A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
AMAY
A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
6 other identifiers
interventional
90
16 countries
81
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2024
Typical duration for phase_3
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2022
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedStudy Start
First participant enrolled
March 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
March 27, 2026
March 1, 2026
3.7 years
August 19, 2022
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline to Week 52
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.
Baseline to Week 52
Secondary Outcomes (17)
Percentage of Participants Achieving Clinical Response by PCDAI
Week 12
Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)
Week 12
Percentage of Participants Achieving Clinical Remission by PCDAI
Week 12
Percentage of Participants Achieving Clinical Remission by CDAI
Week 12
Percentage of Participants Who Achieve PCDAI Clinical Response at Week 12 and PCDAI Clinical Remission and Endoscopic Remission at Week 52
Baseline to Week 52
- +12 more secondary outcomes
Study Arms (3)
Mirikizumab Dose 1
EXPERIMENTALMirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (\>) 40 kilograms (kg).
Mirikizumab Dose 2
EXPERIMENTALMirikizumab 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.
Mirikizumab Dose 3
EXPERIMENTALMirikizumab 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.
Interventions
Administered IV or SC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06032, United States
Emory University
Atlanta, Georgia, 30322, United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, 30342, United States
Riley Childrens Hospital
Indianapolis, Indiana, 46202, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Atlantic Children's Health--Pediatric Gastroenterology
Morristown, New Jersey, 07960, United States
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
New York, New York, 10021-5663, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University Medical Center/New York Presbyterian
New York, New York, 10032, United States
Childrens Medical Center
Dayton, Ohio, 45404, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
AKH - Medizinische Universtität Wien
Vienna, 1090, Austria
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Hospital PUC-CAMPINAS
Campinas, 13060-904, Brazil
Hospital Pequeno Príncipe
Curitiba-PR, 80250-060, Brazil
Hospital das Clínicas - UFG (Universidade Federal de Goiás)
Goiânia, 74605-050, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90050-170, Brazil
NDI - Nucleo de Doenças Infecciosas
Santos Dumont, 29040-091, Brazil
Integral Pesquisa e Ensino
Votuporanga, 15501 405, Brazil
IWK Health Centre
Halifax, B3K 6R8, Canada
London Health Sciences Centre (LHSC) - Victoria Hospital
London, N6A 5W9, Canada
The Hospital for Sick Children
Toronto, M5G 1X8, Canada
Children's & Women's Health Centre of British Columbia
Vancouver, V6H 3V4, Canada
URC CIC
Paris, 75015, France
Soroka Medical Center
Beersheba, 8410101, Israel
Shamir Medical Center (Assaf Harofeh)
Israel, 70300, Israel
Shaare Zedek
Jerusalem, 9103102, Israel
Hadassah University Hospital, Ein Kerem,
Jerusalem, 9112001, Israel
Schneider Children's Medical Center
Petah Tikva, 4920235, Israel
Kaplan Medical Center, Pediatric Gastroenterology Dept.
Rehovot, 7661041, Israel
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo
Alessandria, 15121, Italy
Asst Papa Giovanni Xxiii Bergamo
Bergamo, 24127, Italy
Azienda USL di Bologna
Bologna, 40133, Italy
SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)
Florence, 50139, Italy
Ospedale dei Bambini Vittore Buzzi
Milan, 20154, Italy
Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)
Roma, CAP 00161, Italy
Juntendo University Hospital
Bunkyō City, 113-8431, Japan
Hirosaki University Hospital
Hirosaki, 036, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, 277-0871, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
Saga University Hospital
Saga, 849-8501, Japan
Miyagi Children's Hospital
Sendai, 989 3126, Japan
National Center for Child Health and Development
Setagaya-ku, 157-8535, Japan
Mie University Hospital
Tsu, 514-8507, Japan
Yamaguchi University Hospital
Ube, 755-8505, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, 2308765, Japan
Yokohama City University Medical Center, Center of IBD
Yokohama, 232-0024, Japan
Erasmus Medisch Centrum
Rotterdam, 3015 CN, Netherlands
Akershus Universitetssykehus
Nordbyagen, 01474, Norway
Oslo University Hospital
Oslo, 0450, Norway
Universitetssykehuset Nord-Norge
Tromsø, 9038, Norway
St-Olavs Hospital
Trondheim, 7030, Norway
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302, Poland
Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728, Poland
Instytut Pomnik-Centrum Zdrowia Dziecka
Warsaw, 04-730, Poland
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
Braga, 4710-243, Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Centro Hospitalar de São João, E.P.E.
Porto, 4200 319, Portugal
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, 08208, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Royal Hospital for Children and Young People
Edinburgh, EH16 4TJ, United Kingdom
Oxford University Hospitals NHS trust John Radcliffe hospital
Headington, OX3 9DU, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
London, WC1N 3JH, United Kingdom
Manchester University NHS Foundation Trust
Manchester, M139WL, United Kingdom
Sheffield Children's Hospital
Sheffield, S10 2RX, United Kingdom
Royal London Hospital
Whitechapel, E1 1FR, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2022
First Posted
August 22, 2022
Study Start
March 13, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.