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

August 21, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • AKH - Medizinische Universtität Wien
        • Principal Investigator:
          • Judith Pichler
  • Belgium
      • Brussels, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel
        • Principal Investigator:
          • Elisabeth De Greef
        • Contact:
          • Phone Number: 3224774795
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Principal Investigator:
          • Francoise Smets
        • Contact:
          • Phone Number: +32 2 764 19 33
      • Ghent, Belgium, 9000
        • Recruiting
        • Universitair Ziekenhuis Gent
        • Principal Investigator:
          • Pauline De Bruyne
        • Contact:
          • Phone Number: 3293321338
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
        • Principal Investigator:
          • Ilse Hoffman
  • Brazil
      • Campinas, Brazil, 13060-904
        • Recruiting
        • Hospital PUC-Campinas
        • Principal Investigator:
          • Joaquim Simoes Neto
        • Contact:
          • Phone Number: +55 19 3343-8465
      • Curitiba-PR, Brazil, 80250-060
        • Recruiting
        • Hospital Pequeno Principe
        • Principal Investigator:
          • Sabine Krüger Truppel
        • Contact:
          • Phone Number: +55 (41) 2108-3861
      • Goiânia, Brazil, 74605-050
        • Recruiting
        • Hospital das Clínicas - UFG (Universidade Federal de Goiás)
        • Principal Investigator:
          • Naflesia Oliveira Correa
        • Contact:
          • Phone Number: 55(62) 98607-3907
      • Porto Alegre, Brazil, 90050-170
        • Recruiting
        • Irmandade da Santa Casa de Misericordia de Porto Alegre
        • Contact:
          • Phone Number: +55 51 3214-8143
        • Principal Investigator:
          • Cristina Ferreira
      • Porto Alegre, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Principal Investigator:
          • Luciana Harlacher
        • Contact:
          • Phone Number: +55 51 3359-6331
      • Santos Dumont, Brazil, 29040-091
        • Recruiting
        • NDI - Nucleo de Doenças Infecciosas
        • Principal Investigator:
          • Ana Daniela Izoton de Sadovsky
        • Contact:
          • Phone Number: +55 (27) 999036155
      • Votuporanga, Brazil, 15501 405
        • Recruiting
        • Integral Pesquisa e Ensino
        • Principal Investigator:
          • HERLON VALÉRIO
  • Canada
      • Halifax, Canada, B3K 6R8
        • Recruiting
        • IWK Health Centre
        • Principal Investigator:
          • Anthony Otley
        • Contact:
          • Phone Number: 1-902-470-7009
      • London, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre (LHSC) - Victoria Hospital
        • Principal Investigator:
          • Dhandapani Ashok
        • Contact:
          • Phone Number: 519-685-8500 x56074
      • Toronto, Canada, M5G 1X8
        • Recruiting
        • The Hospital for Sick Children
        • Principal Investigator:
          • Thomas Walters
      • Vancouver, Canada, V6H 3V4
        • Not yet recruiting
        • Children's & Women's Health Centre of British Columbia
        • Principal Investigator:
          • Kevan Jacobson
  • France
      • Paris, France, 75015
        • Terminated
        • URC CIC
  • Israel
      • Beersheba, Israel, 8410101
        • Recruiting
        • Soroka Medical Center
        • Principal Investigator:
          • Baruch Yerushalmi
      • Israel, Israel, 70300
        • Recruiting
        • Shamir Medical Center (Assaf Harofeh)
        • Principal Investigator:
          • EFRAT BROIDE
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek
        • Principal Investigator:
          • Dan Turner
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah University Hospital, Ein Kerem,
        • Principal Investigator:
          • Zev Davidovics
        • Contact:
          • Phone Number: +972528709824
      • Petah Tikva, Israel, 4920235
        • Recruiting
        • Schneider Children's Medical Center
        • Principal Investigator:
          • Dror Shouval
        • Contact:
          • Phone Number: +972-39253039
      • Rehovot, Israel, 7661041
        • Not yet recruiting
        • Kaplan Medical Center, Pediatric Gastroenterology Dept.
        • Contact:
          • Phone Number: 972526274987
        • Principal Investigator:
          • Amit Assa
  • Italy
      • Alessandria, Italy, 15121
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo
        • Contact:
          • Phone Number: +39 0131206893
        • Principal Investigator:
          • Felici Enrico
      • Bergamo, Italy, 24127
        • Recruiting
        • ASST Papa Giovanni XXIII Bergamo
        • Principal Investigator:
          • Naire Sansotta
        • Contact:
          • Phone Number: "39 0352673448 39 0352674553"
      • Bologna, Italy, 40133
        • Recruiting
        • Azienda USL di Bologna
        • Principal Investigator:
          • Patrizia Alvisi
        • Contact:
          • Phone Number: 39 3313198290
      • Florence, Italy, 50139
        • Recruiting
        • SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato)
        • Principal Investigator:
          • Paolo Lionetti
        • Contact:
          • Phone Number: 39 055-5662950
      • Milan, Italy, 20154
        • Recruiting
        • Ospedale dei Bambini Vittore Buzzi
        • Principal Investigator:
          • Lorenzo Norsa
        • Contact:
          • Phone Number: 393400968832
      • Roma, Italy, CAP 00161
        • Recruiting
        • Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica)
        • Principal Investigator:
          • Salvatore Oliva
        • Contact:
          • Phone Number: 393404111671
  • Japan
      • Bunkyō City, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
        • Principal Investigator:
          • Takahiro Kudo
        • Contact:
          • Phone Number: 81120023812
      • Hirosaki, Japan, 036
        • Recruiting
        • Hirosaki University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hirotake Sakuraba
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takuro Nishikawa
      • Kashiwa-shi, Japan, 277-0871
        • Recruiting
        • Kokikai Tsujinaka Hospital Kashiwanoha
        • Principal Investigator:
          • Ken Takeuchi
        • Contact:
          • Phone Number: 81120023812
      • Kobe, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tomoko Horinouchi
      • Saga, Japan, 849-8501
        • Recruiting
        • Saga University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Toshihiko Kakiuchi
      • Sendai, Japan, 989 3126
        • Recruiting
        • Miyagi Children's Hospital
        • Principal Investigator:
          • Daiki Abukawa
        • Contact:
          • Phone Number: 81120023812
      • Setagaya-ku, Japan, 157-8535
        • Recruiting
        • National Center for Child Health and Development
        • Principal Investigator:
          • Katsuhiro Arai
        • Contact:
          • Phone Number: 81120023812
      • Tsu, Japan, 514-8507
        • Not yet recruiting
        • Mie University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yuki Koike
      • Ube, Japan, 755-8505
        • Recruiting
        • Yamaguchi University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Azuma Yoshihiro
      • Yokohama, Japan, 2308765
        • Not yet recruiting
        • Saiseikai Yokohamashi Tobu Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shuichiro Umetsu
      • Yokohama, Japan, 232-0024
        • Recruiting
        • Yokohama City University Medical Center, Center of IBD
        • Principal Investigator:
          • Reiko Kunisaki
        • Contact:
          • Phone Number: 81120023812
  • Netherlands
      • Rotterdam, Netherlands, 3015 CN
        • Recruiting
        • Erasmus Medisch Centrum
        • Contact:
          • Phone Number: +31 (0)10 70 36111
        • Principal Investigator:
          • J.C. Escher
  • Norway
      • Nordbyagen, Norway, 01474
        • Recruiting
        • Akershus universitetssykehus
        • Principal Investigator:
          • Christopher Inchley
        • Contact:
          • Phone Number: +47 67960335
      • Oslo, Norway, 0450
        • Recruiting
        • Oslo University Hospital
        • Principal Investigator:
          • Gori Perminow
        • Contact:
          • Phone Number: +4722117611/ +4790108309
      • Tromsø, Norway, 9038
        • Recruiting
        • Universitetssykehuset Nord-Norge
        • Principal Investigator:
          • Lene Trulsen
      • Trondheim, Norway, 7030
        • Recruiting
        • St-Olavs Hospital
        • Principal Investigator:
          • Henrik Dollner
        • Contact:
          • Phone Number: 4773553497
  • Poland
      • Rzeszów, Poland, 35-302
        • Recruiting
        • Korczowski Bartosz, Gabinet Lekarski
        • Principal Investigator:
          • Bartosz Korczowski
      • Warsaw, Poland, 00-728
        • Recruiting
        • Warsaw IBD Point Profesor Kierkus
        • Principal Investigator:
          • Monika Meglicka
        • Contact:
          • Phone Number: +48517191061
      • Warsaw, Poland, 04-730
        • Recruiting
        • Instytut Pomnik-Centrum Zdrowia Dziecka
        • Principal Investigator:
          • Jaroslaw Kierkus
        • Contact:
          • Phone Number: +48 668 171 443
  • Portugal
      • Braga, Portugal, 4710-243
        • Recruiting
        • Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
        • Principal Investigator:
          • Filipa Neiva
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
        • Principal Investigator:
          • Ana Isabel Lopes
      • Porto, Portugal, 4200 319
        • Recruiting
        • Centro Hospitalar de São João, E.P.E.
        • Principal Investigator:
          • Eunice Trindade
  • South Korea
      • Busan, South Korea, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Principal Investigator:
          • Tae-Oh Kim
      • Daegu, South Korea, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Principal Investigator:
          • Ben Kang
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Hong Koh
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Yon Ho Choe
        • Contact:
          • Phone Number: 82234100641
      • Seoul, South Korea, 3080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Jin Soo Moon
        • Contact:
          • Phone Number: Contact Number: 821092233320
  • Spain
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofía
        • Principal Investigator:
          • Rafael Gonzlez de Caldas
        • Contact:
          • Phone Number: + 393465970480
      • Sabadell, Spain, 08208
        • Recruiting
        • Corporacio Sanitaria Parc Tauli
        • Principal Investigator:
          • Diana Garcia Tirado
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Principal Investigator:
          • Marisa Isabel Colomino
  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4TJ
        • Recruiting
        • Royal Hospital for Children and Young People
        • Principal Investigator:
          • Richard Russell
      • Headington, United Kingdom, OX3 9DU
        • Recruiting
        • Oxford University Hospitals NHS trust John Radcliffe hospital
        • Principal Investigator:
          • Lucy Howarth
        • Contact:
          • Phone Number: 01865 231592
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital For Children NHS Foundation Trust
        • Principal Investigator:
          • Kelsey Jones
      • Manchester, United Kingdom, M139WL
        • Recruiting
        • Manchester University NHS Foundation Trust
        • Principal Investigator:
          • Andrew Fagbemi
        • Contact:
          • Phone Number: +0161 701 6948
      • Sheffield, United Kingdom, S10 2RX
        • Recruiting
        • Sheffield Children's Hospital
        • Principal Investigator:
          • Akshay Kapoor
        • Contact:
          • Phone Number: 0114 2267980
      • Whitechapel, United Kingdom, E1 1FR
        • Recruiting
        • Royal London Hospital
        • Principal Investigator:
          • Ahmed Kadir
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Not yet recruiting
        • Cedars Sinai Medical Center
        • Principal Investigator:
          • David Ziring
        • Contact:
          • Phone Number: 310-248-8516
    • Connecticut
      • Hartford, Connecticut, United States, 06032
        • Recruiting
        • Connecticut Children's Medical Center
        • Principal Investigator:
          • Jeffrey Hyams
        • Contact:
          • Phone Number: 860-837-5591
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Principal Investigator:
          • subra kugathasan
        • Contact:
          • Phone Number: 404-727-4542
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Children's Center for Digestive Health Care, LLC
        • Principal Investigator:
          • Jeffery Lewis
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Childrens Hospital
        • Principal Investigator:
          • Steven Steiner
        • Contact:
          • Phone Number: 317-274-5858
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Boston Children's Hospital
        • Contact:
          • Phone Number: 617-355-6058
        • Principal Investigator:
          • Athos Bousvaros
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Not yet recruiting
        • Atlantic Children's Health--Pediatric Gastroenterology
        • Principal Investigator:
          • Oren Koslowe
        • Contact:
          • Phone Number: 973-971-6489
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Principal Investigator:
          • David Dunkin
        • Contact:
          • Phone Number: 212-659-9443
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/New York Presbyterian
        • Principal Investigator:
          • Joseph Picoraro
      • New York, New York, United States, 10021-5663
        • Recruiting
        • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
        • Principal Investigator:
          • Aliza Solomon
        • Contact:
          • Phone Number: 646-962-7162
    • Ohio
      • Dayton, Ohio, United States, 45404
        • Recruiting
        • Childrens Medical Center
        • Contact:
          • Phone Number: 937-641-5605
        • Principal Investigator:
          • Shehzad Saeed
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Recruiting
        • Children's Hospital of Philadelphia
        • Principal Investigator:
          • Arthur Kastl
        • Contact:
          • Phone Number: 973-971-7747
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Cook Children's Medical Center
        • Principal Investigator:
          • Clifton Huang
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Principal Investigator:
          • Jillian Sullivan
        • Contact:
          • Phone Number: 802-656-9402
    • Washington
      • Seattle, Washington, United States, 98105
        • Not yet recruiting
        • Seattle Children's Hospital
        • Principal Investigator:
          • Ghassan Wahbeh
        • Contact:
          • Phone Number: 206-987-1293

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mirikizumab Dose 1
Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (>) 40 kilograms (kg).
Drug: Mirikizumab
Administered IV or SC
Other Names:
  • LY3074828
Experimental: 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.
Drug: Mirikizumab
Administered IV or SC
Other Names:
  • LY3074828
Experimental: 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.
Drug: Mirikizumab
Administered IV or SC
Other Names:
  • LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Baseline to Week 52
Clinical response based on PCDAI, and clinical remission based on PCDAI.
Baseline to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)
Time Frame: Week 12
Clinical response based on CDAI for participants ≥12 years of age
Week 12
Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Change from Baseline in C-reactive Protein (CRP)
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from Baseline in CRP
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from Baseline in Fecal calprotectin
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from Baseline in Fecal calprotectin
Time Frame: Baseline, Week 52
Baseline, Week 52
Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52
Time Frame: Baseline to Week 52
Clinical response by PCDAI, CDAI for participants ≥12 years of age
Baseline to Week 52
Percentage of Participants Achieving Clinical Remission by PCDAI
Time Frame: Week 52
Clinical remission based on PCDAI
Week 52
Pharmacokinetics (PK): Clearance of Mirikizumab
Time Frame: Baseline through Week 52
Baseline through Week 52
Pharmacokinetics (PK): Volume of Distribution of Mirikizumab
Time Frame: Baseline through Week 52
Baseline through Week 52
Percentage of Participants Achieving Clinical Response by PCDAI
Time Frame: Week 12
Clinical response based on PCDAI.
Week 12
Percentage of Participants Achieving Clinical Remission by PCDAI
Time Frame: Week 12
Clinical remission based on PCDAI.
Week 12
Percentage of Participants Achieving Clinical Remission by CDAI
Time Frame: Week 12
Clinical remission based on CDAI for participants ≥12 years of age.
Week 12
Percentage of Participants Who Achieve PCDAI Clinical Response at Week 12 and PCDAI Clinical Remission and Endoscopic Remission at Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Percentage of Participants Who Achieve PCDAI Clinical Remission and Endoscopic Remission at Week 52
Time Frame: Week 52
Week 52
Percentage of Participants Achieving Endoscopic Response
Time Frame: Week 52
Week 52
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
Time Frame: Baseline to Week 52
Clinical response and clinical remission by PCDAI
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

August 19, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16632
  • I6T-MC-AMAY (Other Identifier: Eli Lilly and Company)
  • I6T-MC-PIBD (Other Identifier: Eli Lilly and Company)
  • MACARONI-23 (Other Identifier: Eli Lilly and Company)
  • PLATFORMPBCRD3001 (Other Identifier: Eli Lilly and Company)
  • 2024-511472-32-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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