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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMAY | Other Identifier | Eli Lilly and Company | |
| MACARONI-23 | Other Identifier | Eli Lilly and Company | |
| PLATFORMPBCRD3001 | Other Identifier | Eli Lilly and Company | |
| I6T-MC-PIBD | Other Identifier | Eli Lilly and Company | |
| 2024-511472-32-00 | EU Trial (CTIS) Number |
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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:
The study will last about 74 weeks and may include up to 19 visits.
Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirikizumab Dose 1 | Experimental | Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (>) 40 kilograms (kg). |
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| Mirikizumab Dose 2 | Experimental | 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. |
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| Mirikizumab Dose 3 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab | Drug | Administered IV or SC |
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| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Response by PCDAI | Clinical response based on PCDAI. | Week 12 |
| Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Not yet recruiting | Los Angeles | California | 90048 | United States |
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| Label | URL |
|---|---|
| A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease (AMAY) | View source |
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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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Clinical response based on CDAI for participants ≥12 years of age
| Week 12 |
| Percentage of Participants Achieving Clinical Remission by PCDAI | Clinical remission based on PCDAI. | Week 12 |
| Percentage of Participants Achieving Clinical Remission by CDAI | 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 | Baseline to Week 52 |
| Percentage of Participants Who Achieve PCDAI Clinical Remission and Endoscopic Remission at Week 52 | Week 52 |
| Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52 | Baseline to Week 52 |
| Change from Baseline in C-reactive Protein (CRP) | Baseline, Week 12 |
| Change from Baseline in CRP | Baseline, Week 52 |
| Change from Baseline in Fecal calprotectin | Baseline, Week 12 |
| Change from Baseline in Fecal calprotectin | Baseline, Week 52 |
| 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 | Baseline to Week 52 |
| Percentage of Participants Achieving Endoscopic Response | Week 52 |
| Percentage of Participants Achieving Clinical Remission by PCDAI | Clinical remission based on PCDAI | 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 | Clinical response and clinical remission by PCDAI | Baseline to Week 52 |
| Pharmacokinetics (PK): Clearance of Mirikizumab | Baseline through Week 52 |
| Pharmacokinetics (PK): Volume of Distribution of Mirikizumab | Baseline through Week 52 |
| Connecticut Children's Medical Center | Recruiting | Hartford | Connecticut | 06032 | United States |
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| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Children's Center for Digestive Health Care, LLC | Recruiting | Atlanta | Georgia | 30342 | United States |
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| Riley Childrens Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Boston Children's Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
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| Atlantic Children's Health--Pediatric Gastroenterology | Not yet recruiting | Morristown | New Jersey | 07960 | United States |
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| Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) | Recruiting | New York | New York | 10021-5663 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| Columbia University Medical Center/New York Presbyterian | Recruiting | New York | New York | 10032 | United States |
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| Childrens Medical Center | Recruiting | Dayton | Ohio | 45404 | United States |
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| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19146 | United States |
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| Cook Children's Medical Center | Recruiting | Fort Worth | Texas | 76104 | United States |
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| University of Vermont Medical Center | Recruiting | Burlington | Vermont | 05401 | United States |
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| Seattle Children's Hospital | Not yet recruiting | Seattle | Washington | 98105 | United States |
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| AKH - Medizinische Universtität Wien | Recruiting | Vienna | 1090 | Austria |
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| Universitair Ziekenhuis Brussel | Recruiting | Brussels | 1090 | Belgium |
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| Cliniques universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
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| Universitair Ziekenhuis Gent | Recruiting | Ghent | 9000 | Belgium |
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| UZ Leuven | Not yet recruiting | Leuven | 3000 | Belgium |
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| Hospital PUC-CAMPINAS | Recruiting | Campinas | 13060-904 | Brazil |
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| Hospital Pequeno Príncipe | Recruiting | Curitiba-PR | 80250-060 | Brazil |
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| Hospital das Clínicas - UFG (Universidade Federal de Goiás) | Recruiting | Goiânia | 74605-050 | Brazil |
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| Hospital de Clínicas de Porto Alegre | Recruiting | Porto Alegre | 90035-903 | Brazil |
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| Irmandade da Santa Casa de Misericórdia de Porto Alegre | Recruiting | Porto Alegre | 90050-170 | Brazil |
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| NDI - Nucleo de Doenças Infecciosas | Recruiting | Santos Dumont | 29040-091 | Brazil |
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| Integral Pesquisa e Ensino | Recruiting | Votuporanga | 15501 405 | Brazil |
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| IWK Health Centre | Not yet recruiting | Halifax | B3K 6R8 | Canada |
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| London Health Sciences Centre (LHSC) - Victoria Hospital | Not yet recruiting | London | N6A 5W9 | Canada |
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| The Hospital for Sick Children | Not yet recruiting | Toronto | M5G 1X8 | Canada |
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| Children's & Women's Health Centre of British Columbia | Not yet recruiting | Vancouver | V6H 3V4 | Canada |
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| URC CIC | Terminated | Paris | 75015 | France |
| Soroka Medical Center | Recruiting | Beersheba | 8410101 | Israel |
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| Shamir Medical Center (Assaf Harofeh) | Recruiting | Israel | 70300 | Israel |
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| Shaare Zedek | Recruiting | Jerusalem | 9103102 | Israel |
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| Hadassah University Hospital, Ein Kerem, | Recruiting | Jerusalem | 9112001 | Israel |
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| Schneider Children's Medical Center | Recruiting | Petah Tikva | 4920235 | Israel |
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| Kaplan Medical Center, Pediatric Gastroenterology Dept. | Not yet recruiting | Rehovot | 7661041 | Israel |
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| Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo | Not yet recruiting | Alessandria | 15121 | Italy |
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| Asst Papa Giovanni Xxiii Bergamo | Recruiting | Bergamo | 24127 | Italy |
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| Azienda USL di Bologna | Recruiting | Bologna | 40133 | Italy |
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| SOC Gastroenterologia e Nutrizione - AOU Meyer (Primo Piano Ala OVEST, accettazione DH centralizzato) | Recruiting | Florence | 50139 | Italy |
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| Ospedale dei Bambini Vittore Buzzi | Recruiting | Milan | 20154 | Italy |
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| Gastroenterologia ed epatologia pediatrica (Piano terra della Clinica Pediatrica) | Recruiting | Roma | CAP 00161 | Italy |
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| Juntendo University Hospital | Recruiting | Bunkyō City | 113-8431 | Japan |
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| Hirosaki University Hospital | Recruiting | Hirosaki | 036 | Japan |
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| Kagoshima University Hospital | Not yet recruiting | Kagoshima | 890-8520 | Japan |
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| Kokikai Tsujinaka Hospital Kashiwanoha | Recruiting | Kashiwa-shi | 277-0871 | Japan |
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| Kobe University Hospital | Not yet recruiting | Kobe | 650-0017 | Japan |
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| Saga University Hospital | Recruiting | Saga | 849-8501 | Japan |
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| Miyagi Children's Hospital | Recruiting | Sendai | 989 3126 | Japan |
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| National Center for Child Health and Development | Recruiting | Setagaya-ku | 157-8535 | Japan |
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| Mie University Hospital | Not yet recruiting | Tsu | 514-8507 | Japan |
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| Yamaguchi University Hospital | Not yet recruiting | Ube | 755-8505 | Japan |
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| Saiseikai Yokohamashi Tobu Hospital | Not yet recruiting | Yokohama | 2308765 | Japan |
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| Yokohama City University Medical Center, Center of IBD | Recruiting | Yokohama | 232-0024 | Japan |
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| Erasmus Medisch Centrum | Recruiting | Rotterdam | 3015 CN | Netherlands |
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| Akershus Universitetssykehus | Recruiting | Nordbyagen | 01474 | Norway |
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| Oslo University Hospital | Recruiting | Oslo | 0450 | Norway |
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| Universitetssykehuset Nord-Norge | Recruiting | Tromsø | 9038 | Norway |
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| St-Olavs Hospital | Recruiting | Trondheim | 7030 | Norway |
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| Korczowski Bartosz, Gabinet Lekarski | Recruiting | Rzeszów | 35-302 | Poland |
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| Warsaw IBD Point Profesor Kierkus | Recruiting | Warsaw | 00-728 | Poland |
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| Instytut Pomnik-Centrum Zdrowia Dziecka | Recruiting | Warsaw | 04-730 | Poland |
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| Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga) | Recruiting | Braga | 4710-243 | Portugal |
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| Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria | Recruiting | Lisbon | 1649-035 | Portugal |
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| Centro Hospitalar de São João, E.P.E. | Recruiting | Porto | 4200 319 | Portugal |
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| Inje University Haeundae Paik Hospital | Recruiting | Busan | 48108 | South Korea |
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| Kyungpook National University Chilgok Hospital | Recruiting | Daegu | 41404 | South Korea |
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| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | 3080 | South Korea |
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| Hospital Universitario Reina Sofia | Recruiting | Córdoba | 14004 | Spain |
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| Corporacio Sanitaria Parc Tauli | Recruiting | Sabadell | 08208 | Spain |
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| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
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| Royal Hospital for Children and Young People | Recruiting | Edinburgh | EH16 4TJ | United Kingdom |
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| Oxford University Hospitals NHS trust John Radcliffe hospital | Recruiting | Headington | OX3 9DU | United Kingdom |
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| Great Ormond Street Hospital For Children NHS Foundation Trust | Recruiting | London | WC1N 3JH | United Kingdom |
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| Manchester University NHS Foundation Trust | Recruiting | Manchester | M139WL | United Kingdom |
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| Sheffield Children's Hospital | Recruiting | Sheffield | S10 2RX | United Kingdom |
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| Royal London Hospital | Recruiting | Whitechapel | E1 1FR | United Kingdom |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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