Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: Oral EP262Drug: 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
- Clinically confirmed diagnosis of active atopic dermatitis for at least 1 year
- BSA of 3% to 20% and a vIGA-AD score of ≥3
- 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