Tests BxC-I17e injections in adults with moderate to severe atopic dermatitis
Tests a new injected treatment against placebo in adults with atopic dermatitis.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Camp Hill, North Little Rock, and Philadelphia, United StatesSee the 3 sites
- Phase
- Phase 1
Where in United States
- DermDox Centers for DermatologyCamp Hill, United StatesTaking people
- Arkansas Research TrialsNorth Little Rock, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Brexogen Inc.
- Trial code
- NCT06055361
- Record updated
- 19 September 2025
- Original 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)Read full original descriptionShow less
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
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)
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: 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; Positive test for hepatitis B surface antigen, and/or hepatitis C antibody; Active dermatologic conditions that may confound the diagnosis of AD; Known history of human immunodeficiency virus (HIV) infection; 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; Pregnant or breastfeeding women.