A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911841
• Other study ID #: 18569
• Secondary ID: J4E-MC-FR01FR01
• Status: Recruiting
• Phase: Phase 2
• Start date: June 21, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: May 1, 2025
• Est. primary completion date: September 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• LY3454738
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Canada	CCA Medical Research	Ajax	Ontario
Canada	Rejuvenation Dermatology	Calgary	Alberta
Canada	Rejuvenation Dermatology	Edmonton	Alberta
Canada	Hamilton Allergy	Hamilton	Ontario
Canada	Lynderm Research Inc.	Markham	Ontario
Canada	Alpha Recherche Clinique	Quebec
Canada	FACET Dermatology	Toronto	Ontario
Canada	Wiseman Dermatology Research Inc.	Winnipeg	Manitoba
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Huashan Hospital Affiliated Fudan University	Shanghai	Shanghai
China	Renmin Hospital of Wuhan University	Wuhan
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvár	Somogy
Hungary	Allergo-Derm Bakos Kft	Szolnok	Jász-Nagykun-Szolnok
Hungary	Markusovszky Egyetemi Oktatokorhaz	Szombathely	Vas
Hungary	Medmare Bt	Veszprém	Veszprém City
Japan	Yasumoto Dermatology Clinic	Chikushino-city	Fukuoka
Japan	Takagi Dermatology	Obihiro-shi	Hokkaido
Japan	Kume Clinic	Sakai City	Osaka
Japan	Tachikawa Dermatology Clinic	Tachikawa	Tokyo
Japan	Nomura Dermatology Clinic	Yokohama-city	Kanagawa
Korea, Republic of	The Catholic University of Korea, Incheon St. Mary's Hospital	Bupyeong-gu	Incheon-gwangyeoksi [Incheon]
Korea, Republic of	Chung-Ang University Hospital	Dongjak-gu	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	National Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Mexico	Scientia Investigacion Clinica S.C.	Chihuahua
Mexico	Cryptex Investigación Clínica S.A. de C.V.	Cuauhtémoc, Ciudad De México	Distrito Federal
Mexico	Centro de Atención en Enfermedades Inflamatorias CATEI	Guadalajara	Jalisco
Mexico	Hospital de Jesús Nazareno	Mexico City	Distrito Federal
Mexico	RM Pharma Specialists	Mexico City	Distrito Federal
Mexico	Trials in Medicine	Mexico City	Distrito Federal
Mexico	Eukarya PharmaSite	Monterrey	Nuevo León
Mexico	Centro de Investigacion Clinica de Oaxaca	Oaxaca
Poland	Specderm Poznanska	Bialystok	Podlaskie
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie
Poland	Diamond Clinic	Krakow	Malopolski
Poland	DERMED Centrum Medyczne Sp. z o.o.	Lodz	Lódzkie
Poland	Dermoklinika - Centrum Medyczne spólka cywilna M. Kierstan, J. Narbutt, A. Lesiak	Lodz	Lódzkie
Poland	Centrum Medyczne Evimed	Warsaw	Mazowieckie
Poland	Medycyna Kliniczna	Warszawa	Mazowieckie
Taiwan	National Taiwan University Hospital - Hsinchu branch	Hsinchu
Taiwan	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung Niao Sung Dist	Kaohsiung
Taiwan	Taipei Medical University Shuang Ho Hospital	New Taipei
Taiwan	New Taipei Municipal TuCheng Hospital	New Taipei City	New Taipei
Taiwan	Chung Shan Medical University Hospital	Taichung City	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City
Taiwan	Tri-Service General Hospital	Taipei City	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan
United States	DermDox Centers for Dermatology	Camp Hill	Pennsylvania
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	Encore Medical Research	Hollywood	Florida
United States	Metropolitan Dermatology - Clark	Kenilworth	New Jersey
United States	Dermatology Research Associates	Los Angeles	California
United States	Arkansas Research Trials	North Little Rock	Arkansas
United States	Allergy and Asthma Specialist	Owensboro	Kentucky
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	ActivMed Practices & Research, Inc.	Portsmouth	New Hampshire
United States	Progressive Clinical Research	San Antonio	Texas
United States	Revival Research Institute - Troy	Troy	Michigan
United States	Center for Clinical Studies, LTD.LLP	Webster	Texas
United States	Conquest Research	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  China,  Hungary,  Japan,  Korea, Republic of,  Mexico,  Poland,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75		Week 16
Secondary	Percentage of Participants Achieving EASI-50		Week 16
Secondary	Percentage of Participants Achieving EASI-90		Week 16
Secondary	Percentage of Participants Achieving SCORing Atopic Dermatitis (SCORAD) 75		Week 16
Secondary	Percentage of Participants Achieving SCORAD-90		Week 16
Secondary	Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (viGA-AD) of 0 or 1		Week 16
Secondary	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		Week 16
Secondary	Mean Percent Change from Baseline in EASI		Baseline, Week 16
Secondary	Mean Percent Change from Baseline in SCORAD		Baseline, Week 16
Secondary	Pharmacokinetics (PK): Serum Trough Concentrations of LY3454738		Baseline to Week 16

External Links

•   A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis