Status:
RECRUITING
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
Lead Sponsor:
Brexogen Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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)
Eligibility Criteria
Inclusion
- Patients (males or females) aged 18 years or older.
- Patients have documented history of moderate to severe AD, that has been present for at least 1 year
- History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD
- 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.
- Willingness and ability to comply with clinic visits and study-related procedures.
- Patients should be able to read, understand, and be willing to sign the ICF
Exclusion
- 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
- Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
- Active dermatologic conditions that may confound the diagnosis of AD
- Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study
- 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
- Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit.
- Known history of human immunodeficiency virus (HIV) infection
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
April 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06055361
Start Date
April 18 2023
End Date
March 31 2026
Last Update
September 19 2025
Active Locations (3)
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1
Arkansas Research Trials
North Little Rock, Arkansas, United States, 72117
2
DermDox Centers for Dermatology
Camp Hill, Pennsylvania, United States, 17011
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104