An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
Status: | Recruiting |
---|---|
Conditions: | Sinusitis |
Therapuetic Areas: | Otolaryngology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 3/13/2019 |
Start Date: | May 9, 2018 |
End Date: | March 18, 2020 |
Contact: | Reference Study ID Number: WA40169 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. Only) |
Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps
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.
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.
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
We found this trial at
36
sites
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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University of South Florida The University of South Florida is a high-impact, global research university...
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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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4350 East Camelback Road
Phoenix, Arizona 85018
Phoenix, Arizona 85018
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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