Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis

NCT ID: NCT06723405

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-13

Study Completion Date

2025-11-17

Brief Summary

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

Detailed Description

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

Conditions

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Atopic Dermatitis (AD) Eczema Eczema Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intravenous EVO301

Group Type EXPERIMENTAL

EVO301

Intervention Type BIOLOGICAL

Intravenous EVO301

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo

Interventions

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EVO301

Intravenous EVO301

Intervention Type BIOLOGICAL

Placebo

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evommune, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cornerstone Dermatology

Coorparoo, , Australia

Site Status

Momentum Clinical Research Darlinghurst

Darlinghurst, , Australia

Site Status

Pacific Clinical Research Network (PCRN) Auckland

Auckland, , New Zealand

Site Status

Optimal Clinical Trials North

Auckland, , New Zealand

Site Status

Optimal Clinical Trials

Auckland, , New Zealand

Site Status

Pacific Clinical Research Network (PCRN) Christchurch

Christchurch, , New Zealand

Site Status

Momentum Clinical Research Dunedin

Dunedin, , New Zealand

Site Status

Clinical Trials New Zealand Ltd

Hamilton, , New Zealand

Site Status

Momentum Clinical Research Lower Hutt

Hutt Central, , New Zealand

Site Status

Pacific Clinical Research Network (PCRN) Tasman

Nelson, , New Zealand

Site Status

Momentum Clinical Research Kapiti

Paraparaumu, , New Zealand

Site Status

Momentum Clinical Research Pukekohe

Pukekohe, , New Zealand

Site Status

Countries

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Australia New Zealand

Other Identifiers

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EVO301-AD001

Identifier Type: -

Identifier Source: org_study_id

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