🔎 Trials Near Me

Home › Atopic Dermatitis (Eczema) › 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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

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)

What is being tested

Sponsor: Brexogen Inc. · Participants: 45 · Started: Apr 18, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06055361

Locations in the U.S.

ArkansasArkansas Research Trials, North Little Rock
PennsylvaniaDermDox Centers for Dermatology, Camp Hill
University of Pennsylvania, Philadelphia

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.