A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single and Multiple Dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis

Description

The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of a single and multiple SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)

Conditions

Atopic Dermatitis

Study Overview

Study Details

Study overview

The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of a single and multiple SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of BxC-I17e Administered Subcutaneously in Patients With Moderate to Severe Atopic Dermatitis

A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single and Multiple Dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

North Little Rock

Arkansas Research Trials, North Little Rock, Arkansas, United States, 72117

Camp Hill

DermDox Centers for Dermatology, Camp Hill, Pennsylvania, United States, 17011

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patients (males or females) aged 18 years or older.
  • 2. Patients have documented history of moderate to severe AD, that has been present for at least 1 year
  • 3. History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD
  • 4. Patients must agree to apply stable doses of additive-free, basic bland emollient lotions twice daily for at least 7 days before the Baseline Visit.
  • 5. Willingness and ability to comply with clinic visits and study-related procedures.
  • 6. Patients should be able to read, understand, and be willing to sign the ICF
  • 1. Presence of any of the following laboratory abnormalities
  • * Hemoglobin \< 11 g/dL
  • * WBC \< 3.5 × 103/μL
  • * Platelet count \< 125 × 103/μL
  • * Neutrophils \< 1.75 × 103/μL
  • * AST/ALT \> 1.5 × ULN
  • * Total bilirubin \> ULN
  • * Creatinine \> ULN
  • * Creatine phosphokinase \> ULN
  • 2. Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
  • 3. Active dermatologic conditions that may confound the diagnosis of AD
  • 4. Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study
  • 5. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the patient's participation in this study
  • 6. Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit.
  • 7. Known history of human immunodeficiency virus (HIV) infection
  • 8. Pregnant or breastfeeding women

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brexogen Inc.,

Study Record Dates

2025-12-30