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

A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis; Ulcerative Colitis Chronic
• Intervention / Treatment: Drug: Mirikizumab; Drug: Mirikizumab

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Not yet recruiting
    • Medizinische Universität Wien
    • Principal Investigator: Wolf-Dietrich Huber
• Belgium
  • Brussels, Belgium, 1200
    • Not yet recruiting
    • Cliniques universitaires Saint-Luc
    • Principal Investigator: Isabelle Scheers
  • Brussels, Belgium, 1090
    • Not yet recruiting
    • UZ Brussel
    • Principal Investigator: Elisabeth De Greef
    • Contact: Phone Number: 3224749399
  • Edegem, Belgium, 2650
    • Not yet recruiting
    • Antwerp University Hospital
    • Principal Investigator: Els Van de Vijver
    • Contact: Phone Number: 3238215524
  • Ghent, Belgium, 9000
    • Not yet recruiting
    • UZ Gent
    • Principal Investigator: Pauline De Bruyne
    • Contact: Phone Number: 3293323966
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Principal Investigator: Ilse Hoffman
    • Contact: Phone Number: 003216343343
• Brazil
  • Campinas, Brazil, 13060-803
    • Not yet recruiting
    • Centro de Pesquisa Sao Lucas
    • Principal Investigator: Joaquim Simoes Neto
    • Contact: Phone Number: 19 3252-5611
  • Curitiba, Brazil, 80250-060
    • Not yet recruiting
    • Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
    • Principal Investigator: Sabine Truppel
    • Contact: Phone Number: +554121083861
  • Goiânia, Brazil, 74605-020
    • Not yet recruiting
    • Universidade Federal de Goias
    • Principal Investigator: Naflesia O. Correa
  • Porto Alegre, Brazil, 90035-903
    • Not yet recruiting
    • Hospital de Clínicas de Porto Alegre
    • Contact: Phone Number: +5551999199815
    • Principal Investigator: Luciana Harlacher
  • Porto Alegre, Brazil, 90050-170
    • Not yet recruiting
    • Irmandade Da Santa Casa de Misericórdia de Porto Alegre
    • Principal Investigator: Vanessa Scheffer
  • Vitória, Brazil, 29040-091
    • Not yet recruiting
    • Hospital Universitario Cassiano Antonio de Moraes
    • Contact: Phone Number: +55 27 999720299
    • Principal Investigator: Ana Daniela Sadovsky
  • Votuporanga, Brazil, 15500-269
    • Not yet recruiting
    • Integral Pesquisa e Ensino
    • Principal Investigator: HERLON VALÉRIO
    • Contact: Phone Number: +5517997472217
• Canada
  • London, Canada, N6A 5W9
    • Not yet recruiting
    • London Health Sciences Centre
    • Contact: Phone Number: 519-685-8500
    • Principal Investigator: Dhandapani Ashok
  • Toronto, Canada, M5G 1X8
    • Recruiting
    • The Hospital for Sick Children
    • Principal Investigator: Thomas Walters
• Germany
  • Mainz, Germany, 55131
    • Recruiting
    • Universitätsmedizin Johannes Gutenberg Universität Mainz
    • Principal Investigator: Stephan Gehring
    • Contact: Phone Number: 00496131175839
  • Munich, Germany, 80337
    • Recruiting
    • Dr. von Haunersches Kinderspital
    • Principal Investigator: Tobias Schwerd
    • Contact: Phone Number: 004989440057931
• Israel
  • Haifa, Israel, 3109601
    • Not yet recruiting
    • Rambam Health Care Campus
    • Principal Investigator: Ramit Magen Rimon
    • Contact: Phone Number: 972-4-7774381
  • Jerusalem, Israel, 9112001
    • Recruiting
    • Hadassah Medical Center
    • Principal Investigator: Zev Davidovics
    • Contact: Phone Number: +97226778718
  • Jerusalem, Israel, 9013102
    • Recruiting
    • Shaare Zedek Medical Center
    • Principal Investigator: Dan Turner
    • Contact: Phone Number: +97226666482
  • Petah Tikva, Israel, 49202
    • Recruiting
    • Schneider Children's Medical Center
    • Principal Investigator: Dror Shouval
    • Contact: Phone Number: 972039253674
  • Ẕerifin, Israel, 70300
    • Recruiting
    • Yitzhak Shamir Medical Center
    • Principal Investigator: EFRAT BROIDE
    • Contact: Phone Number: 972-8-934-9793
• Italy
  • Bergamo, Italy, 24127
    • Not yet recruiting
    • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
    • Principal Investigator: Naire Sansotta
    • Contact: Phone Number: 0352673856
  • Bologna, Italy, 40133
    • Not yet recruiting
    • Ospedale Maggiore Azienda USL di Bologna
    • Principal Investigator: Patrizia Alvisi
  • Florence, Italy, 50139
    • Recruiting
    • Azienda Ospedaliera Universitaria Meyer IRCCS
    • Principal Investigator: Paolo Lionetti
    • Contact: Phone Number: 055 56621
  • Milan, Italy, 20154
    • Recruiting
    • Ospedale dei Bambini Vittore Buzzi
    • Principal Investigator: Lorenzo Norsa
    • Contact: Phone Number: 00390263631
  • Roma, Italy, 00161
    • Recruiting
    • AOU Policlinico Umberto I
    • Principal Investigator: Salvatore Oliva
    • Contact: Phone Number: 0039 0649979330
  • Rome, Italy, 00165
    • Not yet recruiting
    • Ospedale Pediatrico Bambino Gesù IRCCS
    • Principal Investigator: Fiammetta Bracci
    • Contact: Phone Number: 0039 06 68592243
• Japan
  • Bunkyō, Japan, 113-8519
    • Recruiting
    • Institute of Science Tokyo Hospital
    • Principal Investigator: Masakazu Nagahori
    • Contact: Phone Number: 81120023812
  • Bunkyō City, Japan, 113-8431
    • Recruiting
    • Juntendo University Hospital
    • Principal Investigator: Takahiro Kudo
    • Contact: Phone Number: 81120023812
  • Kashiwa, Japan, 273-0011
    • Recruiting
    • Tsujinaka Hospital - Kashiwanoha
    • Principal Investigator: Ken Takeuchi
    • Contact: Phone Number: 81120023812
  • Kobe, Japan, 650-0017
    • Not yet recruiting
    • Kobe University Hospital
    • Contact: Phone Number: 81120023812
    • Principal Investigator: Tomoko Horinouchi
  • Tokyo, Japan, 157-8535
    • Not yet recruiting
    • National Center for Child Health and Development
    • Principal Investigator: Katsuhiro Arai
    • Contact: Phone Number: 81120023812
  • Yokohama, Japan, 232-0024
    • Recruiting
    • Yokohama City University Medical Center
    • Principal Investigator: Reiko Kunisaki
    • Contact: Phone Number: 81120023812
• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Not yet recruiting
    • Erasmus Medisch Centrum
    • Principal Investigator: Lissy De Ridder
• Norway
  • Lørenskog, Norway, 1478
    • Not yet recruiting
    • Akershus Universitetssykehus
    • Principal Investigator: Christopher Inchley
  • Oslo, Norway, 0450
    • Not yet recruiting
    • Oslo Universitetssykehus Ullevål
    • Principal Investigator: Gori Perminow
  • Tromsø, Norway, 9038
    • Not yet recruiting
    • Universitetssykehuset Nord-Norge HF
    • Principal Investigator: Lene Nymo Trulsen
    • Contact: Phone Number: 95821317
  • Trondheim, Norway, 7030
    • Not yet recruiting
    • St. Olavs Hospital
    • Contact: Phone Number: 72574658
    • Principal Investigator: Henrik Døllner
• Poland
  • Rzeszów, Poland, 35-302
    • Recruiting
    • Korczowski Bartosz, Gabinet Lekarski
    • Principal Investigator: Bartosz Korczowski
    • Contact: Phone Number: 604481752
  • Szczecin, Poland, 71-434
    • Recruiting
    • Twoja Przychodnia SCM
    • Principal Investigator: Beata Gawdis-Wojnarska
    • Contact: Phone Number: 48 91 433 29 19
  • Warsaw, Poland, 04-730
    • Recruiting
    • Centrum Zdrowia Dziecka w Warszawie
    • Principal Investigator: Jaroslaw Kierkus
    • Contact: Phone Number: 500111648
  • Warsaw, Poland, 04-501
    • Recruiting
    • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
    • Principal Investigator: Monika Meglicka
  • Wroclaw, Poland, 52-416
    • Recruiting
    • Centrum Medyczne Oporow
    • Principal Investigator: Radoslaw Kempinski
    • Contact: Phone Number: 71 712 70 77
• Portugal
  • Braga, Portugal, 4710-243
    • Not yet recruiting
    • 2Ca Braga
    • Principal Investigator: Filipa Neiva
  • Porto, Portugal, 4200-319
    • Recruiting
    • Centro Hospitalar de Sao Joao - Hospital de Sao Joao
    • Principal Investigator: Eunice Trindade
• South Korea
  • Deagu, South Korea, 41404
    • Recruiting
    • Kyungpook National University Chilgok Hospital
    • Principal Investigator: Ben Kang
  • Seoul, South Korea, 03080
    • Recruiting
    • Seoul National University Hospital
    • Principal Investigator: Jin Soo Moon
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
    • Principal Investigator: Yon Ho Choe
• Spain
  • Córdoba, Spain, 14004
    • Not yet recruiting
    • Hospital Universitario Reina Sofía
    • Principal Investigator: RAFAEL MARCHAL
    • Contact: Phone Number: 34957010350
  • Esplugues de Llobregat, Spain, 08950
    • Not yet recruiting
    • Hospital Sant Joan de Déu
    • Principal Investigator: Javier Martín de Carpi
  • Sabadell, Spain, 08208
    • Not yet recruiting
    • Hospital Universitari Parc Tauli
    • Principal Investigator: Diana García
    • Contact: Phone Number: (+34) 937458305
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitari i Politecnic La Fe
    • Principal Investigator: Marisa Iborra Colomino
    • Contact: Phone Number: 961244055
• United Kingdom
  • London, United Kingdom, E1 1BB
    • Not yet recruiting
    • Royal London Hospital
    • Principal Investigator: Nicholas Croft
    • Contact: Phone Number: 02035941551
  • Oxford, United Kingdom, OX3 9DU
    • Not yet recruiting
    • The John Radcliffe Hospital
    • Principal Investigator: Lucy Howarth
  • Sheffield, United Kingdom, S10 2TH
    • Recruiting
    • Sheffield Children's Hospital
    • Principal Investigator: Akshay Kapoor
• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • UCSF Medical Center at Mission Bay
      • Principal Investigator: Sofia Verstraete
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Recruiting
      • Connecticut Children's Medical Center
      • Principal Investigator: Jeffrey Hyams
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University School of Medicine
      • Principal Investigator: subra kugathasan
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Children's Center for Digestive Health Care, LLC
      • Principal Investigator: Jeffery Lewis
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Phone Number: 617-355-6058
      • Principal Investigator: Athos Bousvaros
    • Waltham, Massachusetts, United States, 02451
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Jess Kaplan
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Principal Investigator: Charles Samson
      • Contact: Phone Number: 314-454-6173
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Phone Number: 212-241-5415
      • Principal Investigator: David Dunkin
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Cook Children's Medical Center
      • Contact: Phone Number: 682-885-1990
      • Principal Investigator: Clifton Huang
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Not yet recruiting
      • Pediatric Specialists of Virginia
      • Principal Investigator: Peter Lee
      • Contact: Phone Number: 703-876-2788

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants from originating studies (I6T-MC-AMBA [NCT05784246], I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130]) , I6T-MC-AMAY [NCT05509777]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
• Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
• Female participants must agree to contraception requirements.

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 Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.
• Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.
• Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
• Participants must not be enrolled in the study if, for any reason, being in the study 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirikizumab Dose 1 for UC; Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.	Drug: Mirikizumab; Administered SC; Other Names: LY3074828; Drug: Mirikizumab; Administered IV; Other Names: LY3074828
Experimental: Mirikizumab Dose 2 for UC; Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.	Drug: Mirikizumab; Administered SC; Other Names: LY3074828; Drug: Mirikizumab; Administered IV; Other Names: LY3074828
Experimental: Mirikizumab Dose 3 for UC; Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.	Drug: Mirikizumab; Administered SC; Other Names: LY3074828; Drug: Mirikizumab; Administered IV; Other Names: LY3074828
Experimental: Mirikizumab Dose 4 for CD; Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.	Drug: Mirikizumab; Administered SC; Other Names: LY3074828; Drug: Mirikizumab; Administered IV; Other Names: LY3074828
Experimental: Mirikizumab Dose 5 for CD; Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.	Drug: Mirikizumab; Administered SC; Other Names: LY3074828; Drug: Mirikizumab; Administered IV; Other Names: LY3074828
Experimental: Mirikizumab Dose 6 for CD; Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.	Drug: Mirikizumab; Administered SC; Other Names: LY3074828; Drug: Mirikizumab; Administered IV; Other Names: LY3074828
Experimental: Mirikizumab Dose 7 for UC or CD; Intravenous (IV) rescue dosing, if response is lost.	Drug: Mirikizumab; Administered SC; Other Names: LY3074828; Drug: Mirikizumab; Administered IV; Other Names: LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission	Clinical Remission based on the MMS	Week 52
Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission	Clinical Remission based on the PCDAI	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with UC in MMS Clinical Response	Clinical Response based on the MMS	Week 52
Percentage of Participants with CD in PCDAI Clinical Response	Clinical Response based on the PCDAI	Week 52
Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response	Clinical Response based on the PUCAI	Week 52
Percentage of Participants with UC in PUCAI Clinical Remission	Clinical Response based on the PUCAI	Week 52
Percentage of Participants with UC in Endoscopic Remission	Endoscopic Remission based on the Endoscopic Subscore (ES)	Week 52
Percentage of Participants with CD in Endoscopic Remission	Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD)	Week 52
Percentage of Participants with UC in Endoscopic Response	Endoscopic Response in Participants based on the ES	Week 52
Percentage of Participants with CD in Endoscopic Response	Endoscopic Response based on the SES-CD	Week 52
Percentage of Participants with UC in having Endoscopic Subscore = 0	Endoscopic Remission when ES = 0	Week 52
Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission	Histologic remission based on histology scoring and endoscopic remission based on endoscopy score	Week 52
Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery	Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery	Week 52
Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery	Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery)	Week 52
Percentage of Participants with CD Achieving Histologic Remission	Histologic remission based on histology scoring	Week 52
Time to First Dose of Corticosteroid Among Participants with UC Entering Study AMAZ Not on Corticosteroids		Week 0 to Week 52
Percentage of Participants Who Achieve both Clinical Remission by PCDAI and Endoscopic Response		Week 52
Change from Baseline Over Time in C-reactive Protein, High Sensitivity (hsCRP)		Baseline, Week 0 to Week 52

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric Ulcerative Colitis; Pediatric Crohn's Disease; Pediatric UC; Pediatric CD
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases; Pediatric ulcerative colitis; Pediatric Crohn's disease; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; mirikizumab
• Other Study ID Numbers: 16633; I6T-MC-AMAZ (Other Identifier: Eli Lilly and Company); 2020-005311-49 (EudraCT Number); ISA-1 UC (Other Identifier: Eli Lilly and Company); ISA-2 CD (Other Identifier: Eli Lilly and Company); ISA-3 UC (Other Identifier: Eli Lilly and Company); ISA-4 CD (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No