Clinical Trials Logo

Clinical Trial Summary

This is a randomized, double blind, placebo controlled, parallel group phase III study designed to assess the clinical efficacy and safety of 100 milligrams (mg) subcutaneous (SC) mepolizumab treatment in adults with CRSwNP/ECRS for the purpose of registration in Japan and China. Approximately 160 participants will be randomized in a 1:1 ratio to receive either 100 mg SC mepolizumab or placebo SC. The study will include a 4-week run-in period followed by randomization to a 52-week treatment period, where participants will be administered 4-weekly doses of mepolizumab or placebo via a pre-filled safety syringe device (SSD) injection.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04607005
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date February 8, 2021
Completion date April 12, 2023

See also
  Status Clinical Trial Phase
Withdrawn NCT02071667 - Association of Periostin Levels and Chronic Sinusitis N/A
Completed NCT01623310 - 12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device Phase 3
Completed NCT02024659 - Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Nasal Polyps Phase 2/Phase 3
Completed NCT00215787 - Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease N/A
Completed NCT04996576 - Infrazygomatic Versus Intranasal Injection Sphinopalatine Ganglion Blockade Effect on Surgical Field in FESS N/A
Recruiting NCT03963648 - NO Measurements in Screening for Asthma and OSA, in Patients With CRSwNP N/A
Recruiting NCT05094570 - Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP Phase 4
Recruiting NCT05009758 - Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps N/A
Completed NCT00731185 - Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218) Phase 3
Active, not recruiting NCT03943121 - The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps N/A
Active, not recruiting NCT03704415 - Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative) N/A
Not yet recruiting NCT06070311 - Wound Healing After Endoscopic Sinus Surgery N/A
Completed NCT02879929 - Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction N/A
Recruiting NCT05672030 - Role of IL-5R Signaling in Non-eosinophil Upper Airway Cells in CRSwNP
Suspended NCT04261582 - Genetics and Genomics of Aspirin Exacerbated Respiratory Disease (AERD)
Recruiting NCT05063981 - Treatment With Mepolizumab on Patients With Severe Refractory Eosinophilic Asthma With or Without CRSwNP.
Completed NCT05180357 - RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.
Completed NCT00788463 - A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps Phase 2
Completed NCT01198912 - Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomized Placebo-controlled Trial Phase 2
Completed NCT03280537 - A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps Phase 3