Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06055361

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

Led by Brexogen Inc. · Updated on 2025-09-19

45

Participants Needed

3

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Documented history of moderate to severe atopic dermatitis for at least 1 year
  • History of inadequate response to stable treatment with topical corticosteroids or calcineurin inhibitors for atopic dermatitis
  • Agree to apply stable doses of additive-free, bland emollient lotions twice daily for at least 7 days before baseline visit
  • Willingness and ability to comply with clinic visits and study procedures
  • Ability to read, understand, and sign informed consent form
Not Eligible

You will not qualify if you...

  • Hemoglobin less than 11 g/dL
  • White blood cell count less than 3.5 x 10^3/μL
  • Platelet count less than 125 x 10^3/μL
  • Neutrophils less than 1.75 x 10^3/μL
  • AST or ALT greater than 1.5 times upper limit of normal
  • Total bilirubin above upper limit of normal
  • Creatinine above upper limit of normal
  • Creatine phosphokinase above upper limit of normal
  • Positive test for hepatitis B surface antigen or hepatitis C antibody
  • Active skin conditions that may interfere with diagnosis of atopic dermatitis
  • Prior use of investigational systemic treatments or current participation in another clinical study
  • Significant illness such as cardiac, renal, neurological, endocrinological, metabolic, or lymphatic disease that could affect study participation
  • Treatment with topical corticosteroids or calcineurin inhibitors within 1 week before baseline visit
  • Known HIV infection
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Arkansas Research Trials

North Little Rock, Arkansas, United States, 72117

Actively Recruiting

2

DermDox Centers for Dermatology

Camp Hill, Pennsylvania, United States, 17011

Actively Recruiting

3

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

H

Hugh Lee

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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