Clinical trial

Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Atopic Dermatitis (EASE)

NCT06144424

Name

EP-262-202

Description

This Phase 2a trial will evaluate the effects of EP262 in subjects with atopic dermatitis

Trial arms

Trial start

2023-10-25

Estimated PCD

2024-09-01

Trial end

2024-10-01

Status

Recruiting

Phase

Early phase I

Treatment

Oral EP262

Once daily

Arms:

EP262 150 mg

Placebo

Once Daily

Arms:

Placebo

Size

Primary endpoint

Safety and tolerability of EP262

Measured from Day 1 to End of Study or Early Termination (Up to 10 weeks)

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-01-30

1 organization

3 products

1 indication

Organization

Escient Pharmaceuticals

Product

Indication

Product

Product