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

PHASE3CompletedINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

November 15, 2017

Primary Completion Date

March 11, 2019

Study Completion Date

March 11, 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 (37)

10117

Charite Campus Mitte, Berlin

10461

Montefiore Medical Center, The Bronx

11021

Northwell Health, Great Neck

23538

Universitatsklinikum Schleswig-Holstein, Lübeck

29425

Medical University of South Carolina Hospital, Charleston

33135

Vitae Research Center, Miami

36024

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

44100

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

59808

Montana Medical Research LLC, Missoula

61166

Municipal Institution of Health Care; Regional Clinical Specialized Center of Radiation protection, Kharkiv

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

83301

Asthma & Allergy of Idaho, Twin Falls

84790

Chrysalis Clinical Research, St. George

90025

Jonathan Corren MD, Inc., Los Angeles

95678

Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc. - SacENT, Roseville

355000

Terapharm, Llc, Stavropol

K1G 6C6

Ottawa Allergy Research Corp, Ottawa

G1S 4L8

CHAUQ Hospital St Sacrement, Québec

656 91

Fakultni nemocnice u sv. Anny v Brne, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

796 04

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

04103

Universitatsklinikum Leipzig, Leipzig

15-879

Synexus Affiliate - ClinicMed Daniluk, Nowak Sp. J., Bialystok

81-384

Synexus - Gdynia, Gdynia

40-611

Centrum Medyczne Angelius Provita, Katowice

30-033

Centrum Medyczne ALL-MED, Krakow

60-702

Synexus - Poznan, Poznan

50-088

Synexus - Wroclaw, 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 - Guimarses, E.P.E, Guimarães

8500-338

Centro Hospitalar do Algarve - Hospital de Portimao, Portimão

04060

Kyiv City Clinical Hospital #9, Kyiv

WN1 2NN

Wigan,Wrighington & Leigh NHS Trust, Wigan

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03280550 - A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps | Biotech Hunter | Biotech Hunter