An Open-label, Multicenter, Phase Ib Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects Aged 2 to 17 Years With Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AOBiome LLC
- 入组人数
- 28
- 试验地点
- 12
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)as Assessed by CTCAE v4.0
研究概览
简要总结
An open-label, multicenter, Phase Ib study of B244 delivered as a topical spray to assess safety in pediatric subjects aged 2 to 17 years with atopic dermatitis
Condition or disease Intervention/treatment Phase Atopic Dermatitis (Eczema) Biological: B244 Phase 1b
详细描述
This is a Phase 1b, open-label, single arm, multiple site study assessing twice daily B244 application for 28 days in pediatric subjects with mild to moderate atopic dermatitis.
Number of Subjects:
The study will enroll 36 subjects in 3 cohorts of 12 subjects:
- Cohort 1: subjects aged 2 to 5 years.
- Cohort 2: subjects aged 6 to 11 years.
- Cohort 3, subjects aged 12 to 17 years.
At Screening and Baseline, all subjects must have confirmed diagnosis of atopic dermatitis, as defined by the Hanifin and Rajka criteria, which involves a minimum of 10% but no more than 60% body surface area and a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scale of 2 or 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is a single arm open label study. Subjects will be assigned to the study treatment arm. Each participant will be scheduled to receive investigational product (IP).
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible to be included in the study only if all of the following criteria apply:
- •Male and female subjects 2 to 17 years of age, inclusive.
- •Confirmed diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria.
- •A minimum of 10% but no more than 60% of the subjects' body surface area (see Appendix 6 for guidance) is affected by atopic dermatitis (affected is defined by physical examination findings: erythema, edema, scaling, lichenification, and excoriation; with the excoriation serving as the physical examination correlate of pruritus).
- •A vIGA-AD scale of 2 or 3 at Screening and Baseline.
- •Subject, or the parent or guardian, to provide written informed consent and authorization for protected health information disclosure.
- •Subjects must be generally in good health based on Investigator's assessment (other than atopic dermatitis).
- •Normal vital signs, or with no clinically significant vital signs that in the opinion of the Investigator, would place the subject at increased risk or would confound the objectives of the study.
- •Females must not be pregnant, as confirmed by negative urine pregnancy testing. Female subjects aged ≥11 years old, or female patients <11 years old who have started menstruating, will have urinary pregnancy test performed at Screening and prior to the first dose with negative results in order to participate in the study. Females must either practice abstinence from heterosexual contact or use one of the highly effective contraceptive options described in the Appendix
- •Male subjects of reproductive potential, must be willing to practice effective contraception during the study while receiving study treatment from Day 1 and for 7 days after the last study visit (Day 28).
- •Ability to comprehend and comply with study procedures.
- •Agree to commit to participate in the current protocol.
- •Provide written informed consent prior to any study procedure being performed.
排除标准
- •Subjects are excluded from the study if any of the following criteria apply:
- •Clinically significant physical or mental disorder which, in the opinion of the Investigator, would place the subject at increased risk or would confound the objectives of the study.
- •Subjects with atopic dermatitis on the face only.
- •Active cutaneous bacterial, viral or fungal infection in any treatment area at Baseline (eg, clinically infected atopic dermatitis).
- •History or presence of immunological deficiencies or diseases, organ transplant, human immunodeficiency virus (HIV), diabetes, malignancy, malignant or pre-malignant skin conditions, serious active or recurrent infection, systemic immunosuppressive regimens, clinically significant renal disease severe hepatic disorders, or other severe uncontrolled conditions (eg, drug or alcohol abuse), that are significant and/or that may pose a health risk to the subject in the study or may have an impact on the study assessments.
- •Unstable atopic dermatitis or a consistent requirement for high-potency corticosteroids (class I-III steroids).
- •Active systemic or localized infection (including infected AD).
- •Subjects unable to comply with the excluded medication/therapy restriction
- •Known hypersensitivity to the study treatment.
- •Known to have hepatitis B, hepatitis C or HIV I or II tests. Details will be recorded in medical history, a blood sample will not be collected for confirmation.
- •Female subject who is pregnant, breastfeeding, or considering pregnancy during the study.
- •Any skin condition which in the Investigator's opinion may interfere with the evaluation of atopic dermatitis.
- •Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than 5 times the drug's half-life, whichever is longer.
- •Use of any biologic within a period of 5 times its half-life.
- •Children or relatives of the Sponsor, clinical research organization, or the Study Site personnel are excluded from participating in the study.
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAEs)as Assessed by CTCAE v4.0
时间窗: Baseline to Day 28
Safety and tolerability endpoints will consist of all adverse events reporting from Baseline to Day 28.
Number of Participants With Clinically Significant Changes From Baseline in Physical Exam.
时间窗: Baseline to Day 28
A physical exam will be conducted by a physician assessing systems (General appearance, Dermatological, Musculoskeletal, Thyroid, HEENT \[Head, eyes, ears, nose, throat\], Lymphatic, Respiratory, Gastrointestinal, Cardiovascular, Neurological, Extremities, and other). Clinical significance of the physical exam will be determined at investigator's discretion. Results for each system were assessed as Normal, Abnormal CS (clinically significant), or Abnormal NCS (not clinically significant) and shift was analyzed from Baseline to Day 28.
Mean Change in Pulse Rate From Baseline at Day 28
时间窗: Baseline to Day 28
Pulse rate (beats per minute \[bpm\]) will be obtained. Clinical significance of pulse rate will be determined at the investigator's discretion. Change from Day 28 to Baseline.
Mean Change in Body Temperature From Baseline at Day 28
时间窗: Baseline to Day 28
Body temperature (°C) will be obtained. Clinical significance of body temperature will be determined at the investigator's discretion. Change from Day 28 to Baseline.
Mean Change in Blood Pressure From Baseline at Day 28
时间窗: Baseline to Day 28
Blood pressure will be obtained (mmHg). Clinical significance of blood pressure will be determined at the investigator's discretion. Change from Day 28 to Baseline.
次要结局
未报告次要终点