A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of a single SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BxC-I17e Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e Single dose on Day 1 |
Drug: BxC-I17e
Pharmaceutical form : solution for injection
|
| Placebo Comparator: Placebo Subcutaneous (SC) injection of the matching placebo Single dose on Day 1 |
Drug: Placebo
Pharmaceutical form : solution for injection
|
Outcome Measures
Primary Outcome Measures
- Incidence of treatment-emergent adverse events (TEAEs) [Baseline to Week 26]
Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
Secondary Outcome Measures
- 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 12-lead electrocardiogram (ECG) [Baseline to Week 26]
PR interval, QRS interval, RR interval, QT interval and QT interval using Friderica's correction (QTcF)
- 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]
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).
- Change and percent change in Body Surface Area (BSA) [Baseline to Week 8]
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).
- Change and percent change in Eczema Area and Severity Index (EASI) [Baseline to Week 8]
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]
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]
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]
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]
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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arkansas Research Trials | North Little Rock | Arkansas | United States | 72117 |
| 2 | DermDox Centers for Dermatology | Camp Hill | Pennsylvania | United States | 17011 |
| 3 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Brexogen Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BRE-AD01-001