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

NCT ID: NCT04844606

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis Ulcerative Colitis Chronic Inflammatory Bowel Diseases Crohn's Disease

Keywords

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Pediatric Ulcerative Colitis Pediatric Crohn's Disease Pediatric UC Pediatric CD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mirikizumab Dose 1 for UC

Dose 1 of Mirikizumab is administered subcutaneously (SC)

Dosing is based on the participant's weight.

Group Type EXPERIMENTAL

Mirikizumab

Intervention Type DRUG

Administered SC

Mirikizumab Dose 2 for UC

Dose 2 of Mirikizumab is administered SC

Dosing is based on the participant's weight.

Group Type EXPERIMENTAL

Mirikizumab

Intervention Type DRUG

Administered SC

Mirikizumab Dose 3 for UC

Dose 3 of Mirikizumab is administered SC

Dosing is based on the participant's weight.

Group Type EXPERIMENTAL

Mirikizumab

Intervention Type DRUG

Administered SC

Mirikizumab Dose 4 for CD

Dose 4 of Mirikizumab is administered SC

Dosing is based on the participant's weight.

Group Type EXPERIMENTAL

Mirikizumab

Intervention Type DRUG

Administered SC

Mirikizumab Dose 5 for CD

Dose 5 of Mirikizumab is administered SC

Dosing is based on the participant's weight.

Group Type EXPERIMENTAL

Mirikizumab

Intervention Type DRUG

Administered SC

Mirikizumab Dose 6 for CD

Dose 6 of Mirikizumab is administered SC

Dosing is based on the participant's weight.

Group Type EXPERIMENTAL

Mirikizumab

Intervention Type DRUG

Administered SC

Mirikizumab Dose 7 for UC or CD

Intravenous (IV) rescue dosing, if response is lost.

Group Type EXPERIMENTAL

Mirikizumab

Intervention Type DRUG

Administered IV

Interventions

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Mirikizumab

Administered SC

Intervention Type DRUG

Mirikizumab

Administered IV

Intervention Type DRUG

Other Intervention Names

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LY3074828 LY3074828

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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UCSF Medical Center at Mission Bay

San Francisco, California, United States

Site Status RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status RECRUITING

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status RECRUITING

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia, United States

Site Status RECRUITING

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Massachusetts General Hospital

Waltham, Massachusetts, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Cook Children's Medical Center

Fort Worth, Texas, United States

Site Status RECRUITING

Pediatric Specialists of Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Medizinische Universität Wien

Vienna, , Austria

Site Status NOT_YET_RECRUITING

UZ Brussel

Brussels, , Belgium

Site Status NOT_YET_RECRUITING

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status NOT_YET_RECRUITING

Antwerp University Hospital

Edegem, , Belgium

Site Status NOT_YET_RECRUITING

UZ Gent

Ghent, , Belgium

Site Status NOT_YET_RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status NOT_YET_RECRUITING

Centro de Pesquisa Sao Lucas

Campinas, , Brazil

Site Status NOT_YET_RECRUITING

Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância

Curitiba, , Brazil

Site Status NOT_YET_RECRUITING

Universidade Federal de Goias

Goiânia, , Brazil

Site Status NOT_YET_RECRUITING

Hospital de Clinicas de Porto Alegre

Porto Alegre, , Brazil

Site Status NOT_YET_RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, , Brazil

Site Status NOT_YET_RECRUITING

Hospital Universitario Cassiano Antonio de Moraes

Vitória, , Brazil

Site Status NOT_YET_RECRUITING

Integral Pesquisa e Ensino

Votuporanga, , Brazil

Site Status NOT_YET_RECRUITING

The Hospital for Sick Children

Toronto, , Canada

Site Status NOT_YET_RECRUITING

Universitätsmedizin Johannes Gutenberg Universität Mainz

Mainz, , Germany

Site Status RECRUITING

Dr. von Haunersches Kinderspital

Munich, , Germany

Site Status RECRUITING

Rambam Health Care Campus

Haifa, , Israel

Site Status NOT_YET_RECRUITING

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status NOT_YET_RECRUITING

Hadassah Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Yitzhak Shamir Medical Center

Ẕerifin, , Israel

Site Status RECRUITING

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Maggiore Azienda USL di Bologna

Bologna, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Meyer IRCCS

Florence, , Italy

Site Status RECRUITING

Ospedale dei Bambini Vittore Buzzi

Milan, , Italy

Site Status NOT_YET_RECRUITING

AOU Policlinico Umberto I

Roma, , Italy

Site Status RECRUITING

Ospedale Pediatrico Bambino Gesù IRCCS

Rome, , Italy

Site Status NOT_YET_RECRUITING

Institute of Science Tokyo Hospital

Bunkyō, , Japan

Site Status RECRUITING

Juntendo University Hospital

Bunkyō City, , Japan

Site Status RECRUITING

Tsujinaka Hospital - Kashiwanoha

Kashiwa, , Japan

Site Status RECRUITING

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Akershus Universitetssykehus

Lørenskog, , Norway

Site Status NOT_YET_RECRUITING

St. Olavs Hospital

Trondheim, , Norway

Site Status NOT_YET_RECRUITING

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, , Poland

Site Status RECRUITING

Twoja Przychodnia SCM

Szczecin, , Poland

Site Status RECRUITING

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

Warsaw, , Poland

Site Status RECRUITING

Centrum Zdrowia Dziecka w Warszawie

Warsaw, , Poland

Site Status RECRUITING

Centrum Medyczne Oporów

Wroclaw, , Poland

Site Status NOT_YET_RECRUITING

2Ca Braga

Braga, , Portugal

Site Status NOT_YET_RECRUITING

Centro Hospitalar de Sao Joao - Hospital de Sao Joao

Porto, , Portugal

Site Status NOT_YET_RECRUITING

Kyungpook National University Chilgok Hospital

Deagu, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Hospital Universitario Reina Sofia

Córdoba, , Spain

Site Status NOT_YET_RECRUITING

Hospital Sant Joan de Déu

Esplugues de Llobregat, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari Parc Tauli

Sabadell, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status NOT_YET_RECRUITING

Royal London Hospital

London, , United Kingdom

Site Status NOT_YET_RECRUITING

The John Radcliffe Hospital

Oxford, , United Kingdom

Site Status NOT_YET_RECRUITING

Sheffield Children's Hospital

Sheffield, , United Kingdom

Site Status RECRUITING

Countries

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France United States Austria Belgium Brazil Canada Germany Israel Italy Japan Netherlands Norway Poland Portugal South Korea Spain United Kingdom

Central Contacts

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

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

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Related Links

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https://trials.lillytrialguide.com/en-US/trial/6Fqthjwf4KUkJi8EyTQv5A

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

Other Identifiers

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16633

Identifier Type: -

Identifier Source: org_study_id

I6T-MC-AMAZ

Identifier Type: OTHER

Identifier Source: secondary_id

2020-005311-49

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ISA-1 UC

Identifier Type: OTHER

Identifier Source: secondary_id

ISA-2 CD

Identifier Type: OTHER

Identifier Source: secondary_id

ISA-3 UC

Identifier Type: OTHER

Identifier Source: secondary_id

ISA-4 CD

Identifier Type: OTHER

Identifier Source: secondary_id