Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis (EASE)
Overview
- Phase
- Phase 2
- Intervention
- Oral EP262
- Conditions
- Atopic Dermatitis
- Sponsor
- Escient Pharmaceuticals, Inc
- Enrollment
- 30
- Locations
- 10
- Primary Endpoint
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
This Phase 2a trial will evaluate the effects of EP262 in subjects with atopic dermatitis
Investigators
Eligibility Criteria
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
Arms & Interventions
EP262 150 mg
Intervention: Oral EP262
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time Frame: 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
Time Frame: 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
Time Frame: up to Week 10
Clinical meaningfulness was determined by the investigator.
Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECGs )
Time Frame: 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
Time Frame: up to Week 10
Clinical meaningfulness was determined by the investigator.
Secondary Outcomes
- 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)