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

NCT06055361 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BRE-AD01-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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

Keywords

Atopic dermatitis; exosome; extracellular vesicles; EV

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

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

  Baseline to Week 26

Secondary Outcomes (12)

• Incidence, severity and relationship of adverse events(AEs)

  Baseline to Week 26

• Number of abnormalities and change from baseline in Vital signs

  Baseline to Week 26

• Number of abnormalities in 12-lead electrocardiogram (ECG)

  Baseline to Week 26

• Number of abnormalities in clinical laboratory parameter

  Baseline to Week 26

• Frequency and proportion of clinically significant finding of physical examination

  Baseline to Week 26

Study Arms (4)

BxC-I17e (Single Dose)

EXPERIMENTAL

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

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

Placebo (Single Dose)

PLACEBO COMPARATOR

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

Drug: Placebo

BxC-I17e (Multiple Dose)

EXPERIMENTAL

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

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

Placebo (Multiple Dose)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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

Pharmaceutical form : solution for injection

BxC-I17e (Multiple Dose); BxC-I17e (Single Dose)

Placebo DRUG

Pharmaceutical form : solution for injection

Placebo (Multiple Dose); Placebo (Single Dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brexogen Inc.: lead

Study Sites (3)

Arkansas Research Trials

North Little Rock, Arkansas, 72117, United States

RECRUITING

DermDox Centers for Dermatology

Camp Hill, Pennsylvania, 17011, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Hugh Lee

CONTACT

1-301-540-2600; hughlee@kcrnresearch.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 26, 2023
• Study Start: April 18, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)