Back to resultsA Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LY3454738
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria: Are candidates for systemic therapy. ISA specific: Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit: EASI score greater than or equal to (≥)16 vIGA-AD score ≥3, and ≥10% of BSA involvement (per EASI BSA). Have applied at least 1 emollient every day for at least 2 weeks before the day of the first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study. Exclusion Criteria: ISA specific: Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB. Are currently being treated with topical or systemic therapy Recent treatment with experimental (biologics and/or small molecules) - doesn't apply for subset of participants who must have been exposed to biologics and/or small molecules.
Sites / Locations
- Johnson DermatologyRecruiting
- Arkansas Research TrialsRecruiting
- Dermatology Research AssociatesRecruiting
- Conquest ResearchRecruiting
- Allergy and Asthma SpecialistRecruiting
- ActivMed Practices & Research, Inc.Recruiting
- Oregon Dermatology and Research CenterRecruiting
- DermDox Centers for DermatologyRecruiting
- Progressive Clinical ResearchRecruiting
- Center for Clinical Studies, LTD.LLPRecruiting
- Rejuvenation DermatologyRecruiting
- Rejuvenation DermatologyRecruiting
- Wiseman Dermatology Research Inc.Recruiting
- CCA Medical ResearchRecruiting
- Lynderm Research Inc.Recruiting
- FACET Dermatology
- Alpha Recherche CliniqueRecruiting
- Renmin Hospital of Wuhan UniversityRecruiting
- Xiangya Hospital Central South UniversityRecruiting
- The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
- Huashan Hospital Affiliated Fudan UniversityRecruiting
- Zhejiang Provincial People's HospitalRecruiting
- Allergo-Derm Bakos KftRecruiting
- Markusovszky Egyetemi Oktatokorhaz
- Medmare BtRecruiting
- Debreceni Egyetem Klinikai KozpontRecruiting
- Aou Ospedali Riuniti Umberto I
- Humanitas
- Ospedale Le Scotte
- Yasumoto Dermatology ClinicRecruiting
- Takagi DermatologyRecruiting
- Nomura Dermatology ClinicRecruiting
- Kume ClinicRecruiting
- Nihonbashi Sakura ClinicRecruiting
- Tachikawa Dermatology ClinicRecruiting
- The Catholic University of Korea, Incheon St. Mary's HospitalRecruiting
- Korea University Ansan HospitalRecruiting
- Chung-Ang University HospitalRecruiting
- Hallym University Kangnam Sacred Heart HospitalRecruiting
- Cryptex Investigación Clínica S.A. de C.V.Recruiting
- RM Pharma Specialists
- Trials in MedicineRecruiting
- Centro de Atención en Enfermedades Inflamatorias CATEIRecruiting
- Eukarya PharmaSite
- Scientia Investigacion Clinica S.C.Recruiting
- Centro de Investigacion Clinica de Oaxaca
- Centrum Medyczne EvimedRecruiting
- Medycyna KlinicznaRecruiting
- Diamond Clinic
- Specderm PoznanskaRecruiting
- Centrum Badan Klinicznych PI-House sp. z o.o.Recruiting
- DERMED Centrum Medyczne Sp. z o.o.Recruiting
- Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. LesiakRecruiting
- Chang Gung Memorial Hospital at KaohsiungRecruiting
- Municipal TuCheng HospitalRecruiting
- Chung Shan Medical University HospitalRecruiting
- National Taiwan University Hospital - Hsinchu branchRecruiting
- Taipei Veterans General HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Chang Gung Medical Foundation-Linkou BranchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
LY3454738 Dose 1
LY3454738 Dose 2
LY3454738 Dose 3
Placebo
Arm Description
Participants will receive LY3454738 subcutaneously (SC).
Participants will receive LY3454738 SC.
Participants will receive LY3454738 SC.
Participants will receive placebo.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
Secondary Outcome Measures
Percentage of Participants Achieving EASI-50
Percentage of Participants Achieving EASI-90
Percentage of Participants Achieving SCORing Atopic Dermatitis (SCORAD) 75
Percentage of Participants Achieving SCORAD-90
Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (viGA-AD) of 0 or 1
Percentage of Participants Achieving ≥4-point improvement from baseline in Itch Numeric Rating Scale (NRS) in the Subset of Participants with ≥4-point Itch NRS at Baseline
Mean Percent Change from Baseline in EASI
Mean Percent Change from Baseline in SCORAD
Pharmacokinetics (PK): Serum Trough Concentrations of LY3454738
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05911841
Brief Title
A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Official Title
A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 52 Week Study to Evaluate the Efficacy and Safety of LY3454738 in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
September 16, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (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 describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe atopic dermatitis (AD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LY3454738 Dose 1
Arm Type
Experimental
Arm Description
Participants will receive LY3454738 subcutaneously (SC).
Arm Title
LY3454738 Dose 2
Arm Type
Experimental
Arm Description
Participants will receive LY3454738 SC.
Arm Title
LY3454738 Dose 3
Arm Type
Experimental
Arm Description
Participants will receive LY3454738 SC.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo.
Intervention Type
Drug
Intervention Name(s)
LY3454738
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving EASI-50
Time Frame
Week 16
Title
Percentage of Participants Achieving EASI-90
Time Frame
Week 16
Title
Percentage of Participants Achieving SCORing Atopic Dermatitis (SCORAD) 75
Time Frame
Week 16
Title
Percentage of Participants Achieving SCORAD-90
Time Frame
Week 16
Title
Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (viGA-AD) of 0 or 1
Time Frame
Week 16
Title
Percentage of Participants Achieving ≥4-point improvement from baseline in Itch Numeric Rating Scale (NRS) in the Subset of Participants with ≥4-point Itch NRS at Baseline
Time Frame
Week 16
Title
Mean Percent Change from Baseline in EASI
Time Frame
Baseline, Week 16
Title
Mean Percent Change from Baseline in SCORAD
Time Frame
Baseline, Week 16
Title
Pharmacokinetics (PK): Serum Trough Concentrations of LY3454738
Time Frame
Baseline to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Are candidates for systemic therapy.
ISA specific:
Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit:
EASI score greater than or equal to (≥)16
vIGA-AD score ≥3, and
≥10% of BSA involvement (per EASI BSA).
Have applied at least 1 emollient every day for at least 2 weeks before the day of the first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study.
Exclusion Criteria:
ISA specific:
Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB.
Are currently being treated with topical or systemic therapy
Recent treatment with experimental (biologics and/or small molecules) - doesn't apply for subset of participants who must have been exposed to biologics and/or small molecules.
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
Johnson Dermatology
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
479-649-3376
First Name & Middle Initial & Last Name & Degree
Sandra Johnson
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
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
Conquest Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-916-0060
First Name & Middle Initial & Last Name & Degree
Malisa Agard
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
ActivMed Practices & Research, Inc.
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abel Jarell
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phoebe Rich, MD
Facility Name
DermDox Centers for Dermatology
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen M. Schleicher
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Stewart Lee
Facility Name
Center for Clinical Studies, LTD.LLP
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
281-333-2288
First Name & Middle Initial & Last Name & Degree
PATRICIA LEE
Facility Name
Rejuvenation Dermatology
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2W 4X9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Kuzel
Facility Name
Rejuvenation Dermatology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5J 3S9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parbeer Grewal
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marni Wiseman
Facility Name
CCA Medical Research
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 7K8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Adam
Facility Name
Lynderm Research Inc.
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
9054718011
First Name & Middle Initial & Last Name & Degree
Charles W Lynde
Facility Name
FACET Dermatology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 1L1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geeta Yadav
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Eve Pinet
Facility Name
Renmin Hospital of Wuhan University
City
Wu Han
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shan Jiang
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Juan
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zheng
Facility Name
Huashan Hospital Affiliated Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinhua Xu
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Pan
Facility Name
Allergo-Derm Bakos Kft
City
Szolnok
State/Province
Jász-Nagykun-Szolnok
ZIP/Postal Code
5000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noemi Bakos
Facility Name
Markusovszky Egyetemi Oktatokorhaz
City
Szombathely
State/Province
Vas
ZIP/Postal Code
9700
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eniko Telegdy
Facility Name
Medmare Bt
City
Veszprém
State/Province
Veszprém City
ZIP/Postal Code
8200
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
Phone
36703797219
First Name & Middle Initial & Last Name & Degree
Levente Pal Kovago
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Szegedi
Facility Name
Aou Ospedali Riuniti Umberto I
City
Ancona
State/Province
Marche
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
0715965451
First Name & Middle Initial & Last Name & Degree
Annamaria Offidani
Facility Name
Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Costanzo
Facility Name
Ospedale Le Scotte
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
0577585893
First Name & Middle Initial & Last Name & Degree
Elisa Cinotti
Facility Name
Yasumoto Dermatology Clinic
City
Chikushino-city
State/Province
Fukuoka
ZIP/Postal Code
818-0083
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81929254112
First Name & Middle Initial & Last Name & Degree
Shinichiro Yasumoto
Facility Name
Takagi Dermatology
City
Obihiro-shi
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hidetoshi Takahashi
Facility Name
Nomura Dermatology Clinic
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuko Nomura
Facility Name
Kume Clinic
City
Sakai City
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81722601241
First Name & Middle Initial & Last Name & Degree
Akihiro Kume
Facility Name
Nihonbashi Sakura Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0025
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuichiro Tsunemi
Facility Name
Tachikawa Dermatology Clinic
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0023
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
+81428431377
First Name & Middle Initial & Last Name & Degree
Hideki Ito
Facility Name
The Catholic University of Korea, Incheon St. Mary's Hospital
City
Bupyeong-gu
State/Province
Incheon-gwangyeoksi [Incheon]
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Hyun Cho
Facility Name
Korea University Ansan Hospital
City
Ansan-si
State/Province
Kyǒnggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Wook Son
Facility Name
Chung-Ang University Hospital
City
Dongjak-gu
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06973
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong Jun Seo
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
07441
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHUN WOOK PARK
Facility Name
Cryptex Investigación Clínica S.A. de C.V.
City
Cuauhtémoc, Ciudad De México
State/Province
Distrito Federal
ZIP/Postal Code
06100
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Elizabeth de la Torre
Facility Name
RM Pharma Specialists
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zamira Faride Barragan-Estudillo
Facility Name
Trials in Medicine
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Fernandez
Facility Name
Centro de Atención en Enfermedades Inflamatorias CATEI
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44638
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delfina Guadalupe Villanueva Quintero
Facility Name
Eukarya PharmaSite
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64718
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Garza Gomez
Facility Name
Scientia Investigacion Clinica S.C.
City
Chihuahua
ZIP/Postal Code
31207
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JACQUELINE AGUIRRE SOTELO
Facility Name
Centro de Investigacion Clinica de Oaxaca
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Guadalupe Matus
Facility Name
Centrum Medyczne Evimed
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-625
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
48510175635
First Name & Middle Initial & Last Name & Degree
Monika Slowinska
Facility Name
Medycyna Kliniczna
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Kolinek
Facility Name
Diamond Clinic
City
Krakow
State/Province
Małopolski
ZIP/Postal Code
31-559
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Rewerska
Facility Name
Specderm Poznanska
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-375
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Poznanska
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
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
Recruiting
Facility Contact:
Phone
48426631444
First Name & Middle Initial & Last Name & Degree
Aleksandra Kaszuba
Facility Name
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
90-436
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Narbutt
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:
First Name & Middle Initial & Last Name & Degree
Ji-Chen Ho
Facility Name
Municipal TuCheng Hospital
City
New Taipei City
State/Province
New Taipei
ZIP/Postal Code
236
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
886975366337
First Name & Middle Initial & Last Name & Degree
Chin-Yi Yang
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
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
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Phone
886228757652
First Name & Middle Initial & Last Name & Degree
Chih-Chiang Chen
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
wen hung Chung
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/407540
Description
A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Learn more about this trial
A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
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