Clinical trial NCT05911841: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-06-22
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving EASI-50
timeFrame: Week 16
measure: Percentage of Participants Achieving EASI-90
timeFrame: Week 16
measure: Percentage of Participants Achieving SCORing Atopic Dermatitis (SCORAD) 75
timeFrame: Week 16
measure: Percentage of Participants Achieving SCORAD-90
timeFrame: Week 16
measure: Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (viGA-AD) of 0 or 1
timeFrame: Week 16
measure: 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
timeFrame: Week 16
measure: Mean Percent Change from Baseline in EASI
timeFrame: Baseline, Week 16
measure: Mean Percent Change from Baseline in SCORAD
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving EASI-75
timeFrame: Week 16
measure: Pharmacokinetics (PK): Serum Trough Concentrations of LY3454738
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Research Trials
state: Arkansas
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Owensboro
country: United States
facility: Allergy and Asthma Specialist
state: Kentucky
city: Troy
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, Inc.
state: New Hampshire
city: Kenilworth
country: United States
facility: Metropolitan Dermatology - Clark
state: New Jersey
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Camp Hill
country: United States
facility: DermDox Centers for Dermatology
state: Pennsylvania
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Calgary
country: Canada
facility: Rejuvenation Dermatology
state: Alberta
city: Edmonton
country: Canada
facility: Rejuvenation Dermatology
state: Alberta
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Ajax
country: Canada
facility: CCA Medical Research
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Allergy
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: FACET Dermatology
state: Ontario
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft
state: Jász-Nagykun-Szolnok
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
state: Somogy
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatokorhaz
state: Vas
city: Veszprém
country: Hungary
facility: Medmare Bt
state: Veszprém City
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Chikushino-city
country: Japan
facility: Yasumoto Dermatology Clinic
state: Fukuoka
city: Obihiro-shi
country: Japan
facility: Takagi Dermatological Clinic
state: Hokkaido
city: Yokohama-city
country: Japan
facility: Nomura Dermatology Clinic
state: Kanagawa
city: Sakai City
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Osaka
city: Chuo-ku
country: Japan
facility: Nihonbashi Sakura Clinic
state: Tokyo
city: Tachikawa
country: Japan
facility: Tachikawa Dermatology Clinic
state: Tokyo
city: Bupyeong-gu
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital
state: Incheon-gwangyeoksi [Incheon]
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan-Kwangyǒkshi
city: Dongjak-gu
country: Korea, Republic of
facility: Chung-Ang University Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: National Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Cuauhtémoc, Ciudad De México
country: Mexico
facility: Cryptex Investigación Clínica S.A. de C.V.
state: Distrito Federal
city: Mexico City
country: Mexico
facility: RM Pharma Specialists
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Trials in Medicine
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro de Atención en Enfermedades Inflamatorias CATEI
state: Jalisco
city: Monterrey
country: Mexico
facility: Eukarya PharmaSite
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Scientia Investigacion Clinica S.C.
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
state: Mazowieckie
city: Krakow
country: Poland
facility: Diamond Clinic
state: Małopolskie
city: Bialystok
country: Poland
facility: Specderm Poznanska
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Lodz
country: Poland
facility: "DERMED" Centrum Medyczne Sp. z o.o.
state: Łódzkie
city: Lodz
country: Poland
facility: Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
state: Łódzkie
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: New Taipei City
country: Taiwan
facility: New Taipei Municipal TuCheng Hospital
state: New Taipei
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
state: Taichung
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
state: Taipei
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital - Hsinchu branch
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: