Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis

December 2, 2025 updated by: Evommune, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Coorparoo, Australia, QLD 4151
        • Cornerstone Dermatology
      • Darlinghurst, Australia, NSW 2010
        • Momentum Clinical Research Darlinghurst
  • New Zealand
      • Auckland, New Zealand, 1010
        • Optimal Clinical Trials
      • Auckland, New Zealand, 0632
        • Optimal Clinical Trials North
      • Auckland, New Zealand, 0622
        • Pacific Clinical Research Network (PCRN) Auckland
      • Christchurch, New Zealand, 8013
        • Pacific Clinical Research Network (PCRN) Christchurch
      • Dunedin, New Zealand, 9016
        • Momentum Clinical Research Dunedin
      • Hamilton, New Zealand, 3204
        • Clinical Trials New Zealand Ltd
      • Hutt Central, New Zealand, 5010
        • Momentum Clinical Research Lower Hutt
      • Nelson, New Zealand, 7011
        • Pacific Clinical Research Network (PCRN) Tasman
      • Paraparaumu, New Zealand, 5032
        • Momentum Clinical Research Kapiti
      • Pukekohe, New Zealand, 2120
        • Momentum Clinical Research Pukekohe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Placebo
Placebo
Experimental: Intravenous EVO301
Biological: EVO301
Intravenous EVO301

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)].
12 weeks
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.
12 weeks
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".
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evommune, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2025

Primary Completion (Actual)

November 17, 2025

Study Completion (Actual)

November 17, 2025

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVO301-AD001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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