A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
NCT ID: NCT05784246
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2023-11-22
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mirikizumab Weight-Based Group 1
Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
Mirikizumab IV
Administered IV
Mirikizumab SC
Administered SC
Mirikizumab Weight-Based Group 2
Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
Mirikizumab IV
Administered IV
Mirikizumab SC
Administered SC
Mirikizumab Weight-Based Group 3
Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
Mirikizumab IV
Administered IV
Mirikizumab SC
Administered SC
Interventions
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Mirikizumab IV
Administered IV
Mirikizumab SC
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have moderate to severe UC.
* Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment.
* Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report.
Exclusion Criteria
* Have immune deficiency syndrome.
* Previous bowel resection or intestinal surgery.
* Evidence of toxic megacolon.
* History or current evidence of cancer of the gastrointestinal tract.
2 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Stanford University
Palo Alto, California, United States
Rady Childrens Hospital
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, United States
Riley Childrens Hospital
Indianapolis, Indiana, United States
Massachusetts General Hospital for Children
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Prisma Health Upstate
Greenville, South Carolina, United States
Texas Children's Hospital -Research Resource Office
Houston, Texas, United States
UZA
Edegem, , Belgium
UZ Leuven
Leuven, , Belgium
IWK Health Centre
Halifax, , Canada
London Health Sciences Centre (LHSC) - Victoria Hospital
London, , Canada
The Hospital for Sick Children
Toronto, , Canada
CHU Amiens - Picardie Site Sud
Amiens, , France
CHU Lyon - Hôpital Femme-Mère-Enfant
Bron, , France
Hôpital Armand Trousseau
Paris, , France
Hôpital Necker - Enfants Malades
Paris, , France
Universitaetsklinikum Erlangen
Erlangen, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, , Germany
LMU-Campus Innenstadt
München, , Germany
Helios Klinikum Wuppertal
Wuppertal, , Germany
Rambam Health Care Campus
Haifa, , Israel
Shaare Zedek
Jerusalem, , Israel
Hadassah University Hospital, Ein Kerem
Jerusalem, , Israel
Schneider Children's Medical Center
Petah Tikva, , Israel
King Fahad Medical City
Rishon LeZiyyon, , Israel
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
Florence, , Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma, , Italy
Ospedale Pediatrico Bambino Gesù
Roma, , Italy
Juntendo University Hospital
Bunkyō City, , Japan
Institute of Science Tokyo Hospital
Bunkyō City, , Japan
Kokikai Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, , Japan
Saga University Hospital
Saga, , Japan
National Center for Child Health and Development
Setagaya-ku, , Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, , Japan
Mie University Hospital
Tsu, , Japan
Yokohama City University Medical Center, Center of IBD
Yokohama, , Japan
Amsterdam UMC, locatie VUmc
Amsterdam, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Gabinet Lekarski Bartosz Korczowski
Rzeszów, , Poland
Twoja Przychodnia-Szczecińskie Centrum Medyczne
Szczecin, , Poland
Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Instytut 'Pomnik - Centrum Zdrowia Dziecka
Warsaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Centro Clínico Académico - Braga, Associação (2CA-Braga)
Braga, , Portugal
Centro Hospitalar Universitário de São João, E.P.E.
Porto, , Portugal
Inje University Haeundae Paik Hospital
Busan, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Royal London Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Facility Contacts
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Related Links
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A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis (SHINE-2)
Other Identifiers
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I6T-MC-AMBA
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502183-20-00
Identifier Type: OTHER
Identifier Source: secondary_id
16634
Identifier Type: -
Identifier Source: org_study_id
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