Phase 2
N=32
Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT06144424 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) — 4; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oral EP262 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Escient Pharmaceuticals, Inc
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
4; 7 | — |
| PRIMARY Number of Participants With Any ≥Grade 3 TEAE |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Meaningful Changes From Baseline in Vital Signs |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Meaningful Changes From Baseline in Electrocardiograms (ECGs ) |
1; 1 | — |
| PRIMARY Number of Participants With Clinically Meaningful Changes From Baseline in Clinical Hematology, Chemistry, or Coagulation Parameters |
0; 0 | — |
| SECONDARY 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 |
0; 0 | — |
Summary
This Phase 2a trial will evaluate the effects of EP262 in subjects with atopic dermatitis
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
Data sourced from ClinicalTrials.gov (NCT06144424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.