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)

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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.


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
Norfolk, Virginia 23507
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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7000 Fannin St
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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Houston, TX
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529 West Markham Street
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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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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Baltimore, Maryland 21236
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Birmingham, Alabama 35209
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Boerne, Texas 78006
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Charleston, South Carolina 29403
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Chevy Chase, Maryland 20815
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1653 West Congress Parkway
Chicago, Illinois 60612
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Colorado Springs, Colorado 80909
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185 De Pintelaan
Gent, 9000
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Great Neck, New York 11021
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905 West Governor Road
Hershey, Pennsylvania 17033
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1490 West 49th Place
Hialeah, Florida 33012
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Los Angeles, California 90025
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1101 Medical Center Boulevard
Marrero, Louisiana 70072
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Miami, Florida 33135
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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5930 West Park Boulevard
Plano, Texas 75093
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6327 Southeast Milwaukie Avenue
Portland, Oregon 97202
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Rancho Cordova, California 95762
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1528 Eureka Road
Roseville, California 95661
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736 South 900 East
Saint George, Utah 84790
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San Antonio, Texas 78251
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Stockton, California 95207
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Tucson, AZ
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Twin Falls, Idaho 83301
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Walnut Creek, California 94598
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