Actively 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
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
Eligibility Criteria
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
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
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
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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