Last updated: 07/29/2020 03:50:04

PGx7667 (207389) Exploratory Pharmacogenetic Investigation of Efficacy Response to mepolizumab in Eosinophilic Granulomatosis Polyangiitis (Churg-Strauss Syndrome) PGstudy 115921

GSK study ID
207389
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: PGx7667 (207389) Exploratory Pharmacogenetic Investigation of Efficacy Response to mepolizumab in Eosinophilic Granulomatosis Polyangiitis (Churg-Strauss Syndrome) PGstudy 115921
Trial description: Mepolizumab obtained orphan drug status for treatment of eosinophilic granulomatosis polyangiitis (EGPA) in the US in July 2011 and February 2013 in the EU. Genetic samples are not available from the previous studies and MEA115921, the pivotal Phase 3 study, provides the first opportunity to assess the impact of genetic variation on response to mepolizumab in patients with EGPA. These pharmacogenetic analyses were designed to assess if genetic variation influences response to mepolizumab using data from MEA115921 with the following co-primary endpoints: accrued duration of remission, average oral corticosteroid (OCS) dose during last 4 weeks, and frequency of EGPA relapse. Genetic variation from across the genome and pre-specified candidate gene variants were assessed using linear regression (for the remission and OCS dose endpoints) and negative binomial regression (for the frequency of relapse endpoint).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Accrued duration of remission in subjects with EGPA randomized to mepolizumab

Timeframe: N/A (Previously acquired blood samples will be utilized to generate genetic data and analyzed with previously collected clinical data from study MEA115921).

Average OCS dose during last 4 weeks in subjects with EGPA randomized to mepolizumab

Timeframe: N/A (Previously acquired blood samples will be utilized to generate genetic data and analyzed with previously collected clinical data from study MEA115921).

Frequency of EGPA relapse in subjects randomized to mepolizumab

Timeframe: N/A (Previously acquired blood samples will be utilized to generate genetic data and analyzed with previously collected clinical data from study MEA115921).

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Treatment with SB240563 (mepolizumab)
    • Enrollment:
    1
    Primary completion date:
    2017-17-03
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Condreay L, Parham L, Qu X, Steinfeld J, Wechsler M, Raby B, Yancey S, Ghosh S.Pharmacogenetic Investigation of Efficacy Response to Mepolizumab in Eosinophilic Granulomatosis with Polyangiitis.Rheumatol Int.2020; DOI: 10.1007/s00296-020-04523-6 PMID: 32009195
    Medical condition
    Churg-Strauss Syndrome
    Product
    mepolizumab
    Collaborators
    Not applicable
    Study date(s)
    March 2017 to March 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 MEA115921, 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 MEA115921, 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 MEA115921, 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 MEA115921, 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
    2017-17-03
    Actual study completion date
    2017-17-03

    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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