Back to resultsA Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-2)
Primary Purpose
Atopic Dermatitis, Eczema
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lebrikizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria: Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI. For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Exclusion Criteria: Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.) Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab. Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.
Sites / Locations
- Clinical Research Center of AlabamaRecruiting
- Arkansas Research TrialsRecruiting
- First OC DermatologyRecruiting
- Antelope Valley Clinical TrialsRecruiting
- Dermatology Research AssociatesRecruiting
- Integrative Skin Science and Research - Location 2Recruiting
- UConn HealthRecruiting
- Solutions Through Advanced ResearchRecruiting
- ForCare Clinical ResearchRecruiting
- Treasure Valley Medical ResearchRecruiting
- Northwestern University
- Allergy and Asthma SpecialistRecruiting
- Massachusetts General Hospital
- Oakland Hills DermatologyRecruiting
- Great Lakes Research Group, Inc.Recruiting
- The Derm Institute of West MichiganRecruiting
- Respiratory Medicine Research Institute of Michigan, PLCRecruiting
- Wright State PhysiciansRecruiting
- The Pennsylvania Centre for Dermatology, LLCRecruiting
- Medical University of South CarolinaRecruiting
- The University of Texas Health Science Center at Houston
- Texas Dermatology and Laser SpecialistsRecruiting
- Medical College of Wisconsin
- Instituto de Neumonología Y DermatologíaRecruiting
- Psoriahue
- Centro de Investigaciones Metabólicas (CINME)Recruiting
- Fundacion Cidea
- CONEXA Investigacion Clinica S.A.Recruiting
- Fundación RespirarRecruiting
- Sydney Children's Hospital
- The Children's Hospital at Westmead
- Cornerstone Dermatology
- Veracity Clinical Research Pty LtdRecruiting
- Hospital de Clinicas de Porto Alegre
- Centro de Pesquisa Sao Lucas
- Dermatology Research Institute
- Alberta Dermasurgery Centre
- DermEdge Research
- Hôpitaux Drôme Nord - RomansRecruiting
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecruiting
- CHU de Toulouse - Hopital LarreyRecruiting
- Hôpital Saint Vincent-de-Paul
- Rosenpark Research GmbH
- Fachklinik Bad BentheimRecruiting
- Universitätsklinikum Münster
- Universitaetsklinikum Carl Gustav Carus Dresden
- Fujita Health UniversityRecruiting
- Fukuyama City HospitalRecruiting
- Asahikawa Medical College HospitalRecruiting
- National Hospital Organization Sagamihara National HospitalRecruiting
- Ina Central HospitalRecruiting
- Osaka Habikino Medical CenterRecruiting
- Kume ClinicRecruiting
- Enomoto ClinicRecruiting
- Sugamo Sengoku DermatologyRecruiting
- Hiroshima University HospitalRecruiting
- University Hospital,Kyoto Prefectural University of MedicineRecruiting
- Okayama City General Medical Center Okayama City HospitalRecruiting
- Hospital de Jesús NazarenoRecruiting
- Trials in Medicine
- Hospital Infantil de Mexico Federico Gomez
- PanAmerican Clinical Research - CuernavacaRecruiting
- Centro de Dermatologia de Monterrey
- Eukarya PharmaSiteRecruiting
- Scientia Investigacion Clinica S.C.
- Arké SMO S.A de C.VRecruiting
- Centrum Medyczne Evimed
- Diamond Clinic
- Centrum Badan Klinicznych PI-House sp. z o.o.
- DERMED Centrum Medyczne Sp. z o.o.
- Hospital Sant Joan de Déu
- Hospital Universitario de Gran Canaria Doctor Negrín
- Hospital Universitario Quironsalud MadridRecruiting
- Clinica Universidad de NavarraRecruiting
- CHOP-Centro De Especialidades De MollabaoRecruiting
- Hospital de ManisesRecruiting
- Hospital Infantil Universitario Niño Jesús
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario La Paz
- Chang Gung Memorial Hospital at KaohsiungRecruiting
- Chung Shan Medical University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- National Taiwan University Hospital - Hsinchu branchRecruiting
- National Taiwan University HospitalRecruiting
- Chang Gung Medical Foundation-Linkou BranchRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lebrikizumab + Placebo
Arm Description
Lebrikizumab will be given subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.
Outcomes
Primary Outcome Measures
Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)
Secondary Outcome Measures
Percentage of Participants with an Investigator's Global Assessment (IGA) Score 0 or 1 and a Reduction ≥2 Points from Baseline of Study KGBI by Visit in Study KGBJ
Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) from Baseline of Study KGBI by Visit in Study KGBJ
Percentage of Participants Achieving EASI-90 from Baseline of Study KGBI by Visit in Study KGBJ
Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline of Study KGBI who Achieve a ≥4-point Reduction from Baseline of Study KGBI by Visit in Study KGBJ
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD)
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI
Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI
Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)
Full Information
NCT ID
NCT05735483
First Posted
February 10, 2023
Last Updated
October 17, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT05735483
Brief Title
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Acronym
ADorable-2
Official Title
A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
November 29, 2025 (Anticipated)
Study Completion Date
June 26, 2026 (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 assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to <18 years of age with moderate-to-severe atopic dermatitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lebrikizumab + Placebo
Arm Type
Experimental
Arm Description
Lebrikizumab will be given subcutaneously (SC).
Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.
Intervention Type
Drug
Intervention Name(s)
Lebrikizumab
Other Intervention Name(s)
LY3650150
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)
Time Frame
Baseline through Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants with an Investigator's Global Assessment (IGA) Score 0 or 1 and a Reduction ≥2 Points from Baseline of Study KGBI by Visit in Study KGBJ
Time Frame
Baseline to Week 52
Title
Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) from Baseline of Study KGBI by Visit in Study KGBJ
Time Frame
Baseline to Week 52
Title
Percentage of Participants Achieving EASI-90 from Baseline of Study KGBI by Visit in Study KGBJ
Time Frame
Baseline to Week 52
Title
Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline of Study KGBI who Achieve a ≥4-point Reduction from Baseline of Study KGBI by Visit in Study KGBJ
Time Frame
Baseline to Week 52
Title
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score
Time Frame
Baseline, Week 52
Title
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD)
Time Frame
Baseline, Week 52
Title
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI
Time Frame
Baseline, Week 52
Title
Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI
Time Frame
Baseline, Week 52
Title
Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)
Time Frame
Baseline, Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI.
For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Exclusion Criteria:
Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.)
Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab.
Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.
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
Clinical Research Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
205-209-4101
First Name & Middle Initial & Last Name & Degree
Weily Soong
Facility Name
Arkansas Research Trials
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
5016211100
First Name & Middle Initial & Last Name & Degree
Scott Michael Dinehart
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian Laquer
Facility Name
Antelope Valley Clinical Trials
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Antonio Tan
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
310-337-7171
First Name & Middle Initial & Last Name & Degree
Howard Sofen
Facility Name
Integrative Skin Science and Research - Location 2
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Ornelas
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Lu
Facility Name
Solutions Through Advanced Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pearl Kwong
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
8132642155
First Name & Middle Initial & Last Name & Degree
Seth Benjamin Forman
Facility Name
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
208-813-6505
First Name & Middle Initial & Last Name & Degree
Elizabeth Swanson
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
312-695-3721
First Name & Middle Initial & Last Name & Degree
Amy Paller
Facility Name
Allergy and Asthma Specialist
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee S. Clore
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
804-301-9948
First Name & Middle Initial & Last Name & Degree
JiaDe Yu
Facility Name
Oakland Hills Dermatology
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
248-858-2255
First Name & Middle Initial & Last Name & Degree
Christofer Buatti
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
989-895-9100
First Name & Middle Initial & Last Name & Degree
Brent Boyce
Facility Name
The Derm Institute of West Michigan
City
Caledonia
State/Province
Michigan
ZIP/Postal Code
49316
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
616-326-0114
First Name & Middle Initial & Last Name & Degree
Kristi Hawley
Facility Name
Respiratory Medicine Research Institute of Michigan, PLC
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
734-528-0477
First Name & Middle Initial & Last Name & Degree
Jeffrey G. Leflein
Facility Name
Wright State Physicians
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
937-245-7500
First Name & Middle Initial & Last Name & Degree
Craig Rohan
Facility Name
The Pennsylvania Centre for Dermatology, LLC
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
610-594-6660
First Name & Middle Initial & Last Name & Degree
Scott Gottlieb
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
843-792-9784
First Name & Middle Initial & Last Name & Degree
Lara Wine Lee
Facility Name
The University of Texas Health Science Center at Houston
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adelaide Hebert
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
210-852-2779
First Name & Middle Initial & Last Name & Degree
John Browning
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Holland
Facility Name
Instituto de Neumonología Y Dermatología
City
Ciudad Autonoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1425BEA
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541148230919
First Name & Middle Initial & Last Name & Degree
Paula Carolina Luna
Facility Name
Psoriahue
City
Ciudad Autonoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
C1425DKG
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
541148238755
First Name & Middle Initial & Last Name & Degree
Gabriel Alejandro Magariños
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Air
ZIP/Postal Code
1027
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Laura Galimberti
Facility Name
Fundacion Cidea
City
Buenos Aires
State/Province
Ciudad Aut
ZIP/Postal Code
C1121ABE
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
541153521290
First Name & Middle Initial & Last Name & Degree
Jorge Fernando Máspero
Facility Name
CONEXA Investigacion Clinica S.A.
City
Buenos Aires
ZIP/Postal Code
1012
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541139899011
First Name & Middle Initial & Last Name & Degree
Pablo Javier Gonzalez
Facility Name
Fundación Respirar
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
Phone
541170781548
First Name & Middle Initial & Last Name & Degree
Maria Florencia Fernández
Facility Name
Sydney Children's Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
61299117277
First Name & Middle Initial & Last Name & Degree
Linda Martin
Facility Name
The Children's Hospital at Westmead
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
0403130173
First Name & Middle Initial & Last Name & Degree
Li-Chuen Wong
Facility Name
Cornerstone Dermatology
City
Coorparoo
State/Province
Queensland
ZIP/Postal Code
4151
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Jin Kim
Facility Name
Veracity Clinical Research Pty Ltd
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
001161730391300
First Name & Middle Initial & Last Name & Degree
Lynda Spelman
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
555133598571
First Name & Middle Initial & Last Name & Degree
Tania Cestari
Facility Name
Centro de Pesquisa Sao Lucas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13060-803
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Livia Matida Gontijo Leal
Facility Name
Dermatology Research Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vimal Hasmukh Prajapati
Facility Name
Alberta Dermasurgery Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
7804377189
First Name & Middle Initial & Last Name & Degree
Jaggi Rao
Facility Name
DermEdge Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4Y 4C5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
9052749996
First Name & Middle Initial & Last Name & Degree
Mark Lomaga
Facility Name
Hôpitaux Drôme Nord - Romans
City
Romans-sur-Isère
State/Province
Drôme
ZIP/Postal Code
26102
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33047568378
First Name & Middle Initial & Last Name & Degree
Francois Skowron
Facility Name
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44093 Cede
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastien Barbarot
Facility Name
CHU de Toulouse - Hopital Larrey
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maella Severino-Freire
Facility Name
Hôpital Saint Vincent-de-Paul
City
Lille
State/Province
Nord-Pas-de-Calais
ZIP/Postal Code
59020
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
33320877576
First Name & Middle Initial & Last Name & Degree
Audrey Lasek
Facility Name
Rosenpark Research GmbH
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64283
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Weirich
Facility Name
Fachklinik Bad Bentheim
City
Bad Bentheim
State/Province
Niedersach
ZIP/Postal Code
48455
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
495922745290
First Name & Middle Initial & Last Name & Degree
Athanasios Tsianakas
Facility Name
Universitätsklinikum Münster
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
00492518356558
First Name & Middle Initial & Last Name & Degree
Nina Magnolo
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
49351458340
First Name & Middle Initial & Last Name & Degree
Susanne Abraham
Facility Name
Fujita Health University
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazumitsu Sugiura
Facility Name
Fukuyama City Hospital
City
Fukuyama
State/Province
Hiroshima
ZIP/Postal Code
721-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masanori Ikeda
Facility Name
Asahikawa Medical College Hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satomi Igawa
Facility Name
National Hospital Organization Sagamihara National Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0392
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
0427428311
First Name & Middle Initial & Last Name & Degree
Motohiro Ebisawa
Facility Name
Ina Central Hospital
City
Ina
State/Province
Nagano
ZIP/Postal Code
396-0033
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MASAO FUKUZAWA
Facility Name
Osaka Habikino Medical Center
City
Habikino
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81729572121
First Name & Middle Initial & Last Name & Degree
Yoko Kataoka
Facility Name
Kume Clinic
City
Sakai City
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akihiro Kume
Facility Name
Enomoto Clinic
City
Kumagaya
State/Province
Saitama
ZIP/Postal Code
360-0018
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shinya Enomoto
Facility Name
Sugamo Sengoku Dermatology
City
Toshima
State/Province
Tokyo
ZIP/Postal Code
170-0002
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maaya Konishi
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akio Tanaka
Facility Name
University Hospital,Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koji Masuda
Facility Name
Okayama City General Medical Center Okayama City Hospital
City
Okayama
ZIP/Postal Code
700-8557
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Manki
Facility Name
Hospital de Jesús Nazareno
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06090
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
5528880413
First Name & Middle Initial & Last Name & Degree
Luis Hernandez
Facility Name
Trials in Medicine
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
525551625211
First Name & Middle Initial & Last Name & Degree
Diana Fernandez
Facility Name
Hospital Infantil de Mexico Federico Gomez
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
525554331566
First Name & Middle Initial & Last Name & Degree
MIRNA ERENDIRA TOLEDO BAHENA
Facility Name
PanAmerican Clinical Research - Cuernavaca
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
7771442353
First Name & Middle Initial & Last Name & Degree
Patricia Sepulveda
Facility Name
Centro de Dermatologia de Monterrey
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
8183471977
First Name & Middle Initial & Last Name & Degree
Remigio Francisco Gonzalez Soto
Facility Name
Eukarya PharmaSite
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64718
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
8183463307
First Name & Middle Initial & Last Name & Degree
Daniel Gonzalez Gaytan
Facility Name
Scientia Investigacion Clinica S.C.
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
6146883416
First Name & Middle Initial & Last Name & Degree
Mavi Patricia Lopez
Facility Name
Arké SMO S.A de C.V
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
2299314102
First Name & Middle Initial & Last Name & Degree
Claudia Bernabe del Rio
Facility Name
Centrum Medyczne Evimed
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-625
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Slowinska
Facility Name
Diamond Clinic
City
Krakow
State/Province
Małopolski
ZIP/Postal Code
31-559
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
4869604902
First Name & Middle Initial & Last Name & Degree
Barbara Rewerska
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o.
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
48513104911
First Name & Middle Initial & Last Name & Degree
Aleksandra Okuniewska
Facility Name
DERMED Centrum Medyczne Sp. z o.o.
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
90-265
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
48426631444
First Name & Middle Initial & Last Name & Degree
Aleksandra Kaszuba
Facility Name
Hospital Sant Joan de Déu
City
Esplugues de Llobregat
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
932804000
First Name & Middle Initial & Last Name & Degree
Eulalia Baselga
Facility Name
Hospital Universitario de Gran Canaria Doctor Negrín
City
Las
State/Province
Las Palmas
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALICIA LOURDES GONZALEZ QUESADA
Facility Name
Hospital Universitario Quironsalud Madrid
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
0034647415381
First Name & Middle Initial & Last Name & Degree
Javier Pedraz
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34948255400
First Name & Middle Initial & Last Name & Degree
Nuria Rodriguez-Garijo
Facility Name
CHOP-Centro De Especialidades De Mollabao
City
Pontevedra
State/Province
Pontevedra [Pontevedra]
ZIP/Postal Code
36001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
0034986800272
First Name & Middle Initial & Last Name & Degree
Maria Angeles Florez Menendez
Facility Name
Hospital de Manises
City
Manises
State/Province
València
ZIP/Postal Code
46940
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
961845065
First Name & Middle Initial & Last Name & Degree
Antonio Martorell
Facility Name
Hospital Infantil Universitario Niño Jesús
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
915035900
First Name & Middle Initial & Last Name & Degree
Antonio Torrelo Fernandez
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
917792261
First Name & Middle Initial & Last Name & Degree
Sara Isabel Palencia Perez
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raul de Lucas Laguna
Facility Name
Chang Gung Memorial Hospital at Kaohsiung
City
Kaohsiung Niao Sung Dist
State/Province
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
8867317123229
First Name & Middle Initial & Last Name & Degree
Ji-Chen Ho
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
8862473959534
First Name & Middle Initial & Last Name & Degree
Po-Ju Lai
Facility Name
Taipei Veterans General Hospital
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
0228757339
First Name & Middle Initial & Last Name & Degree
Chih-Chiang Chen
Facility Name
National Taiwan University Hospital - Hsinchu branch
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
88635326151
First Name & Middle Initial & Last Name & Degree
HSIEN-YI CHIU
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
886223562141
First Name & Middle Initial & Last Name & Degree
Chia-Yu Chu
Facility Name
Chang Gung Medical Foundation-Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chin-Yi Yang
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/389036
Description
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-2)
Learn more about this trial
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
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