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

Conditions

• Chronic Rhinosinusitis
• Nasal Polyps

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Omalizumab — DRUG
  Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.
• Placebo — DRUG
  Participants will not be receiving placebo in this OLE study. Participants who were randomized to the placebo arms for 24 weeks in studies GA39688/GA39855 and then enter this OLE study will receive omalizumab, but they will be placed in separate analysis cohorts.

Study Details

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.

Key Dates

Start date

May 9, 2018

Status verified

Mar 2022

Primary completion

Mar 16, 2020

Completion

Mar 16, 2020

Study Design

Enrollment

249 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A: Study GA39688 Omalizumab
  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.
• Experimental: Cohort A: Study GA39688 Placebo
  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.
• Experimental: Cohort B: Study GA39855 Omalizumab
  Participants who received omalizumab Q2W or Q4W in Study GA39855 will continue to receive omalizumab at Week 24 at the same dosing schedule.
• Experimental: Cohort B: Study GA39855 Placebo
  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.

Primary Outcome Measure

Change From Baseline in Nasal Polyp Score (NPS) [ Time Frame: Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76 ]

Locations (25)

Find similar trials in Birmingham, AL

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