Clinical trial NCT03478930: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasal Polyps
Chronic Rhinosinusitis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Nasal Polyp Score (NPS)
timeFrame: Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76
measure: Change From Baseline in Average Daily Nasal Congestion Score (NCS)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
measure: Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: From Start to End (Weeks 24 to 52) of OLE Study
measure: Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab
timeFrame: From Start to End (Weeks 24 to 76) of OLE Study
Secondary outcomes:
measure: Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS)
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
measure: Change From Baseline in Loss of Sense of Smell Score
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
measure: Change From Baseline in Average Daily Posterior Rhinorrhea Score
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
measure: Change From Baseline in Average Daily Anterior Rhinorrhea Score
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
measure: Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score
timeFrame: Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76
measure: Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score
timeFrame: Baseline, Weeks 16, 24, 36, 52, 64, and 76
measure: Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains
timeFrame: Baseline, Weeks 16, 24, 36, 52, 64 and 76
measure: Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in Participants With Comorbid Asthma Only)
timeFrame: Baseline, Weeks 16, 24, 36, 52, 64, and 76
measure: Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score
timeFrame: Baseline, Weeks 8, 16, 24, 36, 52, 64, and 76
measure: Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Values
timeFrame: Baseline, Weeks 36, 52, 64, and 76
measure: Minimum Serum Concentrations (Ctrough) of Omalizumab at Specified Timepoints
timeFrame: Predose at Weeks 36, 52, 64, and 76
measure: Serum Concentration of Total Immunoglobulin E (IgE)
timeFrame: Predose at Weeks 36, 52, 64, and 76
measure: Serum Concentration of Free IgE
timeFrame: Predose at Weeks 36, 52, 64, and 76
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama, LLC
state: Alabama
city: Tucson
country: United States
facility: Banner University of Arizona Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Jonathan Corren MD, Inc.
state: California
city: Roseville
country: United States
facility: The Allergy Station at Sacramento ENT
state: California
city: Stockton
country: United States
facility: Bensch Clinical Research LLC
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT & Allergy
state: Colorado
city: Hialeah
country: United States
facility: Specialist Global Research
state: Florida
city: Miami
country: United States
facility: Vitae Research Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Twin Falls
country: United States
facility: Asthma & Allergy of Idaho
state: Idaho
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Marrero
country: United States
facility: Tandem Clinical Research, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Chesapeake Clinical Research Inc - CRN
state: Maryland
city: Chevy Chase
country: United States
facility: Institute for Asthma & Allergy
state: Maryland
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri Health Care System
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute PC - CRN
state: Oklahoma
city: Portland
country: United States
facility: Allergy Associates Research Center LLC - CRN
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina Hospital
state: South Carolina
city: Boerne
country: United States
facility: TTS Research
state: Texas
city: San Antonio
country: United States
facility: Allergy & Asthma Res Ctr PA
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Ottawa
country: Canada
facility: Yang Medicine
state: Ontario
city: Quebec City
country: Canada
facility: Hopital du Saint Sacrement
state: Quebec
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove, Chirurgicka klinika
city: Prostejov
country: Czechia
facility: Stredomoravska nemocnicni a.s. - odstepny zavod Nemocnice Prostejov
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin
city: Strasbourg
country: France
facility: Hopital de Hautepierre
city: Strasbourg
country: France
facility: Nouvel Hopital Civil; Pole de Pathologie Thoracique
city: Berlin
country: Germany
facility: Charie Campus Mitte; Hals, Nasen, Ohrenheilkunde
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Hospital
city: Budapest
country: Hungary
facility: Szent Imre Egyetemi Oktatokorhaz
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
city: Chihuahua
country: Mexico
facility: Unidad de Investigacion CIMA SC
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.
city: Bialystok
country: Poland
facility: Synexus Affiliate - Clinic Med s.j. Bialystok
city: Gdynia
country: Poland
facility: Synexus - Gdynia
city: Katowice
country: Poland
facility: Synexus - Katowice
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Krakow
country: Poland
facility: Centrum Medyczne ALL-MED
city: Krakow
country: Poland
facility: Centrum Medyczne Wos i Piwowarczyk
city: Lublin
country: Poland
facility: Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
city: Poznan
country: Poland
facility: Synexus - Poznan
city: Warszawa
country: Poland
facility: Synexus - Warsaw
city: Wieliczka
country: Poland
facility: Centrum Medyczne Biotamed
city: Wroclaw
country: Poland
facility: Synexus - Wroclaw
city: Wrocław
country: Poland
facility: EMC Instytut Medyczny S.A.
city: Aveiro
country: Portugal
facility: Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro; Servicos Farmaceuticos
city: Braga
country: Portugal
facility: Hospital de Braga
city: Guimaraes
country: Portugal
facility: Hospital Senhora da Oliveira - Guimarães, E.P.E
city: Portimao
country: Portugal
facility: Centro Hospitalar do Algarve - Hospital de Portimao
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital With Polyclinic of President Administration of RF
state: Moskovskaja Oblast
city: Smolensk
country: Russian Federation
facility: Medical Center Uromed
state: Moskovskaja Oblast
city: Sankt-peterburg
country: Russian Federation
facility: LLC Kurator
state: Sankt Petersburg
city: Stavropol
country: Russian Federation
facility: Terapharm, Llc
city: Jerez De La Frontera
country: Spain
facility: Hospital de Jerez
state: Cadiz
city: Santiago de Compostela
country: Spain
facility: CHUS - H. Clinico U. de Santiago; Servicio de Farmacia
state: LA Coruña
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Sevilla
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz.
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Kharkiv
country: Ukraine
facility: Municipal Health Care Institution Regional clinical specialized dispensary of radiation protection
state: Kharkiv Governorate
city: Kyiv
country: Ukraine
facility: State Institution Institute of Otolaryngology n.a. Prof. O.S.
state: KIEV Governorate
city: Ternopil
country: Ukraine
facility: Ternopil Municipal City Hospital
state: Podolia Governorate
city: Zaporizhzhia
country: Ukraine
facility: Municipal Institution "City Clinical Hospital #3"
state: Polissya Okruha
city: Ivano-Frankivsk
country: Ukraine
facility: University Clinic
state: Poltava Governorate
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
state: Poltava Governorate
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Central City Clinical Hospital
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital #9
city: Wigan
country: United Kingdom
facility: Wigan,Wrighington & Leigh NHS Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: