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EP262 for Eczema (EASE Trial)
Phase 2
Waitlist Available
Research Sponsored by Escient Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinically confirmed diagnosis of active atopic dermatitis for at least 1 year
BSA of 3% to 20% and a vIGA-AD score of ≥3
Must not have
Use of specific treatments for atopic dermatitis
Clinically infected atopic dermatitis that requires antibiotic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured from day 1 to end of study or early termination (up to 10 weeks)
Summary
This trial will test a new treatment called EP262 to see if it can help people with atopic dermatitis by reducing their symptoms.
Who is the study for?
This trial is for people with atopic dermatitis (eczema) covering 3-20% of their body and a moderate to severe score on a skin assessment. They must have had eczema for at least one year but can't join if they need antibiotics for an infection or have other itchy skin diseases.
What is being tested?
The study tests EP262, an oral medication, against a placebo (a pill without active medicine). Participants won't know which one they're taking. The goal is to see how safe EP262 is and how it affects the body in those with eczema.
What are the potential side effects?
Possible side effects are not detailed here, but generally could include reactions related to the immune system since EP262 targets atopic dermatitis, which involves immune dysregulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with active atopic dermatitis for over a year.
Select...
My skin condition affects 3% to 20% of my body and is moderately severe.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am using specific treatments for my eczema.
Select...
I have a skin condition needing antibiotics.
Select...
I have a skin condition that causes long-term itching.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured from day 1 to end of study or early termination (up to 10 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured from day 1 to end of study or early termination (up to 10 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and tolerability of EP262
Secondary study objectives
Effect of EP262 on skin gene expression
Effect of EP262 on skin histology
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EP262 150 mgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral EP262
2023
Completed Phase 2
~40
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Atopic Dermatitis (AD) include topical corticosteroids, calcineurin inhibitors (like tacrolimus and pimecrolimus), and biologics such as dupilumab. Topical corticosteroids reduce inflammation by inhibiting multiple inflammatory cytokines.
Calcineurin inhibitors block T-cell activation, thereby reducing the immune response that contributes to AD. Dupilumab, a monoclonal antibody, targets the IL-4 and IL-13 pathways, which are crucial in the inflammatory process of AD.
These treatments are essential for AD patients as they help to control the chronic inflammation and immune dysregulation that characterize the disease, thereby reducing symptoms and improving quality of life.
Recent developments in atopic dermatitis.
Recent developments in atopic dermatitis.
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Who is running the clinical trial?
Escient Pharmaceuticals, IncLead Sponsor
5 Previous Clinical Trials
348 Total Patients Enrolled