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

Phase 2
Completed
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

Recruitment & Eligibility

Status
COMPLETED
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
GroupInterventionDescription
EP262 150 mgOral EP262-
PlaceboPlacebo-
Primary Outcome Measures
NameTimeMethod
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)up to Week 10

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.

Number of Participants With Any ≥Grade 3 TEAEup to Week 10

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.

Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signsup to Week 10

Clinical meaningfulness was determined by the investigator.

Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECGs )up to Week 10

Clinical meaningfulness was determined by the investigator.

Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Hematology, Chemistry, or Coagulation Parametersup to Week 10

Clinical meaningfulness was determined by the investigator.

Secondary Outcome Measures
NameTimeMethod
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 SkinBaseline; Week 6

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.

Trial Locations

Locations (10)

Allervie Clinical Research

🇺🇸

Birmingham, Alabama, 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

Revival Research Institute, LLC

🇺🇸

Troy, Michigan, United States

Optima Research Boardman

🇺🇸

Boardman, Ohio, United States

J&S Studies, Inc.

🇺🇸

College Station, Texas, United States

Jordan Valley Dermatology Center

🇺🇸

South Jordan, Utah, United States

Dermatology Specialists of Spokane

🇺🇸

Spokane, Washington, United States

Innovaderm Research Inc.

🇨🇦

Montréal, Quebec, Canada

Allervie Clinical Research
🇺🇸Birmingham, Alabama, United States

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