Atopic Dermatitis EczemaPhase 2NCT05579899
Safety and Efficacy Study of EVO101 Topical Cream in Atopic Dermatitis
A Phase 2 study testing EVO101 in people with Atopic Dermatitis Eczema, run by Evommune, Inc. at 21 sites in United States.
Trial summary
This is a Phase 2a safety and efficacy study of EVO101 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 Eczema
- What is being tested?
- EVO101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 21 sitesUnited States
- Study dates
- 27 Sep 2022to 27 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year
- IGA score of 2 or 3
- BSA of AD involvement of 4-12%
- EASI of 5-20
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
21 sites in 1 country.
21 sites in 1 country
United States21 sites
DermResearch
Austin, Texas, 78759
J&S Studies, Inc
College Station, Texas, 77845
Driven Research, LLC
Coral Gables, Florida, 33134
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Clinical Trials Institute of Northwest Arkansas
Fayetteville, Arkansas, 72703
Dermatology Consulting Services, PLLC
High Point, North Carolina, 27262
Center for Clinical Studies, Ltd LLC
Houston, Texas, 77004
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46250
JDR Dermatology Research, LLC
Las Vegas, Nevada, 89148
Metropolis Dermatology
Los Angeles, California, 90017
Dermatology Research Associate
Los Angeles, California, 90045
Dermatologists of Southwest Ohio
Mason, Ohio, 45040
Lenus Research and Medical Group
Miami, Florida, 33172
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112
Pariser Dermatology Specialists
Norfolk, Virginia, 23502
SkinSpecialists, LLC
Omaha, Nebraska, 69144
Saguaro Dermatology
Phoenix, Arizona, 85008
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Oregon Medical Research Center
Portland, Oregon, 97223
Northwest AR Clinical Trials Center, PLLC
Rogers, Arkansas, 72758
Clinical Science Institute
Santa Monica, California, 90404
About this study
Official title: A Randomized, Vehicle-controlled, Safety and Efficacy Study of EVO101 in Adult Subjects With Atopic Dermatitis
This is a Phase 2a safety and efficacy study of EVO101 for the treatment of adults with atopic dermatitis
Read the detailed description
This is a Phase 2a safety and efficacy study of EVO101 Topical Cream, 0.1%, applied twice daily for 8 weeks in adults with mild-to moderate atopic dermatitis.
- Conditions
- Atopic Dermatitis Eczema
- Being tested
- EVO101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVO101Drug
Topical Cream
| Study group | Role | What they receive |
|---|---|---|
| EVO101 Cream | Experimental | Active Treatment, BID, 8 weeks Receives: Drug: EVO101 |
| Vehicle Cream | Placebo comparator | Vehicle Treatment, BID, 8 weeks Receives: Drug: EVO101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8
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: 8 weeks
Secondary outcomes (3)
Investigator Global Assessment (IGA) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8)
The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale [0 (clear) to 4 (severe)]. The outcome measures is reported as the number of participants achieving a reduction of 2 or greater on the IGA from baseline to Week 8.
Measured: 8 weeks
Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8
BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area. The outcome measure describes the mean change from baseline in percent of the body surface area affected by AD.
Measured: 8 weeks
Pruritus-NRS, Change From Baseline to Week 8
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: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start27 Sep 2022
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic Dermatitis EczemaStudies 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
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evommune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugene Bauer, MD, Study director, Evommune, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579899
- Sponsor's protocol ID
- EVO101-AD001
- Status last verified
- Feb 2025
- First submitted
- 11 Oct 2022
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results published, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Vehicle-controlled, Safety and Efficacy Study of EVO101 in Adult Subjects With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05579899
- Acronym / sponsor ID
- EVO101-AD001
- Conditions
- Atopic Dermatitis Eczema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Evommune, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Posted 5 Mar 2025
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 safety and efficacy study of EVO101 for the treatment of adults with atopic dermatitis
Detailed description
This is a Phase 2a safety and efficacy study of EVO101 Topical Cream, 0.1%, applied twice daily for 8 weeks in adults with mild-to moderate 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 |
|---|---|---|
| EVO101 Cream | Experimental | Drug: EVO101Active Treatment, BID, 8 weeks |
| Vehicle Cream | Placebo comparator | Drug: EVO101Vehicle Treatment, BID, 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or non-pregnant, non-lactating females, age 18 years or older
- Chronic atopic dermatitis for at least 1 year
- IGA score of 2 or 3
- BSA of AD involvement of 4-12%
- EASI of 5-20
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 |
|---|---|---|
| EVO101Topical Cream | Drug | EVO101 Cream, Vehicle Cream |
Primary outcome
Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8
Time frame: 8 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) Response (Number of Participants With >= 2 Points Change From Baseline to Week 8)
Time frame: 8 weeks
Percent Body Surface Area (BSA) Affected by Atopic Dermatitis Over Time, Change From Baseline to Week 8
Time frame: 8 weeks
Pruritus-NRS, Change From Baseline to Week 8
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results published, after deidentification (text, tables, figures, and appendices)
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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.
Eugene Bauer, MD study director
Evommune, Inc.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EVO101 in people with Atopic Dermatitis Eczema, run by Evommune, Inc. at 21 sites in United States.
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 5 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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. 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?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Eczema Area and Severity Index (EASI) From Baseline to Week 8 (time frame: 8 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 5 Mar 2025.