NCT04469062WithdrawnPhase 3
A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 6 May 2021
Reason given: The trial was terminated secondary to a business decision, the original scientific question rendered moot by the external scientific community.
Brief summary (registry, in English)
The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 10 Jul 2020
- Start date
- 20 Apr 2021
- Primary completion date
- 13 Mar 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Ulcerative colitis
- NCT number
- NCT04469062
- EudraCT number
- 2019-001653-99
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants must not have had a previous colectomy
- 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
Other illness
- Participants must not have a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis)
Other
- Participants must not have current evidence of toxic megacolon
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.