A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis

Study Purpose

A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.

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 and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Have an established diagnosis of UC for ≥3 months.
  • - Have confirmed diagnosis of moderately for severely active UC.
  • - Have current bowel urgency.
  • - Have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic/Janus Kinase (JAK) inhibitor/sphingosine-1-phosphate (S1P) receptor modulator therapy for UC.

Exclusion Criteria:

  • - Have Crohn's disease (CD) - Have inflammatory bowel disease-unclassified, formerly known as indeterminate colitis, or.
  • - Have ulcerative proctitis, disease limited to the rectum, that is, distal to the recto-sigmoid junction, which lies approximately 10 to 15 centimeter (cm) from anal verge.
  • - Have an inherited immunodeficiency syndrome or a monogenic cause of UC-like colonic inflammation.
  • - Have any history or current evidence of cancer of the gastrointestinal tract.
  • - Have active tuberculosis.
  • - Have HIV infection.

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.

NCT05767021
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 Recruiting
Countries United States
Conditions

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

Ulcerative Colitis, Ulcerative Colitis Chronic
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Mirikizumab

Participants will receive mirikizumab intravenously (IV) and mirikizumab subcutaneously (SC).

Interventions

Drug: - Mirikizumab

Administered IV

Drug: - Mirikizumab

Administered SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dedicated Clinical Research, Litchfield Park, Arizona

Status

Not yet recruiting

Address

Dedicated Clinical Research

Litchfield Park, Arizona, 85340

Om Research, LLC, Lancaster, California

Status

Not yet recruiting

Address

Om Research, LLC

Lancaster, California, 93534

Sweet Hope Research Specialty, Inc., Hialeah, Florida

Status

Not yet recruiting

Address

Sweet Hope Research Specialty, Inc.

Hialeah, Florida, 33016

Encore Borland-Groover Clinical Research, Jacksonville, Florida

Status

Not yet recruiting

Address

Encore Borland-Groover Clinical Research

Jacksonville, Florida, 32256

Grand Teton Research Group, Idaho Falls, Idaho

Status

Not yet recruiting

Address

Grand Teton Research Group

Idaho Falls, Idaho, 83404

Topeka, Kansas

Status

Recruiting

Address

Cotton-O'Neil Clinical Research Center, Digestive Health

Topeka, Kansas, 66606

Care Access, New Iberia, Louisiana

Status

Not yet recruiting

Address

Care Access

New Iberia, Louisiana, 70560

Chesterfield, Michigan

Status

Not yet recruiting

Address

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047

Wyoming, Michigan

Status

Not yet recruiting

Address

Gastroenterology Associates of Western Michigan, P.L.C.

Wyoming, Michigan, 49519

Wilmington Medical Research, Wilmington, North Carolina

Status

Not yet recruiting

Address

Wilmington Medical Research

Wilmington, North Carolina, 28401

Optimed Research, LTD, Columbus, Ohio

Status

Not yet recruiting

Address

Optimed Research, LTD

Columbus, Ohio, 43235

Care Access - Youngstown, Poland, Ohio

Status

Not yet recruiting

Address

Care Access - Youngstown

Poland, Ohio, 44514

Central Sooner Research, Norman, Oklahoma

Status

Not yet recruiting

Address

Central Sooner Research

Norman, Oklahoma, 73071

Gastro One, Germantown, Tennessee

Status

Not yet recruiting

Address

Gastro One

Germantown, Tennessee, 38138

Galen Medical Group, Hixson, Tennessee

Status

Not yet recruiting

Address

Galen Medical Group

Hixson, Tennessee, 37343

Houston, Texas

Status

Not yet recruiting

Address

Houston Endoscopy and Research Center, Llc

Houston, Texas, 77079

Biopharma Informatic, LLC, Houston, Texas

Status

Not yet recruiting

Address

Biopharma Informatic, LLC

Houston, Texas, 77084

Katy, Texas

Status

Not yet recruiting

Address

Citrine Institute for Research and Wellness

Katy, Texas, 77494

San Antonio Gastroenterology, San Antonio, Texas

Status

Not yet recruiting

Address

San Antonio Gastroenterology

San Antonio, Texas, 78229

Sugar Land, Texas

Status

Not yet recruiting

Address

Gastroenterology Associates of Texas - Denise Rodriguez

Sugar Land, Texas, 77479

Ogden, Utah

Status

Not yet recruiting

Address

Care Access Research LLC - Salt Lake City

Ogden, Utah, 84403

Charlottesville Medical Research, Charlottesville, Virginia

Status

Not yet recruiting

Address

Charlottesville Medical Research

Charlottesville, Virginia, 22911