clinical remission based on PCDAI.

Secondary outcomes

  1. Percentage of Participants Achieving Clinical Response by PCDAI

    Time frame: Week 12

    Clinical response based on PCDAI.

  2. Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)

    Time frame: Week 12

    Clinical response based on CDAI for participants ≥12 years of age

  3. Percentage of Participants Achieving Clinical Remission by PCDAI

    Time frame: Week 12

    Clinical remission based on PCDAI.

  4. Percentage of Participants Achieving Clinical Remission by CDAI

    Time frame: Week 12

    Clinical remission based on CDAI for participants ≥12 years of age.

  5. Percentage of Participants Who Achieve PCDAI Clinical Response at Week 12 and PCDAI Clinical Remission and Endoscopic Remission at Week 52

    Time frame: Baseline to Week 52

  6. Percentage of Participants Who Achieve PCDAI Clinical Remission and Endoscopic Remission at Week 52

    Time frame: Week 52

  7. Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52

    Time frame: Baseline to Week 52

  8. Change from Baseline in C-reactive Protein (CRP)

    Time frame: Baseline, Week 12

  9. Change from Baseline in CRP

    Time frame: Baseline, Week 52

  10. Change from Baseline in Fecal calprotectin

    Time frame: Baseline, Week 12

  11. Change from Baseline in Fecal calprotectin

    Time frame: Baseline, Week 52

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

    Time frame: Baseline to Week 52

    Clinical response by PCDAI, CDAI for participants ≥12 years of age

  13. Percentage of Participants Achieving Endoscopic Response

    Time frame: Week 52

  14. Percentage of Participants Achieving Clinical Remission by PCDAI

    Time frame: Week 52

    Clinical remission based on PCDAI

  15. Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and PCDAI Clinical Remission without the use of Corticosteroids and Who Did Not Have Crohn's Disease (CD)-Related Surgery at Week 52

    Time frame: Baseline to Week 52

    Clinical response and clinical remission by PCDAI

  16. Pharmacokinetics (PK): Clearance of Mirikizumab

    Time frame: Baseline through Week 52

  17. Pharmacokinetics (PK): Volume of Distribution of Mirikizumab

    Time frame: Baseline through Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease

Acronym: AMAY

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 22, 2022
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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