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

Brexogen

Status and phase: Enrolling; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: BxC-I17e; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06055361

BRE-AD01-001

Details and patient eligibility

About

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)

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 4 patient groups, including a placebo group

BxC-I17e (Single Dose)

Experimental group

Description:

* Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e * Single dose on Day 1

Treatment:

Drug: BxC-I17e

Placebo (Single Dose)

Placebo Comparator group

Description:

* Subcutaneous (SC) injection of the matching placebo * Single dose on Day 1

Treatment:

Drug: Placebo

BxC-I17e (Multiple Dose)

Experimental group

Description:

* Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e * 4 doses on Day 1, 15, 29, and 43

Treatment:

Drug: BxC-I17e

Placebo (Multiple Dose)

Placebo Comparator group

Description:

* Subcutaneous (SC) injection of the matching placebo * 4 doses on Day 1, 15, 29, and 43

Treatment:

Drug: Placebo