Status:
COMPLETED
An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Nasal Polyps
Chronic Rhinosinusitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 po...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2020
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT03478930
Start Date
May 9 2018
End Date
March 16 2020
Last Update
April 4 2022
Active Locations (79)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States, 35209
2
Banner University of Arizona Medical Center
Tucson, Arizona, United States, 85724
3
Jonathan Corren MD, Inc.
Los Angeles, California, United States, 90025
4
The Allergy Station at Sacramento ENT
Roseville, California, United States, 95661