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An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps
 
Region Sponsors
California - Northern
Genentech
 
Acronym KP IRB No.
1328999
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Adults with Chronic Rhinosinusitis with Nasal Polyps
 
Purpose
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 Study GA39688 or GA39855. 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.
 
Detailed 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.
 
Gender Age Limit
Male & Female 18 - 75 years
 
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

 
Keywords and/or Specific Medical Conditions
  • Anti-Allergic Agents
  • Pathological Conditions, Anatomical
  • Anti-Asthmatic Agents
  • Polyps
  • Chronic Rhinosinusitis
  • Respiratory System Agents
  • Nasal Polyps
  • Respiratory Tract Diseases
  • Nose Diseases
  • Respiratory Tract Infections
  • Omalizumab
  • Rhinosinusitis
  • Otorhinolaryngologic Diseases
  • Sinusitis
  • Paranasal Sinus Diseases
  • Allergy and Immunology
 
KP Clinical Facility
  • Roseville Medical Center
  • Roseville Medical Center-Rancho Cordova
  • Sacramento Medical Center
 
Clinical Area
  • Allergy and Immunology


Principal Investigator:
Arif Seyal, MD
Contact Information:
- Deborah Macres
-Deborah.J.Macres@kp.org
-Roseville Medical Center-Rancho Cordova


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