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.
Email
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.
Email

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

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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+

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

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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?