Clinical Trials Logo
  1. Home
  2. Atopic Dermatitis
  3. NCT06144424
  4. Details
NCT06144424 Clinical Trial

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

Atopic Dermatitis Clinical Trial

— EASE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06144424
Other study ID # EP-262-202
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 25, 2023
Est. completion date October 2024

Study information
Verified date May 2024
Source Escient Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date October 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oral EP262
Once daily
• Placebo
Once Daily

Locations
Country Name City State
Canada Innovaderm Research Inc. Montréal Quebec
United States Allervie Clinical Research Birmingham Alabama
United States Optima Research Boardman Boardman Ohio
United States J&S Studies, Inc. College Station Texas
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 Jordan Valley Dermatology Center South Jordan Utah
United States Dermatology Specialists of Spokane Spokane Washington
United States Revival Research Institute, LLC Troy Michigan

Sponsors (1)
Lead Sponsor Collaborator
Escient Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of EP262 Assessed by the incidence of treatment-emergent adverse events Measured from Day 1 to End of Study or Early Termination (Up to 10 weeks)
Secondary Effect of EP262 on skin histology Assessed by changes in epidermal thickness and immune cell infiltration from skin biopsy sample Measured from Day 1 to Week 6
Secondary Effect of EP262 on skin gene expression Assessed by RNA sequencing of skin biopsy samples Measured from Day 1 to Week 6
See also
  Status Clinical Trial Phase
Completed NCT05018806 - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Phase 2
Completed NCT04090229 - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Phase 1
Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
Completed NCT05530707 - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer N/A
Completed NCT02595073 - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis Phase 3
Recruiting NCT05509023 - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) Phase 2
Recruiting NCT05048056 - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT04598269 - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis Phase 2
Recruiting NCT03936335 - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2