Chronic rhinosinusitis with nasal polyps MedDRA version: 20.0 Level: PT Classification code 10028756 Term: Nasal polyps System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: XOLAIR
Product Name: Omalizumab
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: OMALIZUMAB
CAS Number: 242138-07-4
Other descriptive name: RO5489789
Concentrat
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Ability to comply with the study protocol, in the investigator's judgment -Participation in Study GA39688 or Study GA39855, including completion of endoscopy and other assessments at Week 24 -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 Study 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 216 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: -Anaphylaxis/hypersensitivity related to study drug in Study GA39688/GA39855 -Serious adverse events related to study drug in Study GA39688/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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate adverse events associated with usage of omalizumab in patients with CRSwNP •To evaluate efficacy of continued treatment with omalizumab after an initial 24 week treatment period •To evaluate the durability of response following treatment discontinuation ;Secondary Objective: •To evaluate the impact of treatment duration with omalizumab on durability of response ;Primary end point(s): 1. Incidence of serious and non-serious adverse events 2. Incidence of adverse events leading to omalizumab discontinuation 3. Change from baseline in NPS 4. Change from baseline in NCS ;Timepoint(s) of evaluation of this end point: 1-2. Up to 76 weeks 3. At Weeks 4, 8, 16, 24 36, 52, 64, and 76 4. At Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Clinically significant change in laboratory values 2. Change from baseline In TNSS 3. Change from baseline In Loss of smell Week 76 4. Change from baseline In Posterior rhinorrhea 5. Change from baseline In Anterior rhinorrhea 6. Change from baseline In SNOT 22 7. Change from baseline In EQ-5D-5L 8. Change from baseline In AQLQ (patients with comorbid asthma only) 9. Change from baseline In UPSIT ;Timepoint(s) of evaluation of this end point: 1. Up to 76 weeks 2-5. At Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76 6. At Weeks 4, 8, 16, 24, 36, 52, 64, and 76 7. At Weeks 16, 24, 36, 52, 64, and 76 8. At Weeks 4, 8, 16, 24, 36, 52, 64, and 76 9. At Weeks 8, 16, 24, 36, 52, 64, and 76 | — |
Countries
Belgium, Canada, Czech Republic, Finland, France, Germany, Hungary, Mexico, Poland, Portugal, Russian Federation, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd.
Outcome results
None listed