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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT03280550
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 participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39855 (POLYP 2; NCT03280537) 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 15, 2017
Status verified
Mar 2020
Primary completion
Mar 11, 2019
Completion
Mar 11, 2019

Study Design

Enrollment
138 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 (11)

FacilityCityStateZIPSite coordinators
Jonathan Corren MD, Inc.Los AngelesCalifornia90025-
Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc. - SacENTRosevilleCalifornia95678-
Vitae Research CenterMiamiFlorida33135-
Asthma & Allergy of IdahoTwin FallsIdaho83301-
Tandem Clinical Research, LLCMarreroLouisiana70072-
Montana Medical Research LLCMissoulaMontana59808-
Northwell HealthGreat NeckNew York11021-
Montefiore Medical CenterThe BronxNew York10461-
Vital Prospects Clinical Research Institute PC - CRNTulsaOklahoma74136-
Medical University of South Carolina HospitalCharlestonSouth Carolina29425-
Chrysalis Clinical ResearchSt. GeorgeUtah84790-

Find similar trials in Los Angeles, CA

By research site
Jonathan Corren MD, Inc.· Los Angeles, CASacramento Ear, Nose and Throat Surgical and Medical Group, Inc. - SacENT· Roseville, CAVitae Research Center· Miami, FLAsthma & Allergy of Idaho· Twin Falls, IDTandem Clinical Research, LLC· Marrero, LAMontana Medical Research LLC· Missoula, MT

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