Effect of Mepolizumab in Severe Bilateral Nasal Polyps
Status:
Completed
Trial end date:
2019-12-11
Target enrollment:
Participant gender:
Summary
Nasal polyps (NP) has long been known as chronic inflammatory disease of the nasal mucosa.
This disease is characterized by the presence of polyps in the upper nasal cavity,
originating from within the ostiomeatal complex. The presence of polyps can cause long-term
symptoms such as prominent nasal obstruction, post-nasal drip, loss of smell, and discharge.
Mepolizumab (SB240563) is an Immunoglobulin G 1 [IgG1], kappa humanized monoclonal antibody
(mAB) that blocks human interleukin-5 (hIL-5) from binding to the interleukin-5 (IL-5)
receptor complex expressed on the eosinophil cell surface and thus inhibits signaling.
Neutralization of IL-5 with mepolizumab has been shown to reduce blood, sputum and tissue
eosinophils and hence is assumed to be a treatment option in a number of eosinophilic
diseases including NP.
The aim of this randomized, double-blind, parallel group, phase 3 (PhIII) study is to assess
the clinical efficacy and safety of 100 milligram (mg) subcutaneous (SC) mepolizumab as an
add on to maintenance treatment in adults with severe bilateral NP. The study will include a
4-week run in period followed by randomization to a 52-week treatment period. Participants
will receive mepolizumab 100 mg or placebo SC by the investigator or delegate via a
pre-filled safety syringe every 4 weeks for 52 weeks. Throughout the entire study period (run
in + treatment period + follow up), participants will receive a standard of care (SoC) for NP
which consists of daily mometasone furorate (MF) nasal spray, and if required, saline nasal
douching, occasional short courses of high dose oral corticosteroids (OCS) and/or
antibiotics. The treatment period will consist of thirteen, 4-weekly doses of mepolizumab or
placebo. In addition, up to the first 200 randomized participants will be followed up every
other month for up to a further 6 months after the Visit 15 (7 months post last dose) in
order to assess maintenance of response and to validate a physiological model derived from
the previous Phase 2 study. Approximately 400 participants will be randomized (200
participants per treatment arm) in to the study. Total duration of the study will be 76 weeks
for first 200 randomized participants and 52 weeks for remainder of participants who are not
participating in the 6 months no treatment follow up.