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

Last updated: March 26, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Inflammatory Bowel Disease

Crohn's Disease (Pediatric)

Colic

Treatment

Mirikizumab

Clinical Study ID

NCT04844606
16633
I6T-MC-AMAZ
ISA-2 CD
ISA-4 CD
2020-005311-49
ISA-3 UC
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. Additional treatment may be available to participants via a Continued Access Period.

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, 1090
    Austria

    Site Not Available

  • Medizinische Universität Wien

    Vienna 2761369, 1090
    Austria

    Site Not Available

  • Cliniques universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • UZ Brussel

    Brussels, 1090
    Belgium

    Site Not Available

  • Cliniques universitaires Saint-Luc

    Brussels 2800866, 1200
    Belgium

    Site Not Available

  • UZ Brussel

    Brussels 2800866, 1090
    Belgium

    Site Not Available

  • Antwerp University Hospital

    Edegem, 2650
    Belgium

    Site Not Available

  • Antwerp University Hospital

    Edegem 2799007, 2650
    Belgium

    Site Not Available

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Gent

    Ghent, 9000
    Belgium

    Site Not Available

  • UZ Gent

    Ghent 2797656, 9000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • Centro de Pesquisa Sao Lucas

    Campinas, 13060-803
    Brazil

    Site Not Available

  • Centro de Pesquisa Sao Lucas

    Campinas 3467865, 13060-803
    Brazil

    Site Not Available

  • Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância

    Curitiba, 80250-060
    Brazil

    Site Not Available

  • Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância

    Curitiba 3464975, 80250-060
    Brazil

    Site Not Available

  • Universidade Federal de Goias

    Goiania, 74605-020
    Brazil

    Site Not Available

  • Universidade Federal de Goias

    Goiânia, 74605-020
    Brazil

    Site Not Available

  • Universidade Federal de Goias

    Goiânia 3462377, 74605-020
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90050-170
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre 3452925, 90035-903
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre 3452925, 90050-170
    Brazil

    Site Not Available

  • Hospital Universitario Cassiano Antonio de Moraes

    Vitoria, 29040-091
    Brazil

    Site Not Available

  • Hospital Universitario Cassiano Antonio de Moraes

    Vitória, 29040-091
    Brazil

    Site Not Available

  • Hospital Universitario Cassiano Antonio de Moraes

    Vitória 3444924, 29040-091
    Brazil

    Site Not Available

  • Integral Pesquisa e Ensino

    Votuporanga, 15500-269
    Brazil

    Site Not Available

  • Integral Pesquisa e Ensino

    Votuporanga 3444864, 15500-269
    Brazil

    Site Not Available

  • London Health Sciences Centre

    London, N6A 5W9
    Canada

    Site Not Available

  • London Health Sciences Centre

    London 6058560, N6A 5W9
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto, M5G 1X8
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto 6167865, M5G 1X8
    Canada

    Site Not Available

  • CHU d'Amiens-Picardie - Hôpital Sud

    Amiens, 80054
    France

    Site Not Available

  • CHU d'Amiens-Picardie - Hôpital Sud

    Amiens 3037854, 80054
    France

    Site Not Available

  • Hôpital Jeanne de Flandre

    Lille, 59000
    France

    Site Not Available

  • Hôpital Jeanne de Flandre

    Lille 2998324, 59000
    France

    Site Not Available

  • Hôpital Armand Trousseau

    Paris, 75012
    France

    Site Not Available

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 75015
    France

    Site Not Available

  • Hôpital Armand Trousseau

    Paris 2988507, 75012
    France

    Site Not Available

  • Hôpital Universitaire Necker Enfants Malades

    Paris 2988507, 75015
    France

    Site Not Available

  • HELIOS Klinikum Wuppertal

    Wuppertal, Nordrhein-Westfalen 42283
    Germany

    Site Not Available

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, 55131
    Germany

    Active - Recruiting

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz 2874225, 55131
    Germany

    Site Not Available

  • Dr. von Haunersches Kinderspital

    Munich, 80337
    Germany

    Active - Recruiting

  • Dr. von Haunersches Kinderspital

    Munich 2867714, 80337
    Germany

    Site Not Available

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9013102
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem 281184, 9112001
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem 281184, 9013102
    Israel

    Site Not Available

  • Schneider Children's Medical Center

    Petah Tikva, 49202
    Israel

    Active - Recruiting

  • Schneider Children's Medical Center

    Petah Tikva 293918, 49202
    Israel

    Site Not Available

  • Schneider Children's Medical Center

    Petah-Tikva, 49202
    Israel

    Site Not Available

  • Yitzhak Shamir Medical Center

    Zerifin, 70300
    Israel

    Site Not Available

  • Yitzhak Shamir Medical Center

    Ẕerifin, 70300
    Israel

    Active - Recruiting

  • Yitzhak Shamir Medical Center

    Ẕerifin 293084, 70300
    Israel

    Site Not Available

  • Policlinico Umberto I

    Roma, Lazio 00161
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo 3182164, 24127
    Italy

    Site Not Available

  • Ospedale Maggiore Azienda USL di Bologna

    Bologna, 40133
    Italy

    Site Not Available

  • Ospedale Maggiore Azienda USL di Bologna

    Bologna 3181928, 40133
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    Firenze, 50139
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    Florence, 50139
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    Florence 3176959, 50139
    Italy

    Site Not Available

  • Ospedale dei Bambini Vittore Buzzi

    Milan, 20154
    Italy

    Active - Recruiting

  • Ospedale dei Bambini Vittore Buzzi

    Milan 3173435, 20154
    Italy

    Site Not Available

  • AOU Policlinico Umberto I

    Roma, 00161
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I

    Roma 8957247, 00161
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù IRCCS

    Rome, 00165
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù IRCCS

    Rome 3169070, 00165
    Italy

    Site Not Available

  • 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

  • Juntendo University Hospital

    Bunkyo-ku, 113-8431
    Japan

    Site Not Available

  • Institute of Science Tokyo Hospital

    Bunkyō, 113-8519
    Japan

    Active - Recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō 11077909, 113-8519
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyō City, 113-8431
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Bunkyō City 11790632, 113-8431
    Japan

    Site Not Available

  • Tsujinaka Hospital - Kashiwanoha

    Kashiwa, 273-0011
    Japan

    Active - Recruiting

  • Tsujinaka Hospital - Kashiwanoha

    Kashiwa 1859924, 273-0011
    Japan

    Site Not Available

  • National Center for Child Health and Development

    Tokyo, 157-8535
    Japan

    Site Not Available

  • National Center for Child Health and Development

    Tokyo 1850147, 157-8535
    Japan

    Site Not Available

  • Yokohama City University Medical Center

    Yokohama, 232-0024
    Japan

    Site Not Available

  • Yokohama City University Medical Center

    Yokohama 1848354, 232-0024
    Japan

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu, Kwangyǒkshi 41404
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Taegu, Taegu-Kwangyǒkshi 41404
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Deagu, 41404
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Amsterdam UMC, locatie AMC

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Amsterdam UMC, locatie AMC

    Amsterdam 2759794, 1105 AZ
    Netherlands

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam 2747891, 3015 GD
    Netherlands

    Site Not Available

  • Akershus Universitetssykehus

    Lørenskog, 1478
    Norway

    Site Not Available

  • Oslo Universitetssykehus Ullevål

    Oslo, 0450
    Norway

    Site Not Available

  • Universitetssykehuset Nord-Norge HF

    Tromsø, 9038
    Norway

    Site Not Available

  • St. Olavs Hospital

    Trondheim, 7030
    Norway

    Site Not Available

  • St. Olavs Hospital

    Trondheim 3133880, 7030
    Norway

    Site Not Available

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302
    Poland

    Active - Recruiting

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów 759734, 35-302
    Poland

    Site Not Available

  • Twoja Przychodnia SCM

    Szczecin, 71-434
    Poland

    Active - Recruiting

  • Twoja Przychodnia SCM

    Szczecin 3083829, 71-434
    Poland

    Site Not Available

  • Centrum Zdrowia Dziecka w Warszawie

    Warsaw, 04-730
    Poland

    Active - Recruiting

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

    Warsaw, 04-501
    Poland

    Active - Recruiting

  • Centrum Zdrowia Dziecka w Warszawie

    Warsaw 756135, 04-730
    Poland

    Active - Recruiting

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

    Warsaw 756135, 04-501
    Poland

    Site Not Available

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

    Warszawa, 04-501
    Poland

    Site Not Available

  • Centrum Medyczne Oporów

    Wroclaw, 52-416
    Poland

    Active - Recruiting

  • Centrum Medyczne Oporów

    Wroclaw 3081368, 52-416
    Poland

    Site Not Available

  • 2Ca Braga

    Braga, 4710-243
    Portugal

    Site Not Available

  • 2Ca Braga

    Braga 2742032, 4710-243
    Portugal

    Site Not Available

  • Centro Hospitalar de Sao Joao - Hospital de Sao Joao

    Porto, 4200-319
    Portugal

    Active - Recruiting

  • Centro Hospitalar de Sao Joao - Hospital de Sao Joao

    Porto 2735943, 4200-319
    Portugal

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Deagu, 41404
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Hospital Universitario Reina Sofia

    Cordoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba 2519240, 14004
    Spain

    Site Not Available

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, 08950
    Spain

    Site Not Available

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat 3122826, 08950
    Spain

    Site Not Available

  • Hospital Universitari Parc Tauli

    Sabadell, 08208
    Spain

    Site Not Available

  • Hospital Universitari Parc Tauli

    Sabadell 3111199, 08208
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Site Not Available

  • Royal London Hospital

    London, E1 1BB
    United Kingdom

    Site Not Available

  • Royal London Hospital

    London 2643743, E1 1BB
    United Kingdom

    Site Not Available

  • The John Radcliffe Hospital

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • The John Radcliffe Hospital

    Oxford 2640729, OX3 9DU
    United Kingdom

    Site Not Available

  • Sheffield Children's Hospital

    Sheffield, S10 2TH
    United Kingdom

    Active - Recruiting

  • Sheffield Children's Hospital

    Sheffield 2638077, S10 2TH
    United Kingdom

    Site Not Available

  • UCSF Medical Center at Mission Bay

    San Francisco, California 94158
    United States

    Active - Recruiting

  • UCSF Medical Center at Mission Bay

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Active - Recruiting

  • Connecticut Children's Medical Center

    Hartford 4835797, Connecticut 4831725 06106
    United States

    Site Not Available

  • 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

  • Children's Center for Digestive Health Care, LLC

    Atlanta 4180439, Georgia 4197000 30342
    United States

    Site Not Available

  • Emory University School of Medicine

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Active - Recruiting

  • 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

  • Boston Children's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Waltham 4954380, Massachusetts 6254926 02451
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Cook Children's Medical Center

    Fort Worth 4691930, Texas 4736286 76104
    United States

    Site Not Available

  • 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

  • Pediatric Specialists of Virginia

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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