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
Brexogen Inc. · NCT06055361
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1
- Target enrollment
- 45
- US sites recruiting
- 3
- Study start
- April 18, 2023
- Record last updated
- September 19, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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)
Being studied: BxC-I17e (primed iMSC derived Extracellular vesicles(EV)); Placebo
Conditions: Atopic Dermatitis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Arkansas Research Trials
North Little Rock, AR 72117
Site contact: Shawna S Owens
DermDox Centers for Dermatology
Camp Hill, PA 17011
Site contact: Elise Magnine
University of Pennsylvania
Philadelphia, PA 19104
Site contact: Paola Santos
Study contacts (from the official record)
- Hugh Lee · 1-301-540-2600 · hughlee@kcrnresearch.com
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