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    Clinical Trial Results:
    A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Mechanism of Action of Ruxolitinib Cream for Vitiligo (TRuE-V MOA)

    Summary
    EudraCT number
    		 2021-000361-32
    Trial protocol
    		 FR  
    Global end of trial date
    10 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 May 2024
    First version publication date
    17 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INCB 18424-214
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cutoff Drive, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the mechanism of action (MOA) of ruxolitinib cream in vitiligo by assessing change in biomarkers.
    Protection of trial subjects
    This study was to be performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws and country-specific regulations in which the study was being conducted
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jun 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 28
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    United States: 27
    Worldwide total number of subjects
    60
    EEA total number of subjects
    5
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    55
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study was conducted at a total of 11 sites in Canada, France, and the United States.

    Period 1
    Period 1 title
    24-Week Double-Blind Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Double-Blind Period: Ruxolitinib cream 1.5% BID
    Arm description
    		 Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ruxolitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    1.5% cream twice daily

    Arm title
    		 Double-Blind Period: Vehicle cream BID
    Arm description
    		 Participants applied matching vehicle cream BID for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    twice daily

    Number of subjects in period 1
    		Double-Blind Period: Ruxolitinib cream 1.5% BID Double-Blind Period: Vehicle cream BID
    Started
    41
    19
    Completed
    37
    14
    Not completed
    4
    5
         Consent withdrawn by subject
    2
    2
         Lost to follow-up
    2
    3
    Period 2
    Period 2 title
    28-Week Treatment-Extension Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment-Extension (TE) Period: Ruxolitinib cream 1.5% BID
    Arm description
    		 Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ruxolitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    1.5% cream twice daily

    Arm title
    		 TE Period: Vehicle cream to Ruxolitinib cream 1.5% BID
    Arm description
    		 Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ruxolitinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    1.5% cream twice daily

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    twice daily

    Number of subjects in period 2
    		Treatment-Extension (TE) Period: Ruxolitinib cream 1.5% BID TE Period: Vehicle cream to Ruxolitinib cream 1.5% BID
    Started
    37
    14
    Completed
    27
    9
    Not completed
    10
    5
         Consent withdrawn by subject
    1
    1
         Pregnancy
    1
    -
         Participant Refused Safety Follow-up
    3
    2
         Lost to follow-up
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Double-Blind Period: Ruxolitinib cream 1.5% BID
    Reporting group description
    		 Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.

    Reporting group title
    Double-Blind Period: Vehicle cream BID
    Reporting group description
    		 Participants applied matching vehicle cream BID for 24 weeks.

    Reporting group values
    		 Double-Blind Period: Ruxolitinib cream 1.5% BID Double-Blind Period: Vehicle cream BID Total
    Number of subjects
    		 41 19 60
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 37 18 55
        From 65-84 years
    		 4 1 5
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.1 ( 12.73 ) 43.7 ( 13.16 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 18 8 26
        Male
    		 23 11 34
    Race/Ethnicity, Customized
    Units: Subjects
        White/Caucasian
    		 25 13 38
        Black/African-American
    		 4 2 6
        Asian
    		 5 3 8
        Native Hawaiian/Pacific Islander
    		 1 0 1
        Not Reported
    		 5 0 5
        South Asian
    		 1 0 1
        Middle Eastern
    		 0 1 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 8 4 12
        Not Hispanic or Latino
    		 30 14 44
        Unknown or Not Reported
    		 3 1 4
    Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an immune biomarker
    Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug.
    Units: nanograms per Liter (ng/L)
        arithmetic mean (standard deviation)
    		 600.066 ( 959.3097 ) 415.471 ( 177.4902 ) -

    End points

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    End points reporting groups
    Reporting group title
    Double-Blind Period: Ruxolitinib cream 1.5% BID
    Reporting group description
    		 Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.

    Reporting group title
    Double-Blind Period: Vehicle cream BID
    Reporting group description
    		 Participants applied matching vehicle cream BID for 24 weeks.
    Reporting group title
    Treatment-Extension (TE) Period: Ruxolitinib cream 1.5% BID
    Reporting group description
    		 Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.

    Reporting group title
    TE Period: Vehicle cream to Ruxolitinib cream 1.5% BID
    Reporting group description
    		 Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.

    Primary: Percentage change from Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an immune biomarker, at Week 4, Week 12, and Week 24

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    End point title
    		 Percentage change from Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an immune biomarker, at Week 4, Week 12, and Week 24 [1]
    End point description
    Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. Percentage change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] / Baseline value)*100.
    End point type
    Primary
    End point timeframe
    Baseline; Week 4, Week 12, and Week 24
    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: Statistical analysis was not conducted for this endpoint.
    End point values
    		 Double-Blind Period: Ruxolitinib cream 1.5% BID Double-Blind Period: Vehicle cream BID
    Number of subjects analysed
    39 [2]
    16 [3]
    Units: percent change
    arithmetic mean (standard deviation)
        Week 4, n=39, 16
    -20.93 ( 36.216 )
    8.13 ( 52.491 )
        Week 12, n=37, 14
    -18.33 ( 40.035 )
    21.13 ( 70.690 )
        Week 24, n=35, 14
    -12.92 ( 46.146 )
    22.17 ( 68.893 )
    Notes
    [2] - Only participants with available data were analyzed.
    [3] - Only participants with available data were analyzed.
    No statistical analyses for this end point

    Secondary: Correlation of key skin inflammatory biomarkers of vitiligo in target lesions to efficacy readouts at Week 12 and Week 24

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    End point title
    		 Correlation of key skin inflammatory biomarkers of vitiligo in target lesions to efficacy readouts at Week 12 and Week 24
    End point description
    Clinical scores (facial Vitiligo Area Scoring Index [F-VASI] and total body Vitiligo Area Scoring Index [T-VASI]) were evaluated for correlation with skin CXCL10 levels.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, and Week 24
    End point values
    		 Double-Blind Period: Ruxolitinib cream 1.5% BID Double-Blind Period: Vehicle cream BID
    Number of subjects analysed
    38 [4]
    17 [5]
    Units: correlation coefficient
    number (not applicable)
        F-VASI
    -0.34
    0.15
        T-VASI
    -0.43
    0.02
    Notes
    [4] - Participants with values at each of 3 timepoints (Baseline, Week 12, and Week 24) were analyzed.
    [5] - Participants with values at each of 3 timepoints (Baseline, Week 12, and Week 24) were analyzed.
    No statistical analyses for this end point

    Secondary: Number of participants with treatment-emergent adverse events (TEAEs) during the Double-Blind Period

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    End point title
    		 Number of participants with treatment-emergent adverse events (TEAEs) during the Double-Blind Period
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
    End point type
    Secondary
    End point timeframe
    from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)
    End point values
    		 Double-Blind Period: Ruxolitinib cream 1.5% BID Double-Blind Period: Vehicle cream BID
    Number of subjects analysed
    41
    19
    Units: participants
    19
    7
    No statistical analyses for this end point

    Secondary: Number of participants with TEAEs during the Treatment-Extension Period

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    End point title
    		 Number of participants with TEAEs during the Treatment-Extension Period
    End point description
    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
    End point type
    Secondary
    End point timeframe
    from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days
    End point values
    		 Treatment-Extension (TE) Period: Ruxolitinib cream 1.5% BID TE Period: Vehicle cream to Ruxolitinib cream 1.5% BID
    Number of subjects analysed
    37
    14
    Units: participants
    12
    3
    No statistical analyses for this end point

    Secondary: Number of participants with a Grade 3 or higher TEAE during the Double-Blind Period

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    End point title
    		 Number of participants with a Grade 3 or higher TEAE during the Double-Blind Period
    End point description
    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. AE severity was assessed per the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal.
    End point type
    Secondary
    End point timeframe
    from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)
    End point values
    		 Double-Blind Period: Ruxolitinib cream 1.5% BID Double-Blind Period: Vehicle cream BID
    Number of subjects analysed
    41
    19
    Units: participants
    1
    0
    No statistical analyses for this end point

    Secondary: Number of participants with a Grade 3 or higher TEAE during the Treatment-Extension Period

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    End point title
    		 Number of participants with a Grade 3 or higher TEAE during the Treatment-Extension Period
    End point description
    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. AE severity was assessed per the CTCAE, version 5.0: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal.
    End point type
    Secondary
    End point timeframe
    from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 days
    End point values
    		 Treatment-Extension (TE) Period: Ruxolitinib cream 1.5% BID TE Period: Vehicle cream to Ruxolitinib cream 1.5% BID
    Number of subjects analysed
    37
    14
    Units: participants
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
    Adverse event reporting additional description
    For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Ruxolitinib cream 1.5% BID
    Reporting group description
    		 Participants applied ruxolitinib cream during the Double-Blind Treatment Period and the Treatment-Extension Period. Participants applied ruxolitinib 1.5% cream BID for 24 weeks. Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.

    Reporting group title
    Vehicle cream BID
    Reporting group description
    		 Participants applied matching vehicle cream twice a day (BID) for 24 weeks in the Double-Blind Period.

    Serious adverse events
    		 Ruxolitinib cream 1.5% BID Vehicle cream BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 19 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ruxolitinib cream 1.5% BID Vehicle cream BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 55 (18.18%)
    7 / 19 (36.84%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Application site exfoliation
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    9 / 55 (16.36%)
    2 / 19 (10.53%)
         occurrences all number
    9
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 19 (5.26%)
         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.
    None reported
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    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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