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Study of BxC-I17e for Moderate to Severe Atopic Dermatitis

This study is looking into BxC-I17e, a solution for injection, for people with moderate to severe atopic dermatitis (AD), a chronic skin condition. Researchers want to see how safe BxC-I17e is, how well people tolerate it, and if it helps improve AD. You might be able to join if you are 18 or older, have had moderate to severe AD for at least a year, and haven't responded well to other treatments like topical corticosteroids (TCSs) or topical calcineurin inhibitors (TCIs). The main goal is to track any side effects that happen during the study. This study is currently unclear about its recruitment status and plans to enroll 45 participants.

Study design
This is an interventional study, meaning participants will receive either BxC-I17e or a placebo (an inactive substance). It plans to enroll 45 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects from when you start treatment until Week 26.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06055361

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
PHASE1Ages 18+InterventionalTreatment
Brexogen Inc.
~45 participants
Updated 2025-09-19 on ClinicalTrials.gov
What's tested:BxC-I17e (primed iMSC derived Extracellular vesicles(EV))Placebo

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events (TEAEs)
Measured over Baseline to Week 26

Conditions

Atopic Dermatitis

Explore related trials

Atopic Dermatitis

Where it's being run

3 sites across 2 states
Pennsylvania2
Arkansas1

Who to contact

Hugh Lee
[email protected]
1-301-540-2600
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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 2. Positive test for hepatitis B surface antigen, and/or hepatitis C antibody 3. Active dermatologic conditions that may confound the diagnosis of AD 4. Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study 5. 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 6. Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit. 7. Known history of human immunodeficiency virus (HIV) infection 8. Pregnant or breastfeeding women

What this trial measures

  • Incidence of treatment-emergent adverse events (TEAEs)Baseline to Week 26

    Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0