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
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Atopic Dermatitis
In brief
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)
Key facts
- Study ID
- NCT06055361
- Run by
- Brexogen Inc.
- People needed
- 45
- Starts
- 2023-04-18
- Expected to finish
- 2026-03-31
- Last updated by the study team
- 2025-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Arkansas Research Trials — North Little Rock, Arkansas, United States (enrolling)
- DermDox Centers for Dermatology — Camp Hill, Pennsylvania, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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