NCT06055361招募中1 期
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
Brexogen Inc.3 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年4月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BxC-I17e (Single Dose)
Experimental
- Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e
- Single dose on Day 1
干预措施: BxC-I17e (primed iMSC derived Extracellular vesicles(EV)) (Drug)
Placebo (Single Dose)
Placebo Comparator
- Subcutaneous (SC) injection of the matching placebo
- Single dose on Day 1
干预措施: Placebo (Drug)
BxC-I17e (Multiple Dose)
Experimental
- Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e
- 4 doses on Day 1, 15, 29, and 43
干预措施: BxC-I17e (primed iMSC derived Extracellular vesicles(EV)) (Drug)
Placebo (Multiple Dose)
Placebo Comparator
- Subcutaneous (SC) injection of the matching placebo
- 4 doses on Day 1, 15, 29, and 43
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Baseline to Week 26
Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0
次要结局
- Number of abnormalities in 12-lead electrocardiogram (ECG)(Baseline to Week 26)
- Change and percent change in Body Surface Area (BSA)(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
- Number of abnormalities in clinical laboratory parameter(Baseline to Week 26)
- Number of abnormalities and change from baseline in Vital signs(Baseline to Week 26)
- Incidence, severity and relationship of adverse events(AEs)(Baseline to Week 26)
- Frequency and proportion of clinically significant finding of physical examination(Baseline to Week 26)
- Change and percent change in Scoring Atopic Dermatitis (SCORAD)(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
- Change and percent change in Patient-Oriented Eczema Measure (POEM)(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
- Change and percent change in Eczema Area and Severity Index (EASI)(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
- Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
- Change and percent change in Pruritus Numerical Rating Scale (NRS)(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
- Change and percent change in Dermatology Life Quality Index (DLQI)(Baseline to Week 8 (single dose) or Week 14 (multiple dose))
研究者
研究点 (3)
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