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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Crisaborole ointment 2%

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

3 Months - 23 Months (Child)All SexesDoes not accept 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)

Sites / Locations

Burke Pharmaceutical Research
Rady Children's Hospital - San Diego/University of California, San Diego
Rady Children's Hospital
University of California, San Francisco
IMMUNOe Research Centers
Baumann Cosmetic and Research Institute
DS Research
Craig A. Spiegel, M.D.
Skin Specialists, PC
Ohio Pediatric Research Association, Inc.
Oklahoma State University - Center for Health Sciences
Oregon Health & Science University
Penn State Hershey Medical Center
DermResearch, Inc.
Texas Dermatology and Laser Specialists
Tanner Clinic
Jordan Valley Dermatology Center
Timber Lane Allergy & Asthma Research, LLC
PI-Coor Clinical Research, LLC
Pediatric Associates of Charlottesville, PLC
Pediatric Research of Charlottesville, LLC (Regulatory Only)
Pediatric Research of Charlottesville, LLC
Dermatology Specialists of Spokane
Australian Clinical Research Network Pty Ltd
The Skin Centre
Veracity Clinical Research
Eastern Health
Sinclair Dermatology
The Royal Children's Hospital
Stollery Children's Hospital
Lynderm Research Inc.
SKiN Centre for Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Crisaborole ointment 2%

Arm Description

Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions

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

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

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

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

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

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

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

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03356977

First Posted

October 31, 2017

Last Updated

September 20, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03356977

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

January 16, 2018 (Actual)

Primary Completion Date

April 12, 2019 (Actual)

Study Completion Date

April 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

137 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Crisaborole ointment 2%

Arm Type

Experimental

Arm Description

Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment.

Intervention Type

Drug

Intervention Name(s)

Crisaborole ointment 2%

Other Intervention Name(s)

Eucrisa

Intervention Description

Applied BID

Primary Outcome Measure Information:

Title

Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions

Description

Time Frame

Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)

Title

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

Description

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.

Time Frame