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

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

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Oral EP262

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Allervie Clinical Research
  • Florida
    • Miami Lakes, Florida, United States, 33014
      • RM Medical Research, Inc.
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Indiana Clinical Trials Center
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Lawrence J. Green, MD LLC
  • Michigan
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, LLC
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Optima Research Boardman
  • Texas
    • College Station, Texas, United States, 77845
      • J&S Studies, Inc.
  • Utah
    • South Jordan, Utah, United States, 84095
      • Jordan Valley Dermatology Center
  • Washington
    • Spokane, Washington, United States, 99202
      • Dermatology Specialists of Spokane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Once Daily
Experimental: EP262 150 mg	Drug: Oral EP262; Once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	up to Week 10
Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs	Clinical meaningfulness was determined by the investigator.	up to Week 10
Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECGs )	Clinical meaningfulness was determined by the investigator.	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.	up to Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline; Week 6

Collaborators and Investigators

• Sponsor: Escient Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: EP-262-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No