An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

Roche

Status and phase: Completed; Phase 3

Conditions: Chronic Rhinosinusitis; Nasal Polyps

Treatments: Drug: Placebo; Drug: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03478930

2017-003450-16 (EudraCT Number)

WA40169

Details and patient eligibility

About

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 studies GA39688 (NCT03280550) or GA39855 (NCT03280537). 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.

Enrollment: 249 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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249 participants in 4 patient groups

Cohort A: Study GA39688 Omalizumab

Experimental group

Description:

Participants who received omalizumab once every 2 weeks (Q2W) or once every 4 weeks (Q4W) in Study GA39688 will continue to receive omalizumab at Week 24 at the same dosing schedule.

Treatment:

Drug: Omalizumab

Cohort A: Study GA39688 Placebo

Experimental group

Description:

Participants who received placebo Q2W or Q4W in Study GA39688 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.

Treatment:

Drug: Omalizumab

Drug: Placebo

Cohort B: Study GA39855 Omalizumab

Experimental group

Description:

Participants who received omalizumab Q2W or Q4W in Study GA39855 will continue to receive omalizumab at Week 24 at the same dosing schedule.

Treatment:

Drug: Omalizumab

Cohort B: Study GA39855 Placebo

Experimental group

Description:

Participants who received placebo Q2W or Q4W in Study GA39855 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.

Treatment:

Drug: Omalizumab

Drug: Placebo