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New treatment option for Crohn's Disease
Official title A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
ClinicalTrials.gov ID: NCT05509777
What this study is testing
What is Mirikizumab?
Mirikizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for crohn's disease.
Also referred to as LY3074828.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by...
- 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...
- Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD...
You likely can't join if
- Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Hartford, Connecticut, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- Dayton, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Fort Worth, Texas, United States
- Burlington, Vermont, United States
- Seattle, Washington, United States
- Vienna, Austria
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Campinas, Brazil
- Curitiba-PR, Brazil
- Goiânia, Brazil
- Porto Alegre, Brazil
+ 51 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Hartford, Connecticut, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States; Boston, Massachusetts, United States; Morristown, New Jersey, United States and 65 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.