Trial Outcomes & Findings for An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps (NCT NCT03478930)

Last Updated: 2022-04-04

Results Overview

Total NPS ranges from 0 to 8 (sum of 0-4 for left and right nasal passage scores per the following criteria), with a lower score indicating smaller-sized nasal polyps: 0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = Polyps reaching below the lower border of the middle turbinate (modified to accommodate those with a middle turbinectomy, such that polyp must have reached the top of the inferior turbinate.); 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate; and 4 = Large polyps causing complete obstruction of the inferior nasal cavity. Two blinded primary independent expert readers reviewed every post-screening recorded video endoscopy for a given participant to determine total NPS. A third reader chose one of the two scores to be used for analysis in cases where there was any discrepancy in total NPS assigned between the two primary readers.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

249 participants

Primary outcome timeframe

Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76

Results posted on

2022-04-04

Participant Flow

Participants who completed the treatment period of Study GA39688/GA39855 and fulfilled the eligibility criteria for the open-label extension (OLE) study were enrolled.

Participant milestones

Participant milestones
Measure	Received Placebo in GA39688 or GA39855 After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Overall Study STARTED	126	123
Overall Study COMPLETED	117	114
Overall Study NOT COMPLETED	9	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Received Placebo in GA39688 or GA39855 After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Overall Study Adverse Event	0	1
Overall Study Lack of Efficacy	3	3
Overall Study Withdrawal by Subject	6	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Total n=249 Participants Total of all reporting groups
Age, Continuous	51.6 years STANDARD_DEVIATION 11.9 • n=5 Participants	49.9 years STANDARD_DEVIATION 13.1 • n=7 Participants	50.8 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	45 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	82 Participants n=5 Participants	78 Participants n=7 Participants	160 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	117 Participants n=5 Participants	110 Participants n=7 Participants	227 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	126 Participants n=5 Participants	117 Participants n=7 Participants	243 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76

Population: Full Analysis Set (FAS) of the open label extension (OLE): all participants enrolled into the OLE, grouped according to the treatment assigned (omalizumab or placebo) at randomization of the previous studies. Participants who were not enrolled in the OLE study, their parent study data were not included in the analyses. All participants in the FAS received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Change From Baseline in Nasal Polyp Score (NPS) Week 4	-0.17 Sore on a scale Interval -0.38 to 0.05	-0.85 Sore on a scale Interval -1.07 to -0.63
Change From Baseline in Nasal Polyp Score (NPS) Week 8	-0.26 Sore on a scale Interval -0.49 to -0.02	-1.06 Sore on a scale Interval -1.3 to -0.82
Change From Baseline in Nasal Polyp Score (NPS) Week 16	-0.17 Sore on a scale Interval -0.38 to 0.05	-1.09 Sore on a scale Interval -1.31 to -0.87
Change From Baseline in Nasal Polyp Score (NPS) Week 24	-0.19 Sore on a scale Interval -0.42 to 0.03	-1.01 Sore on a scale Interval -1.24 to -0.78
Change From Baseline in Nasal Polyp Score (NPS) Week 36	-0.83 Sore on a scale Interval -1.07 to -0.59	-1.09 Sore on a scale Interval -1.32 to -0.85
Change From Baseline in Nasal Polyp Score (NPS) Week 52	-0.97 Sore on a scale Interval -1.25 to -0.69	-1.31 Sore on a scale Interval -1.6 to -1.03
Change From Baseline in Nasal Polyp Score (NPS) Week 64	-0.40 Sore on a scale Interval -0.66 to -0.13	-0.85 Sore on a scale Interval -1.12 to -0.58
Change From Baseline in Nasal Polyp Score (NPS) Week 76	-0.48 Sore on a scale Interval -0.76 to -0.2	-0.54 Sore on a scale Interval -0.83 to -0.25

PRIMARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76

Population: FAS-OLE: all participants enrolled into the OLE, grouped according to the treatment assigned (omalizumab or placebo) at randomization of the previous studies. Participants who were not enrolled in the OLE study, their parent study data were not included in the analyses. All participants in the FAS received at least one dose of study drug.

The Nasal Congestion Score (NCS) was assessed daily by the participant via an electronic diary as the response to the following question: Is your nose blocked? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 4	-0.17 Score on a scale Interval -0.27 to -0.07	-0.39 Score on a scale Interval -0.5 to -0.29
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 8	-0.25 Score on a scale Interval -0.38 to -0.13	-0.73 Score on a scale Interval -0.85 to -0.6
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 12	-0.31 Score on a scale Interval -0.44 to -0.18	-0.81 Score on a scale Interval -0.94 to -0.68
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 16	-0.32 Score on a scale Interval -0.46 to -0.19	-0.88 Score on a scale Interval -1.02 to -0.74
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 20	-0.34 Score on a scale Interval -0.48 to -0.2	-0.85 Score on a scale Interval -1.0 to -0.71
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 24	-0.31 Score on a scale Interval -0.46 to -0.16	-0.85 Score on a scale Interval -1.0 to -0.7
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 28	-0.61 Score on a scale Interval -0.76 to -0.47	-0.88 Score on a scale Interval -1.03 to -0.73
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 32	-0.72 Score on a scale Interval -0.87 to -0.57	-0.90 Score on a scale Interval -1.05 to -0.75
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 36	-0.74 Score on a scale Interval -0.89 to -0.59	-0.98 Score on a scale Interval -1.13 to -0.82
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 40	-0.73 Score on a scale Interval -0.88 to -0.59	-1.02 Score on a scale Interval -1.17 to -0.87
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 44	-0.89 Score on a scale Interval -1.05 to -0.73	-1.04 Score on a scale Interval -1.2 to -0.88
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 48	-0.94 Score on a scale Interval -1.1 to -0.79	-1.04 Score on a scale Interval -1.2 to -0.88
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 52	-0.99 Score on a scale Interval -1.14 to -0.83	-1.12 Score on a scale Interval -1.28 to -0.96
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 56	-0.80 Score on a scale Interval -0.97 to -0.64	-0.98 Score on a scale Interval -1.14 to -0.81
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 60	-0.71 Score on a scale Interval -0.87 to -0.54	-0.88 Score on a scale Interval -1.05 to -0.71
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 64	-0.63 Score on a scale Interval -0.8 to -0.46	-0.88 Score on a scale Interval -1.05 to -0.71
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 68	-0.64 Score on a scale Interval -0.8 to -0.47	-0.78 Score on a scale Interval -0.95 to -0.62
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 72	-0.56 Score on a scale Interval -0.73 to -0.4	-0.71 Score on a scale Interval -0.87 to -0.54
Change From Baseline in Average Daily Nasal Congestion Score (NCS) Week 76	-0.58 Score on a scale Interval -0.76 to -0.41	-0.65 Score on a scale Interval -0.83 to -0.48

PRIMARY outcome

Timeframe: From Start to End (Weeks 24 to 52) of OLE Study

Population: All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.

A serious adverse event was defined as any adverse event that met any of the following criteria: was fatal; was life-threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study drug; or, was a significant medical event in the investigator's judgment. Multiple occurrences of the same serious adverse event in one individual were counted once.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=125 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=124 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) With at least one SAE	4.8 Percentage of Participants	2.4 Percentage of Participants
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) With at least one AE	49.6 Percentage of Participants	43.5 Percentage of Participants

PRIMARY outcome

Timeframe: From Start to End (Weeks 24 to 76) of OLE Study

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=125 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=124 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab	0.8 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76

The Total Nasal Symptom Score (TNSS) was defined as the sum of the four individual scores for Nasal Congestion Score, Anterior Rhinorrhea Score, Posterior Rhinorrhea Score, and Sense of Smell Score, ranging from 0 (no symptoms) to 12 (most severe symptoms), assessed daily by the participant via an electronic diary. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 4	-0.50 Score on a Scale Interval -0.8 to -0.19	-1.44 Score on a Scale Interval -1.75 to -1.13
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 8	-0.72 Score on a Scale Interval -1.09 to -0.34	-2.44 Score on a Scale Interval -2.82 to -2.06
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 12	-0.82 Score on a Scale Interval -1.22 to -0.41	-2.73 Score on a Scale Interval -3.14 to -2.32
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 16	-0.87 Score on a Scale Interval -1.3 to -0.43	-2.84 Score on a Scale Interval -3.29 to -2.4
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 20	-0.93 Score on a Scale Interval -1.36 to -0.49	-2.84 Score on a Scale Interval -3.27 to -2.4
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 24	-0.92 Score on a Scale Interval -1.37 to -0.47	-2.82 Score on a Scale Interval -3.27 to -2.36
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 28	-1.80 Score on a Scale Interval -2.25 to -1.34	-2.94 Score on a Scale Interval -3.4 to -2.48
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 32	-2.19 Score on a Scale Interval -2.64 to -1.74	-3.14 Score on a Scale Interval -3.6 to -2.68
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 36	-2.22 Score on a Scale Interval -2.69 to -1.76	-3.24 Score on a Scale Interval -3.71 to -2.77
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 40	-2.32 Score on a Scale Interval -2.77 to -1.86	-3.40 Score on a Scale Interval -3.87 to -2.94
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 44	-2.72 Score on a Scale Interval -3.21 to -2.24	-3.52 Score on a Scale Interval -4.02 to -3.03
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 48	-2.84 Score on a Scale Interval -3.32 to -2.36	-3.49 Score on a Scale Interval -3.98 to -3.0
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 52	-3.01 Score on a Scale Interval -3.49 to -2.53	-3.83 Score on a Scale Interval -4.31 to -3.34
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 56	-2.54 Score on a Scale Interval -3.04 to -2.04	-3.23 Score on a Scale Interval -3.74 to -2.72
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 60	-2.27 Score on a Scale Interval -2.78 to -1.76	-2.90 Score on a Scale Interval -3.42 to -2.38
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 64	-1.94 Score on a Scale Interval -2.44 to -1.43	-2.97 Score on a Scale Interval -3.49 to -2.46
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 68	-1.83 Score on a Scale Interval -2.33 to -1.33	-2.59 Score on a Scale Interval -3.09 to -2.08
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 72	-1.59 Score on a Scale Interval -2.1 to -1.08	-2.37 Score on a Scale Interval -2.88 to -1.85
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) Week 76	-1.63 Score on a Scale Interval -2.19 to -1.08	-2.18 Score on a Scale Interval -2.74 to -1.62

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76

The Sense of Smell Score was assessed daily by the participant via an electronic diary as the response to the following question: Is your sense of smell reduced? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Change From Baseline in Loss of Sense of Smell Score Week 4	-0.07 Score on a Scale Interval -0.16 to 0.02	-0.22 Score on a Scale Interval -0.31 to -0.13
Change From Baseline in Loss of Sense of Smell Score Week 8	-0.14 Score on a Scale Interval -0.25 to -0.03	-0.43 Score on a Scale Interval -0.55 to -0.32
Change From Baseline in Loss of Sense of Smell Score Week 12	-0.14 Score on a Scale Interval -0.27 to -0.02	-0.57 Score on a Scale Interval -0.7 to -0.45
Change From Baseline in Loss of Sense of Smell Score Week 16	-0.19 Score on a Scale Interval -0.33 to -0.06	-0.58 Score on a Scale Interval -0.72 to -0.44
Change From Baseline in Loss of Sense of Smell Score Week 20	-0.21 Score on a Scale Interval -0.35 to -0.08	-0.58 Score on a Scale Interval -0.72 to -0.45
Change From Baseline in Loss of Sense of Smell Score Week 24	-0.23 Score on a Scale Interval -0.36 to -0.09	-0.56 Score on a Scale Interval -0.7 to -0.43
Change From Baseline in Loss of Sense of Smell Score Week 28	-0.26 Score on a Scale Interval -0.4 to -0.12	-0.58 Score on a Scale Interval -0.72 to -0.44
Change From Baseline in Loss of Sense of Smell Score Week 32	-0.39 Score on a Scale Interval -0.54 to -0.24	-0.65 Score on a Scale Interval -0.8 to -0.5
Change From Baseline in Loss of Sense of Smell Score Week 36	-0.39 Score on a Scale Interval -0.54 to -0.25	-0.63 Score on a Scale Interval -0.77 to -0.48
Change From Baseline in Loss of Sense of Smell Score Week 40	-0.42 Score on a Scale Interval -0.57 to -0.27	-0.66 Score on a Scale Interval -0.81 to -0.51
Change From Baseline in Loss of Sense of Smell Score Week 44	-0.51 Score on a Scale Interval -0.67 to -0.36	-0.70 Score on a Scale Interval -0.85 to -0.54
Change From Baseline in Loss of Sense of Smell Score Week 48	-0.54 Score on a Scale Interval -0.7 to -0.38	-0.70 Score on a Scale Interval -0.86 to -0.54
Change From Baseline in Loss of Sense of Smell Score Week 52	-0.60 Score on a Scale Interval -0.76 to -0.43	-0.76 Score on a Scale Interval -0.92 to -0.59
Change From Baseline in Loss of Sense of Smell Score Week 56	-0.54 Score on a Scale Interval -0.69 to -0.38	-0.62 Score on a Scale Interval -0.78 to -0.46
Change From Baseline in Loss of Sense of Smell Score Week 60	-0.50 Score on a Scale Interval -0.65 to -0.34	-0.56 Score on a Scale Interval -0.71 to -0.4
Change From Baseline in Loss of Sense of Smell Score Week 64	-0.41 Score on a Scale Interval -0.57 to -0.26	-0.53 Score on a Scale Interval -0.68 to -0.37
Change From Baseline in Loss of Sense of Smell Score Week 68	-0.39 Score on a Scale Interval -0.53 to -0.24	-0.44 Score on a Scale Interval -0.59 to -0.3
Change From Baseline in Loss of Sense of Smell Score Week 72	-0.35 Score on a Scale Interval -0.49 to -0.21	-0.42 Score on a Scale Interval -0.56 to -0.28
Change From Baseline in Loss of Sense of Smell Score Week 76	-0.35 Score on a Scale Interval -0.5 to -0.2	-0.39 Score on a Scale Interval -0.54 to -0.24

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76

The Posterior Rhinorrhea Score was assessed daily by the participant via an electronic diary as the response to the following question: Do you feel dripping at the back of the nose? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0=Not at all; 1=Mild; 2=Moderate; and 3=Severe. For each study day, a score was calculated using an average of the prior 7 days among available days within a pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days, otherwise the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 4	-0.13 Score on a Scale Interval -0.23 to -0.03	-0.35 Score on a Scale Interval -0.44 to -0.25
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 8	-0.13 Score on a Scale Interval -0.24 to -0.02	-0.58 Score on a Scale Interval -0.7 to -0.47
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 12	-0.14 Score on a Scale Interval -0.25 to -0.02	-0.60 Score on a Scale Interval -0.72 to -0.48
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 16	-0.11 Score on a Scale Interval -0.24 to 0.02	-0.63 Score on a Scale Interval -0.76 to -0.5
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 20	-0.14 Score on a Scale Interval -0.27 to -0.02	-0.64 Score on a Scale Interval -0.77 to -0.51
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 24	-0.15 Score on a Scale Interval -0.29 to -0.02	-0.66 Score on a Scale Interval -0.79 to -0.52
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 28	-0.36 Score on a Scale Interval -0.49 to -0.22	-0.67 Score on a Scale Interval -0.81 to -0.53
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 32	-0.46 Score on a Scale Interval -0.6 to -0.32	-0.72 Score on a Scale Interval -0.86 to -0.58
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 36	-0.46 Score on a Scale Interval -0.6 to -0.32	-0.76 Score on a Scale Interval -0.9 to -0.62
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 40	-0.49 Score on a Scale Interval -0.62 to -0.36	-0.77 Score on a Scale Interval -0.91 to -0.64
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 44	-0.58 Score on a Scale Interval -0.72 to -0.44	-0.80 Score on a Scale Interval -0.94 to -0.65
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 48	-0.60 Score on a Scale Interval -0.74 to -0.46	-0.77 Score on a Scale Interval -0.91 to -0.62
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 52	-0.62 Score on a Scale Interval -0.75 to -0.48	-0.87 Score on a Scale Interval -1.0 to -0.73
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 56	-0.52 Score on a Scale Interval -0.66 to -0.38	-0.74 Score on a Scale Interval -0.88 to -0.59
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 60	-0.47 Score on a Scale Interval -0.62 to -0.33	-0.70 Score on a Scale Interval -0.85 to -0.55
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 64	-0.38 Score on a Scale Interval -0.52 to -0.23	-0.78 Score on a Scale Interval -0.93 to -0.63
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 68	-0.37 Score on a Scale Interval -0.52 to -0.21	-0.66 Score on a Scale Interval -0.81 to -0.5
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 72	-0.27 Score on a Scale Interval -0.42 to -0.11	-0.61 Score on a Scale Interval -0.76 to -0.45
Change From Baseline in Average Daily Posterior Rhinorrhea Score Week 76	-0.28 Score on a Scale Interval -0.44 to -0.12	-0.53 Score on a Scale Interval -0.7 to -0.37

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76

The Anterior Rhinorrhea Score was assessed daily by the participant via an electronic diary as the response to the following question: Do you have a runny nose? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0=Not at all; 1=Mild; 2=Moderate; and 3=Severe. For each study day, a score was calculated using an average of the prior 7 days among available days within a pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days, otherwise the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 4	-0.13 Score on a Scale Interval -0.23 to -0.03	-0.47 Score on a Scale Interval -0.57 to -0.37
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 8	-0.21 Score on a Scale Interval -0.32 to -0.09	-0.68 Score on a Scale Interval -0.8 to -0.57
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 12	-0.24 Score on a Scale Interval -0.36 to -0.13	-0.73 Score on a Scale Interval -0.85 to -0.61
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 16	-0.26 Score on a Scale Interval -0.38 to -0.13	-0.74 Score on a Scale Interval -0.87 to -0.61
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 20	-0.24 Score on a Scale Interval -0.37 to -0.11	-0.74 Score on a Scale Interval -0.87 to -0.61
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 24	-0.24 Score on a Scale Interval -0.38 to -0.11	-0.73 Score on a Scale Interval -0.87 to -0.59
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 28	-0.58 Score on a Scale Interval -0.71 to -0.45	-0.80 Score on a Scale Interval -0.93 to -0.66
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 32	-0.65 Score on a Scale Interval -0.77 to -0.52	-0.84 Score on a Scale Interval -0.97 to -0.71
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 36	-0.66 Score on a Scale Interval -0.79 to -0.52	-0.85 Score on a Scale Interval -0.99 to -0.71
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 40	-0.71 Score on a Scale Interval -0.85 to -0.57	-0.93 Score on a Scale Interval -1.07 to -0.79
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 44	-0.77 Score on a Scale Interval -0.91 to -0.63	-0.96 Score on a Scale Interval -1.1 to -0.82
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 48	-0.80 Score on a Scale Interval -0.95 to -0.66	-0.94 Score on a Scale Interval -1.09 to -0.8
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 52	-0.85 Score on a Scale Interval -0.98 to -0.71	-1.06 Score on a Scale Interval -1.19 to -0.92
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 56	-0.71 Score on a Scale Interval -0.85 to -0.56	-0.89 Score on a Scale Interval -1.03 to -0.74
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 60	-0.61 Score on a Scale Interval -0.76 to -0.46	-0.75 Score on a Scale Interval -0.9 to -0.6
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 64	-0.54 Score on a Scale Interval -0.69 to -0.39	-0.77 Score on a Scale Interval -0.92 to -0.61
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 68	-0.47 Score on a Scale Interval -0.62 to -0.32	-0.69 Score on a Scale Interval -0.84 to -0.54
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 72	-0.43 Score on a Scale Interval -0.59 to -0.28	-0.62 Score on a Scale Interval -0.77 to -0.46
Change From Baseline in Average Daily Anterior Rhinorrhea Score Week 76	-0.45 Score on a Scale Interval -0.62 to -0.29	-0.57 Score on a Scale Interval -0.74 to -0.4

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76

The SNOT-22 Questionnaire, a disease specific HRQoL measure, comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant was asked to rate how severe each problem had been for them over the past 2 weeks on a scale from 0 (no problem at all) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating less disease and better HRQoL. A negative score indicates a decrease (or improvement) from the baseline score.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score Week 4	-8.43 Score on a Scale Interval -10.82 to -6.04	-17.86 Score on a Scale Interval -20.28 to -15.44
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score Week 8	-8.85 Score on a Scale Interval -11.56 to -6.15	-21.74 Score on a Scale Interval -24.47 to -19.01
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score Week 16	-8.52 Score on a Scale Interval -11.32 to -5.72	-24.56 Score on a Scale Interval -27.4 to -21.73
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score Week 24	-7.76 Score on a Scale Interval -10.73 to -4.8	-23.56 Score on a Scale Interval -26.55 to -20.57
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score Week 36	-17.87 Score on a Scale Interval -20.91 to -14.83	-25.42 Score on a Scale Interval -28.51 to -22.34
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score Week 52	-22.39 Score on a Scale Interval -25.39 to -19.4	-28.47 Score on a Scale Interval -31.52 to -25.42
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score Week 64	-17.02 Score on a Scale Interval -20.31 to -13.72	-22.66 Score on a Scale Interval -26.01 to -19.31
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score Week 76	-15.37 Score on a Scale Interval -18.79 to -11.95	-19.44 Score on a Scale Interval -22.89 to -15.99

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 24, 36, 52, 64, and 76

The EQ-5D-5L contains a visual analog score (VAS), providing a global assessment of health. The EQ-VAS questionnaire is a self-reported questionnaire that measures health state. The VAS is a 100 mm scale from worst (0 mm) to best (100 mm) health the participant can imagine.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score Week 16	-0.6 Score on a Scale Standard Deviation 20.8	6.4 Score on a Scale Standard Deviation 16.7
Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score Week 24	2.3 Score on a Scale Standard Deviation 19.6	7.9 Score on a Scale Standard Deviation 16.9
Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score Week 36	7.4 Score on a Scale Standard Deviation 20.0	9.3 Score on a Scale Standard Deviation 16.1
Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score Week 52	8.5 Score on a Scale Standard Deviation 22.2	10.8 Score on a Scale Standard Deviation 17.9
Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score Week 64	5.3 Score on a Scale Standard Deviation 21.4	5.3 Score on a Scale Standard Deviation 18.4
Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score Week 76	2.8 Score on a Scale Standard Deviation 20.4	4.4 Score on a Scale Standard Deviation 20.8

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 24, 36, 52, 64 and 76

The EQ-5D-5L contains five domains: Mobility, Self-Care, Usual activity, Pain/Discomfort, and Anxiety/Depression, providing a global assessment of health. Each item is rated by the participant on a five-point scale indicating the followings: Level 1 - no problem; Level 2 - slight problems; Level 3 - moderate problems; Level 4 - severe problems; Level 5 - extreme problems.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Baseline Usual activities	57.9 Percentage of Participants	59.5 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Baseline Mobility	67.5 Percentage of Participants	68.6 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Baseline Self-care	83.3 Percentage of Participants	90.9 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Baseline Pain/Discomfort	27.0 Percentage of Participants	27.3 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Baseline Anxiety/Depression	49.2 Percentage of Participants	47.9 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 16 Usual activities	54.0 Percentage of Participants	75.6 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 16 Mobility	60.5 Percentage of Participants	79.7 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 16 Self-care	84.7 Percentage of Participants	91.1 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 16 Pain/Discomfort	32.3 Percentage of Participants	48.0 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 16 Anxiety/Depression	48.4 Percentage of Participants	57.7 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 24 Usual activities	60.8 Percentage of Participants	69.9 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 24 Mobility	66.4 Percentage of Participants	74.0 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 24 Self-care	87.2 Percentage of Participants	89.4 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 24 Pain/Discomfort	29.6 Percentage of Participants	51.2 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 24 Anxiety/Depression	47.2 Percentage of Participants	60.2 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 36 Usual activities	60.3 Percentage of Participants	74.8 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 36 Mobility	69.4 Percentage of Participants	75.6 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 36 Self-care	83.5 Percentage of Participants	90.8 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 36 Pain/Discomfort	40.5 Percentage of Participants	48.7 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 36 Anxiety/Depression	55.4 Percentage of Participants	68.9 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 52 Usual activities	65.5 Percentage of Participants	74.6 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 52 Mobility	72.3 Percentage of Participants	71.9 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 52 Self-care	87.4 Percentage of Participants	91.2 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 52 Pain/Discomfort	40.3 Percentage of Participants	56.1 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 52 Anxiety/Depression	62.2 Percentage of Participants	70.2 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 64 Usual activities	62.9 Percentage of Participants	72.1 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 64 Mobility	62.1 Percentage of Participants	70.3 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 64 Self-care	84.5 Percentage of Participants	90.1 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 64 Pain/Discomfort	32.8 Percentage of Participants	47.7 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 64 Anxiety/Depression	50.9 Percentage of Participants	61.3 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 76 Usual activities	64.6 Percentage of Participants	71.4 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 76 Mobility	66.4 Percentage of Participants	76.8 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 76 Self-care	85.0 Percentage of Participants	89.3 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 76 Pain/Discomfort	34.5 Percentage of Participants	48.2 Percentage of Participants
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains Week 76 Anxiety/Depression	51.3 Percentage of Participants	58.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Weeks 16, 24, 36, 52, 64, and 76

The AQLQ is a 32-item participant-reported measure of asthma-related quality of life (QoL) with a total score (the mean of all 32 responses) ranging from 1 (severely impaired) to 7 (not impaired at all); a higher score indicates a better QoL. An increase of at least 0.5 points in the AQLQ score was considered the minimal important difference for improvement in QoL.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=69 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=73 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in Participants With Comorbid Asthma Only) Week 16	0.05 Score on a Scale Standard Deviation 1.14	0.77 Score on a Scale Standard Deviation 1.15
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in Participants With Comorbid Asthma Only) Week 24	-0.01 Score on a Scale Standard Deviation 0.94	0.84 Score on a Scale Standard Deviation 1.25
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in Participants With Comorbid Asthma Only) Week 36	0.50 Score on a Scale Standard Deviation 1.05	0.84 Score on a Scale Standard Deviation 1.27
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in Participants With Comorbid Asthma Only) Week 52	0.52 Score on a Scale Standard Deviation 1.10	0.95 Score on a Scale Standard Deviation 1.23
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in Participants With Comorbid Asthma Only) Week 64	0.34 Score on a Scale Standard Deviation 1.12	0.66 Score on a Scale Standard Deviation 1.35
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in Participants With Comorbid Asthma Only) Week 76	0.27 Score on a Scale Standard Deviation 1.15	0.42 Score on a Scale Standard Deviation 1.57

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 16, 24, 36, 52, 64, and 76

The UPSIT is a 40-question instrument that measures an individual's ability to detect odors and ranges from 0 to 40, with a higher score indicating a better sense of smell. It is a self-administered "scratch-and-sniff" test provided in booklets that have 40 microencapsulated odorants, each with a multiple-choice option for the response. The number of correct responses is summed to provide a total score.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score Week 8	0.49 Score on a Scale Interval -0.69 to 1.67	5.04 Score on a Scale Interval 3.85 to 6.23
Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score Week 16	0.83 Score on a Scale Interval -0.33 to 1.99	4.31 Score on a Scale Interval 3.14 to 5.48
Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score Week 24	0.46 Score on a Scale Interval -0.71 to 1.64	4.24 Score on a Scale Interval 3.04 to 5.43
Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score Week 36	3.47 Score on a Scale Interval 2.1 to 4.84	4.27 Score on a Scale Interval 2.9 to 5.65
Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score Week 52	3.88 Score on a Scale Interval 2.57 to 5.2	4.13 Score on a Scale Interval 2.78 to 5.47
Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score Week 64	1.81 Score on a Scale Interval 0.56 to 3.06	2.77 Score on a Scale Interval 1.49 to 4.05
Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score Week 76	0.62 Score on a Scale Interval -0.47 to 1.71	1.42 Score on a Scale Interval 0.32 to 2.52

SECONDARY outcome

Timeframe: Baseline, Weeks 36, 52, 64, and 76

Investigators will assess the participants' clinical laboratory values (e.g., serum chemistry, hematology evaluations including complete blood count \[CBC\] with differential and platelet counts, and urinalysis values) at timepoints throughout this OLE study relative to the participants' values at baseline from studies GA39688/GA39855 and parameters with clinically significant changes from baseline will be reported.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Values Week 52	0.0 Percentage of Participants	0.0 Percentage of Participants
Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Values Baseline OLE (Week 24)	0.0 Percentage of Participants	0.0 Percentage of Participants
Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Values Week 36	0.0 Percentage of Participants	0.0 Percentage of Participants
Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Values Week 64	0.0 Percentage of Participants	0.0 Percentage of Participants
Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Values Week 76	0.0 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: Predose at Weeks 36, 52, 64, and 76

Population: The pharmacokinetic evaluable analysis set (PKAS) consisted of participants who received study drug in the form of their per-protocol dose according to baseline total IgE and body weight in the dosing table. Participants receiving the wrong dose or frequency of the treatment assigned (placebo or omalizumab) or the wrong treatment assigned were excluded from this population.

Serum concentrations of omalizumab were quantified using an enzyme-linked immunoabsorbent assay (ELISA) with a lower limit of quantification (LLOQ) of 28.0 nanograms per millilitre (ng/mL). According to the analysis plan, values below the lower limit of quantification (BLQ) were set to 14 ng/mL (i.e. half of LLOQ value). We confirm that all 121 and 123 participants contributed data to the PK outcome measure. The reason why the numbers of participants analyzed per row are different from the overall number of participants is mainly because some PK concentrations at those time points are below LLOQ. Other reasons include: (1) Five participants received accidental dose of Omalizumab at the OLE Week52 thus are excluded for PK sample results for OLE Week64 and OLE Week76, and (2) One participant received omalizumab as concomitant medication in the follow-up period and is excluded from PK sample results for OLE Week76.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=121 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Minimum Serum Concentrations (Ctrough) of Omalizumab at Specified Timepoints Week 36	33100 ng/mL Geometric Coefficient of Variation 83.8	34500 ng/mL Geometric Coefficient of Variation 95.7
Minimum Serum Concentrations (Ctrough) of Omalizumab at Specified Timepoints Week 52	29700 ng/mL Geometric Coefficient of Variation 133.4	27700 ng/mL Geometric Coefficient of Variation 158.5
Minimum Serum Concentrations (Ctrough) of Omalizumab at Specified Timepoints Week 64	1650 ng/mL Geometric Coefficient of Variation 199.8	1780 ng/mL Geometric Coefficient of Variation 214.2
Minimum Serum Concentrations (Ctrough) of Omalizumab at Specified Timepoints Week 76	93.3 ng/mL Geometric Coefficient of Variation 352.7	109 ng/mL Geometric Coefficient of Variation 246.4

SECONDARY outcome

Timeframe: Predose at Weeks 36, 52, 64, and 76

Serum concentrations of total immunoglobulin E (IgE) were measured throughout the study, as target engagement biomarkers of omalizumab, using validated quantitative immunoassays with lower limits of quantification of 2 International Units per millilitre (IU/mL), and upper limits of quantification (ULQ) of 5000 IU/mL.

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Serum Concentration of Total Immunoglobulin E (IgE) Week 76	231 IU/mL Standard Deviation 226	196 IU/mL Standard Deviation 191
Serum Concentration of Total Immunoglobulin E (IgE) Week 36	665 IU/mL Standard Deviation 530	522 IU/mL Standard Deviation 367
Serum Concentration of Total Immunoglobulin E (IgE) Week 52	635 IU/mL Standard Deviation 463	532 IU/mL Standard Deviation 424
Serum Concentration of Total Immunoglobulin E (IgE) Week 64	390 IU/mL Standard Deviation 366	335 IU/mL Standard Deviation 342

SECONDARY outcome

Timeframe: Predose at Weeks 36, 52, 64, and 76

Serum concentrations of free IgE were measured throughout the study, as target engagement biomarkers of omalizumab, using validated quantitative immunoassays with LLOQ of 0.83 IU/mL, and ULQ of 62.5 IU/mL. The free IgE assay had limited range to measure circulating levels of free IgE in the presence of complexes of omalizumab-IgE. Results above ULQ were set to 62.5 IU/mL. If results for 1/3 or fewer of the participants were greater than the ULQ, then all summary statistics were reported. If the results for more than 1/3 of participants were greater than the ULQ, then only the median, interquartile range and minimum were calculated, and the mean, standard deviation, and maximum were non-reportable.The following are available for median and interquartile ranges (IQR; IQ1-IQ3): Placebo: OLE Week 64 median 55.4 (IQR 33.3 - 62.5), OLE Week 76 median 62.5 (IQR 31.1 - 62.5). Omalizumab: OLE Week 64 median 55.8 (IQR 37.5 - 62.5), OLE Week 76 median 62.5 (IQR 47.9 - 62.5)

Outcome measures

Outcome measures
Measure	Received Placebo in GA39688 or GA39855 n=126 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=123 Participants After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Serum Concentration of Free IgE Week 36	8.08 IU/mL Standard Deviation 4.73	7.73 IU/mL Standard Deviation 6.37
Serum Concentration of Free IgE Week 52	9.09 IU/mL Standard Deviation 8.81	9.52 IU/mL Standard Deviation 10.8
Serum Concentration of Free IgE Week 64	NA IU/mL Standard Deviation NA Due to more than 1/3 of the participants having free IgE levels above ULQ, the Mean and SD were not reported (NA) for Weeks 64 and 76. See median and IQR under 'Description', above.	NA IU/mL Standard Deviation NA Due to more than 1/3 of the participants having free IgE levels above ULQ, the Mean and SD were not reported (NA) for Weeks 64 and 76. See median and IQR under 'Description', above.
Serum Concentration of Free IgE Week 76	NA IU/mL Standard Deviation NA Due to more than 1/3 of the participants having free IgE levels above ULQ, the Mean and SD were not reported (NA) for Weeks 64 and 76. See median and IQR under 'Description', above.	NA IU/mL Standard Deviation NA Due to more than 1/3 of the participants having free IgE levels above ULQ, the Mean and SD were not reported (NA) for Weeks 64 and 76. See median and IQR under 'Description', above.

Adverse Events

Received Placebo in GA39688 or GA39855

Serious events: 12 serious events

Other events: 28 other events

Deaths: 0 deaths

Received Omalizumab in GA39688 or GA39855

Serious events: 8 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Received Placebo in GA39688 or GA39855 n=125 participants at risk After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=124 participants at risk After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Infections and infestations Nasopharyngitis	10.4% 13/125 • Number of events 34 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	15.3% 19/124 • Number of events 33 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Infections and infestations Sinusitis	10.4% 13/125 • Number of events 16 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	7.3% 9/124 • Number of events 16 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Respiratory, thoracic and mediastinal disorders Nasal polyps	10.4% 13/125 • Number of events 16 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	3.2% 4/124 • Number of events 4 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Received Placebo in GA39688 or GA39855 n=125 participants at risk After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.	Received Omalizumab in GA39688 or GA39855 n=124 participants at risk After completion of the randomized double-blind placebo controlled studies GA39688 or GA39855, eligible participants were enrolled into WA60169. All participants in WA60169 received 28 weeks of open-label omalizumab as a subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) before entering a 24-week off-treatment observation phase of the study. Omalizumab dose during the 28 weeks open-label treatment was determined based on serum total IgE levels and body weight from the screening data from the parent studies.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/125 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.81% 1/124 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.80% 1/125 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.00% 0/124 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Gastrointestinal disorders Ileus paralytic	0.00% 0/125 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.81% 1/124 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Gastrointestinal disorders Pancreatitis acute	0.80% 1/125 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.00% 0/124 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Infections and infestations Pneumonia	1.6% 2/125 • Number of events 2 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.00% 0/124 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Infections and infestations Post procedural infection	0.80% 1/125 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.00% 0/124 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Infections and infestations Rectal abscess	0.00% 0/125 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.81% 1/124 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Infections and infestations Testicular abscess	0.00% 0/125 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.81% 1/124 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Injury, poisoning and procedural complications Femur fracture	4.0% 1/25 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.00% 0/124 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Injury, poisoning and procedural complications Hip fracture	0.80% 1/125 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.00% 0/124 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Injury, poisoning and procedural complications Spinal compression fracture	0.80% 1/125 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.00% 0/124 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/125 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.81% 1/124 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/125 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.81% 1/124 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Psychiatric disorders Anxiety	0.80% 1/125 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.00% 0/124 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Psychiatric disorders Bipolar disorder	0.00% 0/125 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.81% 1/124 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Respiratory, thoracic and mediastinal disorders Asthma	1.6% 2/125 • Number of events 2 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.81% 1/124 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/125 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.81% 1/124 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.
Vascular disorders Aortic aneurysm	0.80% 1/125 • Number of events 1 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.	0.00% 0/124 • From Start to End (Weeks 24 to 76) of OLE Study All safety analyses were based on the subset of the full analysis set of the OLE study (FAS-OLE), who received at least one dose of omalizumab in the OLE study (Safety-OLE), grouped according to the treatment received (omalizumab or placebo) in the parent studies. One participant randomized to the placebo arm in a parent study accidently received omalizumab.