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

• ClinicalTrials.gov Identifier: NCT06055361
• Recruitment Status: Recruiting
• First Posted: September 26, 2023
• Last Update Posted: September 26, 2023
• Sponsor: Brexogen Inc.
• Information provided by (Responsible Party): Brexogen Inc.

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
Atopic Dermatitis	Drug: BxC-I17e; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of BxC-I17e Administered Subcutaneously in Patients With Moderate to Severe Atopic Dermatitis
• Actual Study Start Date: April 18, 2023
• Estimated Primary Completion Date: April 30, 2024
• Estimated Study Completion Date: September 3, 2024

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 :

1. 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 Outcome Measures :

1. Incidence, severity and relationship of adverse events(AEs) [ Time Frame: Baseline to Week 26 ]
   Incidence, severity and relationship of adverse events as assessed by CTCAE v5.0
2. Number of abnormalities and change from baseline in Vital signs [ Time Frame: Baseline to Week 26 ]
   Supine blood pressure and pulse rate, tympanic temperature, and respiratory rate
3. Number of abnormalities in 12-lead electrocardiogram (ECG) [ Time Frame: Baseline to Week 26 ]
   PR interval, QRS interval, RR interval, QT interval and QT interval using Friderica's correction (QTcF)
4. Number of abnormalities in clinical laboratory parameter [ Time Frame: Baseline to Week 26 ]
   Hematology, clinical chemistry, and urinalysis parameters
5. Frequency and proportion of clinically significant finding of physical examination [ Time Frame: 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
6. Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1 [ Time Frame: 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).
7. Change and percent change in Body Surface Area (BSA) [ Time Frame: 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).
8. Change and percent change in Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to Week 8 ]
   The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.
9. Change and percent change in Scoring Atopic Dermatitis (SCORAD) [ Time Frame: 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).
10. Change and percent change in Pruritus Numerical Rating Scale (NRS) [ Time Frame: 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'
11. Change and percent change in Dermatology Life Quality Index (DLQI) [ Time Frame: 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
12. Change and percent change in Patient-Oriented Eczema Measure (POEM) [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Hugh Lee; 1-301-540-2600; hughlee@kcrnresearch.com

Locations

United States, Arkansas

Arkansas Research Trials; Recruiting

North Little Rock, Arkansas, United States, 72117

Contact: Shawna S Owens

United States, Pennsylvania

DermDox Centers for Dermatology; Recruiting

Camp Hill, Pennsylvania, United States, 17011

Contact: Elise Magnine

University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Paola Santos

Sponsors and Collaborators

Brexogen Inc.

More Information

• Responsible Party: Brexogen Inc.
• ClinicalTrials.gov Identifier: NCT06055361
• Other Study ID Numbers: BRE-AD01-001
• First Posted: September 26, 2023
• Last Update Posted: September 26, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases