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NCT06144424 Clinical Trial

Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— EASE  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06144424
Other study ID # EP-262-202
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 25, 2023
Est. completion date October 2024

Study information
Verified date May 2024
Source Escient Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase 2a trial will evaluate the effects of EP262 in subjects with atopic dermatitis

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date October 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Clinically confirmed diagnosis of active atopic dermatitis for at least 1 year - BSA of 3% to 20% and a vIGA-AD score of =3 Exclusion Criteria: - Other active skin diseases associated with chronic pruritus - Clinically infected atopic dermatitis that requires antibiotic therapy - Use of specific treatments for atopic dermatitis

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oral EP262
Once daily
• Placebo
Once Daily

Locations
Country Name City State
Canada Innovaderm Research Inc. Montréal Quebec
United States Allervie Clinical Research Birmingham Alabama
United States Optima Research Boardman Boardman Ohio
United States J&S Studies, Inc. College Station Texas
United States RM Medical Research, Inc. Miami Lakes Florida
United States Indiana Clinical Trials Center Plainfield Indiana
United States Lawrence J. Green, MD LLC Rockville Maryland
United States Jordan Valley Dermatology Center South Jordan Utah
United States Dermatology Specialists of Spokane Spokane Washington
United States Revival Research Institute, LLC Troy Michigan

Sponsors (1)
Lead Sponsor Collaborator
Escient Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of EP262 Assessed by the incidence of treatment-emergent adverse events Measured from Day 1 to End of Study or Early Termination (Up to 10 weeks)
Secondary Effect of EP262 on skin histology Assessed by changes in epidermal thickness and immune cell infiltration from skin biopsy sample Measured from Day 1 to Week 6
Secondary Effect of EP262 on skin gene expression Assessed by RNA sequencing of skin biopsy samples Measured from Day 1 to Week 6
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