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

Phase 2

Terminated

• Conditions: Atopic Dermatitis
• Interventions: Drug: LY3454738; Drug: Placebo

• Registration Number: NCT05911841
• Lead Sponsor: Eli Lilly and Company

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-12
• Study Start: 2023-06-21
• Study First Posted: 2023-06-22
• Primary Completion: 2024-10-10
• Study Completion: 2025-03-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 236

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3454738 Dose 1	LY3454738	Participants will receive LY3454738 subcutaneously (SC).
Placebo	Placebo	Participants will receive placebo.
LY3454738 Dose 3	LY3454738	Participants will receive LY3454738 SC.
LY3454738 Dose 2	LY3454738	Participants will receive LY3454738 SC.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75	Week 16

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving SCORing Atopic Dermatitis (SCORAD) 75	Week 16
Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (viGA-AD) of 0 or 1	Week 16
Mean Percent Change from Baseline in EASI	Baseline, Week 16
Percentage of Participants Achieving EASI-75	Week 16
Percentage of Participants Achieving SCORAD-90	Week 16
Pharmacokinetics (PK): Serum Trough Concentrations of LY3454738	Baseline to Week 16
Percentage of Participants Achieving EASI-90	Week 16
Mean Percent Change from Baseline in SCORAD	Baseline, Week 16
Percentage of Participants Achieving EASI-50	Week 16
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

Trial Locations

Locations (65)

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

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