A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Inflammatory Bowel Disease

Colic

Bowel Dysfunction

Treatment

Mirikizumab

Clinical Study ID

NCT05509777
16632
I6T-MC-PIBD
MACARONI-23
PLATFORMPBCRD3001
2024-511472-32-00
I6T-MC-AMAY
2022-000811-29
MACARONI-23/PLATFORMPBCRD300
  • Ages 2-17
  • All Genders

Study Summary

Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.

Study periods for the intervention-specific appendix (ISA) will be as follows:

  • A 12-week induction period

  • A maintenance period from Week 12 to Week 52, and

  • A safety follow-up period up to 16 weeks.

The study will last about 74 weeks and may include up to 19 visits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have a diagnosis of CD or fistulizing CD, with active colitis,ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic,and histologic criteria.

  • Participants have moderately to severely active CD (as defined by a baseline PCDAIscore ≥30).

  • Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receivingstudy intervention at Week 0.

  • Participants must have a documented history of inadequate response, loss of responseor intolerance to at least one medication used to treat CD, which may includeimmunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.

Exclusion

Exclusion Criteria:

  • Participants must not have complications of CD such as symptomatic strictures orstenosis, short gut syndrome, or any other manifestations that might be anticipatedto require surgery.

  • Participants must not have an abscess.

  • Participants must not have any kind of bowel resection within 26 weeks or any otherintra-abdominal surgery within 12 weeks of baseline.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Mirikizumab
Phase: 3
Study Start date:
March 13, 2024
Estimated Completion Date:
April 30, 2028

Study Description

Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.

Connect with a study center

  • The Children's Hospital at Westmead

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • 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

  • AKH - Medizinische Universtität Wien

    Vienna, 1090
    Austria

    Active - Recruiting

  • Cliniques universitaires Saint-Luc

    Bruxelles, Brussel 1200
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Brussel

    Brussel, 1090
    Belgium

    Active - Recruiting

  • Cliniques universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Antwerp

    Gent, 9000
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • NDI - Nucleo de Doenças Infecciosas

    Vitória, Espírito Santo 29040 091
    Brazil

    Site Not Available

  • Núcleo de Doenças Infecciosas/CBM/UFES

    Vitória, Espírito Santo 29040 091
    Brazil

    Active - Recruiting

  • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

    Goiânia, Goiás 74605 020
    Brazil

    Active - Recruiting

  • Associação Hospitalar de Proteção à Infância Dr. Raul Carneiro

    Curitiba, Paraná 80250 060
    Brazil

    Active - Recruiting

  • Hospital Pequeno Príncipe

    Curitiba, Paraná 80250 060
    Brazil

    Site Not Available

  • Hospital das Clinicas da FMRP

    Sao Paulo, Paraná 14051-140
    Brazil

    Site Not Available

  • Hospital da Criança Santo Antônio - Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035 074
    Brazil

    Active - Recruiting

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90050-170
    Brazil

    Active - Recruiting

  • HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

    Campinas, Sao Paulo 13060-904
    Brazil

    Active - Recruiting

  • Integral Pesquisa e Ensino

    Votuporanga, Sao Paulo 15501 405
    Brazil

    Active - Recruiting

  • Hospital PUC-CAMPINAS

    Campinas, São Paulo 13060-904
    Brazil

    Active - Recruiting

  • Hospital das Clinicas da FMRP

    Ribeirao Preto, São Paulo 14048-900
    Brazil

    Site Not Available

  • Hospital das Clinicas da FMRP

    Ribeirão Preto, São Paulo 14051-140
    Brazil

    Site Not Available

  • Hospital Pequeno Príncipe

    Curitiba-PR, 80250-060
    Brazil

    Active - Recruiting

  • Hospital das Clínicas - UFG (Universidade Federal de Goiás)

    Goiânia, 74605-050
    Brazil

    Active - Recruiting

  • NDI - Nucleo de Doenças Infecciosas

    Santos Dumont, 29040-091
    Brazil

    Active - Recruiting

  • 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 AMIENS Picardie Site SUD CRC

    Amines, Cedex1 80054
    France

    Site Not Available

  • CHU Amiens - Hopital NORD

    Amines, Cedex1 80054
    France

    Active - Recruiting

  • Hopital Jeanne de Flandre - CHRU Lille

    Lille Cedex, Nord 59037
    France

    Active - Recruiting

  • CHU AMIENS Picardie Site SUD CRC

    Amiens, 80054
    France

    Active - Recruiting

  • Hôpital Necker - Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

  • Hôpital Robert Debré - Paris

    Paris, 75019
    France

    Active - Recruiting

  • URC CIC

    Paris, 75015
    France

    Active - Recruiting

  • Soroka Medical Center

    Beer-Sheva, HaDarom 8410101
    Israel

    Site Not Available

  • Soroka Medical Center

    Beer Sheva, 8410101
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Site Not Available

  • Shamir Medical Center (Assaf Harofeh)

    Israel, 70300
    Israel

    Active - Recruiting

  • Hadassah University Hospital - Mount Scopus

    Jerusalem, 9124001
    Israel

    Site Not Available

  • Hadassah University Hospital, Ein Kerem

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Hadassah University Hospital, Ein Kerem,

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Shaare Zedek

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Schneider Children's Medical Center

    Petah Tiqva, 4920235
    Israel

    Active - Recruiting

  • Schneider Children's Medical Center

    Petah-Tikva, 4920235
    Israel

    Site Not Available

  • Asst Papa Giovanni Xxiii Bergamo

    Bergamo, 24127
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Active - Recruiting

  • Azienda USL di Bologna

    Bologna, 40133
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

    Firenze, 50139
    Italy

    Active - Recruiting

  • SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)

    Firenze, 50139
    Italy

    Active - Recruiting

  • Ospedale dei Bambini Vittore Buzzi

    Milano, 20154
    Italy

    Active - Recruiting

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

    Roma, 00161
    Italy

    Active - Recruiting

  • Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)

    Roma, CAP 00161
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù

    Roma, 00165
    Italy

    Active - Recruiting

  • Hirosaki University Hospital

    Hirosaki, Aomori Pref. 036
    Japan

    Active - Recruiting

  • Kokikai Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, Chiba-Ken 277-0871
    Japan

    Active - Recruiting

  • Kobe University Hospital

    Kobe, Hyogo 650-0017
    Japan

    Site Not Available

  • Yokohama City University Medical Center, Center of IBD

    Yokohama-shi, Kanagawa-Ken 232-0024
    Japan

    Active - Recruiting

  • Miyagi Children's Hospital

    Sendai-shi, Miyagi 989 3126
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • National Center For Child Health And Development

    Setagaya-ku, Tokyo 154
    Japan

    Active - Recruiting

  • National Center for Child Health and Development

    Setagaya-ku, Tokyo 157-8535
    Japan

    Active - Recruiting

  • Saga University Hospital

    Saga, 849-8501
    Japan

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, Gyeongsangbuk-do 41404
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, Korea 06351
    Korea, Republic of

    Active - Recruiting

  • Inje University Haeundae Paik Hospital

    Busan, Kwangyǒkshi 48108
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Teukbyeolsi [Seoul] 3080
    Korea, Republic of

    Active - Recruiting

  • LIilly Korea Ltd

    Seoul, 04637
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Erasmus Medisch Centrum

    Rotterdam, Zuid-Holland 3015 CN
    Netherlands

    Active - Recruiting

  • Akershus Universitetssykehus

    Nordbyagen, 01474
    Norway

    Active - Recruiting

  • Oslo University Hospital

    Oslo, 0450
    Norway

    Active - Recruiting

  • Universitetssykehuset Nord-Norge

    Tromsø, 9038
    Norway

    Active - Recruiting

  • St-Olavs Hospital

    Trondheim, 7030
    Norway

    Active - Recruiting

  • Instytut Pomnik-Centrum Zdrowia Dziecka

    Warszawa, Masovian 04-730
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Dziecięcy w Krakowie

    Krakow, 30 663
    Poland

    Active - Recruiting

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszow, 35-302
    Poland

    Active - Recruiting

  • Warsaw IBD Point Profesor Kierkus

    Warszawa, 00-728
    Poland

    Active - Recruiting

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

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Hospital de Braga

    Braga, 4710-243
    Portugal

    Site Not Available

  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisboa, 1649-035
    Portugal

    Active - Recruiting

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

    Porto, 4200 319
    Portugal

    Active - Recruiting

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat, Barcelona 08950
    Spain

    Active - Recruiting

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona 08208
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofia

    Cordoba, 14004
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Active - Recruiting

  • John Radcliffe Hospital

    Oxford, Gb-oxf OX3 9DU
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS trust John Radcliffe hospital

    Oxford, Gb-oxf OX3 9DU
    United Kingdom

    Site Not Available

  • Royal London Hospital

    Whitechapel, Greater London E1 1FR
    United Kingdom

    Active - Recruiting

  • Royal Manchester Children's Hospital

    Manchester, Greater Manchester M13 9WL
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital For Children NHS Foundation Trust

    London, London, City Of WC1N 3JH
    United Kingdom

    Active - Recruiting

  • Royal Hospital for Children and Young People

    Edinburgh, Lothian Region EH16 4TJ
    United Kingdom

    Active - Recruiting

  • Oxford University Hospitals NHS trust John Radcliffe hospital

    Headington, Oxford OX3 9DU
    United Kingdom

    Active - Recruiting

  • Sheffield Children's Hospital

    Sheffield, South Yorkshire S10 2RX
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital for Children

    London, WC1N 3JH
    United Kingdom

    Active - Recruiting

  • Manchester University NHS Foundation Trust

    Manchester, M139WL
    United Kingdom

    Active - Recruiting

  • Phoenix Childrens Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Arkansas Children's Hospital Research Institute

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California-San Francisco-Mission Bay

    San Francisco, California 94158
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06032
    United States

    Active - Recruiting

  • Nicklaus Children's Hospital

    Miami, Florida 33155
    United States

    Site Not Available

  • Children's Center for Digestive Health Care, LLC

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • The Emory Clinic Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Riley Childrens Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Atlantic Children's Health--Pediatric Gastroenterology

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Atlantic Health System

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Columbia University Medical Center/New York Presbyterian

    New York, New York 10032
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

    New York, New York 10021-5663
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10021-5663
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Childrens Medical Center

    Dayton, Ohio 45404
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19146
    United States

    Active - Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Children's Hospital -Research Resource Office

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Site Not Available

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin 53226 4874
    United States

    Site Not Available

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