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

Официальное название

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

Обзор

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)

Вмешательства

• Препарат BxC-I17e (primed iMSC derived Extracellular vesicles(EV))
  Pharmaceutical form : solution for injection
• Препарат Placebo
  Pharmaceutical form : solution for injection

Первичные конечные точки

• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: Baseline to Week 26]

Вторичные конечные точки (12)

• Incidence, severity and relationship of adverse events(AEs) [Срок оценки: Baseline to Week 26]
• Number of abnormalities and change from baseline in Vital signs [Срок оценки: Baseline to Week 26]
• Number of abnormalities in 12-lead electrocardiogram (ECG) [Срок оценки: Baseline to Week 26]
• Number of abnormalities in clinical laboratory parameter [Срок оценки: Baseline to Week 26]
• Frequency and proportion of clinically significant finding of physical examination [Срок оценки: Baseline to Week 26]
• Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1 [Срок оценки: Baseline to Week 8 (single dose) or Week 14 (multiple dose)]
• Change and percent change in Body Surface Area (BSA) [Срок оценки: Baseline to Week 8 (single dose) or Week 14 (multiple dose)]
• Change and percent change in Eczema Area and Severity Index (EASI) [Срок оценки: Baseline to Week 8 (single dose) or Week 14 (multiple dose)]
• Change and percent change in Scoring Atopic Dermatitis (SCORAD) [Срок оценки: Baseline to Week 8 (single dose) or Week 14 (multiple dose)]
• Change and percent change in Pruritus Numerical Rating Scale (NRS) [Срок оценки: Baseline to Week 8 (single dose) or Week 14 (multiple dose)]
• Change and percent change in Dermatology Life Quality Index (DLQI) [Срок оценки: Baseline to Week 8 (single dose) or Week 14 (multiple dose)]
• Change and percent change in Patient-Oriented Eczema Measure (POEM) [Срок оценки: Baseline to Week 8 (single dose) or Week 14 (multiple dose)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Arkansas Research Trials — North Little Rock
• DermDox Centers for Dermatology — Camp Hill
• University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT06055361 · BRE-AD01-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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