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| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMAZ | Other Identifier | Eli Lilly and Company | |
| 2020-005311-49 | EudraCT Number | ||
| ISA-1 UC | Other Identifier | Eli Lilly and Company | |
| ISA-2 CD | Other Identifier | Eli Lilly and Company | |
| ISA-3 UC | Other Identifier | Eli Lilly and Company | |
| ISA-4 CD | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirikizumab Dose 1 for UC | Experimental | Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight. |
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| Mirikizumab Dose 2 for UC | Experimental | Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
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| Mirikizumab Dose 3 for UC | Experimental | Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
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| Mirikizumab Dose 4 for CD | Experimental | Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
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| Mirikizumab Dose 5 for CD | Experimental | Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
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| Mirikizumab Dose 6 for CD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission | Clinical Remission based on the MMS | Week 52 |
| Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission | Clinical Remission based on the PCDAI | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with UC in MMS Clinical Response | Clinical Response based on the MMS | Week 52 |
| Percentage of Participants with CD in PCDAI Clinical Response | Clinical Response based on the PCDAI |
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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 |
|---|---|---|---|---|---|---|
| UCSF Medical Center at Mission Bay | Recruiting | San Francisco | California | 94158 | United States |
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| Label | URL |
|---|---|
| A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) | 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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Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight. |
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| Mirikizumab Dose 7 for UC or CD | Experimental | Intravenous (IV) rescue dosing, if response is lost. |
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| Mirikizumab | Drug | Administered IV |
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| Week 52 |
| Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response | Clinical Response based on the PUCAI | Week 52 |
| Percentage of Participants with UC in PUCAI Clinical Remission | Clinical Response based on the PUCAI | Week 52 |
| Percentage of Participants with UC in Endoscopic Remission | Endoscopic Remission based on the Endoscopic Subscore (ES) | Week 52 |
| Percentage of Participants with CD in Endoscopic Remission | Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD) | Week 52 |
| Percentage of Participants with UC in Endoscopic Response | Endoscopic Response in Participants based on the ES | Week 52 |
| Percentage of Participants with CD in Endoscopic Response | Endoscopic Response based on the SES-CD | Week 52 |
| Percentage of Participants with UC in having Endoscopic Subscore = 0 | Endoscopic Remission when ES = 0 | Week 52 |
| Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission | Histologic remission based on histology scoring and endoscopic remission based on endoscopy score | Week 52 |
| Percentage of Participants with CD Achieving Histologic Remission | Histologic remission based on histology scoring | Week 52 |
| Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery | Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery | Week 52 |
| Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery | Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery) | Week 52 |
| Time to First Dose of Corticosteroid Among Participants with UC Entering Study AMAZ Not on Corticosteroids | Week 0 to Week 52 |
| Percentage of Participants Who Achieve both Clinical Remission by PCDAI and Endoscopic Response | Week 52 |
| Change from Baseline Over Time in C-reactive Protein, High Sensitivity (hsCRP) | Baseline, Week 0 to Week 52 |
| Connecticut Children's Medical Center | Recruiting | Hartford | Connecticut | 06106 | United States |
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| Emory University School of Medicine | 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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| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Massachusetts General Hospital | Recruiting | Waltham | Massachusetts | 02451 | United States |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | 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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| Children's Hospital of Philadelphia (CHOP) | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Cook Children's Medical Center | Recruiting | Fort Worth | Texas | 76104 | United States |
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| Pediatric Specialists of Virginia | Not yet recruiting | Fairfax | Virginia | 22031 | United States |
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| Medizinische Universität Wien | Not yet recruiting | Vienna | 1090 | Austria |
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| UZ Brussel | Not yet recruiting | Brussels | 1090 | Belgium |
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| Cliniques universitaires Saint-Luc | Not yet recruiting | Brussels | 1200 | Belgium |
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| Antwerp University Hospital | Not yet recruiting | Edegem | 2650 | Belgium |
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| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
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| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| Centro de Pesquisa Sao Lucas | Not yet recruiting | Campinas | 13060-803 | Brazil |
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| Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância | Not yet recruiting | Curitiba | 80250-060 | Brazil |
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| Universidade Federal de Goias | Not yet recruiting | Goiânia | 74605-020 | Brazil |
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| Hospital de Clinicas de Porto Alegre | Not yet recruiting | Porto Alegre | 90035-903 | Brazil |
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| Irmandade da Santa Casa de Misericórdia de Porto Alegre | Not yet recruiting | Porto Alegre | 90050-170 | Brazil |
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| Hospital Universitario Cassiano Antonio de Moraes | Not yet recruiting | Vitória | 29040-091 | Brazil |
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| Integral Pesquisa e Ensino | Not yet recruiting | Votuporanga | 15500-269 | Brazil |
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| London Health Sciences Centre | Not yet recruiting | London | N6A 5W9 | Canada |
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| The Hospital for Sick Children | Recruiting | Toronto | M5G 1X8 | Canada |
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| Universitätsmedizin Johannes Gutenberg Universität Mainz | Recruiting | Mainz | 55131 | Germany |
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| Dr. von Haunersches Kinderspital | Recruiting | Munich | 80337 | Germany |
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| Soroka Medical Center | Not yet recruiting | Beersheba | 8410101 | Israel |
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| Rambam Health Care Campus | Not yet recruiting | Haifa | 3109601 | Israel |
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| Shaare Zedek Medical Center | Recruiting | Jerusalem | 9013102 | Israel |
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| Hadassah Medical Center | Recruiting | Jerusalem | 9112001 | Israel |
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| Schneider Children's Medical Center | Recruiting | Petah Tikva | 49202 | Israel |
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| Yitzhak Shamir Medical Center | Recruiting | Ẕerifin | 70300 | Israel |
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| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Not yet recruiting | Bergamo | 24127 | Italy |
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| Ospedale Maggiore Azienda USL di Bologna | Not yet recruiting | Bologna | 40133 | Italy |
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| Azienda Ospedaliera Universitaria Meyer IRCCS | Recruiting | Florence | 50139 | Italy |
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| Ospedale dei Bambini Vittore Buzzi | Recruiting | Milan | 20154 | Italy |
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| AOU Policlinico Umberto I | Recruiting | Roma | 00161 | Italy |
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| Ospedale Pediatrico Bambino Gesù IRCCS | Not yet recruiting | Rome | 00165 | Italy |
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| Institute of Science Tokyo Hospital | Recruiting | Bunkyō | 113-8519 | Japan |
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| Juntendo University Hospital | Recruiting | Bunkyō City | 113-8431 | Japan |
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| Tsujinaka Hospital - Kashiwanoha | Recruiting | Kashiwa | 273-0011 | Japan |
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| Kobe University Hospital | Not yet recruiting | Kobe | 650-0017 | Japan |
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| National Center for Child Health and Development | Not yet recruiting | Tokyo | 157-8535 | Japan |
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| Yokohama City University Medical Center | Recruiting | Yokohama | 232-0024 | Japan |
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| Erasmus Medisch Centrum | Not yet recruiting | Rotterdam | 3015 GD | Netherlands |
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| Akershus Universitetssykehus | Not yet recruiting | Lørenskog | 1478 | Norway |
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| Oslo Universitetssykehus Ullevål | Not yet recruiting | Oslo | 0450 | Norway |
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| Universitetssykehuset Nord-Norge HF | Not yet recruiting | Tromsø | 9038 | Norway |
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| St. Olavs Hospital | Not yet recruiting | Trondheim | 7030 | Norway |
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| Korczowski Bartosz, Gabinet Lekarski | Recruiting | Rzeszów | 35-302 | Poland |
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| Twoja Przychodnia SCM | Recruiting | Szczecin | 71-434 | Poland |
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| Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś | Recruiting | Warsaw | 04-501 | Poland |
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| Centrum Zdrowia Dziecka w Warszawie | Recruiting | Warsaw | 04-730 | Poland |
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| Centrum Medyczne Oporów | Recruiting | Wroclaw | 52-416 | Poland |
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| 2Ca Braga | Not yet recruiting | Braga | 4710-243 | Portugal |
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| Centro Hospitalar de Sao Joao - Hospital de Sao Joao | Recruiting | Porto | 4200-319 | Portugal |
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| Kyungpook National University Chilgok Hospital | Recruiting | Deagu | 41404 | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| Hospital Universitario Reina Sofia | Not yet recruiting | Córdoba | 14004 | Spain |
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| Hospital Sant Joan de Déu | Not yet recruiting | Esplugues de Llobregat | 08950 | Spain |
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| Hospital Universitari Parc Tauli | Not yet recruiting | Sabadell | 08208 | Spain |
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| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
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| Royal London Hospital | Not yet recruiting | London | E1 1BB | United Kingdom |
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| The John Radcliffe Hospital | Not yet recruiting | Oxford | OX3 9DU | United Kingdom |
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| Sheffield Children's Hospital | Recruiting | Sheffield | S10 2TH | United Kingdom |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| C536315 | Pediatric ulcerative colitis |
| C536215 | Pediatric Crohn's disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000708407 | mirikizumab |
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