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NCT Number: 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

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)

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arkansas Research Trials, North Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BxC-I17e (primed iMSC derived Extracellular vesicles(EV))

Drug

Pharmaceutical form : solution for injection

Placebo

Drug

Pharmaceutical form : solution for injection

Primary outcomes

  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 outcomes

  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 (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).

  7. Change and percent change in Body Surface Area (BSA)

    Time frame: 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).

  8. Change and percent change in Eczema Area and Severity Index (EASI)

    Time frame: 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.

  9. Change and percent change in Scoring Atopic Dermatitis (SCORAD)

    Time frame: 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).

  10. Change and percent change in Pruritus Numerical Rating Scale (NRS)

    Time frame: 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'

  11. Change and percent change in Dermatology Life Quality Index (DLQI)

    Time frame: 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

  12. Change and percent change in Patient-Oriented Eczema Measure (POEM)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hugh Lee

CONTACT

[email protected]

1-301-540-2600

Sponsors and collaborators

Lead sponsor

Brexogen Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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