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

NCT ID: NCT06144424

Last Updated: 2025-08-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2024-07-31

Brief Summary

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

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EP262 150 mg

Group Type EXPERIMENTAL

Oral EP262

Intervention Type DRUG

Once daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once Daily

Interventions

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Oral EP262

Once daily

Intervention Type DRUG

Placebo

Once Daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Escient Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Allervie Clinical Research

Birmingham, Alabama, United States

Site Status

RM Medical Research, Inc.

Miami Lakes, Florida, United States

Site Status

Indiana Clinical Trials Center

Plainfield, Indiana, United States

Site Status

Lawrence J. Green, MD LLC

Rockville, Maryland, United States

Site Status

Revival Research Institute, LLC

Troy, Michigan, United States

Site Status

Optima Research Boardman

Boardman, Ohio, United States

Site Status

J&S Studies, Inc.

College Station, Texas, United States

Site Status

Jordan Valley Dermatology Center

South Jordan, Utah, United States

Site Status

Dermatology Specialists of Spokane

Spokane, Washington, United States

Site Status

Innovaderm Research Inc.

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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EP-262-202

Identifier Type: -

Identifier Source: org_study_id

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