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

June 2, 2026 updated by: Eli Lilly and Company

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

  • Belgium
      • Edegem, Belgium, 2650
        • UZA
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Canada
      • Toronto, Canada, M5G 0A4
        • The Hospital for Sick Children
  • France
      • Paris, France, 75015
        • Hopital 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-Szczecinskie 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 Oporow
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
Time Frame: Baseline to Week 52
Baseline to Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants in MMS Clinical Remission
Time Frame: Week 12
Week 12
Percentage of Participants in MMS Clinical Response
Time Frame: Week 12
Week 12
Percentage of Participants with Endoscopic Remission
Time Frame: Week 12
Week 12
Percentage of Participants with Endoscopic Improvement
Time Frame: Week 12
Week 12
Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
Time Frame: Week 12
Week 12
Percentage of Participants Achieving PUCAI Clinical Remission
Time Frame: Week 12
Week 12
Percentage of Participants Achieving MMS Clinical Response
Time Frame: Week 52
Week 52
Percentage of Participants Achieving MMS Clinical Remission
Time Frame: Week 52
Week 52
Percentage of Participants Achieving PUCAI Clinical Response
Time Frame: Week 52
Week 52
Percentage of Participants Achieving PUCAI Clinical Remission
Time Frame: Week 52
Week 52
Percentage of Participants Achieving Endoscopic Remission
Time Frame: Week 52
Week 52
Percentage of Participants Achieving Endoscopic Improvement
Time Frame: Week 52
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
Time Frame: Baseline to Week 52
Baseline to Week 52
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab
Time Frame: Baseline to Week 52
PK: AUC of Mirikizumab
Baseline to Week 52
PK: Cmax of Mirikizumab
Time Frame: Baseline to Week 52
Baseline to Week 52
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement
Time Frame: Week 12
Week 12
Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement
Time Frame: Week 52
Week 52

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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