An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

PHASE3CompletedINTERVENTIONAL
Enrollment

249

Participants

Timeline

Start Date

May 9, 2018

Primary Completion Date

March 16, 2020

Study Completion Date

March 16, 2020

Conditions
Nasal PolypsChronic Rhinosinusitis
Interventions
DRUG

Omalizumab

Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.

DRUG

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.

Trial Locations (79)

1106

Bajcsy-Zsilinszky Hospital, Budapest

1115

Szent Imre Egyetemi Oktatokorhaz, Budapest

1122

Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak, Budapest

3000

UZ Leuven, Leuven

3680

State Institution Institute of Otolaryngology n.a. Prof. O.S., Kyiv

7602

Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Pécs

9000

UZ Gent, Ghent

10117

Charie Campus Mitte; Hals, Nasen, Ohrenheilkunde, Berlin

10461

Montefiore Medical Center, The Bronx

11021

Northwell Health, Great Neck

11407

Hospital de Jerez, Jerez de la Frontera

15706

CHUS - H. Clinico U. de Santiago; Servicio de Farmacia, Santiago de Compostela

20815

Institute for Asthma & Allergy, Chevy Chase

21236

Chesapeake Clinical Research Inc - CRN, Baltimore

23507

Eastern Virginia Medical School, Norfolk

23538

Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I, Lübeck

28040

Hospital Universitario Fundacion Jimenez Diaz., Madrid

29425

Medical University of South Carolina Hospital, Charleston

31200

Unidad de Investigacion CIMA SC, Chihuahua City

33012

Specialist Global Research, Hialeah

33076

Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin, Bordeaux

33135

Vitae Research Center, Miami

33613

University of South Florida, Tampa

35209

Clinical Research Center of Alabama, LLC, Birmingham

36024

Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi, Poltava

41071

Hospital Universitario Virgen Macarena, Seville

44100

Instituto Jalisciense de Investigacion Clinica S.A. de C.V., Guadalajara

46000

Ternopil Municipal City Hospital, Ternopil

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

50005

Fakultni nemocnice Hradec Kralove, Chirurgicka klinika, Hradec Králové

61166

Municipal Health Care Institution Regional clinical specialized dispensary of radiation protection, Kharkiv

65212

University of Missouri Health Care System, Columbia

66160

University of Kansas Medical Center, Kansas City

67091

Hopital de Hautepierre, Strasbourg

Nouvel Hopital Civil; Pole de Pathologie Thoracique, Strasbourg

69032

"Municipal Institution City Clinical Hospital #3", Zaporizhzhia

70072

Tandem Clinical Research, LLC, Marrero

74136

Vital Prospects Clinical Research Institute PC - CRN, Tulsa

76000

University Clinic, Ivano-Frankivsk

76014

Ivano-Frankivsk Central City Clinical Hospital, Ivano-Frankivsk

78006

TTS Research, Boerne

78251

Allergy & Asthma Res Ctr PA, San Antonio

80909

Colorado ENT & Allergy, Colorado Springs

83301

Asthma & Allergy of Idaho, Twin Falls

84790

Chrysalis Clinical Research, St. George

85724

Banner University of Arizona Medical Center, Tucson

90025

Jonathan Corren MD, Inc., Los Angeles

95207

Bensch Clinical Research LLC, Stockton

95661

The Allergy Station at Sacramento ENT, Roseville

97202

Allergy Associates Research Center LLC - CRN, Portland

121356

Central Clinical Hospital With Polyclinic of President Administration of RF, Moscow

196240

LLC Kurator, Saint Petersburg

214031

Medical Center Uromed, Smolensk

355000

Terapharm, Llc, Stavropol

02115

Brigham and Womens Hospital, Boston

K1G 6C6

Yang Medicine, Ottawa

G1S 4L8

Hopital du Saint Sacrement, Québec

656 91

Fakultni nemocnice u sv. Anny v Brne, Brno

796 04

Stredomoravska nemocnicni a.s. - odstepny zavod Nemocnice Prostejov, Prostějov

04103

Universitatsklinikum Leipzig, Leipzig

15-879

Synexus Affiliate - Clinic Med s.j. Bialystok, Bialystok

81-384

Synexus - Gdynia, Gdynia

40-040

Synexus - Katowice, Katowice

40-611

Centrum Medyczne Angelius Provita, Katowice

30-033

Centrum Medyczne ALL-MED, Krakow

31-572

Centrum Medyczne Wos i Piwowarczyk, Krakow

20-552

Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna, Lublin

60-702

Synexus - Poznan, Poznan

01-192

Synexus - Warsaw, Warsaw

32-020

Centrum Medyczne Biotamed, Wieliczka

50-088

Synexus - Wroclaw, Wroclaw

50-220

EMC Instytut Medyczny S.A., Wroclaw

3814-501

Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro; Servicos Farmaceuticos, Aveiro

4710-243

Hospital de Braga, Braga

4835-044

Hospital Senhora da Oliveira - Guimarães, E.P.E, Guimarães

8500-338

Centro Hospitalar do Algarve - Hospital de Portimao, Portimão

08036

Hospital Clinic de Barcelona, Barcelona

04060

Kyiv City Clinical Hospital #9, Kyiv

WN1 2NN

Wigan,Wrighington & Leigh NHS Trust, Wigan

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03478930 - An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps | Biotech Hunter | Biotech Hunter