Back to resultsA Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease (AMAY)
Primary Purpose
Crohn's Disease
Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mirikizumab
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Inflammatory Bowel Disease
Eligibility Criteria
Inclusion Criteria:
- Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
- Participants must have moderately to severely active CD (as defined by a baseline PCDAI score >30).
- Participants must have endoscopy with evidence of active CD defined as as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) during screening into this study.
- Participants must have a prior or current CD medication history that includes either inadequate response, loss of response to or failure to tolerate current treatment immunomodulators or with oral or IV corticosteroids or have received biologic therapy/JAK inhibitor for the treatment of CD and have a documented history of inadequate response, loss of response (LOR), or intolerance to the biologic therapy/JAK inhibitor.
Exclusion Criteria:
- Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
- Participants must not have an abscess.
- Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.
Sites / Locations
- Phoenix Childrens Hospital
- Arkansas Children's Hospital Research Institute
- University of California San Diego
- Cedars-Sinai Medical Center
- University of California-San Francisco-Mission Bay
- Connecticut Children's Medical Center
- Nicklaus Children's Hospital
- The Emory Clinic Emory University
- Children's Center for Digestive Health Care, LLC
- Riley Childrens Hospital
- Boston Children's Hospital
- Atlantic Health System
- Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
- Icahn School of Medicine at Mount Sinai
- Columbia University Medical Center/New York Presbyterian
- University of North Carolina at Chapel Hill
- The Cleveland Clinic Foundation
- Children's Hospital of Philadelphia
- Cook Children's Medical Center
- Texas Children's Hospital -Research Resource Office
- University of Vermont Medical Center
- Seattle Children's Hospital
- Children's Hospital of Wisconsin
- The Children's Hospital at Westmead
- Mater Hospital Brisbane
- Women'S and Children'S Hospital, Adelaide
- Perth Children's Hospital
- AKH - Medizinische Universtität Wien
- Cliniques Universitaires Saint-Luc
- Universitair Ziekenhuis Antwerp
- UZ Leuven
- Universitair Ziekenhuis Brussel
- Núcleo de Doenças Infecciosas/CBM/UFES
- HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
- Associação Hospitalar de Proteção à Infância Dr. Raul Carneiro
- Hospital da Criança Santo Antônio - Irmandade da Santa Casa de Misericórdia de Porto Alegre
- HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
- Hospital das Clinicas da FMRP
- Integral Pesquisa e Ensino
- 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 Amiens - Hopital NORD
- Hopital Jeanne de Flandre - CHRU Lille
- Hôpital Necker - Enfants Malades
- Hôpital Robert Debré - Paris
- Soroka Medical Center
- Schneider Children's Medical Center
- Rambam Health Care Campus
- Shamir Medical Center (Assaf Harofeh)
- Shaare Zedek
- Hadassah University Hospital - Mount Scopus
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Azienda USL di Bologna
- Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
- Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
- Ospedale Pediatrico Bambino Gesù
- Hirosaki University Hospital
- Kokikai Tsujinaka Hospital Kashiwanoha
- Yokohama City University Medical Center, Center of IBD
- Miyagi Children's Hospital
- Juntendo University Hospital
- National Center For Child Health And Development
- Saga University Hospital
- Severance Hospital, Yonsei University Health System
- Samsung Medical Center
- Inje University Haeundae Paik Hospital
- Kyungpook National University Chilgok Hospital
- Seoul National University Hospital
- Erasmus Medisch Centrum
- Akershus Universitetssykehus
- Oslo University Hospital
- Universitetssykehuset Nord-Norge
- St-Olavs Hospital
- Instytut Pomnik-Centrum Zdrowia Dziecka
- Uniwersytecki Szpital Dziecięcy w Krakowie
- Korczowski Bartosz, Gabinet Lekarski
- Warsaw IBD Point Profesor Kierkus
- Hospital de Braga
- Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
- Centro Hospitalar de São João, E.P.E.
- Hospital Sant Joan de Deu
- Corporacio Sanitaria Parc Tauli
- Hospital Universitario Reina Sofia
- Hospital Universitari i Politecnic La Fe
- John Radcliffe Hospital
- Royal London Hospital
- Royal Manchester Children's Hospital
- Royal Hospital for Children and Young People
- Sheffield Children's Hospital
- Great Ormond Street Hospital for Children
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) or subcutaneously (SC) in participants that weigh greater than (>) 40 kilograms (kg).
Mirikizumab administered IV or SC in participants that weigh >20 kg to less than or equal to (≤) 40 kg. Dosing is based on assessments of the participant's weight and appropriate weight class.
Mirikizumab administered IV or SC in participants that weigh greater than or equal to (≥)10 kg to less than or equal to ≤20 kg. Dosing is based on assessments of the participant's weight and appropriate weight class.
Outcomes
Primary Outcome Measures
Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52
Clinical response based on PCDAI, and endoscopic response based on SES-CD.
Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52
Clinical response based on PCDAI, and clinical remission based on PCDAI.
Secondary Outcome Measures
Percentage of Participants Achieving Clinical Response by PCDAI
Clinical response based on PCDAI.
Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)
Clinical response based on CDAI for participants ≥12 years of age
Percentage of Participants Achieving Clinical Remission by PCDAI
Clinical remission based on PCDAI.
Percentage of Participants Achieving Clinical Remission by CDAI
Clinical remission based on CDAI for participants ≥12 years of age.
Percentage of Participants Achieving Endoscopic Response by SES-CD
Endoscopic response based on SES-CD.
Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52
Change from Baseline in C-reactive Protein (CRP)
Change from Baseline in CRP
Change from Baseline in Fecal calprotectin
Change from Baseline in Fecal calprotectin
Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52
Clinical response by PCDAI, CDAI for participants ≥12 years of age
Percentage of Participants Achieving Endoscopic Response
Endoscopic response by SES-CD
Percentage of Participants Achieving Clinical Remission by PCDAI
Clinical remission based on PCDAI
Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and PCDAI Clinical Remission without the use of Corticosteroids and who did not have Crohn's disease (CD)-Related Surgery at Week 52
Clinical response and clinical remission by PCDAI
Pharmacokinetics (PK): Clearance of Mirikizumab
Pharmacokinetics (PK): Volume of Distribution of Mirikizumab
Full Information
NCT ID
NCT05509777
First Posted
August 19, 2022
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT05509777
Brief Title
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Acronym
AMAY
Official Title
A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 24, 2023 (Anticipated)
Primary Completion Date
July 18, 2027 (Anticipated)
Study Completion Date
October 10, 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.
Study periods for the intervention-specific appendix (ISA) will be as follows:
A 12-week induction period
A maintenance period from Week 12 to Week 52, and
A safety follow-up period up to 16 weeks.
The study will last about 74 weeks and may include up to 19 visits.
Detailed Description
Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Inflammatory Bowel Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mirikizumab Dose 1
Arm Type
Experimental
Arm Description
Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (>) 40 kilograms (kg).
Arm Title
Mirikizumab Dose 2
Arm Type
Experimental
Arm Description
Mirikizumab administered IV or SC in participants that weigh >20 kg to less than or equal to (≤) 40 kg.
Dosing is based on assessments of the participant's weight and appropriate weight class.
Arm Title
Mirikizumab Dose 3
Arm Type
Experimental
Arm Description
Mirikizumab administered IV or SC in participants that weigh greater than or equal to (≥)10 kg to less than or equal to ≤20 kg.
Dosing is based on assessments of the participant's weight and appropriate weight class.
Intervention Type
Drug
Intervention Name(s)
Mirikizumab
Other Intervention Name(s)
LY3074828
Intervention Description
Administered IV or SC
Primary Outcome Measure Information:
Title
Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52
Description
Clinical response based on PCDAI, and endoscopic response based on SES-CD.
Time Frame
Baseline to Week 52
Title
Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52
Description
Clinical response based on PCDAI, and clinical remission based on PCDAI.
Time Frame
Baseline to Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Response by PCDAI
Description
Clinical response based on PCDAI.
Time Frame
Week 12
Title
Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)
Description
Clinical response based on CDAI for participants ≥12 years of age
Time Frame
Week 12
Title
Percentage of Participants Achieving Clinical Remission by PCDAI
Description
Clinical remission based on PCDAI.
Time Frame
Week 12
Title
Percentage of Participants Achieving Clinical Remission by CDAI
Description
Clinical remission based on CDAI for participants ≥12 years of age.
Time Frame
Week 12
Title
Percentage of Participants Achieving Endoscopic Response by SES-CD
Description
Endoscopic response based on SES-CD.
Time Frame
Week 12
Title
Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52
Time Frame
Baseline to Week 52
Title
Change from Baseline in C-reactive Protein (CRP)
Time Frame
Baseline, Week 12
Title
Change from Baseline in CRP
Time Frame
Baseline, Week 52
Title
Change from Baseline in Fecal calprotectin
Time Frame
Baseline, Week 12
Title
Change from Baseline in Fecal calprotectin
Time Frame
Baseline, Week 52
Title
Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52
Description
Clinical response by PCDAI, CDAI for participants ≥12 years of age
Time Frame
Baseline to Week 52
Title
Percentage of Participants Achieving Endoscopic Response
Description
Endoscopic response by SES-CD
Time Frame
Week 52
Title
Percentage of Participants Achieving Clinical Remission by PCDAI
Description
Clinical remission based on PCDAI
Time Frame
Week 52
Title
Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and PCDAI Clinical Remission without the use of Corticosteroids and who did not have Crohn's disease (CD)-Related Surgery at Week 52
Description
Clinical response and clinical remission by PCDAI
Time Frame
Baseline to Week 52
Title
Pharmacokinetics (PK): Clearance of Mirikizumab
Time Frame
Baseline through Week 52
Title
Pharmacokinetics (PK): Volume of Distribution of Mirikizumab
Time Frame
Baseline through 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 must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
Participants must have moderately to severely active CD (as defined by a baseline PCDAI score >30).
Participants must have endoscopy with evidence of active CD defined as as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) during screening into this study.
Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.
Exclusion Criteria:
Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
Participants must not have an abscess.
Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.
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
Phoenix Childrens Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brad Pasternak
Facility Name
Arkansas Children's Hospital Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Travis Ayers
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeannie Huang
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ziring
Facility Name
University of California-San Francisco-Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
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
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Maria Felipez
Facility Name
The Emory Clinic Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
subra kugathasan
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
Jeffrey Lewis
Facility Name
Riley Childrens Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Steiner
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
Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oren Koslowe
Facility Name
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
City
New York
State/Province
New York
ZIP/Postal Code
10021-5663
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliza Solomon
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
Columbia University Medical Center/New York Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Picoraro
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Egberg
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Barry
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur Kastl
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clifton Huang
Facility Name
Texas Children's Hospital -Research Resource Office
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Karam
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jillian Sullivan
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghassan Wahbeh
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226 4874
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JOSE CABRERA
Facility Name
The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shoma Dutt
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
AKH - Medizinische Universtität Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolf-Dietrich Huber
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
State/Province
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francoise Smets
Facility Name
Universitair Ziekenhuis Antwerp
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline De Bruyne
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilse Hoffman
Facility Name
Universitair Ziekenhuis Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth De Greef
Facility Name
Núcleo de Doenças Infecciosas/CBM/UFES
City
Vitória
State/Province
Espírito Santo
ZIP/Postal Code
29040 091
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Daniela Izoton de Sadovsky
Facility Name
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74605 020
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naflesia Bezerra Oliveira Correa
Facility Name
Associação Hospitalar de Proteção à Infância Dr. Raul Carneiro
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80250 060
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Kruger Truppel
Facility Name
Hospital da Criança Santo Antônio - Irmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035 074
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Targa Ferreira
Facility Name
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13060-904
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquim Simoes Neto
Facility Name
Hospital das Clinicas da FMRP
City
Ribeirao Preto
State/Province
São Paulo
ZIP/Postal Code
14048-900
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Sawamura
Facility Name
Integral Pesquisa e Ensino
City
Votuporanga
State/Province
São Paulo
ZIP/Postal Code
15501-405
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herlon Escorsi Valerio
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
Dhandapani Ashok
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
Anne Griffiths
Facility Name
CHU Amiens - Hopital NORD
City
Amines
State/Province
Cedex1
ZIP/Postal Code
80054
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Djeddi Djamal-Dine
Facility Name
Hopital Jeanne de Flandre - CHRU Lille
City
Lille Cedex
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine Ley
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
Hôpital Robert Debré - Paris
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérôme Viala
Facility Name
Soroka Medical Center
City
Beer-Sheva
State/Province
HaDarom
ZIP/Postal Code
8410101
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baruch Yerushalmi
Facility Name
Schneider Children's Medical Center
City
Petah-Tikva
State/Province
HaMerkaz
ZIP/Postal Code
4920235
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dror Shouval
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramit Magen Rimon
Facility Name
Shamir Medical Center (Assaf Harofeh)
City
Israel
ZIP/Postal Code
70300
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EFRAT BROIDE
Facility Name
Shaare Zedek
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
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Norsa
Facility Name
Azienda USL di Bologna
City
Bologna
ZIP/Postal Code
40124
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Alvisi
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
Fiammetta Bracci
Facility Name
Hirosaki University Hospital
City
Hirosaki
State/Province
Aomori PREF
ZIP/Postal Code
036
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hirotake Sakuraba
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
Miyagi Children's Hospital
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
989 3126
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daiki Abukawa
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
National Center For Child Health And Development
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
154
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
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Korea
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Koh
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Korea
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi Jin Kim
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
State/Province
Kwangyǒkshi
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-oh Kim
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
State/Province
Kwangyǒkshi
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Kang
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
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
Akershus Universitetssykehus
City
Nordbyagen
ZIP/Postal Code
1478
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Inchley
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gori Perminow
Facility Name
Universitetssykehuset Nord-Norge
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lene Nymo Trulsen
Facility Name
St-Olavs Hospital
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Lindgren
Facility Name
Instytut Pomnik-Centrum Zdrowia Dziecka
City
Warszawa
State/Province
Masovian
ZIP/Postal Code
04-730
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaroslaw Kierkus
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
Kinga Kowalska Duplaga
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
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
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 Lisboa Norte, E.P.E. - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Isabel Lopes
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
Hospital Sant Joan de Deu
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Javier Martin Carpi
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loverdos Eseverri Ines
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Gonzlez de Caldas
Facility Name
Hospital Universitari i Politecnic La Fe
City
València
ZIP/Postal Code
46026
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisa Isabel Iborra Colomino
Facility Name
John Radcliffe Hospital
City
Oxford
State/Province
Gb-oxf
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holm Uhlig
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
Ahmed Kadir
Facility Name
Royal Manchester Children's Hospital
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Fagbemi
Facility Name
Royal Hospital for Children and Young People
City
Edinburgh
State/Province
Lothian Region
ZIP/Postal Code
EH16 4TJ
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Russell
Facility Name
Sheffield Children's Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2RX
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akshay Kapoor
Facility Name
Great Ormond Street Hospital for Children
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Jones
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/356367
Description
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease (AMAY)
Learn more about this trial
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
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