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

Last updated: February 24, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Colic

Ulcers

Crohn's Disease

Treatment

Mirikizumab IV

Mirikizumab SC

Clinical Study ID

NCT05784246
16634
2022-502183-20-00
I6T-MC-AMBA
  • Ages 2-17
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males or females weighing ≥10 kg and ≥2 and <18 years old at the time of consent forscreening.

  • 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)-Inhibitortreatment.

  • Have UC at least 3 months in duration before baseline, which includes endoscopicevidence of UC corroborated by a histopathology report.

Exclusion

Exclusion Criteria:

  • Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitisor 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.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Mirikizumab IV
Phase: 3
Study Start date:
November 22, 2023
Estimated Completion Date:
March 31, 2027

Study Description

Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).

Connect with a study center

  • Mater Hospital Brisbane

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Women'S and Children'S Hospital, Adelaide

    North Adelaide, South Australia 5006
    Australia

    Site Not Available

  • Perth Children's Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • UZA

    Edegem, 2650
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Children's & Women's Health Centre of British Columbia

    Vancouver, British Columbia V6H 3V4
    Canada

    Site Not Available

  • IWK Health Centre

    Halifax, Nova Scotia B3K 6R8
    Canada

    Site Not Available

  • London Health Sciences Centre (LHSC) - Victoria Hospital

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • CHU Lyon - Hôpital Femme-Mère-Enfant

    Bron, Rhone 69677
    France

    Site Not Available

  • CHU Amiens - Picardie Site Sud

    Amiens, Somme 80054
    France

    Site Not Available

  • CHU d'Amiens-Picardie - Hôpital Sud

    Amiens, Somme 80054
    France

    Site Not Available

  • Groupement Hospitalier Est

    Bron, 69677
    France

    Site Not Available

  • Hôpital Armand Trousseau

    Paris, 75012
    France

    Site Not Available

  • Hôpital Necker - Enfants Malades

    Paris, 75015
    France

    Site Not Available

  • LMU-Campus Innenstadt

    Müenchen, Bavaria 81377
    Germany

    Site Not Available

  • LMU-Campus Innenstadt

    Muenchen, Bayern 80337
    Germany

    Site Not Available

  • Helios Klinikum Wuppertal

    Wuppertal, Nordrhein Westfalen 42283
    Germany

    Active - Recruiting

  • Universitätsmedizin Mainz, Klinik und Poliklinik für Kinder

    Mainz, Rheinland Pfalz 55131
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Rheinland Pfalz 55131
    Germany

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah University Hospital - Mount Scopus

    Jerusalem, 9124001
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Schneider Children's Medical Center

    Petach-Tikva, 4920235
    Israel

    Active - Recruiting

  • Assaf Harofeh Medical Center

    Rishon Lezion, 70300
    Israel

    Site Not Available

  • Shamir Medical Center

    Zerifin, 7030000
    Israel

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

    Firenze, 50139
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

    Florence, 50139
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

    Roma, 00161
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù

    Roma, 00165
    Italy

    Site Not Available

  • Kokikai Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, Chiba-Ken 277-0871
    Japan

    Active - Recruiting

  • Yokohama City University Medical Center, Center of IBD

    Yokohama, Kanagawa 232-0024
    Japan

    Site Not Available

  • Yokohama City University Medical Center, Center of IBD

    Yokohama-shi, Kanagawa-Ken 232-0024
    Japan

    Active - Recruiting

  • Mie University Hospital

    Tsu-Shi, Mie-Ken 514-8507
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Tokyo Medical and Dental University Hospital

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Tokyo Medical and Dental University Hospital

    Bunkyō, Tokyo 113-8519
    Japan

    Site Not Available

  • Tokyo Medical and Dental University Hospital

    Bunkyō-Ku, Tokyo 113-8519
    Japan

    Site Not Available

  • National Center for Child Health and Development

    Setagaya-ku, Tokyo 157-8535
    Japan

    Active - Recruiting

  • Saga University Hospital

    Saga, 849-8501
    Japan

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Korea 03722
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, Kwangyǒkshi 41404
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Medical Center Chilgok Hospital

    Daegu, Kwangyǒkshi 41404
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 06351
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Medical Center Chilgok Hospital

    Deagu, Taegu-Kwangyǒkshi 41404
    Korea, Republic of

    Active - Recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 3080
    Korea, Republic of

    Site Not Available

  • Amsterdam UMC, locatie AMC

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Uniwersytecki Szpital Dziecięcy w Krakowie

    Krakow, 30 663
    Poland

    Site Not Available

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Active - Recruiting

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.

    Szczecin, 71 434
    Poland

    Active - Recruiting

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warszaw, 04 730
    Poland

    Active - Recruiting

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warszawa, 04 730
    Poland

    Active - Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warszawa, 00-728
    Poland

    Site Not Available

  • Warsaw IBD Point Profesor Kierkus

    Warszawa, 00-728
    Poland

    Site Not Available

  • Centrum Medyczne Oporow

    Wroclaw, 52 416
    Poland

    Site Not Available

  • Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)

    Braga, 4710-243
    Portugal

    Site Not Available

  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Site Not Available

  • Centro Hospitalar Universitário São João Serviços Farmacêuticos

    Porto, 4200 319
    Portugal

    Site Not Available

  • Centro Hospitalar de São João, E.P.E.

    Porto, 4200 319
    Portugal

    Site Not Available

  • King's College Hospital

    London, Greater London SE5 9RS
    United Kingdom

    Site Not Available

  • Children's Clinical Research Facility

    Whitechapel, Greater London E1 1FR
    United Kingdom

    Site Not Available

  • Royal London Hospital

    Whitechapel, Greater London E1 1FR
    United Kingdom

    Site Not Available

  • Sheffield Children's Hospital

    Sheffield, South Yorkshire S10 2TH
    United Kingdom

    Active - Recruiting

  • Children's Clinical Research Facility

    London, E1 1FR
    United Kingdom

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Dermatology Research Associates

    Los Angeles, California 90027
    United States

    Site Not Available

  • Rady Children's Hospital- San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • Univ of California San Francisco

    San Francisco, California 94158
    United States

    Active - Recruiting

  • University of California-San Francisco-Mission Bay

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Children's Center for Digestive Health Care, LLC

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • GI Care for Kids

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Riley Childrens Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital for Children

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • St. Louis Children's Hospital

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Morristown Medical Center

    Morristown, New Jersey 07960-6136
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Pediatric Gastroenterology Prisma Health - Upstate

    Greenville, South Carolina 29615
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.