A Master Protocol of Multiple Interventions for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis.

Phase 2

Terminated

• Conditions: Atopic Dermatitis
• Interventions: Drug: LY3454738

• Registration Number: NCT07020351
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This platform trial is designed to enable the investigation of many interventions for AD by means of the introduction of new interventional specific addenda (ISAs) over time. At the inception of this platform trial, at least 1 ISA will be available. Additional ISAs will be added to the platform trial over time.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-21
• Primary Completion: 2024-10-10
• Study Completion: 2024-12-03
• Status Verified: 2025-06
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 317

Inclusion Criteria

• Present with a diagnosis of atopic dermatitis (AD) at least 12 months prior to screening

  • Eczema Area and Severity Index (EASI) score ≥12
  • Validated Investigator Global Assessment AD (vIGA-AD) score ≥3
  • ≥10% of BSA involvement (per EASI BSA)

• Are candidates for systemic therapy, and have a history, documented by a physician and/or the investigator, of inadequate response to existing topical medications within 6 months preceding screening.

Exclusion Criteria

• Have a history of eczema herpeticum:

  • any episode within 12 months prior to screening, or
  • 2 or more episodes during lifetime

• Are currently experiencing or have a history of concomitant skin conditions other than AD, for example, psoriasis or cutaneous lupus, that, in the opinion of the investigator, would interfere with evaluations of the effect of study intervention on AD.

• Are currently experiencing or have a history of erythrodermic, refractory, or unstable skin disease which requires frequent hospitalizations or IV treatment and, in the opinion of the investigator, could interfere with study participation

• Are currently experiencing a skin infection that requires treatment with, or is currently being treated with, topical or systemic antibiotics.

Note: Participants who fail screening due to this criterion should not be rescreened until at least 4 weeks after screen failure and at least 2 weeks after resolution of the infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY FR01 ISA LY3454738	LY3454738	Participants are assigned to the LY3454738 ISA.

Primary Outcome Measures

Name	Time	Method
Number of Participants Allocated to FR01 ISA	Screening to Randomization (Up to 90 Days)

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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