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

Phase 1

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: BxC-I17e; Drug: Placebo

• Registration Number: NCT06055361
• Lead Sponsor: Brexogen Inc.

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-18
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BxC-I17e (Single Dose)	BxC-I17e	* Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e * Single dose on Day 1
Placebo (Multiple Dose)	Placebo	* Subcutaneous (SC) injection of the matching placebo * 4 doses on Day 1, 15, 29, and 43
Placebo (Single Dose)	Placebo	* Subcutaneous (SC) injection of the matching placebo * Single dose on Day 1
BxC-I17e (Multiple Dose)	BxC-I17e	* Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e * 4 doses on Day 1, 15, 29, and 43

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Change and percent change in Body Surface Area (BSA)	Baseline to Week 8 (single dose) or Week 14 (multiple dose)	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).
Number of abnormalities in clinical laboratory parameter	Baseline to Week 26	Hematology, clinical chemistry, and urinalysis parameters
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
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
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
Change and percent change in Scoring Atopic Dermatitis (SCORAD)	Baseline to Week 8 (single dose) or Week 14 (multiple dose)	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 Patient-Oriented Eczema Measure (POEM)	Baseline to Week 8 (single dose) or Week 14 (multiple dose)	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
Change and percent change in Eczema Area and Severity Index (EASI)	Baseline to Week 8 (single dose) or Week 14 (multiple dose)	The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.
Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1	Baseline to Week 8 (single dose) or Week 14 (multiple dose)	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 Pruritus Numerical Rating Scale (NRS)	Baseline to Week 8 (single dose) or Week 14 (multiple dose)	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 (single dose) or Week 14 (multiple dose)	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

Trial Locations

Locations (3)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Arkansas Research Trials; 🇺🇸 North Little Rock, Arkansas, United States

DermDox Centers for Dermatology; 🇺🇸 Camp Hill, Pennsylvania, United States