An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
NCT ID: NCT03478930
Last Updated: 2022-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
249 participants
INTERVENTIONAL
2018-05-09
2020-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort A: Study GA39688 Omalizumab
Participants who received omalizumab once every 2 weeks (Q2W) or once every 4 weeks (Q4W) in Study GA39688 will continue to receive omalizumab at Week 24 at the same dosing schedule.
Omalizumab
Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.
Cohort A: Study GA39688 Placebo
Participants who received placebo Q2W or Q4W in Study GA39688 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.
Omalizumab
Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.
Placebo
Participants will not be receiving placebo in this OLE study. Participants who were randomized to the placebo arms for 24 weeks in studies GA39688/GA39855 and then enter this OLE study will receive omalizumab, but they will be placed in separate analysis cohorts.
Cohort B: Study GA39855 Omalizumab
Participants who received omalizumab Q2W or Q4W in Study GA39855 will continue to receive omalizumab at Week 24 at the same dosing schedule.
Omalizumab
Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.
Cohort B: Study GA39855 Placebo
Participants who received placebo Q2W or Q4W in Study GA39855 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.
Omalizumab
Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.
Placebo
Participants will not be receiving placebo in this OLE study. Participants who were randomized to the placebo arms for 24 weeks in studies GA39688/GA39855 and then enter this OLE study will receive omalizumab, but they will be placed in separate analysis cohorts.
Interventions
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Omalizumab
Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.
Placebo
Participants will not be receiving placebo in this OLE study. Participants who were randomized to the placebo arms for 24 weeks in studies GA39688/GA39855 and then enter this OLE study will receive omalizumab, but they will be placed in separate analysis cohorts.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participation in Study GA39688 or GA39855, including completion of endoscopy and other assessments at Week 24, without discontinuation of study drug
* Completion of eDiary daily assessments for at least 4 out of 7 days in the week prior to the Week 24 visit of Study GA39688 or GA39855
* For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 60 days after the last dose of study drug
Exclusion Criteria
* Serious adverse events related to study drug in Study GA39688 or GA39855 that the investigator or Sponsor determines may jeopardize the patient's safety if he or she continues in the study
* Uncontrolled epistaxis within Study GA39688 or GA39855
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States
Banner University of Arizona Medical Center
Tucson, Arizona, United States
Jonathan Corren MD, Inc.
Los Angeles, California, United States
The Allergy Station at Sacramento ENT
Roseville, California, United States
Bensch Clinical Research LLC
Stockton, California, United States
Colorado ENT & Allergy
Colorado Springs, Colorado, United States
Specialist Global Research
Hialeah, Florida, United States
Vitae Research Center
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Asthma & Allergy of Idaho
Twin Falls, Idaho, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Tandem Clinical Research, LLC
Marrero, Louisiana, United States
Chesapeake Clinical Research Inc - CRN
Baltimore, Maryland, United States
Institute for Asthma & Allergy
Chevy Chase, Maryland, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
University of Missouri Health Care System
Columbia, Missouri, United States
Northwell Health
Great Neck, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Vital Prospects Clinical Research Institute PC - CRN
Tulsa, Oklahoma, United States
Allergy Associates Research Center LLC - CRN
Portland, Oregon, United States
Medical University of South Carolina Hospital
Charleston, South Carolina, United States
TTS Research
Boerne, Texas, United States
Allergy & Asthma Res Ctr PA
San Antonio, Texas, United States
Chrysalis Clinical Research
St. George, Utah, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Yang Medicine
Ottawa, Ontario, Canada
Hopital du Saint Sacrement
Québec, Quebec, Canada
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Chirurgicka klinika
Hradec Králové, , Czechia
Stredomoravska nemocnicni a.s. - odstepny zavod Nemocnice Prostejov
Prostějov, , Czechia
Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin
Bordeaux, , France
Hopital de Hautepierre
Strasbourg, , France
Nouvel Hopital Civil; Pole de Pathologie Thoracique
Strasbourg, , France
Charie Campus Mitte; Hals, Nasen, Ohrenheilkunde
Berlin, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I
Lübeck, , Germany
Bajcsy-Zsilinszky Hospital
Budapest, , Hungary
Szent Imre Egyetemi Oktatokorhaz
Budapest, , Hungary
Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
Budapest, , Hungary
Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
Pécs, , Hungary
Unidad de Investigacion CIMA SC
Chihuahua City, , Mexico
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Guadalajara, , Mexico
Synexus Affiliate - Clinic Med s.j. Bialystok
Bialystok, , Poland
Synexus - Gdynia
Gdynia, , Poland
Synexus - Katowice
Katowice, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Centrum Medyczne ALL-MED
Krakow, , Poland
Centrum Medyczne Wos i Piwowarczyk
Krakow, , Poland
Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
Lublin, , Poland
Synexus - Poznan
Poznan, , Poland
Synexus - Warsaw
Warsaw, , Poland
Centrum Medyczne Biotamed
Wieliczka, , Poland
Synexus - Wroclaw
Wroclaw, , Poland
EMC Instytut Medyczny S.A.
Wroclaw, , Poland
Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro; Servicos Farmaceuticos
Aveiro, , Portugal
Hospital de Braga
Braga, , Portugal
Hospital Senhora da Oliveira - Guimarães, E.P.E
Guimarães, , Portugal
Centro Hospitalar do Algarve - Hospital de Portimao
Portimão, , Portugal
Central Clinical Hospital With Polyclinic of President Administration of RF
Moscow, Moscow Oblast, Russia
Medical Center Uromed
Smolensk, Moscow Oblast, Russia
LLC Kurator
Saint Petersburg, Sankt-Peterburg, Russia
Terapharm, Llc
Stavropol, , Russia
Hospital de Jerez
Jerez de la Frontera, Cadiz, Spain
CHUS - H. Clinico U. de Santiago; Servicio de Farmacia
Santiago de Compostela, LA Coruña, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz.
Madrid, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Municipal Health Care Institution Regional clinical specialized dispensary of radiation protection
Kharkiv, Kharkiv Governorate, Ukraine
State Institution Institute of Otolaryngology n.a. Prof. O.S.
Kyiv, KIEV Governorate, Ukraine
Ternopil Municipal City Hospital
Ternopil, Podolia Governorate, Ukraine
Municipal Institution "City Clinical Hospital #3"
Zaporizhzhia, Polissya Okruha, Ukraine
University Clinic
Ivano-Frankivsk, Poltava Governorate, Ukraine
Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
Poltava, Poltava Governorate, Ukraine
Ivano-Frankivsk Central City Clinical Hospital
Ivano-Frankivsk, , Ukraine
Kyiv City Clinical Hospital #9
Kyiv, , Ukraine
Wigan,Wrighington & Leigh NHS Trust
Wigan, , United Kingdom
Countries
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References
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Gevaert P, Mullol J, Saenz R, Ko J, Steinke JW, Millette LA, Meltzer EO. Omalizumab improves sinonasal outcomes in patients with chronic rhinosinusitis with nasal polyps regardless of allergic status. Ann Allergy Asthma Immunol. 2024 Mar;132(3):355-362.e1. doi: 10.1016/j.anai.2023.11.001. Epub 2023 Nov 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-003450-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WA40169
Identifier Type: -
Identifier Source: org_study_id
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