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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT03280537
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Rhinosinusitis
  • Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39688 (POLYP 1; NCT03280550) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.

Key Dates

Start date
Nov 21, 2017
Status verified
Mar 2020
Primary completion
Mar 7, 2019
Completion
Mar 7, 2019

Study Design

Enrollment
127 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.
  • Placebo Comparator: 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. All participants were also treated during the entire study with intranasal corticosteroids (mometasone nasal spray) as background therapy.

Primary Outcome Measure

Change From Baseline in Nasal Polyp Score (NPS) at Week 24 [ Time Frame: Baseline, Week 24 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Clinical Research Center of Alabama, LLCBirminghamAlabama35209-
Banner University of Arizona Medical CenterTucsonArizona85724-
Kaiser Permanente - Rancho Cordova Medical OfficesRancho CordovaCalifornia95762-
Bensch Clinical Research LLCStocktonCalifornia95207-
Colorado ENT & AllergyColorado SpringsColorado80909-
Specialist Global ResearchHialeahFlorida33012-
University of South FloridaTampaFlorida33613-
University of Kansas Medical CenterKansas CityKansas66160-
Chesapeake Clinical Research Inc - CRNBaltimoreMaryland21236-
Institute for Asthma & AllergyChevy ChaseMaryland20815-
Brigham and Womens HospitalBostonMassachusetts02115-
University of Missouri, ENT and Allergy Center of MissouriColumbiaMissouri65212-
Allergy Associates Research Center LLC - CRNPortlandOregon97202-
TTS ResearchBoerneTexas78006-
Allergy & Asthma Res Ctr PASan AntonioTexas78251-
Eastern Virginia Medical SchoolNorfolkVirginia23507-

Find similar trials in Birmingham, AL

By research site
Clinical Research Center of Alabama, LLC· Birmingham, ALBanner University of Arizona Medical Center· Tucson, AZKaiser Permanente - Rancho Cordova Medical Offices· Rancho Cordova, CABensch Clinical Research LLC· Stockton, CAColorado ENT & Allergy· Colorado Springs, COSpecialist Global Research· Hialeah, FL

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