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

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).

Conditions

Ulcerative Colitis

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Children's Hospital Los Angeles, Los Angeles, California, United States, 90027

San Diego

Rady Children's Hospital- San Diego, San Diego, California, United States, 92123

San Francisco

University of California-San Francisco-Mission Bay, San Francisco, California, United States, 94158

Hartford

Connecticut Children's Medical Center, Hartford, Connecticut, United States, 06106

Atlanta

GI Care for Kids, Atlanta, Georgia, United States, 30342

Indianapolis

Riley Childrens Hospital, Indianapolis, Indiana, United States, 46202

Boston

Massachusetts General Hospital for Children, Boston, Massachusetts, United States, 02114

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Saint Louis

St. Louis Children's Hospital, Saint Louis, Missouri, United States, 63110

Morristown

Morristown Medical Center, Morristown, New Jersey, United States, 07960-6136

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2027-03-31