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

Phase 2

Active, not recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: Oral EP262; Drug: Placebo

• Registration Number: NCT06144424
• Lead Sponsor: Escient Pharmaceuticals, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-25
• Study First Submitted: 2023-11-10
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EP262 150 mg	Oral EP262	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of EP262	Measured from Day 1 to End of Study or Early Termination (Up to 10 weeks)	Assessed by the incidence of treatment-emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Effect of EP262 on skin gene expression	Measured from Day 1 to Week 6	Assessed by RNA sequencing of skin biopsy samples
Effect of EP262 on skin histology	Measured from Day 1 to Week 6	Assessed by changes in epidermal thickness and immune cell infiltration from skin biopsy sample

Trial Locations

Locations (10)

Dermatology Specialists of Spokane; 🇺🇸 Spokane, Washington, United States

Indiana Clinical Trials Center; 🇺🇸 Plainfield, Indiana, United States

J&S Studies, Inc.; 🇺🇸 College Station, Texas, United States

Allervie Clinical Research; 🇺🇸 Birmingham, Alabama, United States

Jordan Valley Dermatology Center; 🇺🇸 South Jordan, Utah, United States

Optima Research Boardman; 🇺🇸 Boardman, Ohio, United States

Lawrence J. Green, MD LLC; 🇺🇸 Rockville, Maryland, United States

Revival Research Institute, LLC; 🇺🇸 Troy, Michigan, United States

RM Medical Research, Inc.; 🇺🇸 Miami Lakes, Florida, United States

Innovaderm Research Inc.; 🇨🇦 Montréal, Quebec, Canada