Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, exosome, extracellular vesicles, EV
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)
Interventions
DRUGBxC-I17e (primed iMSC derived Extracellular vesicles(EV))
Pharmaceutical form : solution for injection
DRUGPlacebo
Pharmaceutical form : solution for injection
Sponsors
Brexogen Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Baseline to Week 26 | Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, severity and relationship of adverse events(AEs) | Baseline to Week 26 | Incidence, severity and relationship of adverse events as assessed by CTCAE v5.0 |
| Number of abnormalities and change from baseline in Vital signs | Baseline to Week 26 | Supine blood pressure and pulse rate, tympanic temperature, and respiratory rate |
| Number of abnormalities in clinical laboratory parameter | Baseline to Week 26 | Hematology, clinical chemistry, and urinalysis parameters |
| Frequency and proportion of clinically significant finding of physical examination | Baseline to Week 26 | 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 |
| 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) | 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). |
| Number of abnormalities in 12-lead electrocardiogram (ECG) | Baseline to Week 26 | PR interval, QRS interval, RR interval, QT interval and QT interval using Friderica's correction (QTcF) |
| Change and percent change in Eczema Area and Severity Index (EASI) | Baseline to Week 8 (single dose) or Week 14 (multiple dose) | The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition. |
| Change and percent change in Scoring Atopic Dermatitis (SCORAD) | Baseline to Week 8 (single dose) or Week 14 (multiple dose) | The SCORAD is a clinical tool for assessing the severity of Atopic Dermatitis. Total score ranged from 0 (absent disease) to 103 (severe disease). |
| Change and percent change in Pruritus Numerical Rating Scale (NRS) | Baseline to Week 8 (single dose) or Week 14 (multiple dose) | 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' |
| Change and percent change in Dermatology Life Quality Index (DLQI) | Baseline to Week 8 (single dose) or Week 14 (multiple dose) | 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 |
| Change and percent change in Patient-Oriented Eczema Measure (POEM) | Baseline to Week 8 (single dose) or Week 14 (multiple dose) | 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 |
| Change and percent change in Body Surface Area (BSA) | Baseline to Week 8 (single dose) or Week 14 (multiple dose) | 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). |
Countries
United States
Contacts
Primary ContactHugh Lee
Outcome results
None listed