Recruiting
Phase 1

BxC-I17e

Sponsor:

Brexogen Inc.

Code:

NCT06055361

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BxC-I17e (primed iMSC derived Extracellular vesicles(EV))

Placebo

Study Details

Brief summary:

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)

Conditions

Atopic Dermatitis

Study ID

NCT06055361

Start date

Apr 18, 2023

Status verified date

Sep, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients (males or females) aged 18 years or older.
2. Patients have documented history of moderate to severe AD, that has been present for at least 1 year
3. History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD
4. 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.
5. Willingness and ability to comply with clinic visits and study-related procedures.
6. Patients should be able to read, understand, and be willing to sign the ICF

Exclusion Criteria:

1. 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
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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BxC-I17e (Single Dose)

  • Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e
  • Single dose on Day 1

placebo comparator: Placebo (Single Dose)

  • Subcutaneous (SC) injection of the matching placebo
  • Single dose on Day 1

experimental: BxC-I17e (Multiple Dose)

  • Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e
  • 4 doses on Day 1, 15, 29, and 43

placebo comparator: Placebo (Multiple Dose)

  • Subcutaneous (SC) injection of the matching placebo
  • 4 doses on Day 1, 15, 29, and 43

Interventions

BxC-I17e (primed iMSC derived Extracellular vesicles(EV))

Pharmaceutical form : solution for injection

Placebo

Pharmaceutical form : solution for injection

Primary outcome measure

  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to Week 26 ]

Central Contacts and Locations

Locations

Arkansas Research Trials

Recruiting

North Little Rock, Arkansas, United States, 72117

DermDox Centers for Dermatology

Recruiting

Camp Hill, Pennsylvania, United States, 17011

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Brexogen Inc.

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Keywords

  • Atopic dermatitis
  • exosome
  • extracellular vesicles
  • EV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Brexogen Inc. on 2025-09-19.