Recruiting
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
I6T-MC-AMAX - ClinicalTrials.gov - NCT04232553
The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
How long will I be in the trial?
The study will last about 172 weeks and may include up to 24 visits.
Recruiting
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
I6T-MC-AMAX - ClinicalTrials.gov - NCT04232553
The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
How long will I be in the trial?
The study will last about 172 weeks and may include up to 24 visits.
Key Requirements
Age :
18+
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+
Sex
All
Participants must
Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
Female participants must meet the contraception requirements
Participants must NOT
Participants may not have received surgery for Crohn’s disease in the originator study or are likely to require surgery for treatment of Crohn’s disease during the study
Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM)
Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study
Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study
Trial Summary
Conditions the trial is for
Crohn's Disease
What the trial is testing?
Mirikizumab, Mirikizumab
Could I receive a Placebo?
no
Enrollment Goal
778
Trial Dates
June 2020 - November 2023
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+
Sex
All
Participants must
Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
Female participants must meet the contraception requirements
Participants must NOT
Participants may not have received surgery for Crohn’s disease in the originator study or are likely to require surgery for treatment of Crohn’s disease during the study
Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM)
Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study
Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study
Trial Summary
Conditions the trial is for
Crohn's Disease
What the trial is testing?
Mirikizumab, Mirikizumab
Could I receive a Placebo?
no
Enrollment Goal
778
Trial Dates
June 2020 - November 2023
Trial Phase
3
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Trial Locations
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Crohn's Disease 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.
