Crohn's Disease study: Mirikizumab
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 injectable medicine being studied as a potential treatment for Crohn's disease. It is designed to block interleukin‑23, a protein that helps drive inflammation in the gut.
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
- This study checks if mirikizumab works well, is safe, and how the body absorbs it in children with Crohn's disease.
- Who it's for
- Children and teenagers who have Crohn's disease.
- What's involved
- Participants will get mirikizumab or another treatment and come in for regular checkups and tests.
- Time commitment
- The study lasts about 74 weeks and may require up to 19 visits.
- 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 is enrolling
- Hartford, Connecticut, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, 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
- Vienna, Austria
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Campinas, Brazil
- Curitiba-PR, Brazil
- Goiânia, Brazil
- Porto Alegre, Brazil
- Santos Dumont, Brazil
- Votuporanga, Brazil
- Halifax, Canada
- London, Canada
+ 42 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, but 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?
This study is enrolling now at Hartford, Connecticut, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States; New York, New York, United States; Dayton, Ohio, United States; Philadelphia, Pennsylvania, United States and 56 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.