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Ulcerative ColitisPhase 3SHINE-ONNCT04844606

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

A Phase 3 study testing Mirikizumab in people with Ulcerative Colitis and Ulcerative Colitis Chronic, run by Eli Lilly and Company at 69 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 19 years
What is being tested?
Mirikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
69 sitesin 16 countries
Study dates
26 May 2021to Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

69 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

69 sites in 16 countries

United States11 sites, 11 recruiting

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

    subra kugathasan

    Recruiting

  • Children's Center for Digestive Health Care, LLC

    Atlanta, Georgia, 30342

    Jeffery Lewis

    Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

    617-355-6058

    Athos Bousvaros

    Recruiting

  • Pediatric Specialists of Virginia

    Fairfax, Virginia, 22031

    703-876-2788

    Peter Lee

    Not yet recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

    682-885-1990

    Clifton Huang

    Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

    Jeffrey Hyams

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    212-241-5415

    David Dunkin

    Recruiting

  • Children's Hospital of Philadelphia (CHOP)

    Philadelphia, Pennsylvania, 19104

    Arthur Kastl

    Not yet recruiting

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158

    Sofia Verstraete

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    314-454-6173

    Charles Samson

    Recruiting

  • Massachusetts General Hospital

    Waltham, Massachusetts, 02451

    Jess Kaplan

    Recruiting

Other trials in United States

Brazil7 sites, 7 recruiting

  • Centro de Pesquisa Sao Lucas

    Campinas, 13060-803

    19 3252-5611

    Joaquim Simoes Neto

    Not yet recruiting

  • Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância

    Curitiba, 80250-060

    +554121083861

    Sabine Truppel

    Not yet recruiting

  • Universidade Federal de Goias

    Goiânia, 74605-020

    Naflesia O. Correa

    Not yet recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 90035-903

    +5551999199815

    Luciana Harlacher

    Not yet recruiting

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90050-170

    Vanessa Scheffer

    Not yet recruiting

  • Hospital Universitario Cassiano Antonio de Moraes

    Vitória, 29040-091

    +55 27 999720299

    Ana Daniela Sadovsky

    Not yet recruiting

  • Integral Pesquisa e Ensino

    Votuporanga, 15500-269

    +5517997472217

    HERLON VALÉRIO

    Not yet recruiting

Other trials in Brazil

Israel6 sites, 6 recruiting

  • Soroka Medical Center

    Beersheba, 8410101

    +97286400693

    Gadi Howard

    Not yet recruiting

  • Rambam Health Care Campus

    Haifa, 3109601

    972-4-7774381

    Ramit Magen Rimon

    Not yet recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9013102

    +97226666482

    Dan Turner

    Recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001

    +97226778718

    Zev Davidovics

    Recruiting

  • Schneider Children's Medical Center

    Petah Tikva, 49202

    972039253674

    Dror Shouval

    Recruiting

  • Yitzhak Shamir Medical Center

    Ẕerifin, 70300

    972-8-934-9793

    EFRAT BROIDE

    Recruiting

Other trials in Israel

Italy6 sites, 6 recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

    0352673856

    Naire Sansotta

    Not yet recruiting

  • Ospedale Maggiore Azienda USL di Bologna

    Bologna, 40133

    Patrizia Alvisi

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Meyer IRCCS

    Florence, 50139

    055 56621

    Paolo Lionetti

    Recruiting

  • Ospedale dei Bambini Vittore Buzzi

    Milan, 20154

    00390263631

    Lorenzo Norsa

    Recruiting

  • AOU Policlinico Umberto I

    Roma, 00161

    0039 0649979330

    Salvatore Oliva

    Recruiting

  • Ospedale Pediatrico Bambino Gesù IRCCS

    Rome, 00165

    0039 06 68592243

    Fiammetta Bracci

    Not yet recruiting

Other trials in Italy

Japan6 sites, 6 recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō, 113-8519

    81120023812

    Masakazu Nagahori

    Recruiting

  • Juntendo University Hospital

    Bunkyō City, 113-8431

    81120023812

    Takahiro Kudo

    Recruiting

  • Tsujinaka Hospital - Kashiwanoha

    Kashiwa, 273-0011

    81120023812

    Ken Takeuchi

    Recruiting

  • Kobe University Hospital

    Kobe, 650-0017

    81120023812

    Tomoko Horinouchi

    Recruiting

  • National Center for Child Health and Development

    Tokyo, 157-8535

    81120023812

    Katsuhiro Arai

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, 232-0024

    81120023812

    Reiko Kunisaki

    Recruiting

Other trials in Japan

Belgium5 sites, 5 recruiting

  • UZ Brussel

    Brussels, 1090

    3224749399

    Elisabeth De Greef

    Recruiting

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

    Isabelle Scheers

    Not yet recruiting

  • Antwerp University Hospital

    Edegem, 2650

    3238215524

    Els Van de Vijver

    Not yet recruiting

  • UZ Gent

    Ghent, 9000

    3293323966

    Pauline De Bruyne

    Recruiting

  • UZ Leuven

    Leuven, 3000

    003216343343

    Ilse Hoffman

    Recruiting

Other trials in Belgium

Poland5 sites, 5 recruiting

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302

    604481752

    Bartosz Korczowski

    Recruiting

  • Twoja Przychodnia SCM

    Szczecin, 71-434

    48 91 433 29 19

    Beata Gawdis-Wojnarska

    Recruiting

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

    Warsaw, 04-501

    Monika Meglicka

    Recruiting

  • Centrum Zdrowia Dziecka w Warszawie

    Warsaw, 04-730

    500111648

    Jaroslaw Kierkus

    Recruiting

  • Centrum Medyczne Oporów

    Wroclaw, 52-416

    71 712 70 77

    Radoslaw Kempinski

    Recruiting

Other trials in Poland

Norway4 sites, 4 recruiting

  • Akershus Universitetssykehus

    Lørenskog, 1478

    Christopher Inchley

    Not yet recruiting

  • Oslo Universitetssykehus Ullevål

    Oslo, 0450

    Gori Perminow

    Not yet recruiting

  • Universitetssykehuset Nord-Norge HF

    Tromsø, 9038

    95821317

    Lene Nymo Trulsen

    Not yet recruiting

  • St. Olavs Hospital

    Trondheim, 7030

    72574658

    Henrik Døllner

    Not yet recruiting

Other trials in Norway

Spain4 sites, 4 recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

    34957010350

    RAFAEL MARCHAL

    Not yet recruiting

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, 08950

    Javier Martín de Carpi

    Not yet recruiting

  • Hospital Universitari Parc Tauli

    Sabadell, 08208

    (+34) 937458305

    Diana García

    Not yet recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    961244055

    Marisa Iborra Colomino

    Recruiting

Other trials in Spain

Portugal3 sites, 3 recruiting

  • 2Ca Braga

    Braga, 4710-243

    Filipa Neiva

    Not yet recruiting

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

    Lisbon, 1649-035

    00351217805229

    Luis Rodrigues

    Not yet recruiting

  • Centro Hospitalar de Sao Joao - Hospital de Sao Joao

    Porto, 4200-319

    Eunice Trindade

    Recruiting

Other trials in Portugal

South Korea3 sites, 3 recruiting

  • Kyungpook National University Chilgok Hospital

    Deagu, 41404

    Ben Kang

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Jin Soo Moon

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Yon Ho Choe

    Recruiting

Other trials in South Korea

United Kingdom3 sites, 3 recruiting

  • Royal London Hospital

    London, E1 1BB

    Ahmed Kadir

    Not yet recruiting

  • The John Radcliffe Hospital

    Oxford, OX3 9DU

    Lucy Howarth

    Not yet recruiting

  • Sheffield Children's Hospital

    Sheffield, S10 2TH

    Akshay Kapoor

    Recruiting

Other trials in United Kingdom

Canada2 sites, 2 recruiting

  • London Health Sciences Centre

    London, N6A 5W9

    519-685-8500

    Dhandapani Ashok

    Not yet recruiting

  • The Hospital for Sick Children

    Toronto, M5G 1X8

    Thomas Walters

    Recruiting

Other trials in Canada

Germany2 sites, 2 recruiting

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, 55131

    00496131175839

    Stephan Gehring

    Recruiting

  • Dr. von Haunersches Kinderspital

    Munich, 80337

    004989440057931

    Tobias Schwerd

    Recruiting

Other trials in Germany

Austria1 site, 1 recruiting

  • Medizinische Universität Wien

    Vienna, 1090

    Wolf-Dietrich Huber

    Not yet recruiting

Other trials in Austria

Netherlands1 site, 1 recruiting

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

    Lissy De Ridder

    Not yet recruiting

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Mirikizumab
Keywords
Pediatric Ulcerative Colitis, Pediatric Crohn's Disease, Pediatric UC, Pediatric CD
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases, Crohn Disease, Pediatric ulcerative colitis, Pediatric Crohn's disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirikizumabDrug

    Also called LY3074828

    Administered SC

  • MirikizumabDrug

    Also called LY3074828

    Administered IV

Study groups in NCT04844606
Study groupRoleWhat they receive
Mirikizumab Dose 1 for UCExperimentalDose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.
Receives: Drug: Mirikizumab
Mirikizumab Dose 2 for UCExperimentalDose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Receives: Drug: Mirikizumab
Mirikizumab Dose 3 for UCExperimentalDose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Receives: Drug: Mirikizumab
Mirikizumab Dose 4 for CDExperimentalDose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Receives: Drug: Mirikizumab
Mirikizumab Dose 5 for CDExperimentalDose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Receives: Drug: Mirikizumab
Mirikizumab Dose 6 for CDExperimentalDose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Receives: Drug: Mirikizumab
Mirikizumab Dose 7 for UC or CDExperimentalIntravenous (IV) rescue dosing, if response is lost.
Receives: Drug: Mirikizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission

    Clinical Remission based on the MMS

    Measured: Week 52

  2. Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission

    Clinical Remission based on the PCDAI

    Measured: Week 52

Secondary outcomes (16)

  1. Percentage of Participants with UC in MMS Clinical Response

    Clinical Response based on the MMS

    Measured: Week 52

  2. Percentage of Participants with CD in PCDAI Clinical Response

    Clinical Response based on the PCDAI

    Measured: Week 52

  3. Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response

    Clinical Response based on the PUCAI

    Measured: Week 52

  4. Percentage of Participants with UC in PUCAI Clinical Remission

    Clinical Response based on the PUCAI

    Measured: Week 52

  5. Percentage of Participants with UC in Endoscopic Remission

    Endoscopic Remission based on the Endoscopic Subscore (ES)

    Measured: Week 52

  6. Percentage of Participants with CD in Endoscopic Remission

    Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD)

    Measured: Week 52

  7. Percentage of Participants with UC in Endoscopic Response

    Endoscopic Response in Participants based on the ES

    Measured: Week 52

  8. Percentage of Participants with CD in Endoscopic Response

    Endoscopic Response based on the SES-CD

    Measured: Week 52

  9. Percentage of Participants with UC in having Endoscopic Subscore = 0

    Endoscopic Remission when ES = 0

    Measured: Week 52

  10. Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission

    Histologic remission based on histology scoring and endoscopic remission based on endoscopy score

    Measured: Week 52

  11. Percentage of Participants with CD Achieving Histologic Remission

    Histologic remission based on histology scoring

    Measured: Week 52

  12. 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

    Measured: Week 52

  13. 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)

    Measured: Week 52

  14. Time to First Dose of Corticosteroid Among Participants with UC Entering Study AMAZ Not on Corticosteroids

    Measured: Week 0 to Week 52

  15. Percentage of Participants Who Achieve both Clinical Remission by PCDAI and Endoscopic Response

    Measured: Week 52

  16. Change from Baseline Over Time in C-reactive Protein, High Sensitivity (hsCRP)

    Measured: Baseline, Week 0 to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start26 May 2021
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04844606
Sponsor's protocol ID
16633
Other IDs
I6T-MC-AMAZ, 2020-005311-49, ISA-1 UC, ISA-2 CD, ISA-3 UC, ISA-4 CD
Acronym
SHINE-ON
Status last verified
Oct 2026
First submitted
12 Apr 2021
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirikizumab in people with Ulcerative Colitis and Ulcerative Colitis Chronic, run by Eli Lilly and Company at 69 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Brazil, Israel, Italy, Japan and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission (time frame: Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04844606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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SHINE-ON Clinical Trial NCT04844606 | AzTrials