A PHASE 4, MULTICENTER, OPEN-LABEL SAFETY STUDY OF CRISABOROLE OINTMENT 2% IN CHILDREN AGED 3 MONTHS TO LESS THAN 24 MONTHS WITH MILD TO MODERATE ATOPIC DERMATITIS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 137
- 试验地点
- 32
- 主要终点
- Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria
研究概览
简要总结
This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.
详细描述
Approximately 125 subjects will be enrolled. Subjects must have mild-to-moderate AD involving at least 5% treatable %BSA assessed on Baseline/Day 1. Treatable %BSA will be defined as the percent of a subject's total body surface area that is AD-involved, excluding the scalp.
In addition, a cohort of at least 16 of the 125 subjects will be included in a subgroup for PK assessment. These subjects must have moderate AD and a minimum of 35% treatable %BSA, excluding the scalp, and must complete all PK assessments to be included in the PK analysis. Of these subjects, at least 3 subjects who are less than 9 months of age will be enrolled. Subjects discontinuing for reasons other than treatment emergent adverse event ( TEAE) may be replaced at the discretion of the sponsor to ensure 16 subjects complete the PK assessments. Only selected study sites will participate in the PK assessment.
Scheduled study visits/telephone contacts for all subjects will occur at Screening (up to 28 days prior to Baseline/Day 1), Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (end of treatment/early termination), Day 36, and Day 57 (end of study).
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
入排标准
- 年龄范围
- 3 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD
排除标准
- •Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)
研究组 & 干预措施
Crisaborole ointment 2%
Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment.
干预措施: Crisaborole ointment 2% (Drug)
结局指标
主要结局
Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria
时间窗: Baseline (Day 1) up to Day 29 (end of treatment)
Body temperature of participants was measured in degree Celsius. The normal body temperature value was \>= 39 degree Celsius.
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria
时间窗: Baseline (Day 1) up to Day 29 (end of treatment)
ECG of participants was measured in terms of millisecond (msec). ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Fridericia's formula (QTcF). ECG values meeting pre-defined criteria were 1) PR interval: greater than equal to (\>=) 25 percent (%) increase when baseline greater than (\>)200 milliseconds (msec); or increase \>=50% when baseline less than or equal to (\<=200) msec; 2) QRS interval: \>=25% increase when baseline \>100 msec; \>=50% increase when baseline \<= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) \> 30 msec. IFB stands for increase from baseline.
Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria
时间窗: Baseline (Day 1) up to Day 29 (end of treatment)
Criteria: hematology: hemoglobin, hematocrit, erythrocytes \< 0.8\*lower limit of normal (LLN), platelets \<0.5\*LLN \>1.75\*upper limit of normal (ULN), leukocytes \<0.6\* LLN \>1.5\* ULN, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes \<0.8\* LLN \>1.2\* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes \>1.2\*ULN. Clinical chemistry: bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3.0\*ULN, protein, albumin \<0.8\* LLN \>1.2\* ULN, blood urea nitrogen, creatinine \>1.3\* ULN, sodium \<0.95\*LLN \>1.05\*ULN, potassium, chloride, bicarbonate \<0.9\* LLN \>1.1\* ULN, glucose \<0.6\*LLN \>1.5\*ULN.
Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria
时间窗: Baseline (Day 1) up to Day 29 (end of treatment)
Height of participants was measured in terms of centimeter (cm). The pre-defined criteria for measuring the height was less than (\<) 55 cm and greater than (\>) 92.5 cm.
Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria
时间窗: Baseline (Day 1) up to Day 29 (end of treatment)
Weight of participants was measured in terms of kilogram (kg). The pre-defined criteria of measuring the weight of participants was less than equal to (\<=) 4.5 kg and \>15 kg.
Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria
时间窗: Baseline (Day 1) up to Day 29 (end of treatment)
Respiratory rate was measured in terms of number of breaths per minute. The pre-defined criteria of measuring the respiratory rate of participants was \< 22 breaths per min and \> 53 breaths per min.
Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria
时间窗: Baseline (Day 1) up to Day 29 (end of treatment)
Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) of participants was measured in terms of millimeters of mercury (mmHg). The clinically significant pre-defined criteria were, SBP: change of greater than equal to (\>=) 30 mmHg increase from baseline (IFB) and SBP change of \>= 30 mmHg decrease from baseline (DFB); DBP: change of \>=20 mmHg IFB and DBP change of \>=20 mmHg DFB.
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions
时间窗: Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Site reactions are reactions which occurred in participants at the site of application of investigational product.
Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria
时间窗: Baseline (Day 1) up to Day 29 (end of treatment)
Pulse rate of participants was measured in terms of beats per minute (bpm). The pre-defined criteria of measuring the pulse rate of participants was \<90 bpm and \>180 bpm.
次要结局
未报告次要终点