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    Clinical Trial Results:
    A Phase 4, Multicenter, Open-Label Safety Study of Crisaborole Ointment 2% in Children Aged 3 Months to Less Than 24 Months Wth Mild to Moderate Atopic Dermatitis (AD)

    Summary
    EudraCT number
    		 2019-002836-10
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2019
    First version publication date
    04 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C3291002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03356977
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Apr 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the safety of crisaborole ointment 2% applied twice daily (BID) in children aged 3 months to less than 24 months with mild to moderate AD
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jan 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 15
    Country: Number of subjects enrolled
    Canada: 10
    Country: Number of subjects enrolled
    United States: 112
    Worldwide total number of subjects
    137
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    137
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was conducted in the 3 countries from 16 January 2018 to 12 April 2019. A total of 137 subjects were enrolled.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Crisaborole Topical Ointment, 2 Percent
    Arm description
    		 Subjects with mild to moderate atopic dermatitis (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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Crisaborole Topical Ointment, 2%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Crisaborole topical ointment, 2 percent to treatment targeted lesions, twice daily from Day 1 to Day 29.

    Number of subjects in period 1
    		Crisaborole Topical Ointment, 2 Percent
    Started
    137
    Completed
    132
    Not completed
    5
         WITHDRAWAL BY PARENT/GUARDIAN
    2
         Lost to follow-up
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Crisaborole Topical Ointment, 2 Percent
    Reporting group description
    		 Subjects with mild to moderate atopic dermatitis (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.

    Reporting group values
    		 Crisaborole Topical Ointment, 2 Percent Total
    Number of subjects
    		 137 137
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 137 137
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 13.6 ( 6.42 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 49 49
        Male
    		 88 88
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 1
        Asian
    		 27 27
        Native Hawaiian or Other Pacific Islander
    		 1 1
        Black or African American
    		 11 11
        White
    		 84 84
        More than one race
    		 13 13
        Unknown or Not Reported
    		 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 16 16
        Not Hispanic or Latino
    		 118 118
        Unknown or Not Reported
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Crisaborole Topical Ointment, 2 Percent
    Reporting group description
    		 Subjects with mild to moderate atopic dermatitis (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.

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

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions [1]
    End point description
    An AE was any untoward medical occurrence in a subject 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. 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 subjects at the site of application of investigational product. Safety analysis set included any subject who received at least 1 dose of investigational product.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Crisaborole Topical Ointment, 2 Percent
    Number of subjects analysed
    137
    Units: subjects
        AEs
    88
        SAEs
    1
        Application site Reactions
    15
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Height Values Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects With Clinically Significant Height Values Meeting Pre-defined Criteria [2]
    End point description
    Height of subjects 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. Safety analysis set included any subject who received at least 1 dose of investigational product. . Here, “Number of Subjects Analysed" signifies subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to Day 29 (end of treatment)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Crisaborole Topical Ointment, 2 Percent
    Number of subjects analysed
    134
    Units: subjects
        < 55 cm
    0
        > 92.5 cm
    3
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Weight Values Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects With Clinically Significant Weight Values Meeting Pre-defined Criteria [3]
    End point description
    Weight of subjects was measured in terms of kilogram (kg). The pre-defined criteria of measuring the weight of subjects was less than equal to (<=) 4.5 kg and >15 kg. Safety analysis set included any subject who received at least 1 dose of investigational product. Here, "Number of Subjects Analysed" signifies subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to Day 29 (end of treatment)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Crisaborole Topical Ointment, 2 Percent
    Number of subjects analysed
    135
    Units: subjects
        <= 4.5 kg
    0
        > 15 kg
    3
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria [4]
    End point description
    Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) of subjects 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. Safety analysis set included any subject who received at least 1 dose of investigational product. Here, "Number of Subjects Analysed" signifies subjects who were evaluable for this endpoint and "n" signifies subjects evaluable for specific rows.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to Day 29 (end of treatment)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Crisaborole Topical Ointment, 2 Percent
    Number of subjects analysed
    136
    Units: subjects
        SBP:change of>=30 mmHg IFB (n= 136)
    3
        SBP:change of>=30 mmHg DFB (n=136)
    4
        DSBP: change of >= 20 mmHg IFB (n=135)
    8
        DSBP: change of >= 20 mmHg DFB (n=135)
    18
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria [5]
    End point description
    Pulse rate of subjects was measured in terms of beats per minute (bpm). The pre-defined criteria of measuring the pulse rate of subjects was <90 bpm and >180 bpm. Safety analysis set included any subject who received at least 1 dose of investigational product.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to Day 29 (end of treatment)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Crisaborole Topical Ointment, 2 Percent
    Number of subjects analysed
    137
    Units: subjects
        <90 bpm
    12
        >180 bpm
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria [6]
    End point description
    Respiratory rate was measured in terms of number of breaths per minute. The pre-defined criteria of measuring the respiratory rate of subjects was < 22 breaths per min and > 53 breaths per min. Safety analysis set included any subject who received at least 1 dose of investigational product.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1), Day 8, Day 15, Day 29 (end of treatment)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Crisaborole Topical Ointment, 2 Percent
    Number of subjects analysed
    137
    Units: subjects
        < 22 breaths per minute
    17
        > 53 breaths per minute
    4
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria [7]
    End point description
    Body temperature of subjects was measured in degree Celsius. The normal body temperature value was >= 39 degree Celsius. Safety analysis set included any subject received at least 1 dose of investigational product.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to Day 29 (end of treatment)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Crisaborole Topical Ointment, 2 Percent
    Number of subjects analysed
    137
    Units: subjects
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria [8]
    End point description
    ECG of subjects 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. Safety analysis set included any subject who received at least 1 dose of investigational product. Here, “Number of Subjects Analysed" signifies subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to Day 29 (end of treatment)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Crisaborole Topical Ointment, 2 Percent
    Number of subjects analysed
    135
    Units: subjects
        PR Interval: > 200 msec and >=25% IFB
    0
        PR Interval: <= 200 msec and >=50% IFB
    1
        QRS Duration: < 100 msec and >= 50% IFB
    0
        QRS Duration: >= 100 msec and >= 25% IFB
    0
        QTcF Interval: >30 msec
    10
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria

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    End point title
    		 Number of Subjects With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria [9]
    End point description
    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. Safety analysis set included any subject who received >=1 dose of investigational product. Here, "Number of Subjects Analysed" signifies subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to Day 29 (end of treatment)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Crisaborole Topical Ointment, 2 Percent
    Number of subjects analysed
    122
    Units: subjects
    105
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)
    Adverse event reporting additional description
    Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Crisaborole Topical Ointment, 2 Percent
    Reporting group description
    		 Subjects 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.

    Serious adverse events
    		 Crisaborole Topical Ointment, 2 Percent
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 137 (0.73%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 137 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Crisaborole Topical Ointment, 2 Percent
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 137 (29.93%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    13 / 137 (9.49%)
         occurrences all number
    13
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 137 (7.30%)
         occurrences all number
    10
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 137 (5.11%)
         occurrences all number
    7
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    9 / 137 (6.57%)
         occurrences all number
    9
    Dermatitis diaper
         subjects affected / exposed
    9 / 137 (6.57%)
         occurrences all number
    9
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 137 (7.30%)
         occurrences all number
    10

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 May 2018
    Added that any subject with a new or ongoing adverse event at the time of the Day 57 (end of study) follow-up contact, should be seen in the clinic for evaluation of that adverse event.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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