RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

Official Title

A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis

Quick Facts

Study Start:2023-11-22

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05784246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Males or females weighing ≥10 kg and ≥2 and \<18 years old at the time of consent for screening. * Have moderate to severe UC. * Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment. * Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report.	* Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis. * Have immune deficiency syndrome. * Previous bowel resection or intestinal surgery. * Evidence of toxic megacolon. * History or current evidence of cancer of the gastrointestinal tract.

Inclusion Criteria

Exclusion Criteria

* Males or females weighing ≥10 kg and ≥2 and \<18 years old at the time of consent for screening.
* Have moderate to severe UC.
* Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment.
* Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report.

* Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis.
* Have immune deficiency syndrome.
* Previous bowel resection or intestinal surgery.
* Evidence of toxic megacolon.
* History or current evidence of cancer of the gastrointestinal tract.

Contacts and Locations

Study Contact

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

CONTACT

1-317-615-4559

ClinicalTrials.gov@lilly.com

Principal Investigator

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)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

Children's Hospital Los Angeles

Los Angeles, California, 90027

United States

Rady Children's Hospital- San Diego

San Diego, California, 92123

United States

University of California-San Francisco-Mission Bay

San Francisco, California, 94158

United States

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

United States

GI Care for Kids

Atlanta, Georgia, 30342

United States

Riley Childrens Hospital

Indianapolis, Indiana, 46202

United States

Massachusetts General Hospital for Children

Boston, Massachusetts, 02114

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

St. Louis Children's Hospital

Saint Louis, Missouri, 63110

United States

Morristown Medical Center

Morristown, New Jersey, 07960-6136

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-22

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-11-22

Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

Ulcerative Colitis