Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis

NCT06723405 | Completed Phase 2

• 1 other identifier: EVO301-AD001
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 12

Brief Summary

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

Conditions

Atopic Dermatitis (AD); Eczema; Eczema Atopic Dermatitis

Keywords

atopic dermatitis; eczema

Outcome Measures

Primary Outcomes (1)

• Eczema Area and Severity Index (EASI)

  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.

  12 weeks

Secondary Outcomes (3)

• Investigator Global Assessment (IGA)

  12 weeks

• Body Surface Area (BSA)

  12 weeks

• Pruritus-NRS

  12 weeks

Study Arms (2)

Intravenous EVO301

EXPERIMENTAL

Biological: EVO301

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

EVO301 BIOLOGICAL

Intravenous EVO301

Intravenous EVO301

Placebo BIOLOGICAL

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Evommune, Inc.: lead

Study Sites (12)

Cornerstone Dermatology

Coorparoo, QLD 4151, Australia

Location

Momentum Clinical Research Darlinghurst

Darlinghurst, NSW 2010, Australia

Location

Pacific Clinical Research Network (PCRN) Auckland

Auckland, 0622, New Zealand

Location

Optimal Clinical Trials North

Auckland, 0632, New Zealand

Location

Optimal Clinical Trials

Auckland, 1010, New Zealand

Location

Pacific Clinical Research Network (PCRN) Christchurch

Christchurch, 8013, New Zealand

Location

Momentum Clinical Research Dunedin

Dunedin, 9016, New Zealand

Location

Clinical Trials New Zealand Ltd

Hamilton, 3204, New Zealand

Location

Momentum Clinical Research Lower Hutt

Hutt Central, 5010, New Zealand

Location

Pacific Clinical Research Network (PCRN) Tasman

Nelson, 7011, New Zealand

Location

Momentum Clinical Research Kapiti

Paraparaumu, 5032, New Zealand

Location

Momentum Clinical Research Pukekohe

Pukekohe, 2120, New Zealand

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: February 13, 2025
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

AU (2); NZ (10)