Atopic DermatitisPhase 2EASENCT06144424
Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis
A Phase 2 study testing Oral EP262 in people with Atopic Dermatitis, run by Escient Pharmaceuticals, Inc at 10 sites in 2 countries.
Trial summary
This Phase 2a trial will evaluate the effects of EP262 in subjects with atopic dermatitis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Oral EP262
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 25 Oct 2023to 31 Jul 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically confirmed diagnosis of active atopic dermatitis for at least 1 year
- BSA of 3% to 20% and a vIGA-AD score of ≥3
Who cannot join
- Other active skin diseases associated with chronic pruritus
- Clinically infected atopic dermatitis that requires antibiotic therapy
- Use of specific treatments for atopic dermatitis
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Allervie Clinical Research
Birmingham, Alabama, 35209
Optima Research Boardman
Boardman, Ohio, 44512
J&S Studies, Inc.
College Station, Texas, 77845
RM Medical Research, Inc.
Miami Lakes, Florida, 33014
Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Lawrence J. Green, MD LLC
Rockville, Maryland, 20850
Jordan Valley Dermatology Center
South Jordan, Utah, 84095
Dermatology Specialists of Spokane
Spokane, Washington, 99202
Revival Research Institute, LLC
Troy, Michigan, 48084
About this study
Official title: Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis (EASE)
This Phase 2a trial will evaluate the effects of EP262 in subjects with atopic dermatitis
- Conditions
- Atopic Dermatitis
- Being tested
- Oral EP262, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral EP262Drug
Once daily
PlaceboDrug
Once Daily
| Study group | Role | What they receive |
|---|---|---|
| EP262 150 mg | Experimental | Not described Receives: Drug: Oral EP262 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A TEAE is defined as an adverse event (AE) with an onset after the first dose of study drug or an existing event that worsened after the first dose during the study.
Measured: up to Week 10
Number of Participants With Any ≥Grade 3 TEAE
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A TEAE is defined as an adverse event (AE) with an onset after the first dose of study drug or an existing event that worsened after the first dose during the study. AEs were graded for severity using the the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v.5). CTCAE grades were scored as: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life threatening; Grade 5 = death related to the AE.
Measured: up to Week 10
Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs
Clinical meaningfulness was determined by the investigator.
Measured: up to Week 10
Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECGs )
Clinical meaningfulness was determined by the investigator.
Measured: up to Week 10
Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Hematology, Chemistry, or Coagulation Parameters
Clinical meaningfulness was determined by the investigator.
Measured: up to Week 10
Secondary outcomes (1)
Number of Participants With a Change From Baseline to Week 6 in Gene Expression Signature and Skin Histology (Epidermal Thickness, Immune Cell Infiltration, Markers of Epidermal Proliferation) as Assessed From Biopsies of Lesional Skin
Biopsies were taken from lesional and nonlesional skin, and differential gene expression was analyzed by comparing lesional samples at baseline and Week 6 to nonlesional reference samples at baseline. Genes were classified as differentially expressed if they met 2 criteria: an absolute log2 fold change greater than 1.5 and an adjusted p-value less than 0.05 using Wilcoxon signed rank test or paired Students t-test and Bonferroni correction.
Measured: Baseline; Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start25 Oct 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escient Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144424
- Sponsor's protocol ID
- EP-262-202
- Acronym
- EASE
- Status last verified
- Aug 2025
- First submitted
- 10 Nov 2023
- Last updated
- 24 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dehn S, Cooper D, Weyer C, Ferguson B, Srinivasan S, Saint-Cyr Proulx E, Bissonnette R. EP262, an MRGPRX2 Antagonist for the Treatment of Atopic Dermatitis: Results From the Phase 2 Randomized EASE Study. Dermatol Ther (Heidelb). 2026 Aug 21. doi: 10.1007/s13555-026-01883-y. Online ahead of print.
PubMed 42629547
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis (EASE)
- ClinicalTrials.gov ID
- NCT06144424
- Acronym / sponsor ID
- EASE / EP-262-202
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Escient Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Posted 24 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2a trial will evaluate the effects of EP262 in subjects with atopic dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EP262 150 mg | Experimental | Drug: Oral EP262 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically confirmed diagnosis of active atopic dermatitis for at least 1 year
- BSA of 3% to 20% and a vIGA-AD score of ≥3
Key exclusion criteria (3 listed)
- Other active skin diseases associated with chronic pruritus
- Clinically infected atopic dermatitis that requires antibiotic therapy
- Use of specific treatments for atopic dermatitis
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 |
|---|---|---|
| Oral EP262Once daily | Drug | EP262 150 mg |
| PlaceboOnce Daily | Drug | Placebo |
Primary outcome
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: up to Week 10
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A TEAE is defined as an adverse event (AE) with an onset after the first dose of study drug or an existing event that worsened after the first dose during the study.
Number of Participants With Any ≥Grade 3 TEAE
Time frame: up to Week 10
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable or unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A TEAE is defined as an adverse event (AE) with an onset after the first dose of study drug or an existing event that worsened after the first dose during the study. AEs were graded for severity using the the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v.5). CTCAE grades were scored as: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life threatening; Grade 5 = death related to the AE.
Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs
Time frame: up to Week 10
Clinical meaningfulness was determined by the investigator.
Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECGs )
Time frame: up to Week 10
Clinical meaningfulness was determined by the investigator.
Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Hematology, Chemistry, or Coagulation Parameters
Time frame: up to Week 10
Clinical meaningfulness was determined by the investigator.
1 secondary outcome
Number of Participants With a Change From Baseline to Week 6 in Gene Expression Signature and Skin Histology (Epidermal Thickness, Immune Cell Infiltration, Markers of Epidermal Proliferation) as Assessed From Biopsies of Lesional Skin
Time frame: Baseline; Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42629547Dehn S, Cooper D, Weyer C, Ferguson B, Srinivasan S, Saint-Cyr Proulx E, Bissonnette R. EP262, an MRGPRX2 Antagonist for the Treatment of Atopic Dermatitis: Results From the Phase 2 Randomized EASE Study. Dermatol Ther (Heidelb). 2026 Aug 21. doi: 10.1007/s13555-026-01883-y. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
10 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 Oral EP262 in people with Atopic Dermatitis, run by Escient Pharmaceuticals, Inc at 10 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 2 inclusion and 3 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 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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 24 Aug 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?
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) (time frame: up to Week 10). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06144424, which also lists 1 linked publication.
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 24 Aug 2025.