Atopic Dermatitis (AD)Phase 2NCT06723405
Efficacy Study of EVO301 in Moderate to Severe Atopic Dermatitis
A Phase 2 study testing EVO301 in people with Atopic Dermatitis (AD) and Eczema, run by Evommune, Inc. at 12 sites in 2 countries.
Trial summary
This is a Phase 2a efficacy and safety study of EVO301 for the treatment of adults with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis (AD), Eczema, Eczema Atopic Dermatitis
- What is being tested?
- EVO301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 13 Feb 2025to 17 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
New Zealand10 sites
Pacific Clinical Research Network (PCRN) Auckland
Auckland, 0622
Optimal Clinical Trials North
Auckland, 0632
Optimal Clinical Trials
Auckland, 1010
Pacific Clinical Research Network (PCRN) Christchurch
Christchurch, 8013
Momentum Clinical Research Dunedin
Dunedin, 9016
Clinical Trials New Zealand Ltd
Hamilton, 3204
Momentum Clinical Research Lower Hutt
Hutt Central, 5010
Pacific Clinical Research Network (PCRN) Tasman
Nelson, 7011
Momentum Clinical Research Kapiti
Paraparaumu, 5032
Momentum Clinical Research Pukekohe
Pukekohe, 2120
Australia2 sites
Cornerstone Dermatology
Coorparoo, QLD 4151
Momentum Clinical Research Darlinghurst
Darlinghurst, NSW 2010
About this study
Official title: 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.
Read the detailed description
This is a Phase 2a efficacy and safety study of intravenous EVO301 in adults with moderate to severe atopic dermatitis.
- Conditions
- Atopic Dermatitis (AD), Eczema, Eczema Atopic Dermatitis
- Being tested
- EVO301, Placebo
- Keywords
- atopic dermatitis, eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVO301Biological
Intravenous EVO301
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intravenous EVO301 | Experimental | Not described Receives: Biological: EVO301 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
Investigator Global Assessment (IGA)
The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale [0 (clear) to 4 (severe)].
Measured: 12 weeks
Body Surface Area (BSA)
BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area.
Measured: 12 weeks
Pruritus-NRS
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".
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start13 Feb 2025
- Primary completion17 Nov 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evommune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723405
- Sponsor's protocol ID
- EVO301-AD001
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study of EVO301 in Adults With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06723405
- Acronym / sponsor ID
- EVO301-AD001
- Conditions
- Atopic Dermatitis (AD), Eczema, Eczema Atopic Dermatitis
- Keywords
- atopic dermatitis, eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Evommune, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous EVO301 | Experimental | Biological: EVO301 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVO301Intravenous EVO301 | Biological | Intravenous EVO301 |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
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.
3 secondary outcomes
Investigator Global Assessment (IGA)
Time frame: 12 weeks
Body Surface Area (BSA)
Time frame: 12 weeks
Pruritus-NRS
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EVO301 in people with Atopic Dermatitis (AD) and Eczema, run by Evommune, Inc. at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity Index (EASI) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.