A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease (NCT05509777)
A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Cedars Sinai Medical Center — Los Angeles, California
Age range: 2 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (81 Sites)
Showing the first 25 of 81 sites.
- Cedars Sinai Medical Center — Los Angeles, California
- Connecticut Children's Medical Center — Hartford, Connecticut
- Emory University — Atlanta, Georgia
- Children's Center for Digestive Health Care, LLC — Atlanta, Georgia
- Riley Childrens Hospital — Indianapolis, Indiana
- Boston Children's Hospital — Boston, Massachusetts
- Atlantic Children's Health--Pediatric Gastroenterology — Morristown, New Jersey
- Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) — New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York
- Columbia University Medical Center/New York Presbyterian — New York, New York
- Childrens Medical Center — Dayton, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Cook Children's Medical Center — Fort Worth, Texas
- University of Vermont Medical Center — Burlington, Vermont
- Seattle Children's Hospital — Seattle, Washington
- AKH - Medizinische Universtität Wien — Vienna,
- Universitair Ziekenhuis Brussel — Brussels,
- Cliniques universitaires Saint-Luc — Brussels,
- Universitair Ziekenhuis Gent — Ghent,
- UZ Leuven — Leuven,
- Hospital PUC-CAMPINAS — Campinas,
- Hospital Pequeno Príncipe — Curitiba-PR,
- Hospital das Clínicas - UFG (Universidade Federal de Goiás) — Goiânia,
- Hospital de Clínicas de Porto Alegre — Porto Alegre,
- Irmandade da Santa Casa de Misericórdia de Porto Alegre — Porto Alegre,
📞 Contact the Study Coordinator
Phone: (317) 615-4559
Email: LillyTrials@Lilly.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Crohn's Disease
- A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) — Birmingham, Alabama
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease — Birmingham, Alabama
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. — Sun City, Arizona
- Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice. — Blacktown, New South Wales
- Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients — San Francisco, California
- Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis — Boston, Massachusetts
Explore by condition: All Crohn's Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.