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
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
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
Not the right fit? Sign up to receive updates on new trials.
Trial Locations
Hide locations not currently recruiting
Enter your postal code to see sites near you
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.
