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.
Email
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.
Email

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

What the trial is testing?

Mirikizumab

Could I receive a Placebo?

no

Enrollment Goal

30

Trial Dates

May 2020 - July 2022

Trial Phase

2

Enter your postal code to find the nearest site

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

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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Ulcerative Colitis Resources

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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.
Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?