A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

Last updated: May 20, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Crohn's Disease

Ulcerative Colitis

Ulcers

Treatment

Mirikizumab

Clinical Study ID

NCT04844606
16633
I6T-MC-AMAZ
ISA-2 CD
2020-005311-49
ISA-1 UC
  • Ages 2-19
  • All Genders

Study Summary

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants from originating studies (I6T-MC-AMBA [NCT05784246], I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130]) , I6T-MC-AMAY [NCT05509777]) who would, inthe opinion of the investigator, derive clinical benefit from further treatment withmirikizumab

  • Participants from prior studies who have completed assessments and procedures atlast visit of originating study and remain on study drug treatment.

  • Female participants must agree to contraception requirements.

Exclusion

Exclusion Criteria:

  • Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of StudyAMAZ that continued treatment with mirikizumab would present an unreasonable riskfor the participant.

  • Participants must not have had permanently or temporarily stopped study drug in theoriginating study, such that restarting mirikizumab would pose an unacceptable riskfor the participant in Study AMAZ.

  • Participants must not have an unstable or uncontrolled illness that wouldpotentially affect participant safety.

  • Participants must not be enrolled in the study if, for any reason, being in thestudy would compromise the participant's safety or confound data interpretation.

  • Participants must not have adenomatous polyps that have not been removed.

  • Participants must not be pregnant or breastfeeding.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Mirikizumab
Phase: 3
Study Start date:
May 26, 2021
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Medizinische Universität Wien

    Vienna, Wien 1090
    Austria

    Site Not Available

  • Antwerp University Hospital

    Edegem, Antwerpen 2650
    Belgium

    Site Not Available

  • Cliniques universitaires Saint-Luc

    Brussels, Bruxelles-Capitale, Région De 1200
    Belgium

    Site Not Available

  • UZ Brussel

    Brussels, Bruxelles-Capitale, Région De 1090
    Belgium

    Site Not Available

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • Hospital Universitario Cassiano Antonio de Moraes

    Vitoria, Espírito Santo 29040-091
    Brazil

    Site Not Available

  • Universidade Federal de Goias

    Goiania, Goiás 74605-020
    Brazil

    Site Not Available

  • Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância

    Curitiba, Paraná 80250-060
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90050-170
    Brazil

    Site Not Available

  • Centro de Pesquisa Sao Lucas

    Campinas, São Paulo 13060-803
    Brazil

    Site Not Available

  • Integral Pesquisa e Ensino

    Votuporanga, São Paulo 15501-405
    Brazil

    Site Not Available

  • Hôpital Jeanne de Flandre

    Lille, Nord-Pas-de-Calais 59000
    France

    Site Not Available

  • CHU d'Amiens-Picardie - Hôpital Sud

    Amiens, Somme 80054
    France

    Site Not Available

  • Hôpital Armand Trousseau

    Paris, 75012
    France

    Site Not Available

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 75015
    France

    Site Not Available

  • Dr. von Haunersches Kinderspital

    Munich, Bayern 80337
    Germany

    Site Not Available

  • HELIOS Klinikum Wuppertal

    Wuppertal, Nordrhein-Westfalen 42283
    Germany

    Site Not Available

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • Schneider Children's Medical Center

    Petah-Tikva, HaMerkaz 49202
    Israel

    Site Not Available

  • Yitzhak Shamir Medical Center

    Zerifin, HaMerkaz 70300
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, HaTsafon 3109601
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, Yerushalayim 9112001
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, Yerushalayim 9013102
    Israel

    Site Not Available

  • AOU Policlinico Umberto I

    Roma, Lazio 00161
    Italy

    Active - Recruiting

  • Policlinico Umberto I

    Roma, Lazio 00161
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, Lombardia 24127
    Italy

    Site Not Available

  • Ospedale dei Bambini Vittore Buzzi

    Milan, Milano 20154
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù IRCCS

    Rome, Roma 00165
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    Firenze, Toscana 50139
    Italy

    Site Not Available

  • Ospedale Maggiore Azienda USL di Bologna

    Bologna, 40133
    Italy

    Site Not Available

  • Tsujinaka Hospital - Kashiwanoha

    Kashiwa, Chiba 273-0011
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Tokyo Medical And Dental University Medical Hospital

    Bunkyō, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Tokyo Medical and Dental University Hospital

    Bunkyō, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, Kwangyǒkshi 41404
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

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

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 03080
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Deagu, Taegu-Kwangyǒkshi 41404
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Taegu, Taegu-Kwangyǒkshi 41404
    Korea, Republic of

    Site Not Available

  • Amsterdam UMC, locatie AMC

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam, Zuid-Holland 3015 GD
    Netherlands

    Site Not Available

  • Centrum Zdrowia Dziecka w Warszawie

    Warsaw, Mazowieckie 04-730
    Poland

    Active - Recruiting

  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

    Warszawa, Mazowieckie 04-501
    Poland

    Site Not Available

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, Podkarpackie 35-302
    Poland

    Active - Recruiting

  • Twoja Przychodnia SCM

    Szczecin, Zachodniopomorskie 71-434
    Poland

    Site Not Available

  • Hospital Universitario Reina Sofia

    Cordoba, Andalucía 14004
    Spain

    Site Not Available

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [Barcelona] 08950
    Spain

    Site Not Available

  • Hospital Universitari Parc Tauli

    Sabadell, Barcelona [Barcelona] 08208
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia, València 46026
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Site Not Available

  • The John Radcliffe Hospital

    Oxford, England OX3 9DU
    United Kingdom

    Site Not Available

  • Sheffield Children's Hospital

    Sheffield, S10 2TH
    United Kingdom

    Site Not Available

  • UCSF Medical Center at Mission Bay

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Active - Recruiting

  • Children's Center for Digestive Health Care, LLC

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Children's Center for Digestive Healthcare

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Emory University School of Medicine

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • The Hospital for Sick Children

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Boston's Childrens Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • MGH for Children - Waltham

    Waltham, Massachusetts 02451
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Waltham, Massachusetts 02451
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Pediatric Specialists of Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Children's Specialty Group, PPLC

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

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