Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
GlaxoSmithKline
Study ID
NCT02654145
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mepolizumab 100mg SC — DRUG
    At Visit 2 (Week 0) eligible subjects will receive mepolizumab 100mg SC into the upper arm or thigh every 4 weeks over a period of 28 weeks.
  • Albuterol/salbutamol MDIs — DRUG
    Albuterol/salbutamol metered dose inhalers (MDIs) will be provided as rescue medication during treatment period.
  • Omalizumab — DRUG
    Subjects receiving omalizumab will enter in a run-in period and will continue to receive omalizumab throughout the run-in period. At Visit 2 (week 0) subjects will discontinue omalizumab.

Study Details

Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and reduces eosinophil counts in both sputum and blood. Omalizumab an anti-immunoglobulin E (IgE) monoclonal antibody (mAb) is effective in the treatment of moderate to severe allergic asthma. The aim of this study is to investigate whether subjects not optimally controlled on their current omalizumab treatment, who are eligible for therapy with mepolizumab can be effectively and safely switched to treatment with mepolizumab to improve asthma control. The study will provide data on the efficacy, safety, immunogenicity, and tolerability of mepolizumab when switched directly from omalizumab without any wash-out. The learnings from this study may help guide physicians when substituting one biologic with another for the treatment of patients with severe eosinophilic asthma. The study will be a multi-centre, open-label single arm trial. Patients with severe eosinophilic asthma who are receiving omalizumab, but are not optimally controlled will be eligible to participate. Subjects will remain on their current maintenance therapy including omalizumab throughout the run-in period for a minimum of one week and up to 4 weeks. At Visit 2 (week 0) subjects will discontinue their omalizumab treatment and be switched to mepolizumab 100 mg subcutaneous (SC) every 4 weeks for 28 weeks. The treatment period is 32 weeks, including an Exit Visit/Early Withdrawal Visit, 4 weeks following the subject's last dose of mepolizumab.

Key Dates

Start date
Mar 17, 2016
Status verified
Aug 2019
Primary completion
May 31, 2017
Completion
May 31, 2017

Study Design

Enrollment
145 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab switch to mepolizumab 100mg SC every 4 weeks
    Subjects with severe eosinophilic asthma who are receiving omalizumab will enter a run-in period for a minimum of one week and a up to 4 weeks. Subjects will remain on their current maintenance therapy throughout the run-in period, including omalizumab. At Visit 2 (week 0) subjects will discontinue omalizumab treatment and will be switched to receiving mepolizumab 100 mg SC every 4 weeks for 28 weeks. Except for omalizumab, subjects will remain on their current maintenance therapy throughout the open-label treatment period. Albuterol/salbutamol metered dose inhalers (MDIs) will be provided as rescue medication during treatment period.

Primary Outcome Measure

Mean Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 32 [ Time Frame: Baseline and at Week 32 ]

Locations (13)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteBirminghamAlabama35209-
GSK Investigational SiteRiversideCalifornia92506-
GSK Investigational SiteRosevilleCalifornia95661-
GSK Investigational SiteSan DiegoCalifornia92123-
GSK Investigational SiteUplandCalifornia91786-
GSK Investigational SiteBaltimoreMaryland21224-
GSK Investigational SitePiscatawayNew Jersey08854-
GSK Investigational SiteRochesterNew York14642-
GSK Investigational SiteCharlotteNorth Carolina28277-
GSK Investigational SiteDurhamNorth Carolina27705-
GSK Investigational SiteEast ProvidenceRhode Island02914-
GSK Investigational SiteRichmondVirginia23229-
GSK Investigational SiteWilliamsburgVirginia23188-

Find similar trials in Birmingham, AL

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
GSK Investigational Site· Birmingham, ALGSK Investigational Site· Riverside, CAGSK Investigational Site· Roseville, CAGSK Investigational Site· San Diego, CAGSK Investigational Site· Upland, CAGSK Investigational Site· Baltimore, MD

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