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    Clinical Trial Results:
    A Phase 3, Multicenter, Open-Label Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Subjects With Mild to Moderate Atopic Dermatitis (AD)

    Summary
    EudraCT number
    		 2021-001266-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Dec 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Oct 2021
    First version publication date
    30 Jun 2021
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    C3291027
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04498403
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 JapicCTI: JapicCTI-205464
    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)
    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
    27 Apr 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To study the safety of crisaborole ointment, 2% applied twice daily (BID) in Japanese pediatric and adult subjects with mild to moderate AD
    Protection of trial subjects
    The study was conducted 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
    14 Sep 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 40
    Worldwide total number of subjects
    40
    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)
    0
    Children (2-11 years)
    22
    Adolescents (12-17 years)
    8
    Adults (18-64 years)
    10
    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 Japan from 14 September 2020 to 18 December 2020. A total of 40 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
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: Crisaborole 2%, Age group: Less than (<) 18 Years
    Arm description
    		 Subjects aged < 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Subjects were followed up to at least 28 days after last dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Crisaborole
    Investigational medicinal product code
    PF-06930164
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received crisaborole topical ointment, 2 % to treatment targeted lesions, twice daily.

    Arm title
    		 Cohort 2: Crisaborole 2%, Age group: >= 18 Years
    Arm description
    		 Subjects aged >= 18 years with mild to moderate AD received crisaborole ointment, 2 ) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Subjects were followed up to at least 28 days after last dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Crisaborole
    Investigational medicinal product code
    PF-06930164
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received crisaborole topical ointment, 2 % to treatment targeted lesions, twice daily.

    Number of subjects in period 1
    		Cohort 1: Crisaborole 2%, Age group: Less than (<) 18 Years Cohort 2: Crisaborole 2%, Age group: >= 18 Years
    Started
    30
    10
    Completed Follow up
    30
    10
    Completed
    0
    0
    Not completed
    30
    10
         Study Terminated By Sponsor
    29
    10
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Crisaborole 2%, Age group: Less than (<) 18 Years
    Reporting group description
    		 Subjects aged < 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Subjects were followed up to at least 28 days after last dose of study drug.

    Reporting group title
    Cohort 2: Crisaborole 2%, Age group: >= 18 Years
    Reporting group description
    		 Subjects aged >= 18 years with mild to moderate AD received crisaborole ointment, 2 ) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Subjects were followed up to at least 28 days after last dose of study drug.

    Reporting group values
    		 Cohort 1: Crisaborole 2%, Age group: Less than (<) 18 Years Cohort 2: Crisaborole 2%, Age group: >= 18 Years Total
    Number of subjects
    		 30 10 40
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 22 0 22
        Adolescents (12-17 years)
    		 8 0 8
        Adults (18-64 years)
    		 0 10 10
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 9.3 ± 3.99 31.8 ± 7.97 -
    Sex: Female, Male
    Units: Subject
        Female
    		 15 4 19
        Male
    		 15 6 21
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 30 10 40
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 0 0 0
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 30 10 40
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Crisaborole 2%, Age group: Less than (<) 18 Years
    Reporting group description
    		 Subjects aged < 18 years with mild to moderate atopic dermatitis (AD) received crisaborole ointment, 2 percent (%) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Subjects were followed up to at least 28 days after last dose of study drug.

    Reporting group title
    Cohort 2: Crisaborole 2%, Age group: >= 18 Years
    Reporting group description
    		 Subjects aged >= 18 years with mild to moderate AD received crisaborole ointment, 2 ) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Subjects were followed up to at least 28 days after last dose of study drug.

    Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [1]
    End point description
    An adverse events (AE) is any untoward medical occurrence in clinical investigation subject administered a product or medical device; event need not necessarily to have a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. Safety population included all subjects who took at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
    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 analysed for this endpoint
    End point values
    		 Cohort 1: Crisaborole 2%, Age group: Less than (<) 18 Years Cohort 2: Crisaborole 2%, Age group: >= 18 Years
    Number of subjects analysed
    30
    10
    Units: Subjects
        TEAEs
    11
    3
        SAEs
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Cohort 2: Crisaborole 2%, Age group: >= 18 Years
    Reporting group description
    		 Subjects aged >= 18 years with mild to moderate AD received crisaborole ointment, 2 ) on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Subjects were followed up to at least 28 days after last dose of study drug.

    Reporting group title
    Cohort 1: Crisaborole 2%, Age group: Less than (<) 18 Years
    Reporting group description
    		 Subjects aged < 18 years with mild to moderate AD received crisaborole ointment, 2 % on treatable AD lesions, twice daily. Treatable AD lesions were identified at Baseline (Day 1) by investigator. Subjects were followed up to at least 28 days after last dose of study drug.

    Serious adverse events
    		 Cohort 2: Crisaborole 2%, Age group: >= 18 Years Cohort 1: Crisaborole 2%, Age group: Less than (<) 18 Years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cohort 2: Crisaborole 2%, Age group: >= 18 Years Cohort 1: Crisaborole 2%, Age group: Less than (<) 18 Years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    11 / 30 (36.67%)
    Injury, poisoning and procedural complications
    Wound
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Dermatitis atopic
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Dermatitis contact
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Joint effusion
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Molluscum contagiosum
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    5
    Otitis media acute
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Subjects were planned to be followed up to Week 56, however due to early termination of the study, subjects were followed up to only Week 12.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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