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An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

Primary Purpose

Nasal Polyps, Chronic Rhinosinusitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Omalizumab

Placebo

About this trial

This is an interventional treatment trial for Nasal Polyps

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ability to comply with the study protocol, in the investigator's judgment
Participation in Study GA39688 or GA39855, including completion of endoscopy and other assessments at Week 24, without discontinuation of study drug
Completion of eDiary daily assessments for at least 4 out of 7 days in the week prior to the Week 24 visit of Study GA39688 or GA39855
For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 60 days after the last dose of study drug

Exclusion Criteria:

Anaphylaxis/hypersensitivity related to study drug in Study GA39688 or GA39855
Serious adverse events related to study drug in Study GA39688 or GA39855 that the investigator or Sponsor determines may jeopardize the patient's safety if he or she continues in the study
Uncontrolled epistaxis within Study GA39688 or GA39855
Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

Sites / Locations

Clinical Research Center of Alabama, LLC
Banner University of Arizona Medical Center
Jonathan Corren MD, Inc.
The Allergy Station at Sacramento ENT
Bensch Clinical Research LLC
Colorado ENT & Allergy
Specialist Global Research
Vitae Research Center
University of South Florida
Asthma & Allergy of Idaho
University of Kansas Medical Center
Tandem Clinical Research, LLC
Chesapeake Clinical Research Inc - CRN
Institute for Asthma & Allergy
Brigham and Womens Hospital
University of Missouri Health Care System
Montefiore Medical Center
Northwell Health
Vital Prospects Clinical Research Institute PC - CRN
Allergy Associates Research Center LLC - CRN
Medical University of South Carolina Hospital
TTS Research
Allergy & Asthma Res Ctr PA
Chrysalis Clinical Research
Eastern Virginia Medical School
UZ Gent
UZ Leuven
Yang Medicine
Hopital du Saint Sacrement
Fakultni nemocnice u sv. Anny v Brne
Fakultni nemocnice Hradec Kralove, Chirurgicka klinika
Stredomoravska nemocnicni a.s. - odstepny zavod Nemocnice Prostejov
Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin
Hopital de Hautepierre
Nouvel Hopital Civil; Pole de Pathologie Thoracique
Charie Campus Mitte; Hals, Nasen, Ohrenheilkunde
Universitatsklinikum Leipzig
Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I
Bajcsy-Zsilinszky Hospital
Szent Imre Egyetemi Oktatokorhaz
Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
Unidad de Investigacion CIMA SC
Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
Synexus Affiliate - Clinic Med s.j. Bialystok
Synexus - Gdynia
Synexus - Katowice
Centrum Medyczne Angelius Provita
Centrum Medyczne ALL-MED
Centrum Medyczne Wos i Piwowarczyk
Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
Synexus - Poznan
Synexus - Warsaw
Centrum Medyczne Biotamed
Synexus - Wroclaw
EMC Instytut Medyczny S.A.
Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro; Servicos Farmaceuticos
Hospital de Braga
Hospital Senhora da Oliveira - Guimarães, E.P.E
Centro Hospitalar do Algarve - Hospital de Portimao
Central Clinical Hospital With Polyclinic of President Administration of RF
Medical Center Uromed
LLC Kurator
Terapharm, Llc
Hospital de Jerez
CHUS - H. Clinico U. de Santiago; Servicio de Farmacia
Hospital Universitario Virgen Macarena
Hospital Clinic de Barcelona
Hospital Universitario Fundacion Jimenez Diaz.
Hospital Universitari i Politecnic La Fe de Valencia
Municipal Health Care Institution Regional clinical specialized dispensary of radiation protection
State Institution Institute of Otolaryngology n.a. Prof. O.S.
Ternopil Municipal City Hospital
Municipal Institution "City Clinical Hospital #3"
University Clinic
Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
Ivano-Frankivsk Central City Clinical Hospital
Kyiv City Clinical Hospital #9
Wigan,Wrighington & Leigh NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort A: Study GA39688 Omalizumab

Cohort A: Study GA39688 Placebo

Cohort B: Study GA39855 Omalizumab

Cohort B: Study GA39855 Placebo

Arm Description

Participants who received omalizumab once every 2 weeks (Q2W) or once every 4 weeks (Q4W) in Study GA39688 will continue to receive omalizumab at Week 24 at the same dosing schedule.

Participants who received placebo Q2W or Q4W in Study GA39688 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.

Participants who received omalizumab Q2W or Q4W in Study GA39855 will continue to receive omalizumab at Week 24 at the same dosing schedule.

Participants who received placebo Q2W or Q4W in Study GA39855 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.

Outcomes

Primary Outcome Measures

Change From Baseline in Nasal Polyp Score (NPS)

Total NPS ranges from 0 to 8 (sum of 0-4 for left and right nasal passage scores per the following criteria), with a lower score indicating smaller-sized nasal polyps: 0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = Polyps reaching below the lower border of the middle turbinate (modified to accommodate those with a middle turbinectomy, such that polyp must have reached the top of the inferior turbinate.); 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate; and 4 = Large polyps causing complete obstruction of the inferior nasal cavity. Two blinded primary independent expert readers reviewed every post-screening recorded video endoscopy for a given participant to determine total NPS. A third reader chose one of the two scores to be used for analysis in cases where there was any discrepancy in total NPS assigned between the two primary readers.

Change From Baseline in Average Daily Nasal Congestion Score (NCS)

The Nasal Congestion Score (NCS) was assessed daily by the participant via an electronic diary as the response to the following question: Is your nose blocked? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.

Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

A serious adverse event was defined as any adverse event that met any of the following criteria: was fatal; was life-threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study drug; or, was a significant medical event in the investigator's judgment. Multiple occurrences of the same serious adverse event in one individual were counted once.

Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab

Secondary Outcome Measures

Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS)

The Total Nasal Symptom Score (TNSS) was defined as the sum of the four individual scores for Nasal Congestion Score, Anterior Rhinorrhea Score, Posterior Rhinorrhea Score, and Sense of Smell Score, ranging from 0 (no symptoms) to 12 (most severe symptoms), assessed daily by the participant via an electronic diary. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.

Change From Baseline in Loss of Sense of Smell Score

The Sense of Smell Score was assessed daily by the participant via an electronic diary as the response to the following question: Is your sense of smell reduced? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.

Change From Baseline in Average Daily Posterior Rhinorrhea Score

The Posterior Rhinorrhea Score was assessed daily by the participant via an electronic diary as the response to the following question: Do you feel dripping at the back of the nose? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0=Not at all; 1=Mild; 2=Moderate; and 3=Severe. For each study day, a score was calculated using an average of the prior 7 days among available days within a pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days, otherwise the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.

Change From Baseline in Average Daily Anterior Rhinorrhea Score

The Anterior Rhinorrhea Score was assessed daily by the participant via an electronic diary as the response to the following question: Do you have a runny nose? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0=Not at all; 1=Mild; 2=Moderate; and 3=Severe. For each study day, a score was calculated using an average of the prior 7 days among available days within a pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days, otherwise the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.

Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score

The SNOT-22 Questionnaire, a disease specific HRQoL measure, comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant was asked to rate how severe each problem had been for them over the past 2 weeks on a scale from 0 (no problem at all) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating less disease and better HRQoL. A negative score indicates a decrease (or improvement) from the baseline score.

Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score

The EQ-5D-5L contains a visual analog score (VAS), providing a global assessment of health. The EQ-VAS questionnaire is a self-reported questionnaire that measures health state. The VAS is a 100 mm scale from worst (0 mm) to best (100 mm) health the participant can imagine.

Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains

The EQ-5D-5L contains five domains: Mobility, Self-Care, Usual activity, Pain/Discomfort, and Anxiety/Depression, providing a global assessment of health. Each item is rated by the participant on a five-point scale indicating the followings: Level 1 - no problem; Level 2 - slight problems; Level 3 - moderate problems; Level 4 - severe problems; Level 5 - extreme problems.

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in Participants With Comorbid Asthma Only)

The AQLQ is a 32-item participant-reported measure of asthma-related quality of life (QoL) with a total score (the mean of all 32 responses) ranging from 1 (severely impaired) to 7 (not impaired at all); a higher score indicates a better QoL. An increase of at least 0.5 points in the AQLQ score was considered the minimal important difference for improvement in QoL.

Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score

The UPSIT is a 40-question instrument that measures an individual's ability to detect odors and ranges from 0 to 40, with a higher score indicating a better sense of smell. It is a self-administered "scratch-and-sniff" test provided in booklets that have 40 microencapsulated odorants, each with a multiple-choice option for the response. The number of correct responses is summed to provide a total score.

Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Values

Investigators will assess the participants' clinical laboratory values (e.g., serum chemistry, hematology evaluations including complete blood count [CBC] with differential and platelet counts, and urinalysis values) at timepoints throughout this OLE study relative to the participants' values at baseline from studies GA39688/GA39855 and parameters with clinically significant changes from baseline will be reported.

Minimum Serum Concentrations (Ctrough) of Omalizumab at Specified Timepoints

Serum concentrations of omalizumab were quantified using an enzyme-linked immunoabsorbent assay (ELISA) with a lower limit of quantification (LLOQ) of 28.0 nanograms per millilitre (ng/mL). According to the analysis plan, values below the lower limit of quantification (BLQ) were set to 14 ng/mL (i.e. half of LLOQ value). We confirm that all 121 and 123 participants contributed data to the PK outcome measure. The reason why the numbers of participants analyzed per row are different from the overall number of participants is mainly because some PK concentrations at those time points are below LLOQ. Other reasons include: (1) Five participants received accidental dose of Omalizumab at the OLE Week52 thus are excluded for PK sample results for OLE Week64 and OLE Week76, and (2) One participant received omalizumab as concomitant medication in the follow-up period and is excluded from PK sample results for OLE Week76.

Serum Concentration of Total Immunoglobulin E (IgE)

Serum concentrations of total immunoglobulin E (IgE) were measured throughout the study, as target engagement biomarkers of omalizumab, using validated quantitative immunoassays with lower limits of quantification of 2 International Units per millilitre (IU/mL), and upper limits of quantification (ULQ) of 5000 IU/mL.

Serum Concentration of Free IgE

Serum concentrations of free IgE were measured throughout the study, as target engagement biomarkers of omalizumab, using validated quantitative immunoassays with LLOQ of 0.83 IU/mL, and ULQ of 62.5 IU/mL. The free IgE assay had limited range to measure circulating levels of free IgE in the presence of complexes of omalizumab-IgE. Results above ULQ were set to 62.5 IU/mL. If results for 1/3 or fewer of the participants were greater than the ULQ, then all summary statistics were reported. If the results for more than 1/3 of participants were greater than the ULQ, then only the median, interquartile range and minimum were calculated, and the mean, standard deviation, and maximum were non-reportable.The following are available for median and interquartile ranges (IQR; IQ1-IQ3): Placebo: OLE Week 64 median 55.4 (IQR 33.3 - 62.5), OLE Week 76 median 62.5 (IQR 31.1 - 62.5). Omalizumab: OLE Week 64 median 55.8 (IQR 37.5 - 62.5), OLE Week 76 median 62.5 (IQR 47.9 - 62.5)

Full Information

NCT ID

NCT03478930

First Posted

March 12, 2018

Last Updated

March 31, 2022

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT03478930

Brief Title

An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

Official Title

Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

May 9, 2018 (Actual)

Primary Completion Date

March 16, 2020 (Actual)

Study Completion Date

March 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase III studies GA39688 (NCT03280550) or GA39855 (NCT03280537). Participants will be eligible for enrollment in the study at, or within 28 days after, the Week 24 visit of Studies GA39688/GA39855. After enrollment into this open-label extension (OLE) study, participants will receive 28 weeks of dosing of omalizumab before entering a 24-week off-treatment observation phase of the study. Baseline in this OLE study is defined as the last pre-treatment measurement prior to randomization in Studies GA39688/GA39855 (i.e., baseline of Studies GA39688/GA39855). The data that will be reported from baseline to Week 24 inclusive will come from Studies GA39688/GA39855.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasal Polyps, Chronic Rhinosinusitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Although this is an open-label study and all participants will be receiving omalizumab, in order to minimize bias in this study participants and the evaluating physicians will be blinded to treatment assignment of the previous studies (GA39688/GA39855) until all participants have either completed the study through the follow-up period (Week 76) or discontinued early from the study, the database is locked, and the study analyses are final.

Allocation

Non-Randomized

Enrollment

249 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A: Study GA39688 Omalizumab

Arm Type

Experimental

Arm Description

Participants who received omalizumab once every 2 weeks (Q2W) or once every 4 weeks (Q4W) in Study GA39688 will continue to receive omalizumab at Week 24 at the same dosing schedule.

Arm Title

Cohort A: Study GA39688 Placebo

Arm Type

Experimental

Arm Description

Participants who received placebo Q2W or Q4W in Study GA39688 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.

Arm Title

Cohort B: Study GA39855 Omalizumab

Arm Type

Experimental

Arm Description

Participants who received omalizumab Q2W or Q4W in Study GA39855 will continue to receive omalizumab at Week 24 at the same dosing schedule.

Arm Title

Cohort B: Study GA39855 Placebo

Arm Type

Experimental

Arm Description

Participants who received placebo Q2W or Q4W in Study GA39855 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.

Intervention Type

Drug

Intervention Name(s)

Omalizumab

Other Intervention Name(s)

Xolair

Intervention Description

Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will not be receiving placebo in this OLE study. Participants who were randomized to the placebo arms for 24 weeks in studies GA39688/GA39855 and then enter this OLE study will receive omalizumab, but they will be placed in separate analysis cohorts.

Primary Outcome Measure Information:

Title

Change From Baseline in Nasal Polyp Score (NPS)

Description

Time Frame

Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76

Title

Change From Baseline in Average Daily Nasal Congestion Score (NCS)

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76

Title

Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

Description

Time Frame

From Start to End (Weeks 24 to 52) of OLE Study

Title

Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab

Description

Time Frame

From Start to End (Weeks 24 to 76) of OLE Study

Secondary Outcome Measure Information:

Title

Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS)

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76

Title

Change From Baseline in Loss of Sense of Smell Score

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76

Title

Change From Baseline in Average Daily Posterior Rhinorrhea Score

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76

Title

Change From Baseline in Average Daily Anterior Rhinorrhea Score

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76

Title

Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score

Description

Time Frame

Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76

Title

Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score

Description

Time Frame

Baseline, Weeks 16, 24, 36, 52, 64, and 76

Title

Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains

Description

Time Frame

Baseline, Weeks 16, 24, 36, 52, 64 and 76

Title

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in Participants With Comorbid Asthma Only)

Description

Time Frame

Baseline, Weeks 16, 24, 36, 52, 64, and 76

Title

Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score

Description

Time Frame

Baseline, Weeks 8, 16, 24, 36, 52, 64, and 76

Title

Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Values

Description

Time Frame

Baseline, Weeks 36, 52, 64, and 76

Title

Minimum Serum Concentrations (Ctrough) of Omalizumab at Specified Timepoints

Description

Time Frame

Predose at Weeks 36, 52, 64, and 76

Title

Serum Concentration of Total Immunoglobulin E (IgE)

Description

Time Frame

Predose at Weeks 36, 52, 64, and 76

Title

Serum Concentration of Free IgE

Description

Time Frame

Predose at Weeks 36, 52, 64, and 76

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to comply with the study protocol, in the investigator's judgment Participation in Study GA39688 or GA39855, including completion of endoscopy and other assessments at Week 24, without discontinuation of study drug Completion of eDiary daily assessments for at least 4 out of 7 days in the week prior to the Week 24 visit of Study GA39688 or GA39855 For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 60 days after the last dose of study drug Exclusion Criteria: Anaphylaxis/hypersensitivity related to study drug in Study GA39688 or GA39855 Serious adverse events related to study drug in Study GA39688 or GA39855 that the investigator or Sponsor determines may jeopardize the patient's safety if he or she continues in the study Uncontrolled epistaxis within Study GA39688 or GA39855 Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Research Center of Alabama, LLC

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Banner University of Arizona Medical Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Jonathan Corren MD, Inc.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

The Allergy Station at Sacramento ENT

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

Bensch Clinical Research LLC

City

Stockton

State/Province

California

ZIP/Postal Code

95207

Country

United States

Facility Name

Colorado ENT & Allergy

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80909

Country

United States

Facility Name

Specialist Global Research

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Vitae Research Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Asthma & Allergy of Idaho

City

Twin Falls

State/Province

Idaho

ZIP/Postal Code

83301

Country

United States

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Tandem Clinical Research, LLC

City

Marrero

State/Province

Louisiana

ZIP/Postal Code

70072

Country

United States

Facility Name

Chesapeake Clinical Research Inc - CRN

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21236

Country

United States

Facility Name

Institute for Asthma & Allergy

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

Country

United States

Facility Name

Brigham and Womens Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

University of Missouri Health Care System

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Northwell Health

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Vital Prospects Clinical Research Institute PC - CRN

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Allergy Associates Research Center LLC - CRN

City

Portland

State/Province

Oregon

ZIP/Postal Code

97202

Country

United States

Facility Name

Medical University of South Carolina Hospital

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

TTS Research

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

Allergy & Asthma Res Ctr PA

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78251

Country

United States

Facility Name

Chrysalis Clinical Research

City

Saint George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

Eastern Virginia Medical School

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

UZ Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Yang Medicine

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1G 6C6

Country

Canada

Facility Name

Hopital du Saint Sacrement

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1S 4L8

Country

Canada

Facility Name

Fakultni nemocnice u sv. Anny v Brne

City

Brno

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Fakultni nemocnice Hradec Kralove, Chirurgicka klinika

City

Hradec Kralove

ZIP/Postal Code

50005

Country

Czechia

Facility Name

Stredomoravska nemocnicni a.s. - odstepny zavod Nemocnice Prostejov

City

Prostejov

ZIP/Postal Code

796 04

Country

Czechia

Facility Name

Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Hopital de Hautepierre

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Nouvel Hopital Civil; Pole de Pathologie Thoracique

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Charie Campus Mitte; Hals, Nasen, Ohrenheilkunde

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Universitatsklinikum Leipzig

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

City

Lubeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Bajcsy-Zsilinszky Hospital

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Szent Imre Egyetemi Oktatokorhaz

City

Budapest

ZIP/Postal Code

1115

Country

Hungary

Facility Name

Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

City

Pecs

ZIP/Postal Code

7602

Country

Hungary

Facility Name

Unidad de Investigacion CIMA SC

City

Chihuahua

ZIP/Postal Code

31200

Country

Mexico

Facility Name

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

City

Guadalajara

ZIP/Postal Code

44100

Country

Mexico

Facility Name

Synexus Affiliate - Clinic Med s.j. Bialystok

City

Bialystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Synexus - Gdynia

City

Gdynia

ZIP/Postal Code

81-384

Country

Poland

Facility Name

Synexus - Katowice

City

Katowice

ZIP/Postal Code

40-040

Country

Poland

Facility Name

Centrum Medyczne Angelius Provita

City

Katowice

ZIP/Postal Code

40-611

Country

Poland

Facility Name

Centrum Medyczne ALL-MED

City

Krakow

ZIP/Postal Code

30-033

Country

Poland

Facility Name

Centrum Medyczne Wos i Piwowarczyk

City

Krakow

ZIP/Postal Code

31-572

Country

Poland

Facility Name

Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

City

Lublin

ZIP/Postal Code

20-552

Country

Poland

Facility Name

Synexus - Poznan

City

Poznan

ZIP/Postal Code

60-702

Country

Poland

Facility Name

Synexus - Warsaw

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

Centrum Medyczne Biotamed

City

Wieliczka

ZIP/Postal Code

32-020

Country

Poland

Facility Name

Synexus - Wroclaw

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

EMC Instytut Medyczny S.A.

City

Wrocław

ZIP/Postal Code

50-220

Country

Poland

Facility Name

Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro; Servicos Farmaceuticos

City

Aveiro

ZIP/Postal Code

3814-501

Country

Portugal

Facility Name

Hospital de Braga

City

Braga

ZIP/Postal Code

4710-243

Country

Portugal

Facility Name

Hospital Senhora da Oliveira - Guimarães, E.P.E

City

Guimaraes

ZIP/Postal Code

4835-044

Country

Portugal

Facility Name

Centro Hospitalar do Algarve - Hospital de Portimao

City

Portimao

ZIP/Postal Code

8500-338

Country

Portugal

Facility Name

Central Clinical Hospital With Polyclinic of President Administration of RF

City

Moscow

State/Province

Moskovskaja Oblast

ZIP/Postal Code

121356

Country

Russian Federation

Facility Name

Medical Center Uromed

City

Smolensk

State/Province

Moskovskaja Oblast

ZIP/Postal Code

214031

Country

Russian Federation

Facility Name

LLC Kurator

City

Sankt-peterburg

State/Province

Sankt Petersburg

ZIP/Postal Code

196240

Country

Russian Federation

Facility Name

Terapharm, Llc

City

Stavropol

ZIP/Postal Code

355000

Country

Russian Federation

Facility Name

Hospital de Jerez

City

Jerez De La Frontera

State/Province

Cadiz

ZIP/Postal Code

11407

Country

Spain

Facility Name

CHUS - H. Clinico U. de Santiago; Servicio de Farmacia

City

Santiago de Compostela

State/Province

LA Coruña

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena

City

Seville

State/Province

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

Hospital Clinic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Universitario Fundacion Jimenez Diaz.

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitari i Politecnic La Fe de Valencia

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Municipal Health Care Institution Regional clinical specialized dispensary of radiation protection

City

Kharkiv

State/Province

Kharkiv Governorate

ZIP/Postal Code

61166

Country

Ukraine

Facility Name

State Institution Institute of Otolaryngology n.a. Prof. O.S.

City

Kyiv

State/Province

KIEV Governorate

ZIP/Postal Code

3680

Country

Ukraine

Facility Name

Ternopil Municipal City Hospital

City

Ternopil

State/Province

Podolia Governorate

ZIP/Postal Code

46000

Country

Ukraine

Facility Name

Municipal Institution "City Clinical Hospital #3"

City

Zaporizhzhia

State/Province

Polissya Okruha

ZIP/Postal Code

69032

Country

Ukraine

Facility Name

University Clinic

City

Ivano-Frankivsk

State/Province

Poltava Governorate

ZIP/Postal Code

76000

Country

Ukraine

Facility Name

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

City

Poltava

State/Province

Poltava Governorate

ZIP/Postal Code

36024

Country

Ukraine

Facility Name

Ivano-Frankivsk Central City Clinical Hospital

City

Ivano-Frankivsk

ZIP/Postal Code

76014

Country

Ukraine

Facility Name

Kyiv City Clinical Hospital #9

City

Kyiv

ZIP/Postal Code

04060

Country

Ukraine

Facility Name

Wigan,Wrighington & Leigh NHS Trust

City

Wigan

ZIP/Postal Code

WN1 2NN

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

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