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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BxC-I17e (Single Dose) | Experimental |
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| Placebo (Single Dose) | Placebo Comparator |
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| BxC-I17e (Multiple Dose) | Experimental |
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| Placebo (Multiple Dose) | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BxC-I17e (primed iMSC derived Extracellular vesicles(EV)) | Drug | Pharmaceutical form : solution for injection |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Presence of any of the following laboratory abnormalities
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hugh Lee | Contact | 1-301-540-2600 | hughlee@kcrnresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Research Trials | Recruiting | North Little Rock | Arkansas | 72117 | United States |
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| Placebo | Drug | Pharmaceutical form : solution for injection |
|
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) |
| DermDox Centers for Dermatology | Recruiting | Camp Hill | Pennsylvania | 17011 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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