A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
NCT ID: NCT05911841
Last Updated: 2025-12-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
234 participants
INTERVENTIONAL
2023-06-21
2025-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
LY3454738
Administered SC
Placebo
Administered SC
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.
LY3454738
Administered SC
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.
LY3454738
Administered SC
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.
LY3454738
Administered SC
Interventions
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LY3454738
Administered SC
Placebo
Administered SC
Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Johnson Dermatology
Fort Smith, Arkansas, United States
Arkansas Research Trials
North Little Rock, Arkansas, United States
Dermatology Research Associates
Los Angeles, California, United States
Encore Medical Research
Hollywood, Florida, United States
Conquest Research
Winter Park, Florida, United States
Allergy and Asthma Specialist
Owensboro, Kentucky, United States
Revival Research Institute, LLC
Troy, Michigan, United States
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, United States
Metropolitan Dermatology - Clark
Kenilworth, New Jersey, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
DermDox Centers for Dermatology
Camp Hill, Pennsylvania, United States
Progressive Clinical Research
San Antonio, Texas, United States
Center for Clinical Studies
Webster, Texas, United States
Rejuvenation Dermatology
Calgary, Alberta, Canada
Rejuvenation Dermatology
Edmonton, Alberta, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
CCA Medical Research
Ajax, Ontario, Canada
Hamilton Allergy
Hamilton, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
FACET Dermatology
Toronto, Ontario, Canada
Alpha Recherche Clinique
Québec, , Canada
Xiangya Hospital Central South University
Changsha, Hunan, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Renmin Hospital of Wuhan University
Wuhan, , China
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy County, Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, Vas County, Hungary
Medmare Bt
Veszprém, Veszprém City, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Yasumoto Dermatology Clinic
Chikushino-shi, Fukuoka, Japan
Takagi Dermatological Clinic
Obihiro-shi, Hokkaido, Japan
Nomura Dermatology Clinic
Yokohama, Kanagawa, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, Japan
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, Japan
Tachikawa Dermatology Clinic
Tachikawa, Tokyo, Japan
Centro de Atención en Enfermedades Inflamatorias CATEI
Guadalajara, Jalisco, Mexico
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, Ciudad de México, Mexico City, Mexico
RM Pharma Specialists
Mexico City, Mexico City, Mexico
Trials in Medicine
Mexico City, Mexico City, Mexico
Eukarya PharmaSite
Monterrey, Nuevo León, Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City, , Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, , Mexico
Diamond Clinic
Krakow, Lesser Poland Voivodeship, Poland
MICS Centrum Medyczne Warszawa
Warsaw, Masovian Voivodeship, Poland
Specderm Poznanska
Bialystok, Podlaskie Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, Poland
"DERMED" Centrum Medyczne Sp. z o.o.
Lodz, Łódź Voivodeship, Poland
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, Poland
The Catholic University of Korea, Incheon St. Mary's Hospital
Bupyeong-gu, Incheon-gwangyeoksi [Incheon], South Korea
Korea University Ansan Hospital
Ansan-si, Kyǒnggi-do, South Korea
Pusan National University Hospital
Busan, Pusan-Kwangyǒkshi, South Korea
Chung-Ang University Hospital
Dongjak-gu, Seoul-teukbyeolsi [Seoul], South Korea
National Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
New Taipei Municipal TuCheng Hospital
New Taipei City, New Taipei, Taiwan
Chung Shan Medical University Hospital
Taichung, Taichung, Taiwan
Tri-Service General Hospital
Taipei City, Taipei, Taiwan
National Taiwan University Hospital - Hsinchu branch
Hsinchu, , Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol: IMMB(b) Protocol
Document Type: Study Protocol: FR01(c) Protocol
Document Type: Statistical Analysis Plan: FR01 Statistical Analysis Plan (Version 3)
Document Type: Statistical Analysis Plan: IMMB Statistical Analysis Plan (Version 1)
Related Links
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A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
Other Identifiers
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NCT07020351
Identifier Type: -
Identifier Source: nct_alias
J4E-MC-FR01
Identifier Type: OTHER
Identifier Source: secondary_id
FR01 ISA
Identifier Type: OTHER
Identifier Source: secondary_id
J4E-MC-IMMB Master Protocol
Identifier Type: OTHER
Identifier Source: secondary_id
2022-502888-38-00
Identifier Type: OTHER
Identifier Source: secondary_id
18569
Identifier Type: -
Identifier Source: org_study_id
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