A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03356977

Enrollment

137

Registered

2017-11-29

Start date

2018-01-16

Completion date

2019-04-12

Last updated

2019-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

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.

Detailed description

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).

Interventions

DRUGCrisaborole ointment 2%

Applied BID

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Months to 23 Months

Healthy volunteers

Inclusion criteria

Aged ≥ 3 months at the screening visit to \< 24 months on baseline/Day 1, diagnosed with AD

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions	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 Height Values Meeting Pre-defined Criteria	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	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 Blood Pressure Values Meeting Pre-defined Criteria	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 Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria	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.
Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria	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 Body Temperature Values Meeting Pre-defined Criteria	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	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	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.

Countries

Australia, Canada, United States

Participant flow

Participants by arm

Arm	Count
Crisaborole Topical Ointment, 2 Percent Participants with mild to moderate AD received crisaborole ointment, 2 percent on treatable AD lesions, twice daily from Day 1 to Day 29. Treatable AD lesions were identified at Baseline (Day 1) by investigator.	137
Total	137

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	3
Overall Study	Withdrawal by parent/guardian	2

Baseline characteristics

Characteristic	Crisaborole Topical Ointment, 2 Percent
Age, Continuous	13.6 months STANDARD_DEVIATION 6.42
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	118 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	27 Participants
Race (NIH/OMB) Black or African American	11 Participants
Race (NIH/OMB) More than one race	13 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	84 Participants
Sex: Female, Male Female	49 Participants
Sex: Female, Male Male	88 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 137
other Total, other adverse events	41 / 137
serious Total, serious adverse events	1 / 137

Outcome results

Primary

Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria

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.