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

Primary Purpose

Ulcerative Colitis

Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mirikizumab IV
Mirikizumab SC
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

Eligibility Criteria

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

Inclusion Criteria: Males or females weighing >10 kg and ≥2 and <18 years old Have moderate to severe UC Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, 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

Sites / Locations

  • Dermatology Research Associates
  • Rady Children's Hospital- San Diego
  • University of California-San Francisco-Mission Bay
  • Connecticut Children's Medical Center
  • Children's Center for Digestive Health Care, LLC
  • Riley Childrens Hospital
  • Massachusetts General Hospital for Children
  • Boston Children's Hospital
  • St. Louis Children's Hospital
  • Morristown Medical Center
  • Icahn School of Medicine at Mount Sinai
  • Cincinnati Childrens Hospital Medical Center
  • Mater Hospital Brisbane
  • Women'S and Children'S Hospital, Adelaide
  • Perth Children's Hospital
  • UZA
  • UZ Leuven
  • Children's & Women's Health Centre of British Columbia
  • IWK Health Centre
  • London Health Sciences Centre (LHSC) - Victoria Hospital
  • The Hospital for Sick Children
  • CHU Lyon - Hôpital Femme-Mère-Enfant
  • CHU Amiens - Picardie Site Sud
  • Hôpital Armand Trousseau
  • Hôpital Necker - Enfants Malades
  • LMU-Campus Innenstadt
  • Helios Klinikum Wuppertal
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Rambam Health Care Campus
  • Shaare Zedek Medical Center
  • Hadassah University Hospital - Mount Scopus
  • Schneider Children's Medical Center
  • Assaf Harofeh Medical Center
  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
  • Ospedale Pediatrico Bambino Gesù
  • Kokikai Tsujinaka Hospital Kashiwanoha
  • Yokohama City University Medical Center, Center of IBD
  • Mie University Hospital
  • Juntendo University Hospital
  • Tokyo Medical and Dental University Hospital
  • National Center for Child Health and Development
  • Saga University Hospital
  • Kyungpook National University Medical Center Chilgok Hospital
  • Inje University Haeundae Paik Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • Amsterdam UMC, locatie AMC
  • Erasmus Medisch Centrum
  • Uniwersytecki Szpital Dziecięcy w Krakowie
  • Korczowski Bartosz, Gabinet Lekarski
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
  • Warsaw IBD Point Profesor Kierkus
  • Instytut "Pomnik - Centrum Zdrowia Dziecka"
  • Hospital de Braga
  • Centro Hospitalar de São João, E.P.E.
  • King's College Hospital
  • Royal London Hospital
  • Sheffield Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Mirikizumab Weight-Based Group 1

Mirikizumab Weight-Based Group 2

Mirikizumab Weight-Based Group 3

Arm Description

Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).

Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.

Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.

Outcomes

Primary Outcome Measures

Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders

Secondary Outcome Measures

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

Full Information

First Posted
March 13, 2023
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05784246
Brief Title
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
Acronym
SHINE-2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 15, 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 26, 2023 (Anticipated)
Primary Completion Date
July 20, 2026 (Anticipated)
Study Completion Date
March 31, 2027 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Mirikizumab Weight-Based Group 1
Arm Type
Experimental
Arm Description
Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
Arm Title
Mirikizumab Weight-Based Group 2
Arm Type
Experimental
Arm Description
Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
Arm Title
Mirikizumab Weight-Based Group 3
Arm Type
Experimental
Arm Description
Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
Intervention Type
Drug
Intervention Name(s)
Mirikizumab IV
Other Intervention Name(s)
LY3074828
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Mirikizumab SC
Other Intervention Name(s)
LY3074828
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Percentage of Participants in MMS Clinical Remission
Time Frame
Week 12
Title
Percentage of Participants in MMS Clinical Response
Time Frame
Week 12
Title
Percentage of Participants with Endoscopic Remission
Time Frame
Week 12
Title
Percentage of Participants with Endoscopic Improvement
Time Frame
Week 12
Title
Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response
Time Frame
Week 12
Title
Percentage of Participants Achieving PUCAI Clinical Remission
Time Frame
Week 12
Title
Percentage of Participants in Histologic Endoscopic Mucosal Remission
Time Frame
Week 12
Title
Percentage of Participants Achieving MMS Clinical Response
Time Frame
Week 52
Title
Percentage of Participants Achieving MMS Clinical Remission
Time Frame
Week 52
Title
Percentage of Participants Achieving PUCAI Clinical Response
Time Frame
Week 52
Title
Percentage of Participants Achieving PUCAI Clinical Remission
Time Frame
Week 52
Title
Percentage of Participants Achieving Endoscopic Remission
Time Frame
Week 52
Title
Percentage of Participants Achieving Endoscopic Improvement
Time Frame
Week 52
Title
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
Title
Percentage of Participants in Histologic Endoscopic Mucosal Remission
Time Frame
Week 52
Title
Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab
Description
PK: AUC of Mirikizumab
Time Frame
Baseline to Week 52
Title
PK: Cmax of Mirikizumab
Time Frame
Baseline to 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: Males or females weighing >10 kg and ≥2 and <18 years old Have moderate to severe UC Have failed corticosteroids, biologics, anti-TNF antibodies or anti-integrin antibodies, 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
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 - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mallory Chavannes
Facility Name
Rady Children's Hospital- San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeannie Huang
Facility Name
University of California-San Francisco-Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Verstraete
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Hyams
Facility Name
Children's Center for Digestive Health Care, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffery Lewis
Facility Name
Riley Childrens Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Contact:
Phone
317-944-3774
First Name & Middle Initial & Last Name & Degree
Steve Steiner
Facility Name
Massachusetts General Hospital for Children
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jess Kaplan
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athos Bousvaros
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Contact:
Phone
314-454-6173
First Name & Middle Initial & Last Name & Degree
Charles Samson
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960-6136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oren Koslowe
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Dunkin
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillip Minar
Facility Name
Mater Hospital Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakob Begun
Facility Name
Women'S and Children'S Hospital, Adelaide
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Couper
Facility Name
Perth Children's Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zubin Grover
Facility Name
UZA
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Els Van de Vijver
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilse Hoffman
Facility Name
Children's & Women's Health Centre of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevan Jacobson
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Otley
Facility Name
London Health Sciences Centre (LHSC) - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen Crowley
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas WALTERS
Facility Name
CHU Lyon - Hôpital Femme-Mère-Enfant
City
Bron
State/Province
Rhone
ZIP/Postal Code
69677
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Remi Duclaux-Loras
Facility Name
CHU Amiens - Picardie Site Sud
City
Amiens
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Djeddi Djamal-Dine
Facility Name
Hôpital Armand Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Lemale
Facility Name
Hôpital Necker - Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Ruemmele
Facility Name
LMU-Campus Innenstadt
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Schwerd
Facility Name
Helios Klinikum Wuppertal
City
Wuppertal
State/Province
Nordrhein Westfalen
ZIP/Postal Code
42283
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Hensel
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
State/Province
Rheinland Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Gehring
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ron Shaoul
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Turner
Facility Name
Hadassah University Hospital - Mount Scopus
City
Jerusalem
ZIP/Postal Code
9124001
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zev Davidovics
Facility Name
Schneider Children's Medical Center
City
Petach-Tikva
ZIP/Postal Code
4920235
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dror Shouval
Facility Name
Assaf Harofeh Medical Center
City
Rishon Lezion
ZIP/Postal Code
70300
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EFRAT BROIDE
Facility Name
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Lionetti
Facility Name
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Aloi
Facility Name
Ospedale Pediatrico Bambino Gesù
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Knafelz
Facility Name
Kokikai Tsujinaka Hospital Kashiwanoha
City
Kashiwa-shi
State/Province
Chiba-Ken
ZIP/Postal Code
277-0871
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Takeuchi
Facility Name
Yokohama City University Medical Center, Center of IBD
City
Yokohama-shi
State/Province
Kanagawa-Ken
ZIP/Postal Code
232-0024
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reiko Kunisaki
Facility Name
Mie University Hospital
City
Tsu-Shi
State/Province
Mie-Ken
ZIP/Postal Code
514-8507
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuki Koike
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takahiro Kudo
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyō-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ami Kawamoto
Facility Name
National Center for Child Health and Development
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katsuhiro Arai
Facility Name
Saga University Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshihiko Kakiuchi
Facility Name
Kyungpook National University Medical Center Chilgok Hospital
City
Daegu
State/Province
Gyeongsangbuk-do
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Kang
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-oh Kim
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Soo Moon
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sowon Park
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi Jin Kim
Facility Name
Amsterdam UMC, locatie AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Van Limbergen
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lissy De Ridder
Facility Name
Uniwersytecki Szpital Dziecięcy w Krakowie
City
Krakow
ZIP/Postal Code
30 663
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malgorzata Sladek
Facility Name
Korczowski Bartosz, Gabinet Lekarski
City
Rzeszow
ZIP/Postal Code
35-302
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bartosz Korczowski
Facility Name
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
City
Szczecin
ZIP/Postal Code
71 434
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beata Gawdis-Wojnarska
Facility Name
Warsaw IBD Point Profesor Kierkus
City
Warszawa
ZIP/Postal Code
00-728
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Meglicka
Facility Name
Instytut "Pomnik - Centrum Zdrowia Dziecka"
City
Warszawa
ZIP/Postal Code
04 730
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaroslaw Kierkus
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filipa Neiva
Facility Name
Centro Hospitalar de São João, E.P.E.
City
Porto
ZIP/Postal Code
4200 319
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eunice Trindade
Facility Name
King's College Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Babu Vadamalayan
Facility Name
Royal London Hospital
City
Whitechapel
State/Province
Greater London
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Croft
Facility Name
Sheffield Children's Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akshay Kapoor

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.lilly.com/en-US/trial/395116
Description
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis (SHINE-2)

Learn more about this trial

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

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