Recruiting
A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
I6T-MC-AMAP - ClinicalTrials.gov - NCT03519945
This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).
How long will I be in the trial?
The study will last about 176 weeks and may include up to 43 visits.
Recruiting
A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
I6T-MC-AMAP - ClinicalTrials.gov - NCT03519945
This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).
How long will I be in the trial?
The study will last about 176 weeks and may include up to 43 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 completed Studies AMAC (NCT02589665) or AMBG (NCT03524092), received study drug, and did not stop study drug early - Female participants must agree to contraception requirements
Participants must NOT
Participants must not have developed a new condition, including cancer, in the originator study
Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
Participants must not have received surgery for UC in the originator study and must not be likely to require surgery for treatment of UC during this study
Participants must not have developed growths, known as polyps, that develop on the lining of the large intestine during the originator study that have not been removed prior to the start of this study
Trial Summary
Conditions the trial is for
Ulcerative Colitis
What the trial is testing?
Mirikizumab
Could I receive a Placebo?
no
Enrollment Goal
840
Trial Dates
July 2018 - July 2025
Trial Phase
3
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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 completed Studies AMAC (NCT02589665) or AMBG (NCT03524092), received study drug, and did not stop study drug early - Female participants must agree to contraception requirements
Participants must NOT
Participants must not have developed a new condition, including cancer, in the originator study
Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
Participants must not have received surgery for UC in the originator study and must not be likely to require surgery for treatment of UC during this study
Participants must not have developed growths, known as polyps, that develop on the lining of the large intestine during the originator study that have not been removed prior to the start of this study
Trial Summary
Conditions the trial is for
Ulcerative Colitis
What the trial is testing?
Mirikizumab
Could I receive a Placebo?
no
Enrollment Goal
840
Trial Dates
July 2018 - July 2025
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.
