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A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC) (SHINE1)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
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 Interleukin-23 (IL-23) antibody, IL-23p19, Pediatric

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants weighing >10 kg
  • Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications
  • Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment
  • Participants must have evidence of UC extending proximal to the rectum
  • Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC

Exclusion Criteria:

  • Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis
  • Participants must not have had surgery to remove part of their colon
  • Participants must not have current evidence of toxic megacolon
  • Participants must not have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening endoscopy
  • Participants must not have had an inadequate response to Interleukin 12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)

Sites / Locations

  • Childrens Hospital of Orange County
  • UCSF Medical Center at Mission Bay
  • Children's Hospital of Colorado
  • Connecticut Children's Medical Center
  • Emory University
  • Children's Center for Digestive Health Care, LLC
  • University of Chicago Hospital
  • Riley Hospital for Children
  • Boston Children's Hospital
  • MGH for Children - Waltham
  • Washington University School of Medicine
  • Goryeb Children's Hospital / Atlantic Health System
  • Icahn Sch of Med at Mt. Sinai
  • Cincinnati Childrens Hospital Medical Center
  • The Abbigail Wexner Research Institute at Nationwide Children's Hospital
  • Children's Hospital of Philadelphia
  • UPMC Children's Hospital of Pittsburgh
  • Cook Children's Hospital
  • Texas Childrens Hospital
  • Pediatrics Specialists of Virginia
  • Children's Hospital of The King's Daughters Inc
  • Seattle Children's Hospital Research Foundation
  • University of Alberta Hospital
  • IWK Health Centre
  • The Hospital for Sick Children
  • Rambam Medical Center
  • The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition; Shaare Zedek Medical Center
  • Schneider Children's Medical Center
  • Kurume University Hospital
  • Saiseikai Yokohamashi Tobu Hospital
  • Saitama Children's Medical Center
  • Juntendo University Hospital
  • Tokyo Medical and Dental University Hospital
  • National Center For Child Health And Development
  • Tokyo Medical University Hospital
  • Kyungpook National University Medical Center Chilgok Hospital
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Mirikizumab Dose 1

Mirikizumab Dose 2

Mirikizumab Dose 3

Arm Description

Mirikizumab administered intravenously (IV) and Subcutaneously (SC). Participants >40 kilograms (kg)

Mirikizumab administered IV and SC. Participants ≤40 kg

Mirikizumab administered IV and SC. Participants ≤40 kg

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Clearance of Mirikizumab
Clearance of Mirikizumab

Secondary Outcome Measures

Percentage of Participants in Clinical Remission
Clinical Remission based on the modified Mayo Score (MMS)
Percentage of Participants in Clinical Response
Clinical Response based on the MMS
Percentage of Participants Who are in MMS Clinical Remission Without the Use of Corticosteroids
Corticosteroid-free Clinical Remission based on the MMS
Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)
Clinical Remission based on the PUCAI
Percentage of Participants in Clinical Response Based on the PUCAI
Clinical Response based on the PUCAI
Percentage of Participants in Endoscopic Remission
Endoscopic Remission based on the MMS Endoscopic Subscore (ES)
Percentage of Participants in Symptomatic Remission
Symptomatic Remission based on MMS Stool Frequency (SF) and Rectal Bleeding (RB) Subscores
Height Velocity (in Centimeters/Year)
Height Velocity (in Centimeters/Year)
Change from Baseline in Body Weight
Change from Baseline in Body Weight
Percentage of Participants with Histologic-Endoscopic Mucosal Remission
Combination of endoscopic remission and mucosal healing based on a histologic disease activity index
Change from baseline in 7-day average of Abdominal Pain Numeric Rating Scale (NRS) score at Week 12
Change from baseline in 7-day average of Abdominal Pain NRS score

Full Information

First Posted
June 29, 2019
Last Updated
April 26, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04004611
Brief Title
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
Acronym
SHINE1
Official Title
Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

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
No

5. Study Description

Brief Summary
This study is designed to evaluate how the body processes and removes mirikizumab. The study will also evaluate safety and disease response in pediatric participants with UC taking mirikizumab. The study will last about 52 weeks and may include up to 18 visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Interleukin-23 (IL-23) antibody, IL-23p19, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirikizumab Dose 1
Arm Type
Experimental
Arm Description
Mirikizumab administered intravenously (IV) and Subcutaneously (SC). Participants >40 kilograms (kg)
Arm Title
Mirikizumab Dose 2
Arm Type
Experimental
Arm Description
Mirikizumab administered IV and SC. Participants ≤40 kg
Arm Title
Mirikizumab Dose 3
Arm Type
Experimental
Arm Description
Mirikizumab administered IV and SC. Participants ≤40 kg
Intervention Type
Drug
Intervention Name(s)
Mirikizumab
Other Intervention Name(s)
LY3074828
Intervention Description
Administered IV and SC
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Clearance of Mirikizumab
Description
Clearance of Mirikizumab
Time Frame
Baseline through Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants in Clinical Remission
Description
Clinical Remission based on the modified Mayo Score (MMS)
Time Frame
Week 52
Title
Percentage of Participants in Clinical Response
Description
Clinical Response based on the MMS
Time Frame
Week 52
Title
Percentage of Participants Who are in MMS Clinical Remission Without the Use of Corticosteroids
Description
Corticosteroid-free Clinical Remission based on the MMS
Time Frame
Week 52
Title
Percentage of Participants in Clinical Remission Based on the Pediatric Ulcerative Colitis Activity Index (PUCAI)
Description
Clinical Remission based on the PUCAI
Time Frame
Week 52
Title
Percentage of Participants in Clinical Response Based on the PUCAI
Description
Clinical Response based on the PUCAI
Time Frame
Week 52
Title
Percentage of Participants in Endoscopic Remission
Description
Endoscopic Remission based on the MMS Endoscopic Subscore (ES)
Time Frame
Week 52
Title
Percentage of Participants in Symptomatic Remission
Description
Symptomatic Remission based on MMS Stool Frequency (SF) and Rectal Bleeding (RB) Subscores
Time Frame
Week 52
Title
Height Velocity (in Centimeters/Year)
Description
Height Velocity (in Centimeters/Year)
Time Frame
Week 52
Title
Change from Baseline in Body Weight
Description
Change from Baseline in Body Weight
Time Frame
Week 52
Title
Percentage of Participants with Histologic-Endoscopic Mucosal Remission
Description
Combination of endoscopic remission and mucosal healing based on a histologic disease activity index
Time Frame
Week 52
Title
Change from baseline in 7-day average of Abdominal Pain Numeric Rating Scale (NRS) score at Week 12
Description
Change from baseline in 7-day average of Abdominal Pain NRS score
Time Frame
Baseline, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants weighing >10 kg Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment Participants must have evidence of UC extending proximal to the rectum Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC Exclusion Criteria: Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis Participants must not have had surgery to remove part of their colon Participants must not have current evidence of toxic megacolon Participants must not have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening endoscopy Participants must not have had an inadequate response to Interleukin 12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)
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 - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Childrens Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSF Medical Center at Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Children's Hospital of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Children's Center for Digestive Health Care, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Riley Hospital for Children
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46302
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
MGH for Children - Waltham
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Goryeb Children's Hospital / Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Icahn Sch of Med at Mt. Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
The Abbigail Wexner Research Institute at Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Cook Children's Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Childrens Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pediatrics Specialists of Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Children's Hospital of The King's Daughters Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Seattle Children's Hospital Research Foundation
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C9
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
The Juliet Keidan Institute of Paediatric Gastroenterology and Nutrition; Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Facility Name
Schneider Children's Medical Center
City
Petah Tiqva
ZIP/Postal Code
4920235
Country
Israel
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Saiseikai Yokohamashi Tobu Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2308765
Country
Japan
Facility Name
Saitama Children's Medical Center
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
330 8777
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyō
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
National Center For Child Health And Development
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Kyungpook National University Medical Center Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of

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 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://www.clinicalstudydatarequest.com
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/2c0yudZdAogZJ3JBUHvV8U
Description
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)

Learn more about this trial

A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)

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