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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 19 visits
  • Time periods mentioned: 16 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests mirikizumab in children with moderate to severe Crohn’s disease, which causes swelling in the digestive tract. It looks at how well the drug works, its safety, side effects, and how the body absorbs it. The study lasts about 74 weeks and may include up to 19 visits.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed Crohn’s disease with active swelling in the large intestine, the last part of the small intestine, or both. Crohn’s with fistulas (abnormal tunnels between body parts) may qualify.
  • Have moderate to severe Crohn’s disease, with a score of at least 30 on a children’s Crohn’s disease activity scale.
  • Have a bowel exam with a camera within 1 month before starting study treatment. The exam must show active disease, with a score of at least 6, or at least 4 if only the last part of the small intestine is affected.
  • Have records showing that at least one Crohn’s medicine did not work well enough, stopped working, or caused side effects you could not tolerate.

Who can't join

  • Have Crohn’s complications, such as bowel narrowing that causes symptoms, short gut syndrome (too little working small intestine), or other problems likely to need surgery.
  • Have an abscess (a pocket of pus).
  • Have had part of the bowel removed within 26 weeks before the study starts, or other surgery inside the belly within 12 weeks before the study starts.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 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.

Study sites (15)

CA

CT

GA

IN

MA

NJ

NY

  • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) · New York, NY 10021-5663 · Study contact · 646-962-7162Aliza Solomon · Principal investigatorMore trials in New York
  • Icahn School of Medicine at Mount Sinai · New York, NY 10029 · Study contact · 212-659-9443David Dunkin · Principal investigatorMore trials in New York
  • Columbia University Medical Center/New York Presbyterian · New York, NY 10032Joseph Picoraro · Principal investigatorMore trials in New York

OH

PA

TX

VT

WA