NCT06055374WithdrawnPhase 1
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
Brexogen Inc.0 sitesStarted: May 1, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Incidence of treatment-emergent adverse events (TEAEs)
Study Overview
Brief Summary
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
BxC-I17e
Experimental
- Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e
- Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses
Intervention: BxC-I17e (Drug)
Placebo
Placebo Comparator
- Subcutaneous (SC) injection of the matching placebo
- Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Baseline to Week 26
Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
Secondary Outcomes
- Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1(Baseline to Week 14)
- Change and percent change in Dermatology Life Quality Index (DLQI)(Baseline to Week 14)
- Changes in the level of total Immunoglobulin E (IgE) in the serum and correlation with other parameters(Baseline to Week 14)
- Incidence, severity and relationship of adverse events(AEs)(Baseline to Week 26)
- Number of abnormalities and change from baseline in Vital signs(Baseline to Week 26)
- Number of abnormalities in clinical laboratory parameter(Baseline to Week 26)
- Frequency and proportion of clinically significant finding of physical examination(Baseline to Week 26)
- Number of abnormalities in 12-lead electrocardiogram (ECG)(Baseline to Week 26)
- Change and percent change in Body Surface Area (BSA)(Baseline to Week 14)
- Change and percent change in Eczema Area and Severity Index (EASI)(Baseline to Week 14)
- Change and percent change in Pruritus Numerical Rating Scale (NRS)(Baseline to Week 14)
- Change and percent change in Patient-Oriented Eczema Measure (POEM)(Baseline to Week 14)
- Changes in the level of eosinophils in the serum and correlation with other parameters(Baseline to Week 14)
- Changes in the level of Thymus Activation Regulated Chemokine (TARC) in the serum and correlation with other parameters(Baseline to Week 14)
- Changes in the level of Pulmonary Activation-Regulated Chemokine (PARC) in the serum and correlation with other parameters(Baseline to Week 14)
- Changes in the level of Macrophage-Derived Chemokine (MDC) in the serum and correlation with other parameters(Baseline to Week 14)
- Change and percent change in Scoring Atopic Dermatitis (SCORAD)(Baseline to Week 14)
- Changes in the level of eotaxin-3 in the serum and correlation with other parameters(Baseline to Week 14)
- Changes in the level of periostin in the serum and correlation with other parameters(Baseline to Week 14)
- Changes in the level of total Interleukin-13 (IL-13) in the serum and correlation with other parameters(Baseline to Week 14)
- Changes in the level of total Interleukin-31 (IL-31) in the serum and correlation with other parameters(Baseline to Week 14)
- Changes in the level of total Interleukin-22 (IL-22) in the serum and correlation with other parameters(Baseline to Week 14)
Investigators
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