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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: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT02654145 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 145 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. ACQ-5 score range from 0 to 6. Higher sc
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 |
What the finished NCT02654145 record still lists
NCT02654145 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Omalizumab is the first listed.
NCT02654145 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02654145's enrollment target sits among peer trials
145 573rd of 2000 higher than 1,424 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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