I6T-MC-AMBI - ClinicalTrials.gov - NCT04469062
I6T-MC-AMBI - ClinicalTrials.gov - NCT04469062
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 UC for at least 3 months prior to baseline
Participants must have a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS)
Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC
Participants must, if female, meet the contraception requirements
Participants must NOT
Participants must not have a current diagnosis of Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis)
Participants must not have had a previous colectomy
Participants must not have current evidence of toxic megacolon
Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab
Participants must not have prior clinical failure or intolerance to anti-IL12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy
Trial Summary
Conditions the trial is for
Ulcerative Colitis
What the trial is testing?
Mirikizumab
Could I receive a Placebo?
yes
Enrollment Goal
1100
Trial Dates
April 2021 - June 2024
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 UC for at least 3 months prior to baseline
Participants must have a confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS)
Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC
Participants must, if female, meet the contraception requirements
Participants must NOT
Participants must not have a current diagnosis of Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis)
Participants must not have had a previous colectomy
Participants must not have current evidence of toxic megacolon
Participants must not have prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab
Participants must not have prior clinical failure or intolerance to anti-IL12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy
Trial Summary
Conditions the trial is for
Ulcerative Colitis
What the trial is testing?
Mirikizumab
Could I receive a Placebo?
yes
Enrollment Goal
1100
Trial Dates
April 2021 - June 2024
Trial Phase
3
Trial Locations
Hide locations not currently recruiting