Ulcerative Colitis study: Mirikizumab
Official title A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
ClinicalTrials.gov ID: NCT04844606
What this study is testing
What is Mirikizumab?
Mirikizumab is an investigational injectable medicine being studied as a potential treatment for ulcerative colitis. It is designed to block interleukin‑23 (IL‑23) signaling, which may reduce inflammation.
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 is testing whether mirikizumab works well over a long time. It looks at how safe the medicine is for children.
- Who it's for
- You may be able to join if you are a child with ulcerative colitis or Crohn's disease.
- What's involved
- You would get shots of mirikizumab. You would also go to the doctor for check-ups and tests.
- Time commitment
- The study lasts about three years and may include up to 44 visits.
- Phase 3: a large, late-stage study
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 19
You may be able to join if
- Participants from originating studies (I6T-MC-AMBA [NCT05784246], I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130]) , I6T-MC-AMAY [NCT05509777])...
- Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
- Female participants must agree to contraception requirements.
You likely can't join if
- Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before...
- Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an...
- Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
- Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data...
- Participants must not have adenomatous polyps that have not been removed.
- Participants must not be pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Hartford, Connecticut, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- Waltham, Massachusetts, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Fort Worth, Texas, United States
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Toronto, Canada
- Mainz, Germany
- Munich, Germany
- Jerusalem, Israel
- Petah Tikva, Israel
- Tsrifin, Israel
- Florence, Italy
- Milan, Italy
- Roma, Italy
+ 15 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 19 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States; Hartford, Connecticut, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; Waltham, Massachusetts, United States; St Louis, Missouri, United States and 29 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.