Recruiting
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
I6T-MC-AMBU - ClinicalTrials.gov - NCT04004611
This study is designed to evaluate how the body processes and removes mirikizumab. The study will also evaluate safety and disease response in pediatric participants with UC taking mirikizumab.
How long will I be in the trial?
The study will last about 52 weeks and may include up to 17 visits.
Recruiting
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
I6T-MC-AMBU - ClinicalTrials.gov - NCT04004611
This study is designed to evaluate how the body processes and removes mirikizumab. The study will also evaluate safety and disease response in pediatric participants with UC taking mirikizumab.
How long will I be in the trial?
The study will last about 52 weeks and may include up to 17 visits.
Key Requirements
Age :
2-17
Sex:
All
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
2-17
Sex
All
Participants must
Participants must weigh >10 kg Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications
Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment
Participants must have evidence of UC extending proximal to the rectum
Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC
Participants must NOT
Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis
Participants must not have had surgery to remove part of their colon
Participants must not have current evidence of toxic megacolon
Participants must not have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening
Participants must not have inadequate response to Interleukin 12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)
Trial Summary
Conditions the trial is for
Ulcerative Colitis, Pediatric Ulcerative Colitis
What the trial is testing?
Mirikizumab
Could I receive a Placebo?
no
Enrollment Goal
30
Trial Dates
May 2020 - July 2022
Trial Phase
2
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Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
2-17
Sex
All
Participants must
Participants must weigh >10 kg Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications
Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment
Participants must have evidence of UC extending proximal to the rectum
Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC
Participants must NOT
Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis
Participants must not have had surgery to remove part of their colon
Participants must not have current evidence of toxic megacolon
Participants must not have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening
Participants must not have inadequate response to Interleukin 12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)
Trial Summary
Conditions the trial is for
Ulcerative Colitis, Pediatric Ulcerative Colitis
What the trial is testing?
Mirikizumab
Could I receive a Placebo?
no
Enrollment Goal
30
Trial Dates
May 2020 - July 2022
Trial Phase
2
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Trial Locations
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Resources
Crohn's + Ulcerative Colitis Research
New treatments for Crohn’s Disease and Ulcerative Colitis cannot be developed without clinical trial volunteers. By volunteering to participate, you may be able to make important contributions to scientific research. Each clinical trial is different, but the information provided below can help you consider whether a clinical trial may be right for you.
