I6T-MC-AMAM - ClinicalTrials.gov - NCT03926130
I6T-MC-AMAM - ClinicalTrials.gov - NCT03926130
Key Requirements
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.
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 - April 2023
Trial Phase
3
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.
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 - April 2023
Trial Phase
3
Trial Locations
Hide locations not currently recruiting