A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps

PHASE3CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

November 21, 2017

Primary Completion Date

March 7, 2019

Study Completion Date

March 7, 2019

Conditions
Nasal PolypsChronic Rhinosinusitis
Interventions
DRUG

Omalizumab

Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table.

DRUG

Placebo

Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table.

Trial Locations (45)

1106

Bajcsy-Zsilinszky Korhaz es Rendelointezet, Budapest

1115

Szent Imre Egyetemi Oktatokorhaz, Budapest

1122

Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak, Budapest

3000

UZ Leuven, Leuven

7602

Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Pécs

9000

UZ Gent, Ghent

11407

Hospital de Jerez, Jerez de la Frontera

15706

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

20815

Institute for Asthma & Allergy, Chevy Chase

21236

Chesapeake Clinical Research Inc - CRN, Baltimore

23507

Eastern Virginia Medical School, Norfolk

28040

Hospital Universitario Fundacion Jimenez Diaz., Madrid

31205

Unidad de Investigacion CIMA SC, Chihuahua City

33012

Specialist Global Research, Hialeah

33076

Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin, Bordeaux

33100

Terveystalo Tampere, Tampere

33613

University of South Florida, Tampa

35209

Clinical Research Center of Alabama, LLC, Birmingham

41071

Hospital Universitario Virgen Macarena, Seville

46000

Ternopil Municipal City Hospital, Ternopil

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

65212

University of Missouri, ENT and Allergy Center of Missouri, 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

78006

TTS Research, Boerne

78251

Allergy & Asthma Res Ctr PA, San Antonio

80909

Colorado ENT & Allergy, Colorado Springs

85724

Banner University of Arizona Medical Center, Tucson

95207

Bensch Clinical Research LLC, Stockton

95762

Kaiser Permanente - Rancho Cordova Medical Offices, Rancho Cordova

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

02115

Brigham and Womens Hospital, Boston

40-040

Synexus - Katowice, Katowice

31-572

Centrum Medyczne Wos i Piwowarczyk, Krakow

20-552

Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna, Lublin

01-192

Synexus - Warsaw, Warsaw

32-020

Centrum Medyczne Biotamed, Wieliczka

50-220

EMC Instytut Medyczny S.A., Wroclaw

08036

Hospital Clinic de Barcelona, Barcelona

03680

SI Institute of Otolaryngology n.a. Prof. O.S. Kolomiychenko, Kyiv

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03280537 - A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps | Biotech Hunter | Biotech Hunter