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    Clinical Trial Results:
    A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects with Gorlin Syndrome (Basal Cell Nevus Syndrome)

    Summary
    EudraCT number
    		 2020-000253-27
    Trial protocol
    		 GB   FR   NL   DK   ES   BE   IT  
    Global end of trial date
    14 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2023
    First version publication date
    06 Jul 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Pelle-926-301E
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    PellePharm, Inc. / Sol-Gel Technologies Ltd
    Sponsor organisation address
    7 Golda Meir St, Ness Ziona, Israel, 7403650
    Public contact
    VP, Clinical Development, Sol-Gel Technologies Ltd, ofral@sol-gel.com
    Scientific contact
    VP, Clinical Development, Sol-Gel Technologies Ltd, ofral@sol-gel.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
    14 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the safety and tolerability of Patidegib Topical Gel, 2% in subjects who have completed PellePharm Study Pelle-926-201 or Pelle-926-301.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles originating from the Declaration of Helsinki, ICH guidelines, GCP, and in compliance with local regulatory requirements. The protocol, informed consent form and other information provided to subjects, and all appropriate amendments were properly reviewed and approved by the IRB/EC/REB. The IRB-approved informed consent form followed the Protection of Human Subjects regulations listed in 21 Code of Federal Regulations Part 50, and had to be signed and dated by each subject prior to conduct of any study procedures. The background of the study and the benefits and risks of the procedures and study had to be clearly and understandably explained to the subjects. Subject data was protected by ensuring that no captured data contained subject names, addresses, telephone numbers, email addresses, or other directly identifying personal information.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jun 2020
    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
    Netherlands: 8
    Country: Number of subjects enrolled
    Spain: 14
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    United States: 51
    Worldwide total number of subjects
    108
    EEA total number of subjects
    47
    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)
    83
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 To be recruited, the subjects had to have completed PellePharm Study 926-201 or 926-301, abstain from application of facial non-study topical medication, could not be pregnant or breastfeeding, and willing to use effective contraception if the they or their partner was a woman of childbearing potential.

    Period 1
    Period 1 title
    Recruitment period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Recruited patients
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Recruited patients
    Started
    108
    Completed
    105
    Not completed
    3
         No treatment received
    3
    Period 2
    Period 2 title
    Treatment period
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable.

    Arms
    Arm title
    		 Patidegib
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Patidegib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical
    Dosage and administration details
    Patidegib Topical Gel, 2% (w/w) was applied to the area extending from the anterior hairline to the jaw line at the clinic on study day 1 (baseline).

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 was the recruitment period. Baseline information was summarised only for the patients who received any treatment (Period 2).
    Number of subjects in period 2 [2]
    		Patidegib
    Started
    105
    Completed
    3
    Not completed
    102
         Consent withdrawn by subject
    4
         Other
    1
         Sponsor decision
    95
         Lost to follow-up
    1
         Lack of efficacy
    1
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline information was summarised for the patients who received any treatment. Three patients in the recruitment period (worldwide number) did not receive any treatment and baseline data was therefore not summarised for these patients.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 105 105
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.9 ( 13.88 ) -
    Gender categorical
    Units: Subjects
        Female
    		 46 46
        Male
    		 59 59

    End points

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    End points reporting groups
    Reporting group title
    Recruited patients
    Reporting group description
    		 -
    Reporting group title
    Patidegib
    Reporting group description
    		 -

    Primary: Safety

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    End point title
    		 Safety [1]
    End point description
    End point type
    Primary
    End point timeframe
    From start of treatment until 30 days after last dose.
    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: The study ended prematurely and no statistical analyses were performed.
    End point values
    		 Patidegib
    Number of subjects analysed
    105
    Units: % of subjects with at least one AE
        number (not applicable)
    43.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From start of treatment until 30 days after last dose.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Treated patients
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious adverse events that affected 5% or more of the patients. Overall, 46 patients had at least one adverse event.
    Serious adverse events
    		 Treated patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 105 (2.86%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 105 (0.95%)
         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
    		 Treated patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 105 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jan 2020
    The study received a new EudraCT number. This occurred before the recruitment of any patient.

    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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