Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis

Phase 2

Recruiting

• Conditions: Atopic Dermatitis (AD); Eczema; Eczema Atopic Dermatitis
• Interventions: Biological: EVO301; Biological: Placebo

• Registration Number: NCT06723405
• Lead Sponsor: Evommune, Inc.

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.

Study Timeline

• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-09
• Status Verified: 2025-02
• Study Start: 2025-02-13
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous EVO301	EVO301	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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".

Trial Locations

Locations (12)

Cornerstone Dermatology; 🇦🇺 Coorparoo, Australia

Momentum Clinical Research Darlinghurst; 🇦🇺 Darlinghurst, Australia

Pacific Clinical Research Network (PCRN) Auckland; 🇳🇿 Auckland, New Zealand

Optimal Clinical Trials North; 🇳🇿 Auckland, New Zealand

Optimal Clinical Trials; 🇳🇿 Auckland, New Zealand

Pacific Clinical Research Network (PCRN) Christchurch; 🇳🇿 Christchurch, New Zealand

Momentum Clinical Research Dunedin; 🇳🇿 Dunedin, New Zealand

Clinical Trials New Zealand Ltd; 🇳🇿 Hamilton, New Zealand

Momentum Clinical Research Lower Hutt; 🇳🇿 Hutt Central, New Zealand

Pacific Clinical Research Network (PCRN) Tasman; 🇳🇿 Nelson, New Zealand

Momentum Clinical Research Kapiti; 🇳🇿 Paraparaumu, New Zealand

Momentum Clinical Research Pukekohe; 🇳🇿 Pukekohe, New Zealand