Not yet recruiting

A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis (LUCENT-ACT)

I6T-MC-AMBI - ClinicalTrials.gov - NCT04469062

The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).
How long will I be in the trial?
This study will last about 68 weeks and include at least 19 visits
Email
Not yet recruiting

A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis (LUCENT-ACT)

I6T-MC-AMBI - ClinicalTrials.gov - NCT04469062

The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).
How long will I be in the trial?
This study will last about 68 weeks and include at least 19 visits
Email

Key Requirements

Age :

18-80

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

18-80

Sex

All

Participants must

Participants must have a diagnosis of UC for at least 3 months prior to baseline

Participants must have a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS)

Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC

Participants must, if female, meet the contraception requirements

Participants must NOT

Participants must not have a current diagnosis of Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis)

Participants must not have had a previous colectomy

Participants must not have current evidence of toxic megacolon

Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab

Participants must not have prior clinical failure or intolerance to anti-IL12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy

Trial Summary

Conditions the trial is for

Ulcerative Colitis

What the trial is testing?

Mirikizumab

Could I receive a Placebo?

yes

Enrollment Goal

1100

Trial Dates

April 2021 - June 2024

Trial Phase

3

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

18-80

Sex

All

Participants must

Participants must have a diagnosis of UC for at least 3 months prior to baseline

Participants must have a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS)

Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC

Participants must, if female, meet the contraception requirements

Participants must NOT

Participants must not have a current diagnosis of Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis)

Participants must not have had a previous colectomy

Participants must not have current evidence of toxic megacolon

Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab

Participants must not have prior clinical failure or intolerance to anti-IL12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy

Trial Summary

Conditions the trial is for

Ulcerative Colitis

What the trial is testing?

Mirikizumab

Could I receive a Placebo?

yes

Enrollment Goal

1100

Trial Dates

April 2021 - June 2024

Trial Phase

3

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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?