NCT06055361RecruitingPhase 1
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 enrollmentStarted: April 18, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 3
- Primary Endpoint
- Incidence of treatment-emergent adverse events (TEAEs)
Study 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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •Pregnant or breastfeeding women
Arms & Interventions
BxC-I17e (Single Dose)
Experimental
- 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)) (Drug)
Placebo (Single Dose)
Placebo Comparator
- Subcutaneous (SC) injection of the matching placebo
- Single dose on Day 1
Intervention: Placebo (Drug)
BxC-I17e (Multiple Dose)
Experimental
- 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)) (Drug)
Placebo (Multiple Dose)
Placebo Comparator
- Subcutaneous (SC) injection of the matching placebo
- 4 doses on Day 1, 15, 29, and 43
Intervention: Placebo (Drug)
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))
Investigators
Study Sites (3)
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