Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02654145 · ClinicalTrials.gov registry record · Phase 4
Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 145
- Enrollment target
NCT02654145 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 145 participants.
The verdict
NCT02654145, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 145 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Omalizumab
- DRUG Mepolizumab 100mg SC
- DRUG Albuterol/salbutamol MDIs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2016-03-17 |
| Est. Completion | 2017-05-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02654145
The ClinicalTrials.gov registry entry for NCT02654145 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Omalizumab is the first listed.
NCT02654145 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02654145 about?
NCT02654145 is a clinical study titled "Omalizumab to Mepolizumab Switch Study in Severe Eosinophilic Asthma Patients". 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 stud...
What is the current status of trial NCT02654145?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 145 participants. The study started on 2016-03-17. Estimated completion is 2017-05-31.
What interventions are being tested in trial NCT02654145?
The interventions under investigation include: Omalizumab (DRUG), Mepolizumab 100mg SC (DRUG), Albuterol/salbutamol MDIs (DRUG).
Who is sponsoring clinical trial NCT02654145?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.