Recruiting

An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

I6T-MC-AMAN - ClinicalTrials.gov - NCT03518086

The purpose of this study is to evaluate the safety and efficacy of mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or who cannot tolerate conventional or biologic therapy for UC.
How long will I be in the trial?
The study will last about 12 weeks and may include up to 6 visits.
Email
Recruiting

An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

I6T-MC-AMAN - ClinicalTrials.gov - NCT03518086

The purpose of this study is to evaluate the safety and efficacy of mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or who cannot tolerate conventional or biologic therapy for UC.
How long will I be in the trial?
The study will last about 12 weeks and may include up to 6 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 ulcerative colitis for at least 3 months before the planned start date for the study medications

Participants must have moderately or severely active ulcerative colitis at the start of the study

Participants must have had unsatisfactory results with or were unable to take other therapies for UC

Participants who are female must meet birth control requirements in order to participate in the study

Participants must NOT

Participants must not have other types of inflammatory bowel disease, such as Crohn’s disease or indeterminate colitis (also known as “inflammatory bowel disease-unclassified”)

Participants must not have had surgery in the past in order to remove part of the colon

Participants must not have certain complications of ulcerative colitis. One of these is called toxic megacolon. This is a condition where the colon is abnormally enlarged or dilated, often requiring surgical treatment

Participants must not have received certain types of medications for inflammatory diseases in the past. The study doctor can determine if you have received these when they speak with you at the screening visit

Trial Summary

Conditions the trial is for

Ulcerative Colitis

What the trial is testing?

Mirikizumab, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

1160

Trial Dates

June 2018 - December 2021

Trial Phase

3

Enter your postal code to find the nearest site

Think this trial might be a good fit for you?

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 ulcerative colitis for at least 3 months before the planned start date for the study medications

Participants must have moderately or severely active ulcerative colitis at the start of the study

Participants must have had unsatisfactory results with or were unable to take other therapies for UC

Participants who are female must meet birth control requirements in order to participate in the study

Participants must NOT

Participants must not have other types of inflammatory bowel disease, such as Crohn’s disease or indeterminate colitis (also known as “inflammatory bowel disease-unclassified”)

Participants must not have had surgery in the past in order to remove part of the colon

Participants must not have certain complications of ulcerative colitis. One of these is called toxic megacolon. This is a condition where the colon is abnormally enlarged or dilated, often requiring surgical treatment

Participants must not have received certain types of medications for inflammatory diseases in the past. The study doctor can determine if you have received these when they speak with you at the screening visit

Trial Summary

Conditions the trial is for

Ulcerative Colitis

What the trial is testing?

Mirikizumab, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

1160

Trial Dates

June 2018 - December 2021

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?