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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of BxC-I17e Administered Subcutaneously in Patients With Moderate to Severe Atopic Dermatitis

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)

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: BxC-I17e (primed iMSC derived Extracellular vesicles(EV))

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hugh Lee; Phone Number: 1-301-540-2600; Email: hughlee@kcrnresearch.com

Study Locations

• United States
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Recruiting
      • Arkansas Research Trials
      • Contact: Shawna S Owens
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Recruiting
      • DermDox Centers for Dermatology
      • Contact: Elise Magnine
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Paola Santos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BxC-I17e (Single Dose); 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)); Pharmaceutical form : solution for injection
Placebo Comparator: Placebo (Single Dose); Subcutaneous (SC) injection of the matching placebo; Single dose on Day 1	Drug: Placebo; Pharmaceutical form : solution for injection
Experimental: BxC-I17e (Multiple Dose); 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)); Pharmaceutical form : solution for injection
Placebo Comparator: Placebo (Multiple Dose); Subcutaneous (SC) injection of the matching placebo; 4 doses on Day 1, 15, 29, and 43	Drug: Placebo; Pharmaceutical form : solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs)	Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0	Baseline to Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, severity and relationship of adverse events(AEs)	Incidence, severity and relationship of adverse events as assessed by CTCAE v5.0	Baseline to Week 26
Number of abnormalities and change from baseline in Vital signs	Supine blood pressure and pulse rate, tympanic temperature, and respiratory rate	Baseline to Week 26
Number of abnormalities in 12-lead electrocardiogram (ECG)	PR interval, QRS interval, RR interval, QT interval and QT interval using Friderica's correction (QTcF)	Baseline to Week 26
Number of abnormalities in clinical laboratory parameter	Hematology, clinical chemistry, and urinalysis parameters	Baseline to Week 26
Frequency and proportion of clinically significant finding of physical examination	Assessments of the following body categories : skin, HEENT (head, eye, ears, nose, and throat), cardiovascular, respiratory, gastrointestinal, endocrine/metabolic, genitourinary, psychiatric, hematologic/lymphatics, musculoskeletal, neurologic, hepatic, and allergic/immunologic	Baseline to Week 26
Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1	The IGA is an assessment instrument used in clinical studies to rate the severity of Atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).	Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Change and percent change in Body Surface Area (BSA)	The BSA affected by atopic dermatitis will be assessed for each major section of the body (head, trunk, arms, and legs). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).	Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Change and percent change in Eczema Area and Severity Index (EASI)	The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.	Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Change and percent change in Scoring Atopic Dermatitis (SCORAD)	The SCORAD is a clinical tool for assessing the severity of Atopic Dermatitis. Total score ranged from 0 (absent disease) to 103 (severe disease).	Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Change and percent change in Pruritus Numerical Rating Scale (NRS)	The Pruritus NRS is a simple assessment tool used to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the' worst itch imaginable'	Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Change and percent change in Dermatology Life Quality Index (DLQI)	The DLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life	Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Change and percent change in Patient-Oriented Eczema Measure (POEM)	The POEM is a validated 7-item questionnaire used to assess disease symptoms with a scoring system of 1 to 28. The higher score, the higher morbidity	Baseline to Week 8 (single dose) or Week 14 (multiple dose)

Collaborators and Investigators

• Sponsor: Brexogen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Atopic dermatitis; exosome; extracellular vesicles; EV
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: BRE-AD01-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No