Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06723405

Enrollment

Registered

2024-12-09

Start date

2025-02-13

Completion date

2025-11-17

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis (AD), Eczema, Eczema Atopic Dermatitis

Keywords

atopic dermatitis, eczema

Brief summary

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

Detailed description

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

Interventions

BIOLOGICALEVO301

Intravenous EVO301

BIOLOGICALPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Males or non-pregnant, non-lactating females, age 18 years or older 2. Chronic atopic dermatitis for at least 6 months 3. BSA of AD involvement of at least 10% 4. EASI score of at least 16.

Exclusion criteria

1. Significant AD flare with 4 weeks 2. Use of biologic therapy within 12 weeks 3. Regular use of tanning booth within 4 weeks 4. Skin condition that could interfere with study assessments

Design outcomes

Primary

Measure	Time frame	Description
Eczema Area and Severity Index (EASI)	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

Measure	Time frame	Description
Investigator Global Assessment (IGA)	12 weeks	The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale \[0 (clear) to 4 (severe)\].
Body Surface Area (BSA)	12 weeks	BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area.
Pruritus-NRS	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.

Countries

Australia, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026