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
Status: Terminated
Location: See all (66) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Johnson Dermatology
Fort Smith
Arkansas Research Trials
North Little Rock
California
Dermatology Research Associates
Los Angeles
Florida
Encore Medical Research
Hollywood
Conquest Research
Winter Park
Kentucky
Allergy and Asthma Specialist
Owensboro
Michigan
Revival Research Institute, LLC
Troy
New Hampshire
ActivMed Practices & Research, Inc.
Portsmouth
New Jersey
Metropolitan Dermatology - Clark
Kenilworth
Oregon
Oregon Dermatology and Research Center
Portland
Pennsylvania
DermDox Centers for Dermatology
Camp Hill
Texas
Progressive Clinical Research
San Antonio
Center for Clinical Studies
Webster
Other Locations
Canada
CCA Medical Research
Ajax
Rejuvenation Dermatology
Calgary
Rejuvenation Dermatology
Edmonton
Hamilton Allergy
Hamilton
Lynderm Research Inc.
Markham
Alpha Recherche Clinique
Québec
FACET Dermatology
Toronto
Wiseman Dermatology Research Inc.
Winnipeg
China
Xiangya Hospital Central South University
Changsha
Zhejiang Provincial People's Hospital
Hangzhou
Huashan Hospital, Fudan University
Shanghai
Renmin Hospital of Wuhan University
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Affiliated Hospital of Jiangsu University
Zhenjiang
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár
Allergo-Derm Bakos Kft
Szolnok
Markusovszky Egyetemi Oktatokorhaz
Szombathely
Medmare Bt
Veszprém
Japan
Yasumoto Dermatology Clinic
Chikushino-shi
Nihonbashi Sakura Clinic
Chuo-ku
Takagi Dermatological Clinic
Obihiro-shi
Dermatology and Ophthalmology Kume Clinic
Sakai
Tachikawa Dermatology Clinic
Tachikawa
Nomura Dermatology Clinic
Yokohama
Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Ciudad De México
Centro de Atención en Enfermedades Inflamatorias CATEI
Guadalajara
RM Pharma Specialists
Mexico City
Trials in Medicine
Mexico City
Eukarya PharmaSite
Monterrey
Centro de Investigacion Clinica de Oaxaca
Oaxaca City
Poland
Specderm Poznanska
Bialystok
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk
Diamond Clinic
Krakow
DERMED Centrum Medyczne Sp. z o.o.
Lodz
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz
MICS Centrum Medyczne Warszawa
Warsaw
Republic of Korea
Korea University Ansan Hospital
Ansan-si
The Catholic University of Korea, Incheon St. Mary's Hospital
Bupyeong-gu
Pusan National University Hospital
Busan
Chung-Ang University Hospital
Dongjak-gu
Hallym University Kangnam Sacred Heart Hospital
Seoul
National Medical Center
Seoul
Taiwan
National Taiwan University Hospital - Hsinchu branch
Hsinchu
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist
New Taipei Municipal TuCheng Hospital
New Taipei City
Taipei Medical University Shuang Ho Hospital
New Taipei City
Chung Shan Medical University Hospital
Taichung
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei City
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District
Time Frame
Start Date: 2023-06-21
Completion Date: 2025-03-14
Participants
Target number of participants: 234
Treatments
Placebo_comparator: Placebo
Participants received placebo administered subcutaneously (SC) every two weeks (Q2W) from baseline to Week 14. Week 16 responders entered maintenance period and received placebo SC every four weeks (Q4W) until Week 40. Week 16 non-responders entered escape arm and received 800 milligrams (mg) of LY3454738 administered SC Q4W until Week 40.
Experimental: 75 mg LY3454738
Participants received 75 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and received 150 mg of LY3454738 administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.
Experimental: 300 mg LY3454738
Participants received 300 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and continued receiving 300 mg of LY3454738 administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.
Experimental: 800 mg LY3454738
Participants received 800 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and were re-randomized to either receive 800 mg of LY3454738 or placebo administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company