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

Brexogen Inc.3 sites in 1 country45 target enrollmentApril 18, 2023

ConditionsAtopic Dermatitis

InterventionsBxC-I17e (primed iMSC derived Extracellular vesicles(EV))Placebo

Overview

Phase: Phase 1
Intervention: BxC-I17e (primed iMSC derived Extracellular vesicles(EV))
Conditions: Atopic Dermatitis
Sponsor: Brexogen Inc.
Enrollment: 45
Locations: 3
Primary Endpoint: Incidence of treatment-emergent adverse events (TEAEs)
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

April 18, 2023

End Date

March 31, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Brexogen Inc.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

BxC-I17e (Single Dose)

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

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

Placebo (Single Dose)

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

Intervention: Placebo

BxC-I17e (Multiple Dose)

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

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

Placebo (Multiple Dose)

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

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs)

Time Frame: Baseline to Week 26

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

Secondary Outcomes

Number of abnormalities in 12-lead electrocardiogram (ECG)(Baseline to Week 26)
Change and percent change in Body Surface Area (BSA)(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
Number of abnormalities in clinical laboratory parameter(Baseline to Week 26)
Number of abnormalities and change from baseline in Vital signs(Baseline to Week 26)
Incidence, severity and relationship of adverse events(AEs)(Baseline to Week 26)
Frequency and proportion of clinically significant finding of physical examination(Baseline to Week 26)
Change and percent change in Scoring Atopic Dermatitis (SCORAD)(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
Change and percent change in Patient-Oriented Eczema Measure (POEM)(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
Change and percent change in Eczema Area and Severity Index (EASI)(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
Change and percent change in Pruritus Numerical Rating Scale (NRS)(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
Change and percent change in Dermatology Life Quality Index (DLQI)(Baseline to Week 8 (single dose) or Week 14 (multiple dose))