Active, not recruiting

Study Description:

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.

GSK Study ID:

205687


ClinicalTrials.gov Identifier:

NCT03085797


EudraCT Number:

2016-004255-70


Study Overview

Medical Conditions

Eye, Ear, Nose & Throat - Other

Product

mepolizumab

Collaborators

CRF health


Date

May 2017 to December 2019

Type

Interventional

Phase

3


Gender

All

Age

18 years - N/A

Accepts Healthy Volunteers

No


Study Documents

No documents available
This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Argentina, Buenos Aires C1425BENCompleted
Argentina, Ciudad Autónoma de Buenos Aires C1426ABPActive, not recruiting
Argentina, Ciudad Autónoma de Buenos Aires C1121ABECompleted
Argentina, Mendoza 5500Completed
Argentina, San Miguel de Tucumán 4000Completed
Argentina, Buenos Aires, Ciudad Autonoma de Buenos Aires C1414AIFCompleted
Argentina, Buenos Aires, Florida 1602Completed
Argentina, Buenos Aires, La Plata Completed
Argentina, Buenos Aires, Mar del Plata 7600Completed
Argentina, Mendoza, Mendoza M5500CCGCompleted
Argentina, Santa Fe, Rosario S2000DBSCompleted
Australia, New South Wales, Darlinghurst 2010Active, not recruiting
Australia, New South Wales, Westmead 2145Active, not recruiting
Australia, Victoria, Clayton 3169Active, not recruiting
Australia, Victoria, Melbourne 3004Active, not recruiting
Australia, Western Australia, Murdoch 6150Active, not recruiting
Canada, British Columbia, Vancouver V5Z 1M9Active, not recruiting
Canada, Ontario, Hamilton L8L 2X2Active, not recruiting
Canada, Ontario, London N6A 4V2Completed
Canada, Ontario, Ottawa K1G 6C6Completed
Canada, Québec, Montreal H3G 1L5Completed
Canada, Québec, Montreal H2X 1P1Completed
Canada, Québec, Québec G1S 4L8Completed
Canada, Saskatchewan, Saskatoon S7K 1N4Completed
Germany, Baden-Wuerttemberg, Tuebingen 72076Completed
Germany, Bayern, Muenchen 81377Completed
Germany, Bayern, Muenchen 81675Completed
Germany, Berlin, Berlin 13353Completed
Germany, Hessen, Wiesbaden 65183Completed
Germany, Nordrhein-Westfalen, Duesseldorf 40225Completed
Germany, Nordrhein-Westfalen, Muenster 48149Completed
Germany, Sachsen, Dresden 01307Completed
Germany, Sachsen, Dresden 01139Completed
Germany, Schleswig-Holstein, Luebeck 23538Completed
Netherlands, AMSTERDAM 1105 AZCompleted
Romania, Brasov 500283Active, not recruiting
Romania, Brasov 500091Completed
Romania, Bucuresti 014452Completed
Romania, Cluj Napoca 400015Completed
Romania, Targu Mures 540098Completed
Russia, Moscow 142190Completed
Russia, Moscow 119991Completed
Russia, Moscow 123095Completed
Russia, Moscow 127473Completed
Russia, Moscow 123182Completed
Russia, Saint-Peterburgh 197022Completed
Russia, Saint-Petersburg 190013Completed
Russia, St. Petersburg 194356Completed
Russia, Yaroslavl 150003Completed
South Korea, Incheon 21565Completed
South Korea, Seongnam-si, Gyeonggi-do 13620Active, not recruiting
South Korea, Seoul 03722Completed
South Korea, Seoul 06351Completed
South Korea, Seoul 06591Completed
Sweden, GÖTEBORG SE-413 45Completed
Sweden, HELSINGBORG SE-251 87Active, not recruiting
Sweden, LUND SE-221 85Completed
Sweden, STOCKHOLM SE-114 86Active, not recruiting
Sweden, STOCKHOLM SE-171 76Completed
United Kingdom, London SW3 6HPActive, not recruiting
United Kingdom, Manchester M23 9QZCompleted
United Kingdom, Newcastle upon Tyne NE7 7DNCompleted
United Kingdom, Rotherham S60 2UDCompleted
United Kingdom, Durham, Darlington DL3 6HXCompleted
United Kingdom, London, London SE1 9RTActive, not recruiting
United Kingdom, London, London WC1X 8DACompleted
United Kingdom, Merseyside, Liverpool L9 7ALCompleted
United States, Alabama, Birmingham 35209Completed
United States, California, Riverside 92506Active, not recruiting
United States, California, Roseville 95661Completed
United States, California, San Diego 92103Completed
United States, Colorado, Colorado Springs 80907Active, not recruiting
United States, Florida, Lake Mary 32746Completed
United States, Idaho, Meridian 83642Active, not recruiting
United States, Illinois, Chicago 60657Active, not recruiting
United States, Iowa, Des Moines 50312Completed
United States, Iowa, West Des Moines 50265Completed
United States, Kentucky, Louisville 40205Completed
United States, Louisiana, Marrero 70072Completed
United States, Maryland, White Marsh 21162Active, not recruiting
United States, Missouri, Columbia 65212Active, not recruiting
United States, Missouri, St. Louis 63141Completed
United States, New Jersey, Piscataway 08854Completed
United States, New York, New York 10016Completed
United States, North Carolina, Matthews 28105Active, not recruiting
United States, North Carolina, Raleigh 27607Active, not recruiting
United States, North Carolina, Winston-Salem 27103Completed
United States, Oklahoma, Oklahoma City 73120Active, not recruiting
United States, Oregon, Medford 97504Completed
United States, Pennsylvania, Bethlehem 18017Active, not recruiting
United States, Pennsylvania, Pittsburgh 15213Active, not recruiting
United States, South Carolina, Charleston 29425Completed
United States, South Carolina, Orangeburg 29118Completed
United States, Texas, Dallas 75235Active, not recruiting
United States, Texas, Frisco 75035Completed
United States, Texas, McKinney 75070Completed
United States, Texas, San Antonio 78258Completed
United States, Utah, North Logan 84341Completed
United States, Utah, Salt Lake City 84102Active, not recruiting
United States, Virginia, Lynchburg 24501Completed
United States, Virginia, Norfolk 23507Active, not recruiting
United States, Virginia, Richmond 23235Completed

Study Design

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: Yes
  • Masked Caregiver: Yes
  • Masked Investigator: Yes
  • Masked Assessor: No
Primary Outcomes:

  • Change from Baseline in total endoscopic NP score at Week 52
    Timeframe: Baseline and Week 52

  • Change from Baseline in mean nasal obstruction visual analogue scale (VAS) score during the 4 weeks prior to Week 52
    Timeframe: Baseline and up to Week 52

Secondary Outcomes:

  • Time to first nasal surgery up to Week 52
    Timeframe: Up to Week 52

  • Change from Baseline in mean overall VAS symptom score during the 4 weeks prior to Week 52
    Timeframe: Baseline and up to Week 52

  • Change from Baseline in sino-nasal outcome test (SNOT)-22 total score at Week 52
    Timeframe: Baseline and Week 52

  • Number of mgs per year of prednisolone-equivalent OCS dose up to Week 52
    Timeframe: Up to Week 52

Arms:
  • 2

Interventions:

  • Drug: Mepolizumab
  • Drug: Placebo
  • Drug: Mometasone furoate

Keyword:

  • SB240563, Nasal Polyps, Mepolizumab, Phase 3, Parallel group, Efficacy
Enrollment: 413