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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: LY3454738

Study type: Interventional

Funder types: Industry

Identifiers

NCT05911841

18569

FR01 ISA (Other Identifier)

J4E-MC-FR01 (Other Identifier)

2022-502888-38-00 (Other Identifier)

J4E-MC-IMMB Master Protocol (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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260 participants in 4 patient groups, including a placebo group

LY3454738 Dose 1

Experimental group

Description:

Participants will receive LY3454738 subcutaneously (SC).

Treatment:

Drug: LY3454738

LY3454738 Dose 2

Experimental group

Description:

Participants will receive LY3454738 SC.

Treatment:

Drug: LY3454738

LY3454738 Dose 3

Experimental group

Description:

Participants will receive LY3454738 SC.

Treatment:

Drug: LY3454738

Placebo

Placebo Comparator group

Description:

Participants will receive placebo.

Treatment:

Drug: Placebo