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    Clinical Trial Results:
    A Phase 2a Study to Evaluate Safety, Tolerability, and Efficacy of PRCL-02 in Patients with Moderate to Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    		 2018-001216-29
    Trial protocol
    		 SK  
    Global end of trial date
    08 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Oct 2021
    First version publication date
    03 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PRCL-PoC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03614078
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    PRCL Research Inc
    Sponsor organisation address
    1255 Robert-Bourassa #1610, Montreal, Canada, H3B 3X3
    Public contact
    Jurij Khrustalev, SanaClis TOV, +38 067504 36 00, jurij.khrustalev@sanaclis.eu
    Scientific contact
    Jurij Khrustalev, SanaClis TOV, +38 067504 36 00, jurij.khrustalev@sanaclis.eu
    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
    08 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of PRCL-02 after 12 weeks of once-daily oral dosing in subjects with moderate to severe chronic plaque psoriasis.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Sep 2018
    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
    Slovakia: 36
    Country: Number of subjects enrolled
    Canada: 22
    Country: Number of subjects enrolled
    Ukraine: 34
    Worldwide total number of subjects
    92
    EEA total number of subjects
    36
    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)
    88
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of the 92 subjects who were randomly assigned to study treatment, 77 completed the study, and 15 did not complete the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PRCL-02 25 milligrams (mg)
    Arm description
    		 Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    PRCL-02
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Loading dose followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks

    Arm title
    		 PRCL-02 50 mg
    Arm description
    		 Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    PRCL-02
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Loading dose followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks

    Arm title
    		 Placebo
    Arm description
    		 Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks

    Number of subjects in period 1
    		PRCL-02 25 milligrams (mg) PRCL-02 50 mg Placebo
    Started
    31
    30
    31
    Completed
    28
    23
    26
    Not completed
    3
    7
    5
         Consent withdrawn by subject
    2
    2
    3
         High neutrophils
    -
    -
    2
         Participant did not return for visit
    -
    1
    -
         Adverse event, non-fatal
    -
    2
    -
         Dizziness and rash
    -
    1
    -
         Exacerbation of Psoriasis
    -
    1
    -
         Participant did not meet elgibility
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PRCL-02 25 milligrams (mg)
    Reporting group description
    		 Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks

    Reporting group title
    PRCL-02 50 mg
    Reporting group description
    		 Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks

    Reporting group values
    		 PRCL-02 25 milligrams (mg) PRCL-02 50 mg Placebo Total
    Number of subjects
    		 31 30 31 92
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 30 29 29 88
        From 65-84 years
    		 1 1 2 4
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 14 11 8 33
        Male
    		 17 19 23 59
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0
        Not Hispanic or Latino
    		 31 30 31 92
        Unknown or Not Reported
    		 0 0 0 0
    Race
    Units: Subjects
        Asian
    		 1 1 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 27 29 31 87
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 2 0 0 2
        American Indian or Alaska Native
    		 1 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    PRCL-02 25 milligrams (mg)
    Reporting group description
    		 Loading dose of 150 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks

    Reporting group title
    PRCL-02 50 mg
    Reporting group description
    		 Loading dose of 300 mg followed by a once daily maintenance dose commencing on Day 2 and continuing for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Loading dose followed by a once daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks

    Primary: Percentage of Subjects Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement

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    End point title
    		 Percentage of Subjects Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement
    End point description
    Number of subjects is shown for each reporting group in lieu of percentage. Following 12 weeks of treatment. The Psoriasis Area and Severity Index (PASI) scores the severity of disease on a scale from 0 to 72 (where a score of 72 indicates extreme disease severity). PASI 75 indicates 75% improvement from baseline to Week 12 in the Psoriasis Area and Severity Index. Intent to treat population included all randomized subjects with moderate to severe chronic plaque psoriasis who took at least 1 dose of double-blind study treatment and at least the Week 1 post-baseline PASI assessment.
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 PRCL-02 25 milligrams (mg) PRCL-02 50 mg Placebo
    Number of subjects analysed
    30
    29
    31
    Units: subjects
    4
    1
    0
    Statistical analysis title
    		 PRCL-02 25 mg vs placebo
    Comparison groups
    Placebo v PRCL-02 25 milligrams (mg)
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.053
    Method
    		 Fisher exact
    Parameter type
    		 lower 90% exact unconditional CI
    Point estimate
    13.3
    Confidence interval
         level
    		 90%
         sides
    1-sided
         lower limit
    		 -3.4
         upper limit
    		 -
    Statistical analysis title
    		 PRCL-02 50 mg vs Placebo
    Comparison groups
    PRCL-02 50 mg v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.483
    Method
    		 Fisher exact
    Parameter type
    		 Difference (90% lower confidence limit
    Point estimate
    3.4
    Confidence interval
         level
    		 90%
         sides
    1-sided
         lower limit
    		 -13.6
         upper limit
    		 -

    Secondary: Number of Subjects With Any Treatment Emergent Adverse Event

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    End point title
    		 Number of Subjects With Any Treatment Emergent Adverse Event
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 18
    End point values
    		 PRCL-02 25 milligrams (mg) PRCL-02 50 mg Placebo
    Number of subjects analysed
    31
    30
    31
    Units: Subjects
    14
    12
    10
    No statistical analyses for this end point

    Secondary: Area Under the Concentration Time Curve (AUC0-t)

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    End point title
    		 Area Under the Concentration Time Curve (AUC0-t) [1]
    End point description
    Pharmacokinetic (PK) analysis set included all randomized subjects who took at least 1 dose of double-blind study treatment and provide sufficient data for PK assessments.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PK endpoints were analyzed only in PRCL-02 25 mg and 50 mg dose groups.
    End point values
    		 PRCL-02 25 milligrams (mg) PRCL-02 50 mg
    Number of subjects analysed
    24
    20
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    165000 ± 627
    439000 ± 492
    No statistical analyses for this end point

    Secondary: Maximum Observed Drug Concentration (Cmax)

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    End point title
    		 Maximum Observed Drug Concentration (Cmax) [2]
    End point description
    PK analysis set included all randomized subjects who took at least 1 dose of double-blind study treatment and provide sufficient data for PK assessments.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PK endpoints were analyzed only in PRCL-02 25 mg and 50 mg dose groups.
    End point values
    		 PRCL-02 25 milligrams (mg) PRCL-02 50 mg
    Number of subjects analysed
    24
    20
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    984 ± 200
    2220 ± 139
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Observed Drug Concentration (Tmax)

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    End point title
    		 Time to Reach Maximum Observed Drug Concentration (Tmax) [3]
    End point description
    PK analysis set included all randomized subjects who took at least 1 dose of double-blind study treatment and provide sufficient data for PK assessments.
    End point type
    Secondary
    End point timeframe
    Pre-dose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PK endpoints were analyzed only in PRCL-02 25 mg and 50 mg dose groups.
    End point values
    		 PRCL-02 25 milligrams (mg) PRCL-02 50 mg
    Number of subjects analysed
    24
    20
    Units: Hours
        median (full range (min-max))
    2.00 (0 to 8.12)
    4.00 (0 to 358)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    20 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    PRCL-02 25 milligrams (mg)
    Reporting group description
    		 Loading dose of 150 mg followed by a once-daily maintenance dose commencing on Day 2 and continuing for 12 weeks.

    Reporting group title
    PRCL-02 50 mg
    Reporting group description
    		 Loading dose followed by a once-daily maintenance dose commencing on Day 2 and continuing for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Loading dose followed by a once-daily maintenance dose at matching treatment levels, commencing on Day 2 and continuing for 12 weeks.

    Serious adverse events
    		 PRCL-02 25 milligrams (mg) PRCL-02 50 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Measles
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 30 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PRCL-02 25 milligrams (mg) PRCL-02 50 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 31 (9.68%)
    3 / 30 (10.00%)
    4 / 31 (12.90%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    2
    2
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 30 (6.67%)
    0 / 31 (0.00%)
         occurrences all number
    1
    2
    0
    Musculoskeletal and connective tissue disorders
    Psoriatric Arthritis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    2
    Recurrent Psoriatric Arthritis
         subjects affected / exposed
    0 / 31 (0.00%)
    0 / 30 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jul 2018
    Amendment 1 -To indicate that male patients should avoid donating sperm while participating in this trial and for 4 months after stopping the study treatment. -To indicate that patients must withdraw from the study if they become pregnant. -Follicle Stimulating Hormone is now included in the Clinical Laboratory Tests, as this test may be used for assessment of patient eligibility for the study.

    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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