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

Primary Purpose

Atopic Dermatitis

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BxC-I17e
Placebo
Sponsored by
Brexogen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    BxC-I17e

    Placebo

    Arm Description

    Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses

    Subcutaneous (SC) injection of the matching placebo Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses

    Outcomes

    Primary Outcome Measures

    Incidence of treatment-emergent adverse events (TEAEs)
    Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0

    Secondary Outcome Measures

    Incidence, severity and relationship of adverse events(AEs)
    Incidence, severity and relationship of adverse events as assessed by CTCAE v5.0
    Number of abnormalities and change from baseline in Vital signs
    Supine blood pressure and pulse rate, tympanic temperature, and respiratory rate
    Number of abnormalities in 12-lead electrocardiogram (ECG)
    PR interval, QRS interval, RR interval, QT interval and QT interval using Friderica's correction (QTcF)
    Number of abnormalities in clinical laboratory parameter
    Hematology, clinical chemistry, and urinalysis parameters
    Frequency and proportion of clinically significant finding of physical examination
    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
    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)
    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)
    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)
    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)
    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)
    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)
    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.
    Changes in the level of eosinophils in the serum and correlation with other parameters
    The level of biomarkers in serum
    Changes in the level of Thymus Activation Regulated Chemokine (TARC) in the serum and correlation with other parameters
    The level of biomarkers in serum
    Changes in the level of Pulmonary Activation-Regulated Chemokine (PARC) in the serum and correlation with other parameters
    The level of biomarkers in serum
    Changes in the level of eotaxin-3 in the serum and correlation with other parameters
    The level of biomarkers in serum
    Changes in the level of Macrophage-Derived Chemokine (MDC) in the serum and correlation with other parameters
    The level of biomarkers in serum
    Changes in the level of periostin in the serum and correlation with other parameters
    The level of biomarkers in serum
    Changes in the level of total Immunoglobulin E (IgE) in the serum and correlation with other parameters
    The level of biomarkers in serum
    Changes in the level of total Interleukin-13 (IL-13) in the serum and correlation with other parameters
    The level of biomarkers in serum
    Changes in the level of total Interleukin-22 (IL-22) in the serum and correlation with other parameters
    The level of biomarkers in serum
    Changes in the level of total Interleukin-31 (IL-31) in the serum and correlation with other parameters
    The level of biomarkers in serum

    Full Information

    First Posted
    September 12, 2023
    Last Updated
    September 20, 2023
    Sponsor
    Brexogen Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06055374
    Brief Title
    A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Repeated-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2024 (Anticipated)
    Primary Completion Date
    April 30, 2025 (Anticipated)
    Study Completion Date
    August 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Brexogen Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atopic Dermatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BxC-I17e
    Arm Type
    Experimental
    Arm Description
    Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subcutaneous (SC) injection of the matching placebo Treatment on Day 1, 15, 29, and 43 for a total 4 biweekly doses
    Intervention Type
    Drug
    Intervention Name(s)
    BxC-I17e
    Intervention Description
    Pharmaceutical form : solution for injection
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Pharmaceutical form : solution for injection
    Primary Outcome Measure Information:
    Title
    Incidence of treatment-emergent adverse events (TEAEs)
    Description
    Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
    Time Frame
    Baseline to Week 26
    Secondary Outcome Measure Information:
    Title
    Incidence, severity and relationship of adverse events(AEs)
    Description
    Incidence, severity and relationship of adverse events as assessed by CTCAE v5.0
    Time Frame
    Baseline to Week 26
    Title
    Number of abnormalities and change from baseline in Vital signs
    Description
    Supine blood pressure and pulse rate, tympanic temperature, and respiratory rate
    Time Frame
    Baseline to Week 26
    Title
    Number of abnormalities in 12-lead electrocardiogram (ECG)
    Description
    PR interval, QRS interval, RR interval, QT interval and QT interval using Friderica's correction (QTcF)
    Time Frame
    Baseline to Week 26
    Title
    Number of abnormalities in clinical laboratory parameter
    Description
    Hematology, clinical chemistry, and urinalysis parameters
    Time Frame
    Baseline to Week 26
    Title
    Frequency and proportion of clinically significant finding of physical examination
    Description
    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
    Time Frame
    Baseline to Week 26
    Title
    Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1
    Description
    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).
    Time Frame
    Baseline to Week 14
    Title
    Change and percent change in Body Surface Area (BSA)
    Description
    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).
    Time Frame
    Baseline to Week 14
    Title
    Change and percent change in Eczema Area and Severity Index (EASI)
    Description
    The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.
    Time Frame
    Baseline to Week 14
    Title
    Change and percent change in Scoring Atopic Dermatitis (SCORAD)
    Description
    The SCORAD is a clinical tool for assessing the severity of Atopic dermatitis. Total score ranged from 0 (absent disease) to 103 (severe disease).
    Time Frame
    Baseline to Week 14
    Title
    Change and percent change in Pruritus Numerical Rating Scale (NRS)
    Description
    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.
    Time Frame
    Baseline to Week 14
    Title
    Change and percent change in Dermatology Life Quality Index (DLQI)
    Description
    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
    Time Frame
    Baseline to Week 14
    Title
    Change and percent change in Patient-Oriented Eczema Measure (POEM)
    Description
    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.
    Time Frame
    Baseline to Week 14
    Title
    Changes in the level of eosinophils in the serum and correlation with other parameters
    Description
    The level of biomarkers in serum
    Time Frame
    Baseline to Week 14
    Title
    Changes in the level of Thymus Activation Regulated Chemokine (TARC) in the serum and correlation with other parameters
    Description
    The level of biomarkers in serum
    Time Frame
    Baseline to Week 14
    Title
    Changes in the level of Pulmonary Activation-Regulated Chemokine (PARC) in the serum and correlation with other parameters
    Description
    The level of biomarkers in serum
    Time Frame
    Baseline to Week 14
    Title
    Changes in the level of eotaxin-3 in the serum and correlation with other parameters
    Description
    The level of biomarkers in serum
    Time Frame
    Baseline to Week 14
    Title
    Changes in the level of Macrophage-Derived Chemokine (MDC) in the serum and correlation with other parameters
    Description
    The level of biomarkers in serum
    Time Frame
    Baseline to Week 14
    Title
    Changes in the level of periostin in the serum and correlation with other parameters
    Description
    The level of biomarkers in serum
    Time Frame
    Baseline to Week 14
    Title
    Changes in the level of total Immunoglobulin E (IgE) in the serum and correlation with other parameters
    Description
    The level of biomarkers in serum
    Time Frame
    Baseline to Week 14
    Title
    Changes in the level of total Interleukin-13 (IL-13) in the serum and correlation with other parameters
    Description
    The level of biomarkers in serum
    Time Frame
    Baseline to Week 14
    Title
    Changes in the level of total Interleukin-22 (IL-22) in the serum and correlation with other parameters
    Description
    The level of biomarkers in serum
    Time Frame
    Baseline to Week 14
    Title
    Changes in the level of total Interleukin-31 (IL-31) in the serum and correlation with other parameters
    Description
    The level of biomarkers in serum
    Time Frame
    Baseline to Week 14

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hugh Lee
    Phone
    1-301-540-2600
    Email
    hughlee@kcrnresearch.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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