A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)

Study Purpose

This study is designed to evaluate how the body processes and removes mirikizumab. The study will also evaluate safety and disease response in pediatric participants with UC taking mirikizumab. The study will last about 52 weeks and may include up to 17 visits.

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 2 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Participants weighing >10 kg - Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications - Have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment - Have evidence of UC extending proximal to the rectum - Participants have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC

Exclusion Criteria:

- Participants with a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis - Participants must not have had surgery to remove part of their colon - Participants with current evidence of toxic megacolon - Have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening - Inadequate response to Interleukin 12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)

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.

NCT04004611
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 2
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 Canada, Israel, Japan, Korea, Republic of, United States
Conditions

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

Ulcerative Colitis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Mirikizumab Dose 1

Mirikizumab administered intravenously (IV) and Subcutaneously (SC). Participants >40 kilograms (kg)

Experimental: Mirikizumab Dose 2

Mirikizumab administered IV and SC. Participants ≤40 kg

Experimental: Mirikizumab Dose 3

Mirikizumab administered IV and SC. Participants ≤40 kg

Interventions

Drug: - Mirikizumab

Administered IV and 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.

Childrens Hospital of Orange County, Orange, California

Status

Recruiting

Address

Childrens Hospital of Orange County

Orange, California, 92868

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94158

Children's Hospital of Colorado, Denver, Colorado

Status

Not yet recruiting

Address

Children's Hospital of Colorado

Denver, Colorado, 80045

Connecticut Children's Medical Center, Hartford, Connecticut

Status

Recruiting

Address

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30322

University of Chicago Hospital, Chicago, Illinois

Status

Recruiting

Address

University of Chicago Hospital

Chicago, Illinois, 60637

Riley Hospital for Children, Carmel, Indiana

Status

Recruiting

Address

Riley Hospital for Children

Carmel, Indiana, 46302

Boston Children's Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Boston Children's Hospital

Boston, Massachusetts, 02115

MGH for Children - Waltham, Waltham, Massachusetts

Status

Recruiting

Address

MGH for Children - Waltham

Waltham, Massachusetts, 02451

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Morristown, New Jersey

Status

Not yet recruiting

Address

Goryeb Children's Hospital / Atlantic Health System

Morristown, New Jersey, 07960

Icahn Sch of Med at Mt. Sinai, New York, New York

Status

Recruiting

Address

Icahn Sch of Med at Mt. Sinai

New York, New York, 10029

Cincinnati, Ohio

Status

Not yet recruiting

Address

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229

Columbus, Ohio

Status

Not yet recruiting

Address

The Abbigail Wexner Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania

Status

Recruiting

Address

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224

Cook Children's Hospital, Fort Worth, Texas

Status

Recruiting

Address

Cook Children's Hospital

Fort Worth, Texas, 76104

Texas Childrens Hospital, Houston, Texas

Status

Recruiting

Address

Texas Childrens Hospital

Houston, Texas, 77030

Pediatrics Specialists of Virginia, Fairfax, Virginia

Status

Recruiting

Address

Pediatrics Specialists of Virginia

Fairfax, Virginia, 22031

Children of the King's Daughters, Norfolk, Virginia

Status

Recruiting

Address

Children of the King's Daughters

Norfolk, Virginia, 23507

Seattle, Washington

Status

Recruiting

Address

Seattle Children's Hospital Research Foundation

Seattle, Washington, 98105

International Sites

University of Alberta Hospital, Edmonton, Alberta, Canada

Status

Not yet recruiting

Address

University of Alberta Hospital

Edmonton, Alberta, T6G 1C9

IWK Health Centre, Halifax, Nova Scotia, Canada

Status

Recruiting

Address

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8

The Hospital for Sick Children, Toronto, Ontario, Canada

Status

Not yet recruiting

Address

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8

Rambam Medical Center, Haifa, Israel

Status

Recruiting

Address

Rambam Medical Center

Haifa, , 3109601

Jerusalem, Israel

Status

Recruiting

Address

The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition; Shaare Zedek Medical Center

Jerusalem, ,

Schneider Children's Medical Center, Petah Tiqva, Israel

Status

Recruiting

Address

Schneider Children's Medical Center

Petah Tiqva, , 4920235

Kurume University Hospital, Kurume, Fukuoka, Japan

Status

Recruiting

Address

Kurume University Hospital

Kurume, Fukuoka, 830 0011

Saitama Children's Medical Center, Saitama-shi, Saitama, Japan

Status

Recruiting

Address

Saitama Children's Medical Center

Saitama-shi, Saitama, 330 8777

Juntendo University Hospital, Bunkyo-ku, Tokyo, Japan

Status

Recruiting

Address

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431

Bunkyō, Tokyo, Japan

Status

Recruiting

Address

Tokyo Medical And Dental University Medical Hospital

Bunkyō, Tokyo, 113-8519

Setagaya-ku, Tokyo, Japan

Status

Recruiting

Address

National Center For Child Health And Development

Setagaya-ku, Tokyo, 157-8535

Daegu, Korea, Republic of

Status

Recruiting

Address

Kyungpook National University Medical Center Chilgok Hospital

Daegu, , 41404

Seoul National University, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University

Seoul, , 3080

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