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

Last updated: August 7, 2024
Sponsor: Brexogen Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Eczema (Atopic Dermatitis - Pediatric)

Skin Wounds

Allergy

Treatment

BxC-I17e

Placebo

Clinical Study ID

NCT06055361
BRE-AD01-001
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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 forat least 1 year

  3. History of inadequate response to a stable regimen of TCSs or TCIs as treatment forAD

  4. Patients must agree to apply stable doses of additive-free, basic bland emollientlotions 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

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

  1. Positive test for hepatitis B surface antigen, and/or hepatitis C antibody

  2. Active dermatologic conditions that may confound the diagnosis of AD

  3. Prior exposure to any investigational systemic treatment or is currently enrolled inanother clinical study

  4. Significant concomitant illness or history of significant illness such as cardiac,renal, neurological, endocrinological, metabolic or lymphatic disease, or any otherillness or condition that would adversely affect the patient's participation in thisstudy

  5. Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit.

  6. Known history of human immunodeficiency virus (HIV) infection

  7. Pregnant or breastfeeding women

Study Design

Total Participants: 45
Treatment Group(s): 2
Primary Treatment: BxC-I17e
Phase: 1
Study Start date:
April 18, 2023
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Arkansas Research Trials

    North Little Rock, Arkansas 72117
    United States

    Active - Recruiting

  • DermDox Centers for Dermatology

    Camp Hill, Pennsylvania 17011
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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