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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
Pharmaceutical form : solution for injection
Pharmaceutical form : solution for injection
Arkansas Research Trials
North Little Rock, Arkansas, United States
RECRUITINGDermDox Centers for Dermatology
Camp Hill, Pennsylvania, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGIncidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
Time frame: Baseline to Week 26
Incidence, severity and relationship of adverse events(AEs)
Incidence, severity and relationship of adverse events as assessed by CTCAE v5.0
Time frame: 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
Time frame: 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)
Time frame: Baseline to Week 26
Number of abnormalities in clinical laboratory parameter
Hematology, clinical chemistry, and urinalysis parameters
Time frame: 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
Time frame: 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).
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Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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'
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)