Last updated: 02/11/2020 16:30:10

PGx7679: Exploratory Genetic Analysis for GSK2894512 for efficacy in psoriasis patients in 203120

GSK study ID
207697
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: PGx7679: Exploratory Genetic Analysis for GSK2894512 for efficacy in psoriasis patients in 203120
Trial description: GSK2894512 is a novel, non-steroidal, topical anti-inflammatory agent currently in parallel development for atopic dermatitis and psoriasis indications. Genetic samples are not available from the previous studies and 203120 provides the first opportunity to assess the impact of genetic variation on response to GSK2894512 in patients with psoriasis. These pharmacogenetic analyses are designed to assess if genetic variation influences response to GSK2894512 using data from 203120 using the following endpoint: Proportion of subjects who have a Physician Global Assessment (PGA) score of clear or almost clear (0 or 1) at Week 12 and a minimum 2 grade improvement in PGA score from Baseline to Week 12. Genetic variation from across the genome and three pre-specified candidate gene variants (rs4112788 in late cornified envelope [LCE]3D, rs1581803 in LCE3A, and rs12191877 in human leukocyte antigen [HLA]-C) will be assessed using logistic regression models.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Determine if genetic markers are associated with the proportion of subjects who have a PGA score of clear or almost clear at week 12 and a minimum 2 grade improvement in PGA score from Baseline to week 12 in subjects randomized to GSK2894512 in 203120.

Timeframe: Previously acquired blood samples will be utilized to generate genetic data and analyzed with previously collected clinical data from study 203120

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Treatment with GSK2894512 (tapinarof)
    • Enrollment:
    0
    Primary completion date:
    2017-17-05
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Psoriasis
    Product
    tapinarof
    Collaborators
    Not applicable
    Study date(s)
    April 2017 to May 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Provided written informed consent for genetic research when they enrolled in the clinical study 203120, and did not withdraw consent prior to the genetic experiment
    • Provided a blood sample for genotyping
    • Did not provide written informed consent for genetic research when they enrolled in the clinical study 203120, or withdrew their genetic consent prior to the genetic experiment
    • Did not provide any or an adequate blood sample for genotyping
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Provided written informed consent for genetic research when they enrolled in the clinical study 203120, and did not withdraw consent prior to the genetic experiment
    • Provided a blood sample for genotyping
    • Successfully genotyped and pass quality control measures
    • Valid clinical data available
    Exclusion criteria:
    • Did not provide written informed consent for genetic research when they enrolled in the clinical study 203120, or withdrew their genetic consent prior to the genetic experiment
    • Did not provide any or an adequate blood sample for genotyping
    • Failed genotyping
    • Did not have valid clinical data available

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2017-17-05
    Actual study completion date
    2017-17-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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