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

NCT06144424 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EP-262-202
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 10

Brief Summary

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• 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

  Baseline; Week 6

Study Arms (2)

EP262 150 mg

EXPERIMENTAL

Drug: Oral EP262

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oral EP262 DRUG

Once daily

EP262 150 mg

Placebo DRUG

Once Daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically confirmed diagnosis of active atopic dermatitis for at least 1 year
• BSA of 3% to 20% and a vIGA-AD score of ≥3

You may not qualify if:

• Other active skin diseases associated with chronic pruritus
• Clinically infected atopic dermatitis that requires antibiotic therapy
• Use of specific treatments for atopic dermatitis

Sponsors & Collaborators

• Escient Pharmaceuticals, Inc: lead

Study Sites (10)

Allervie Clinical Research

Birmingham, Alabama, 35209, United States

Location

RM Medical Research, Inc.

Miami Lakes, Florida, 33014, United States

Location

Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Lawrence J. Green, MD LLC

Rockville, Maryland, 20850, United States

Location

Revival Research Institute, LLC

Troy, Michigan, 48084, United States

Location

Optima Research Boardman

Boardman, Ohio, 44512, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

Jordan Valley Dermatology Center

South Jordan, Utah, 84095, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 22, 2023
• Study Start: October 25, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 24, 2025
• Results First Posted: August 24, 2025

Record last verified: 2025-08

Locations

US (9); CA (1)