Clinical trial NCT06055361: A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single and Multiple Dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of BxC-I17e Administered Subcutaneously in Patients With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Lead sponsor: Brexogen Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: Inclusion Criteria:

1. Patients (males or females) aged 18 years or older.
2. Patients have documented history of moderate to severe AD, that has been present for at least 1 year
3. History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD
4. 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.
5. Willingness and ability to comply with clinic visits and study-related procedures.
6. Patients should be able to read, understand, and be willing to sign the ICF

Exclusion Criteria:

1. 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
2. Positive test for hepatitis B surface antigen, and/or hepatitis C antibody
3. Active dermatologic conditions that may confound the diagnosis of AD
4. Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study
5. 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
6. Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit.
7. Known history of human immunodeficiency virus (HIV) infection
8. Pregnant or breastfeeding women

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Incidence, severity and relationship of adverse events(AEs)
timeFrame: Baseline to Week 26
measure: Number of abnormalities and change from baseline in Vital signs
timeFrame: Baseline to Week 26
measure: Number of abnormalities in 12-lead electrocardiogram (ECG)
timeFrame: Baseline to Week 26
measure: Number of abnormalities in clinical laboratory parameter
timeFrame: Baseline to Week 26
measure: Frequency and proportion of clinically significant finding of physical examination
timeFrame: Baseline to Week 26
measure: Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1
timeFrame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
measure: Change and percent change in Body Surface Area (BSA)
timeFrame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
measure: Change and percent change in Eczema Area and Severity Index (EASI)
timeFrame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
measure: Change and percent change in Scoring Atopic Dermatitis (SCORAD)
timeFrame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
measure: Change and percent change in Pruritus Numerical Rating Scale (NRS)
timeFrame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
measure: Change and percent change in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
measure: Change and percent change in Patient-Oriented Eczema Measure (POEM)
timeFrame: Baseline to Week 8 (single dose) or Week 14 (multiple dose)
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Arkansas Research Trials
state: Arkansas
city: Camp Hill
country: United States
facility: DermDox Centers for Dermatology
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: