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.
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.
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
March 2018 - November 2022
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 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
March 2018 - November 2022
Trial Phase
3
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Trial Locations
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Ulcerative Colitis 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.
