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New treatment option for Ulcerative Colitis
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 medicine, given as an injection under the skin, being studied as a potential treatment for ulcerative colitis.
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
- The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks 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's taking place
- 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
- Philadelphia, Pennsylvania, United States
- Fort Worth, Texas, United States
- Fairfax, Virginia, United States
- Vienna, Austria
- Brussels, Belgium
- Edegem, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Campinas, Brazil
- Curitiba, Brazil
- Goiânia, Brazil
- Porto Alegre, Brazil
- Vitória, Brazil
+ 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 - 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?
Study sites include 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 56 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.