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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03280537

Public ClinicalTrials.gov record NCT03280537. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:53 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Clinical Trial of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03280537
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
127 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 20, 2017
Primary completion
Mar 6, 2019
Completion
Mar 6, 2019
Last update posted
Mar 22, 2020

2017 – 2019

United States locations

U.S. sites
16
U.S. states
12
U.S. cities
16
Facility City State ZIP Site status
Clinical Research Center of Alabama, LLC Birmingham Alabama 35209
Banner University of Arizona Medical Center Tucson Arizona 85724
Kaiser Permanente - Rancho Cordova Medical Offices Rancho Cordova California 95762
Bensch Clinical Research LLC Stockton California 95207
Colorado ENT & Allergy Colorado Springs Colorado 80909
Specialist Global Research Hialeah Florida 33012
University of South Florida Tampa Florida 33613
University of Kansas Medical Center Kansas City Kansas 66160
Chesapeake Clinical Research Inc - CRN Baltimore Maryland 21236
Institute for Asthma & Allergy Chevy Chase Maryland 20815
Brigham and Womens Hospital Boston Massachusetts 02115
University of Missouri, ENT and Allergy Center of Missouri Columbia Missouri 65212
Allergy Associates Research Center LLC - CRN Portland Oregon 97202
TTS Research Boerne Texas 78006
Allergy & Asthma Res Ctr PA San Antonio Texas 78251
Eastern Virginia Medical School Norfolk Virginia 23507

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03280537, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 22, 2020 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03280537 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →