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Completed

NCT Number: NCT06723405

Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis

This is a Phase 2a efficacy and safety study of EVO301 for the treatment of adults with atopic dermatitis.

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Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Eczema Atopic Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cornerstone Dermatology, Coorparoo, Australia

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About this study

This is a Phase 2a efficacy and safety study of intravenous EVO301 in adults with moderate to severe atopic dermatitis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or non-pregnant, non-lactating females, age 18 years or older
  • Chronic atopic dermatitis for at least 6 months
  • BSA of AD involvement of at least 10%
  • EASI score of at least 16.

Exclusion criteria

  • Significant AD flare with 4 weeks
  • Use of biologic therapy within 12 weeks
  • Regular use of tanning booth within 4 weeks
  • Skin condition that could interfere with study assessments

Treatment and study plan

EVO301

Biological

Intravenous EVO301

Placebo

Biological

Placebo

Primary outcomes

  1. Eczema Area and Severity Index (EASI)

    Time frame: 12 weeks

    EASI assesses the extent and severity of atopic dermatitis. EASI is a composite index with scores ranging from 0 to 72. Higher values indicate more severe or extensive disease.

Secondary outcomes

  1. Investigator Global Assessment (IGA)

    Time frame: 12 weeks

    The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale [0 (clear) to 4 (severe)].

  2. Body Surface Area (BSA)

    Time frame: 12 weeks

    BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area.

  3. Pruritus-NRS

    Time frame: 12 weeks

    The pruritus-NRS is an 11-point scale used by subjects to rate their worst itch severity over the past 24 hours with 0 indicating "no itch" and 10 indicating "worst itch imaginable".

Sponsors and collaborators

Lead sponsor

Evommune, Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study of EVO301 in Adults With Atopic Dermatitis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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