Evaluating Mirikizumab for Children with Crohn's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy, safety, and tolerability of mirikizumab in pediatric participants diagnosed with Crohn's disease. Participants will be screened and randomly assigned to receive either mirikizumab or another intervention. The study includes a 12-week induction period followed by a maintenance phase lasting up to 52 weeks, with a total duration of approximately 74 weeks and up to 19 visits. The study aims to assess how well mirikizumab is absorbed in the body and its overall effectiveness in treating active Crohn's disease in children.

Why it matters

Who can join: the full rules

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.

Where it's running

• Connecticut Children's Medical Center
  Hartford, Connecticut, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Children's Center for Digestive Health Care, LLC
  Atlanta, Georgia, United States Recruiting
• Riley Childrens Hospital
  Indianapolis, Indiana, United States Recruiting
• Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
  New York, New York, United States Recruiting
• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting

+31 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mirikizumab with or without tirzepatide for adults with moderately to severely active Crohn's disease who are overweight or have obesity

  This trial tests whether adding tirzepatide to mirikizumab helps adults with moderately to severely active Crohn's disease who are overweight or have obesity.

  Recruiting at 174 sites Phase 3 Eli Lilly and Company · Dothan, Alabama and 182 other locations · NCT06937099

• Evaluating Mirikizumab for Children with Ulcerative Colitis or Crohn's Disease

  This study is testing if a medication called mirikizumab can help children with ulcerative colitis or Crohn's disease feel better over a long period of time.

  Recruiting at 39 sites Phase 3 Eli Lilly and Company · San Francisco, California and 68 other locations · NCT04844606

• Iron treatment for children and young adults with Crohn’s disease and iron deficiency anemia

  This study tests how different iron treatment approaches work for kids and young adults with Crohn’s disease and iron deficiency anemia.

  Recruiting Phase 4 Weill Medical College of Cornell University · New York, New York · NCT07925450

• Autologous intestinal organoids applied to Crohn's ulcers in a first-in-human dose-escalation study

  This early-phase study tests a patient-derived intestinal organoid therapy (ATORM-C) delivered during colonoscopy to Crohn’s ulcers to see if it is safe and tolerable and to get a sense of healing.

  Recruiting Phase 1 Organoidsciences LTD. · Seoul · NCT07822087

• SL-325 in Crohn's Disease: a phase 2 test for adults with moderate to severe disease

  This phase 2 study tests SL-325 against placebo in adults with moderately to severely active Crohn's disease to see if it helps improve symptoms and disease activity.

  Recruiting Phase 2 Shattuck Labs, Inc. · Little Rock, Arkansas and 19 other locations · NCT07753850

• Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults

  This study tests combinations of risankizumab with either trosunilimab or ABBV-701 in adults with moderately to severely active Crohn's disease or ulcerative colitis.

  Recruiting at 66 sites Phase 2 AbbVie · Dothan, Alabama and 65 other locations · NCT07697456

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.