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Protocol NumberJ4E-MC-IMMB/ISA：J4E-MC-FR01
Completed

2023-07-31 - 2026-05-27

Phase II

Recruiting8

ICD-10L22

Diaper dermatitis

ICD-9691.0

Diaper or napkin rash

Master Protocol Title: A Master Protocol for Randomized, Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Adults with Moderate-to-Severe Atopic Dermatitis ISA 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

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

    Eli Lilly and Company

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 邱顯鎰 Division of Dermatology
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴柏如 Division of Dermatology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Yu Chu Division of Dermatology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳奕先 Division of Dermatology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 何宜承 Division of Dermatology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Chiang Chen Division of Dermatology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Hung Chung Division of Dermatology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Woan-Ruoh Lee
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

f Adults with Moderate-to-Severe Atopic Dermatitis

Objectives

To compare the efficacy of LY3454738 versus placebo as measured by EASI-75 in the treatment of biologic-and-small-molecule-naive participants with moderate-to-severe AD

Test Drug

N/A

Active Ingredient

LY3454738

Dosage Form

N/A

Dosage

300 mg/2 mL

Endpoints

Proportion of participants achieving EASI-75 at
Week 16

Inclution Criteria

Are from 18 to 70 years of age (inclusive) at the time of signing the ICF(s).

Exclusion Criteria

Have, in the screening period (Visit 0), any of the skin conditions, infections,
or medical conditions listed in Section 5.2 of the master IMMB protocol.

The Estimated Number of Participants

  • Taiwan

    14 participants

  • Global

    260 participants

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