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 73 weeks and may include up to 19 visits.
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 73 weeks and may include up to 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 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) or short bowel syndrome
Participants must not have a stoma, ileoanal pouch 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, Mirikizumab, Ustekinumab, Ustekinumab, Placebo, Placebo
Could I receive a Placebo?
yes
Enrollment Goal
1150
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) or short bowel syndrome
Participants must not have a stoma, ileoanal pouch 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, Mirikizumab, Ustekinumab, Ustekinumab, Placebo, Placebo
Could I receive a Placebo?
yes
Enrollment Goal
1150
Trial Dates
July 2019 - July 2023
Trial Phase
3
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Trial Locations
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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.
