A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04469062
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Mirikizumab

Mirikizumab administered intravenously (IV) and subcutaneously (SC).

Active Comparator: Vedolizumab

Vedolizumab administered IV.

Placebo Comparator: Placebo

Placebo administered SC and IV.

Interventions

Drug: - Mirikizumab IV

Administered IV

Drug: - Mirikizumab SC

Administered SC

Drug: - Vedolizumab IV

Administered IV

Drug: - Placebo IV

Administered IV

Drug: - Placebo SC

Administered SC

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Clinicaltrials.gov@lilly.com

1-317-615-4559

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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