A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis (SHINE-2)

A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis

The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Mirikizumab IV; Drug: Mirikizumab SC

Detailed Description

Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • UZA
  • Leuven, Belgium, 3000
    • UZ Leuven
• Canada
  • Toronto, Canada, M5G 0A4
    • The Hospital for Sick Children
• France
  • Paris, France, 75015
    • Hôpital Necker - Enfants Malades
• Germany
  • Mainz, Germany, 55131
    • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
  • München, Germany, 80337
    • LMU-Campus Innenstadt
  • Wuppertal, Germany, 42283
    • Helios Klinikum Wuppertal
• Israel
  • Jerusalem, Israel, 9103102
    • Shaare Zedek
  • Jerusalem, Israel, 911200
    • Hadassah University Hospital, Ein Kerem
  • Petah Tikva, Israel, 4920235
    • Schneider Children's Medical Center
  • Rishon LeZiyyon, Israel, 70300
    • King Fahad Medical City
• Italy
  • Florence, Italy, 50139
    • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
  • Roma, Italy, 00161
    • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
• Japan
  • Bunkyō City, Japan, 113-8431
    • Juntendo University Hospital
  • Bunkyō City, Japan, 113-8519
    • Institute of Science Tokyo Hospital
  • Kashiwa-shi, Japan, 277-0871
    • Kokikai Tsujinaka Hospital Kashiwanoha
  • Saga, Japan, 849-8501
    • Saga University Hospital
  • Setagaya-ku, Japan, 157-8535
    • National Center for Child Health and Development
  • Yokohama, Japan, 232-0024
    • Yokohama City University Medical Center, Center of IBD
• Poland
  • Rzeszów, Poland, 35-302
    • Gabinet Lekarski Bartosz Korczowski
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia-Szczecińskie Centrum Medyczne
  • Warsaw, Poland, 04-501
    • Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor Kierkus
  • Warsaw, Poland, 04-730
    • Instytut 'Pomnik - Centrum Zdrowia Dziecka
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporów
• South Korea
  • Daegu, South Korea, 41404
    • Kyungpook National University Chilgok Hospital
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
• United Kingdom
  • Sheffield, United Kingdom, S102TH
    • Sheffield Children's Hospital
• United States
  • California
    • San Francisco, California, United States, 94158
      • University of California, San Francisco
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Children's Center for Digestive Health Care, LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Childrens Hospital
  • Missouri
    • St Louis, Missouri, United States, 63110-1010
      • Washington University
  • New York
    • New York, New York, United States, 10029
      • Icahn School Of Medicine At Mount Sinai
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males or females weighing ≥10 kg and ≥2 and <18 years old at the time of consent for screening.
• 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 Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis.
• Have immune deficiency syndrome.
• Previous bowel resection or intestinal surgery.
• Evidence of toxic megacolon.
• History or current evidence of cancer of the gastrointestinal tract.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirikizumab Weight-Based Group 1; Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).	Drug: Mirikizumab IV; Administered IV; Other Names: LY3074828; Drug: Mirikizumab SC; Administered SC; Other Names: LY3074828
Experimental: Mirikizumab Weight-Based Group 2; Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.	Drug: Mirikizumab IV; Administered IV; Other Names: LY3074828; Drug: Mirikizumab SC; Administered SC; Other Names: LY3074828
Experimental: Mirikizumab Weight-Based Group 3; Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.	Drug: Mirikizumab IV; Administered IV; Other Names: LY3074828; Drug: Mirikizumab SC; Administered SC; Other Names: LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders	Baseline to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in MMS Clinical Remission		Week 12
Percentage of Participants in MMS Clinical Response		Week 12
Percentage of Participants with Endoscopic Remission		Week 12
Percentage of Participants with Endoscopic Improvement		Week 12
Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response		Week 12
Percentage of Participants Achieving PUCAI Clinical Remission		Week 12
Percentage of Participants Achieving MMS Clinical Response		Week 52
Percentage of Participants Achieving MMS Clinical Remission		Week 52
Percentage of Participants Achieving PUCAI Clinical Response		Week 52
Percentage of Participants Achieving PUCAI Clinical Remission		Week 52
Percentage of Participants Achieving Endoscopic Remission		Week 52
Percentage of Participants Achieving Endoscopic Improvement		Week 52
Percentage of Participants Achieving MMS Clinical Remission without Surgery at Week 52 among Clinical Responders at Week 12 and without the Use of Corticosteroids		Baseline to Week 52
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab	PK: AUC of Mirikizumab	Baseline to Week 52
PK: Cmax of Mirikizumab		Baseline to Week 52
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement		Week 12
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement		Week 52

Collaborators and Investigators

• 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

Helpful Links

• A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis (SHINE-2)

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Actual): May 1, 2026
• Study Completion (Actual): May 1, 2026

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; mirikizumab
• Other Study ID Numbers: 16634; I6T-MC-AMBA (Other Identifier: Eli Lilly and Company); 2022-502183-20-00 (Other Identifier: EU Trial Number)

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
• product manufactured in and exported from the U.S.: Yes