Back to resultsA Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BxC-I17e
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
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
Sites / Locations
- Arkansas Research TrialsRecruiting
- DermDox Centers for DermatologyRecruiting
- University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BxC-I17e
Placebo
Arm Description
Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e Single dose on Day 1
Subcutaneous (SC) injection of the matching placebo Single dose on Day 1
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06055361
Brief Title
A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
September 3, 2024 (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 preliminary efficacy of a single 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
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BxC-I17e
Arm Type
Experimental
Arm Description
Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e
Single dose on Day 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous (SC) injection of the matching placebo
Single dose on Day 1
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 8
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 8
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 8
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 8
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 8
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 8
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 8
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
Facility Information:
Facility Name
Arkansas Research Trials
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawna S Owens
Facility Name
DermDox Centers for Dermatology
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise Magnine
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola Santos
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 Single-dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
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