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Crohn's DiseasePhase 3AMAYNCT05509777

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

A Phase 3 study testing Mirikizumab in people with Crohn's Disease, run by Eli Lilly and Company at 81 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

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. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Crohn's Disease
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
90 participants
Where
81 sitesin 16 countries
Study dates
13 Mar 2024to Apr 2028
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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

81 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

81 sites in 16 countries

United States15 sites, 15 recruiting

  • Emory University

    Atlanta, Georgia, 30322

    404-727-4542

    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

    Not yet recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    802-656-9402

    Jillian Sullivan

    Recruiting

  • Childrens Medical Center

    Dayton, Ohio, 45404

    937-641-5605

    Shehzad Saeed

    Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

    Clifton Huang

    Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06032

    860-837-5591

    Jeffrey Hyams

    Recruiting

  • Riley Childrens Hospital

    Indianapolis, Indiana, 46202

    317-274-5858

    Steven Steiner

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    310-248-8516

    David Ziring

    Not yet recruiting

  • Atlantic Children's Health--Pediatric Gastroenterology

    Morristown, New Jersey, 07960

    973-971-6489

    Oren Koslowe

    Not yet recruiting

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

    New York, New York, 10021-5663

    646-962-7162

    Aliza Solomon

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    212-659-9443

    David Dunkin

    Recruiting

  • Columbia University Medical Center/New York Presbyterian

    New York, New York, 10032

    Joseph Picoraro

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19146

    973-971-7747

    Arthur Kastl

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    206-987-1293

    Ghassan Wahbeh

    Not yet recruiting

Other trials in United States

Japan12 sites, 12 recruiting

  • Juntendo University Hospital

    Bunkyō City, 113-8431

    81120023812

    Takahiro Kudo

    Recruiting

  • Hirosaki University Hospital

    Hirosaki, 036

    81120023812

    Hirotake Sakuraba

    Recruiting

  • Kagoshima University Hospital

    Kagoshima, 890-8520

    81120023812

    Takuro Nishikawa

    Recruiting

  • Kokikai Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, 277-0871

    81120023812

    Ken Takeuchi

    Recruiting

  • Kobe University Hospital

    Kobe, 650-0017

    81120023812

    Tomoko Horinouchi

    Recruiting

  • Saga University Hospital

    Saga, 849-8501

    81120023812

    Toshihiko Kakiuchi

    Recruiting

  • Miyagi Children's Hospital

    Sendai, 989 3126

    81120023812

    Daiki Abukawa

    Recruiting

  • National Center for Child Health and Development

    Setagaya-ku, 157-8535

    81120023812

    Katsuhiro Arai

    Recruiting

  • Mie University Hospital

    Tsu, 514-8507

    81120023812

    Yuki Koike

    Not yet recruiting

  • Yamaguchi University Hospital

    Ube, 755-8505

    81120023812

    Azuma Yoshihiro

    Recruiting

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, 2308765

    81120023812

    Shuichiro Umetsu

    Not yet recruiting

  • Yokohama City University Medical Center, Center of IBD

    Yokohama, 232-0024

    81120023812

    Reiko Kunisaki

    Recruiting

Other trials in Japan

Brazil7 sites, 7 recruiting

  • Hospital PUC-CAMPINAS

    Campinas, 13060-904

    +55 19 3343-8465

    Joaquim Simoes Neto

    Recruiting

  • Hospital Pequeno Príncipe

    Curitiba-PR, 80250-060

    +55 (41) 2108-3861

    Sabine Krüger Truppel

    Recruiting

  • Hospital das Clínicas - UFG (Universidade Federal de Goiás)

    Goiânia, 74605-050

    55(62) 98607-3907

    Naflesia Oliveira Correa

    Recruiting

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903

    +55 51 3359-6331

    Luciana Harlacher

    Recruiting

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90050-170

    +55 51 3214-8143

    Cristina Ferreira

    Recruiting

  • NDI - Nucleo de Doenças Infecciosas

    Santos Dumont, 29040-091

    +55 (27) 999036155

    Ana Daniela Izoton de Sadovsky

    Recruiting

  • Integral Pesquisa e Ensino

    Votuporanga, 15501 405

    Herlon Valerio

    Recruiting

Other trials in Brazil

Israel6 sites, 6 recruiting

  • Soroka Medical Center

    Beersheba, 8410101

    Baruch Yerushalmi

    Recruiting

  • Shamir Medical Center (Assaf Harofeh)

    Israel, 70300

    EFRAT BROIDE

    Recruiting

  • Shaare Zedek

    Jerusalem, 9103102

    Dan Turner

    Recruiting

  • Hadassah University Hospital, Ein Kerem,

    Jerusalem, 9112001

    +972528709824

    Zev Davidovics

    Recruiting

  • Schneider Children's Medical Center

    Petah Tikva, 4920235

    +972-39253039

    Dror Shouval

    Recruiting

  • Kaplan Medical Center, Pediatric Gastroenterology Dept.

    Rehovot, 7661041

    972526274987

    Amit Assa

    Not yet recruiting

Other trials in Israel

Italy6 sites, 6 recruiting

  • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo

    Alessandria, 15121

    +39 0131206893

    Felici Enrico

    Not yet recruiting

  • Asst Papa Giovanni Xxiii Bergamo

    Bergamo, 24127

    "39 0352673448 39 0352674553"

    Naire Sansotta

    Recruiting

  • Azienda USL di Bologna

    Bologna, 40133

    39 3313198290

    Patrizia Alvisi

    Recruiting

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

    Florence, 50139

    39 055-566295039

    Paolo Lionetti

    Recruiting

  • Ospedale dei Bambini Vittore Buzzi

    Milan, 20154

    393400968832

    Lorenzo Norsa

    Recruiting

  • Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)

    Roma, CAP 00161

    393404111671

    Salvatore Oliva

    Recruiting

Other trials in Italy

United Kingdom6 sites, 6 recruiting

  • Royal Hospital for Children and Young People

    Edinburgh, EH16 4TJ

    Richard Russell

    Recruiting

  • Oxford University Hospitals NHS trust John Radcliffe hospital

    Headington, OX3 9DU

    01865 231592

    Lucy Howarth

    Recruiting

  • Great Ormond Street Hospital For Children NHS Foundation Trust

    London, WC1N 3JH

    Kelsey Jones

    Recruiting

  • Manchester University NHS Foundation Trust

    Manchester, M139WL

    +0161 701 6948

    Andrew Fagbemi

    Recruiting

  • Sheffield Children's Hospital

    Sheffield, S10 2RX

    0114 2267980

    Akshay Kapoor

    Recruiting

  • Royal London Hospital

    Whitechapel, E1 1FR

    Ahmed Kadir

    Recruiting

Other trials in United Kingdom

South Korea5 sites, 5 recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108

    Tae-oh Kim

    Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

    Ben Kang

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Hong Koh

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    82234100641

    Yon Ho Choe

    Recruiting

  • Seoul National University Hospital

    Seoul, 3080

    Contact Number: 821092233320

    Jin Soo Moon

    Recruiting

Other trials in South Korea

Belgium4 sites, 4 recruiting

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

    3224774795

    Elisabeth De Greef

    Recruiting

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

    +32 2 764 19 33

    Francoise Smets

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    3293321338

    Pauline De Bruyne

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Ilse Hoffman

    Recruiting

Other trials in Belgium

Canada4 sites, 4 recruiting

  • IWK Health Centre

    Halifax, B3K 6R8

    1-902-470-7009

    Anthony Otley

    Recruiting

  • London Health Sciences Centre (LHSC) - Victoria Hospital

    London, N6A 5W9

    519-685-8500 x56074

    Dhandapani Ashok

    Recruiting

  • The Hospital for Sick Children

    Toronto, M5G 1X8

    Thomas Walters

    Recruiting

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

    Vancouver, V6H 3V4

    Kevan Jacobson

    Not yet recruiting

Other trials in Canada

Norway4 sites, 4 recruiting

  • Akershus Universitetssykehus

    Nordbyagen, 01474

    +47 67960335

    Christopher Inchley

    Recruiting

  • Oslo University Hospital

    Oslo, 0450

    +4722117611/ +4790108309

    Gori Perminow

    Recruiting

  • Universitetssykehuset Nord-Norge

    Tromsø, 9038

    Lene Trulsen

    Recruiting

  • St-Olavs Hospital

    Trondheim, 7030

    4773553497

    Henrik Dollner

    Recruiting

Other trials in Norway

Poland3 sites, 3 recruiting

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302

    Bartosz Korczowski

    Recruiting

  • Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

    +48517191061

    Monika Meglicka

    Recruiting

  • Instytut Pomnik-Centrum Zdrowia Dziecka

    Warsaw, 04-730

    +48 668 171 443

    Jaroslaw Kierkus

    Recruiting

Other trials in Poland

Portugal3 sites, 3 recruiting

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

    Braga, 4710-243

    Filipa Neiva

    Recruiting

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

    Lisbon, 1649-035

    Ana Isabel Lopes

    Recruiting

  • Centro Hospitalar de São João, E.P.E.

    Porto, 4200 319

    Eunice Trindade

    Recruiting

Other trials in Portugal

Spain3 sites, 3 recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

    + 393465970480

    Rafael Gonzlez de Caldas

    Recruiting

  • Corporacio Sanitaria Parc Tauli

    Sabadell, 08208

    Diana Garcia Tirado

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    Marisa Isabel Colomino

    Recruiting

Other trials in Spain

Austria1 site, 1 recruiting

  • AKH - Medizinische Universtität Wien

    Vienna, 1090

    Judith Pichler

    Recruiting

Other trials in Austria

France1 site

  • URC CIC

    Paris, 75015

    Terminated

Other trials in France

Netherlands1 site, 1 recruiting

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CN

    +31 (0)10 70 36111

    J.C. Escher

    Recruiting

Other trials in Netherlands

About this study

Official title: A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease

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.

Read the detailed description

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

Conditions
Crohn's Disease
Being tested
Mirikizumab
Keywords
Inflammatory Bowel Disease
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

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

  • MirikizumabDrug

    Also called LY3074828

    Administered IV or SC

Study groups in NCT05509777
Study groupRoleWhat they receive
Mirikizumab Dose 1ExperimentalMirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (>) 40 kilograms (kg).
Receives: Drug: Mirikizumab
Mirikizumab Dose 2ExperimentalMirikizumab 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.
Receives: Drug: Mirikizumab
Mirikizumab Dose 3ExperimentalMirikizumab 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.
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 Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52

    Clinical response based on PCDAI, and endoscopic response based on SES-CD.

    Measured: Baseline to Week 52

  2. Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52

    Clinical response based on PCDAI, and clinical remission based on PCDAI.

    Measured: Baseline to Week 52

Secondary outcomes (17)

  1. Percentage of Participants Achieving Clinical Response by PCDAI

    Clinical response based on PCDAI.

    Measured: Week 12

  2. Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)

    Clinical response based on CDAI for participants ≥12 years of age

    Measured: Week 12

  3. Percentage of Participants Achieving Clinical Remission by PCDAI

    Clinical remission based on PCDAI.

    Measured: Week 12

  4. Percentage of Participants Achieving Clinical Remission by CDAI

    Clinical remission based on CDAI for participants ≥12 years of age.

    Measured: Week 12

  5. Percentage of Participants Who Achieve PCDAI Clinical Response at Week 12 and PCDAI Clinical Remission and Endoscopic Remission at Week 52

    Measured: Baseline to Week 52

  6. Percentage of Participants Who Achieve PCDAI Clinical Remission and Endoscopic Remission at Week 52

    Measured: Week 52

  7. Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52

    Measured: Baseline to Week 52

  8. Change from Baseline in C-reactive Protein (CRP)

    Measured: Baseline, Week 12

  9. Change from Baseline in CRP

    Measured: Baseline, Week 52

  10. Change from Baseline in Fecal calprotectin

    Measured: Baseline, Week 12

  11. Change from Baseline in Fecal calprotectin

    Measured: Baseline, Week 52

  12. Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52

    Clinical response by PCDAI, CDAI for participants ≥12 years of age

    Measured: Baseline to Week 52

  13. Percentage of Participants Achieving Endoscopic Response

    Measured: Week 52

  14. Percentage of Participants Achieving Clinical Remission by PCDAI

    Clinical remission based on PCDAI

    Measured: Week 52

  15. Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and PCDAI Clinical Remission without the use of Corticosteroids and Who Did Not Have Crohn's Disease (CD)-Related Surgery at Week 52

    Clinical response and clinical remission by PCDAI

    Measured: Baseline to Week 52

  16. Pharmacokinetics (PK): Clearance of Mirikizumab

    Measured: Baseline through Week 52

  17. Pharmacokinetics (PK): Volume of Distribution of Mirikizumab

    Measured: Baseline through 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 posted22 Aug 2022
  2. Study start13 Mar 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionApr 2028 (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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05509777
Sponsor's protocol ID
16632
Other IDs
I6T-MC-AMAY, MACARONI-23, PLATFORMPBCRD3001, I6T-MC-PIBD, 2024-511472-32-00
Acronym
AMAY
Status last verified
Oct 2026
First submitted
19 Aug 2022
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 Crohn's Disease, run by Eli Lilly and Company at 81 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 4 inclusion and 3 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 81 sites in United States, Japan, Brazil, Israel, Italy 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 Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 (time frame: Baseline to 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 NCT05509777.

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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