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A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) (SHINE-ON)

Primary Purpose

Ulcerative Colitis, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mirikizumab
Mirikizumab
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Pediatric Ulcerative Colitis, Pediatric Crohn's Disease, Pediatric UC, Pediatric CD

Eligibility Criteria

2 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants from originating studies (I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130]) , I6T-MC-AMAY [NCT05509777]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab
  • Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.
  • Female participants must agree to contraception requirements.

Exclusion Criteria:

  • Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.
  • Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.
  • Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.
  • Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.
  • Participants must not have adenomatous polyps that have not been removed.
  • Participants must not be pregnant or breastfeeding.

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting
  • Children's Hospital of The King's DaughtersRecruiting
  • Shaare Zedek Medical Center
  • Juntendo University HospitalRecruiting
  • Tokyo Medical And Dental University Medical HospitalRecruiting
  • Seoul National University Hospital
  • Kyungpook National University Chilgok Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Mirikizumab Dose 1 for UC

Mirikizumab Dose 2 for UC

Mirikizumab Dose 3 for UC

Mirikizumab Dose 4 for CD

Mirikizumab Dose 5 for CD

Mirikizumab Dose 6 for CD

Mirikizumab Dose 7 for UC or CD

Arm Description

Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.

Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Intravenous (IV) rescue dosing, if response is lost.

Outcomes

Primary Outcome Measures

Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission
Clinical Remission based on the MMS
Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
Clinical Remission based on the PCDAI

Secondary Outcome Measures

Percentage of Participants with UC in MMS Clinical Response
Clinical Response based on the MMS
Percentage of Participants with CD in PCDAI Clinical Response
Clinical Response based on the PCDAI
Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
Clinical Response based on the PUCAI
Percentage of Participants with UC in PUCAI Clinical Remission
Clinical Response based on the PUCAI
Percentage of Participants with UC in Endoscopic Remission
Endoscopic Remission based on the Endoscopic Subscore (ES)
Percentage of Participants with CD in Endoscopic Remission
Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD)
Percentage of Participants with UC in Endoscopic Response
Endoscopic Response in Participants based on the ES
Percentage of Participants with CD in Endoscopic Response
Endoscopic Response based on the SES-CD
Percentage of Participants with UC in having Endoscopic Subscore = 0
Endoscopic Remission when ES = 0
Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission
Histologic remission based on histology scoring and endoscopic remission based on endoscopy score
Percentage of Participants with CD Achieving Histologic Response
Histologic response based on histology scoring
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
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)

Full Information

First Posted
April 12, 2021
Last Updated
October 10, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04844606
Brief Title
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)
Acronym
SHINE-ON
Official Title
A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
May 12, 2028 (Anticipated)
Study Completion Date
July 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases, Crohn's Disease
Keywords
Pediatric Ulcerative Colitis, Pediatric Crohn's Disease, Pediatric UC, Pediatric CD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mirikizumab Dose 1 for UC
Arm Type
Experimental
Arm Description
Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.
Arm Title
Mirikizumab Dose 2 for UC
Arm Type
Experimental
Arm Description
Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Arm Title
Mirikizumab Dose 3 for UC
Arm Type
Experimental
Arm Description
Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Arm Title
Mirikizumab Dose 4 for CD
Arm Type
Experimental
Arm Description
Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Arm Title
Mirikizumab Dose 5 for CD
Arm Type
Experimental
Arm Description
Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Arm Title
Mirikizumab Dose 6 for CD
Arm Type
Experimental
Arm Description
Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.
Arm Title
Mirikizumab Dose 7 for UC or CD
Arm Type
Experimental
Arm Description
Intravenous (IV) rescue dosing, if response is lost.
Intervention Type
Drug
Intervention Name(s)
Mirikizumab
Other Intervention Name(s)
LY3074828
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Mirikizumab
Other Intervention Name(s)
LY3074828
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission
Description
Clinical Remission based on the MMS
Time Frame
Week 52
Title
Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
Description
Clinical Remission based on the PCDAI
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants with UC in MMS Clinical Response
Description
Clinical Response based on the MMS
Time Frame
Week 52
Title
Percentage of Participants with CD in PCDAI Clinical Response
Description
Clinical Response based on the PCDAI
Time Frame
Week 52
Title
Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
Description
Clinical Response based on the PUCAI
Time Frame
Week 52
Title
Percentage of Participants with UC in PUCAI Clinical Remission
Description
Clinical Response based on the PUCAI
Time Frame
Week 52
Title
Percentage of Participants with UC in Endoscopic Remission
Description
Endoscopic Remission based on the Endoscopic Subscore (ES)
Time Frame
Week 52
Title
Percentage of Participants with CD in Endoscopic Remission
Description
Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD)
Time Frame
Week 52
Title
Percentage of Participants with UC in Endoscopic Response
Description
Endoscopic Response in Participants based on the ES
Time Frame
Week 52
Title
Percentage of Participants with CD in Endoscopic Response
Description
Endoscopic Response based on the SES-CD
Time Frame
Week 52
Title
Percentage of Participants with UC in having Endoscopic Subscore = 0
Description
Endoscopic Remission when ES = 0
Time Frame
Week 52
Title
Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission
Description
Histologic remission based on histology scoring and endoscopic remission based on endoscopy score
Time Frame
Week 52
Title
Percentage of Participants with CD Achieving Histologic Response
Description
Histologic response based on histology scoring
Time Frame
Week 52
Title
Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery
Description
Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery
Time Frame
Week 52
Title
Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery
Description
Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery)
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants from originating studies (I6T-MC-AMBA [NCT05784246], I6T-MC-AMBU [NCT04004611], I6T-MC-AMAM [NCT03926130]) , I6T-MC-AMAY [NCT05509777]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment. Female participants must agree to contraception requirements. Exclusion Criteria: Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant. Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ. Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety. Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation. Participants must not have adenomatous polyps that have not been removed. Participants must not be pregnant or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLilly (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Dunkin
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameer Lapsia
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
9722666666
First Name & Middle Initial & Last Name & Degree
Dan Turner
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takahiro Kudo
Facility Name
Tokyo Medical And Dental University Medical Hospital
City
Bunkyō
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masakazu Nagahori
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Kyungpook National University Chilgok Hospital
City
Deagu
State/Province
Taegu-Kwangyǒkshi
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/6Fqthjwf4KUkJi8EyTQv5A
Description
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

Learn more about this trial

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

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