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

JRCT ID: jRCT2031230201

Registered date:01/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 25/09/2023
• Target sample size: 260
• Countries of recruitment: Canada,Japan,China,Japan,Hungary,Japan,Italy,Japan,Korea,Japan,Republic of Mexico,Japan,Poland,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: LY3454738
Administered SC
Drug: Placebo
Administered SC

[Study Arms]
Experimental: LY3454738 Dose 1
Participants will receive LY3454738 subcutaneously (SC).
Intervention: Drug: LY3454738
Experimental: LY3454738 Dose 2
Participants will receive LY3454738 SC.
Intervention: Drug: LY3454738
Experimental: LY3454738 Dose 3
Participants will receive LY3454738 SC.
Intervention: Drug: LY3454738
Placebo Comparator: Placebo
Participants will receive placebo.
Intervention: Drug: Placebo

Outcome(s)

• Primary Outcome: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75 [ Time Frame: Week 16 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 70age old
• Gender: Both

Include 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.

Exclude 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 Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05911841