A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Repeated-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability, and efficacy of a multiple SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Efficacy of BxC-I17e Administered Subcutaneously in Patients With Moderate to Severe Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: BxC-I17e
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BxC-I17e<br>Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses | Drug: BxC-I17e<br>* Pharmaceutical form : solution for injection<br>|
| Placebo Comparator: Placebo<br>Subcutaneous (SC) injection of the matching placebo Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses | Drug: Placebo<br>* Pharmaceutical form : solution for injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 14 | 
| 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 14 | 
| 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 14 | 
| 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 14 | 
| 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 14 | 
| 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 14 | 
| 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 14 | 
| Changes in the level of eosinophils in the serum and correlation with other parameters | The level of biomarkers in serum | Baseline to Week 14 | 
| Changes in the level of Thymus Activation Regulated Chemokine (TARC) in the serum and correlation with other parameters | The level of biomarkers in serum | Baseline to Week 14 | 
| Changes in the level of Pulmonary Activation-Regulated Chemokine (PARC) in the serum and correlation with other parameters | The level of biomarkers in serum | Baseline to Week 14 | 
| Changes in the level of eotaxin-3 in the serum and correlation with other parameters | The level of biomarkers in serum | Baseline to Week 14 | 
| Changes in the level of Macrophage-Derived Chemokine (MDC) in the serum and correlation with other parameters | The level of biomarkers in serum | Baseline to Week 14 | 
| Changes in the level of periostin in the serum and correlation with other parameters | The level of biomarkers in serum | Baseline to Week 14 | 
| Changes in the level of total Immunoglobulin E (IgE) in the serum and correlation with other parameters | The level of biomarkers in serum | Baseline to Week 14 | 
| Changes in the level of total Interleukin-13 (IL-13) in the serum and correlation with other parameters | The level of biomarkers in serum | Baseline to Week 14 | 
| Changes in the level of total Interleukin-22 (IL-22) in the serum and correlation with other parameters | The level of biomarkers in serum | Baseline to Week 14 | 
| Changes in the level of total Interleukin-31 (IL-31) in the serum and correlation with other parameters | The level of biomarkers in serum | Baseline to Week 14 |