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

Completed · Phase 3 · Has a placebo group

Conditions studied: Nasal Polyps, Chronic Rhinosinusitis

In brief

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.

Key facts

Study ID

NCT03478930

Run by

Hoffmann-La Roche

People needed

249

Starts

2018-05-09

Expected to finish

2020-03-16

Last updated by the study team

2022-04-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner University of Arizona Medical Center — Tucson, Arizona, United States
• Jonathan Corren MD, Inc. — Los Angeles, California, United States
• The Allergy Station at Sacramento ENT — Roseville, California, United States
• Bensch Clinical Research LLC — Stockton, California, United States
• Colorado ENT & Allergy — Colorado Springs, Colorado, United States
• Specialist Global Research — Hialeah, Florida, United States
• Vitae Research Center — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Asthma & Allergy of Idaho — Twin Falls, Idaho, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Tandem Clinical Research, LLC — Marrero, Louisiana, United States
• Chesapeake Clinical Research Inc - CRN — Baltimore, Maryland, United States
• Institute for Asthma & Allergy — Chevy Chase, Maryland, United States
• Brigham and Womens Hospital — Boston, Massachusetts, United States
• University of Missouri Health Care System — Columbia, Missouri, United States
• Northwell Health — Great Neck, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Vital Prospects Clinical Research Institute PC - CRN — Tulsa, Oklahoma, United States
• Allergy Associates Research Center LLC - CRN — Portland, Oregon, United States
• Medical University of South Carolina Hospital — Charleston, South Carolina, United States
• TTS Research — Boerne, Texas, United States
• Allergy & Asthma Res Ctr PA — San Antonio, Texas, United States
• Chrysalis Clinical Research — St. George, Utah, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States
• Clinical Research Center of Alabama, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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