This Phase 2a trial will evaluate the effects of EP262 in subjects with atopic dermatitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Once daily
Once Daily
Allervie Clinical Research
Birmingham, Alabama, United States
RM Medical Research, Inc.
Miami Lakes, Florida, United States
Indiana Clinical Trials Center
Plainfield, Indiana, United States
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.
Time frame: 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.
Time frame: up to Week 10
Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs
Clinical meaningfulness was determined by the investigator.
Time frame: up to Week 10
Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECGs )
Clinical meaningfulness was determined by the investigator.
Time frame: up to Week 10
Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Hematology, Chemistry, or Coagulation Parameters
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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.
Montreal, Quebec, Canada
Clinical meaningfulness was determined by the investigator.
Time frame: up to Week 10
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
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.
Time frame: Baseline; Week 6