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A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

NCT ID: NCT05509777

Last Updated: 2025-12-23

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2028-04-30

Brief Summary

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Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.

Study periods for the intervention-specific appendix (ISA) will be as follows:

* A 12-week induction period
* A maintenance period from Week 12 to Week 52, and
* A safety follow-up period up to 16 weeks.

The study will last about 74 weeks and may include up to 19 visits.

Detailed Description

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Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.

Conditions

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Crohn's Disease

Keywords

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Inflammatory Bowel Disease

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

Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (\>) 40 kilograms (kg).

Group Type EXPERIMENTAL

Mirikizumab

Intervention Type DRUG

Administered IV or SC

Mirikizumab Dose 2

Mirikizumab administered IV or SC in participants that weigh \>20 kg to less than or equal to (≤) 40 kg.

Dosing is based on assessments of the participant's weight and appropriate weight class.

Group Type EXPERIMENTAL

Mirikizumab

Intervention Type DRUG

Administered IV or SC

Mirikizumab Dose 3

Mirikizumab administered IV or SC in participants that weigh greater than or equal to (≥) 9 kg to less than or equal to ≤20 kg.

Dosing is based on assessments of the participant's weight and appropriate weight class.

Group Type EXPERIMENTAL

Mirikizumab

Intervention Type DRUG

Administered IV or SC

Interventions

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Mirikizumab

Administered IV or SC

Intervention Type DRUG

Other Intervention Names

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LY3074828

Eligibility Criteria

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Inclusion Criteria

* Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
* Participants have moderately to severely active CD (as defined by a baseline PCDAI score ≥30).
* Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0.
* Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.

Exclusion Criteria

* Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
* Participants must not have an abscess.
* Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 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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University of California San Diego

La Jolla, California, United States

Site Status NOT_YET_RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status NOT_YET_RECRUITING

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Children's Center for Digestive Health Care, LLC

Atlanta, Georgia, United States

Site Status RECRUITING

Riley Childrens Hospital

Indianapolis, Indiana, United States

Site Status RECRUITING

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Atlantic Children's Health--Pediatric Gastroenterology

Morristown, New Jersey, United States

Site Status NOT_YET_RECRUITING

Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

New York, New York, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Columbia University Medical Center/New York Presbyterian

New York, New York, United States

Site Status RECRUITING

Childrens Medical Center

Dayton, Ohio, United States

Site Status RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Cook Children's Medical Center

Fort Worth, Texas, United States

Site Status RECRUITING

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status NOT_YET_RECRUITING

AKH - Medizinische Universtität Wien

Vienna, , Austria

Site Status RECRUITING

Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status RECRUITING

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status NOT_YET_RECRUITING

Hospital PUC-CAMPINAS

Campinas, , Brazil

Site Status RECRUITING

Hospital Pequeno Príncipe

Curitiba-PR, , Brazil

Site Status RECRUITING

Hospital das Clínicas - UFG (Universidade Federal de Goiás)

Goiânia, , Brazil

Site Status RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, , Brazil

Site Status RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, , Brazil

Site Status RECRUITING

NDI - Nucleo de Doenças Infecciosas

Santos Dumont, , Brazil

Site Status RECRUITING

Integral Pesquisa e Ensino

Votuporanga, , Brazil

Site Status RECRUITING

IWK Health Centre

Halifax, , Canada

Site Status NOT_YET_RECRUITING

London Health Sciences Centre (LHSC) - Victoria Hospital

London, , Canada

Site Status NOT_YET_RECRUITING

The Hospital for Sick Children

Toronto, , Canada

Site Status NOT_YET_RECRUITING

Children's & Women's Health Centre of British Columbia

Vancouver, , Canada

Site Status NOT_YET_RECRUITING

URC CIC

Paris, , France

Site Status TERMINATED

Soroka Medical Center

Beersheba, , Israel

Site Status RECRUITING

Shamir Medical Center (Assaf Harofeh)

Israel, , Israel

Site Status RECRUITING

Shaare Zedek

Jerusalem, , Israel

Site Status RECRUITING

Hadassah University Hospital, Ein Kerem,

Jerusalem, , Israel

Site Status RECRUITING

Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Kaplan Medical Center, Pediatric Gastroenterology Dept.

Rehovot, , Israel

Site Status NOT_YET_RECRUITING

Asst Papa Giovanni Xxiii Bergamo

Bergamo, , Italy

Site Status RECRUITING

Azienda USL di Bologna

Bologna, , Italy

Site Status RECRUITING

SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)

Florence, , Italy

Site Status RECRUITING

Ospedale dei Bambini Vittore Buzzi

Milan, , Italy

Site Status RECRUITING

Ospedale Pediatrico Bambino Gesù

Roma, , Italy

Site Status NOT_YET_RECRUITING

Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)

Roma, , Italy

Site Status RECRUITING

Juntendo University Hospital

Bunkyō City, , Japan

Site Status RECRUITING

Hirosaki University Hospital

Hirosaki, , Japan

Site Status RECRUITING

Kagoshima University Hospital

Kagoshima, , Japan

Site Status NOT_YET_RECRUITING

Kokikai Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, , Japan

Site Status RECRUITING

Kobe University Hospital

Kobe, , Japan

Site Status NOT_YET_RECRUITING

Saga University Hospital

Saga, , Japan

Site Status RECRUITING

Miyagi Children's Hospital

Sendai, , Japan

Site Status RECRUITING

National Center for Child Health and Development

Setagaya-ku, , Japan

Site Status RECRUITING

Mie University Hospital

Tsu, , Japan

Site Status NOT_YET_RECRUITING

Yamaguchi University Hospital

Ube, , Japan

Site Status NOT_YET_RECRUITING

Saiseikai Yokohamashi Tobu Hospital

Yokohama, , Japan

Site Status NOT_YET_RECRUITING

Yokohama City University Medical Center, Center of IBD

Yokohama, , Japan

Site Status RECRUITING

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Site Status RECRUITING

Akershus Universitetssykehus

Nordbyagen, , Norway

Site Status RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

Universitetssykehuset Nord-Norge

Tromsø, , Norway

Site Status RECRUITING

St-Olavs Hospital

Trondheim, , Norway

Site Status RECRUITING

Uniwersytecki Szpital Dziecięcy w Krakowie

Krakow, , Poland

Site Status NOT_YET_RECRUITING

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, , Poland

Site Status RECRUITING

Centrum Zdrowia MDM

Warsaw, , Poland

Site Status NOT_YET_RECRUITING

Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Site Status RECRUITING

Instytut Pomnik-Centrum Zdrowia Dziecka

Warsaw, , Poland

Site Status RECRUITING

Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)

Braga, , Portugal

Site Status RECRUITING

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

Lisbon, , Portugal

Site Status RECRUITING

Centro Hospitalar de São João, E.P.E.

Porto, , Portugal

Site Status RECRUITING

Inje University Haeundae Paik Hospital

Busan, , South Korea

Site Status RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Hospital Universitario Reina Sofia

Córdoba, , Spain

Site Status RECRUITING

Hospital Sant Joan de Deu

Esplugues de Llobregat, , Spain

Site Status NOT_YET_RECRUITING

Corporacio Sanitaria Parc Tauli

Sabadell, , Spain

Site Status RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status RECRUITING

Royal Hospital for Children and Young People

Edinburgh, , United Kingdom

Site Status RECRUITING

Oxford University Hospitals NHS trust John Radcliffe hospital

Headington, , United Kingdom

Site Status RECRUITING

Great Ormond Street Hospital For Children NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Site Status RECRUITING

Sheffield Children's Hospital

Sheffield, , United Kingdom

Site Status RECRUITING

Royal London Hospital

Whitechapel, , United Kingdom

Site Status RECRUITING

Countries

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Australia United States Austria Belgium Brazil Canada France 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.lilly.com/en-US/trial/356367

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease (AMAY)

Other Identifiers

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I6T-MC-AMAY

Identifier Type: OTHER

Identifier Source: secondary_id

MACARONI-23

Identifier Type: OTHER

Identifier Source: secondary_id

PLATFORMPBCRD3001

Identifier Type: OTHER

Identifier Source: secondary_id

I6T-MC-PIBD

Identifier Type: OTHER

Identifier Source: secondary_id

2024-511472-32-00

Identifier Type: CTIS

Identifier Source: secondary_id

16632

Identifier Type: -

Identifier Source: org_study_id