Recruiting

A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

I6T-MC-AMAM - ClinicalTrials.gov - NCT03926130

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
How long will I be in the trial?
The study will last about 72 weeks and may include up to 19 visits.
Email
Recruiting

A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

I6T-MC-AMAM - ClinicalTrials.gov - NCT03926130

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
How long will I be in the trial?
The study will last about 72 weeks and may include up to 19 visits.
Email

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 Crohn's Disease (CD) for at least 3 months prior to baseline

Participants must have a confirmed diagnosis of moderate to severe CD

Participants must have demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD

Participants must, if female, meet the contraception recommendations

Participants must NOT

Participants must not have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis), abdominal or perianal abscess or short bowel syndrome

Participants must not have a stoma or ostomy

Participants must not have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline

Participants must not have ever received any monoclonal antibodies binding IL-23

Trial Summary

Conditions the trial is for

Crohn's Disease, Pediatric Crohn's Disease

What the trial is testing?

Mirikizumab

Could I receive a Placebo?

yes

Enrollment Goal

1100

Trial Dates

July 2019 - July 2023

Trial Phase

3

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Think this trial might be a good fit for you?

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 Crohn's Disease (CD) for at least 3 months prior to baseline

Participants must have a confirmed diagnosis of moderate to severe CD

Participants must have demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD

Participants must, if female, meet the contraception recommendations

Participants must NOT

Participants must not have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis), abdominal or perianal abscess or short bowel syndrome

Participants must not have a stoma or ostomy

Participants must not have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline

Participants must not have ever received any monoclonal antibodies binding IL-23

Trial Summary

Conditions the trial is for

Crohn's Disease, Pediatric Crohn's Disease

What the trial is testing?

Mirikizumab

Could I receive a Placebo?

yes

Enrollment Goal

1100

Trial Dates

July 2019 - July 2023

Trial Phase

3

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Trial Locations

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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?