Last updated: 02/11/2020 16:30:10
PGx7679: Exploratory Genetic Analysis for GSK2894512 for efficacy in psoriasis patients in 203120
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2017-17-05
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)
No location data available.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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