A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Repeated-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
BxC-I17e
Placebo
Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses
Subcutaneous (SC) injection of the matching placebo Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses