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

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

Primary Outcome Measures

Name	Time	Method
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 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. 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 Signs	up 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 Parameters	up to Week 10	Clinical meaningfulness was determined by the investigator.

Secondary Outcome Measures

Name	Time	Method
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	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