A Phase 3 interventional study of Omalizumab and Placebo in Nasal Polyps and Chronic Rhinosinusitis, sponsored by Hoffmann-La Roche. Completed at 79 sites in 14 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase III studies GA39688 (NCT03280550) or GA39855 (NCT03280537). Participants will be eligible for enrollment in the study at, or within 28 days after, the Week 24 visit of Studies GA39688/GA39855. After enrollment into this open-label extension (OLE) study, participants will receive 28 weeks of dosing of omalizumab before entering a 24-week off-treatment observation phase of the study. Baseline in this OLE study is defined as the last pre-treatment measurement prior to randomization in Studies GA39688/GA39855 (i.e., baseline of Studies GA39688/GA39855). The data that will be reported from baseline to Week 24 inclusive will come from Studies GA39688/GA39855.
236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.
This study's enrollment of 249 is above the median of 60 across 181 interventional studies indexed under Nasal Polyps.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who received omalizumab once every 2 weeks (Q2W) or once every 4 weeks (Q4W) in Study GA39688 will continue to receive omalizumab at Week 24 at the same dosing schedule.
Drug: Omalizumab
Participants who received placebo Q2W or Q4W in Study GA39688 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.
Drug: Omalizumab · Drug: Placebo
Participants who received omalizumab Q2W or Q4W in Study GA39855 will continue to receive omalizumab at Week 24 at the same dosing schedule.
Drug: Omalizumab
Participants who received placebo Q2W or Q4W in Study GA39855 will start receiving omalizumab Q2W or Q4W at Week 24 at the same dosing schedule.
Drug: Omalizumab · Drug: Placebo
Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.
Also known as: Xolair
Participants will not be receiving placebo in this OLE study. Participants who were randomized to the placebo arms for 24 weeks in studies GA39688/GA39855 and then enter this OLE study will receive omalizumab, but they will be placed in separate analysis cohorts.
Change From Baseline in Nasal Polyp Score (NPS)
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.
Time frame: Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76
Change From Baseline in Average Daily Nasal Congestion Score (NCS)
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
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.
Time frame: From Start to End (Weeks 24 to 52) of OLE Study
Percentage of Participants With Adverse Events Leading to Discontinuation of 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.
Time frame: From Start to End (Weeks 24 to 76) of OLE Study
Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS)
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
Change From Baseline in Loss of Sense of Smell Score
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
Change From Baseline in Average Daily Posterior Rhinorrhea Score
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
Change From Baseline in Average Daily Anterior Rhinorrhea Score
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.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score
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.
Time frame: Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76
Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score
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.
Time frame: Baseline, Weeks 16, 24, 36, 52, 64, and 76
Percentage of Participants Reporting "No Problem" in the European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Subdomains
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.
Time frame: Baseline, Weeks 16, 24, 36, 52, 64 and 76
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score (in Participants With Comorbid Asthma Only)
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.
Time frame: Baseline, Weeks 16, 24, 36, 52, 64, and 76
Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score
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.
Time frame: Baseline, Weeks 8, 16, 24, 36, 52, 64, and 76
Percentage of Participants With a Clinically Significant Change From Baseline in Laboratory Values
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.
Time frame: Baseline, Weeks 36, 52, 64, and 76
Minimum Serum Concentrations (Ctrough) of Omalizumab at Specified Timepoints
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.
Time frame: Predose at Weeks 36, 52, 64, and 76
Serum Concentration of Total Immunoglobulin E (IgE)
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.
Time frame: Predose at Weeks 36, 52, 64, and 76
Serum Concentration of Free IgE
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)
Time frame: Predose at Weeks 36, 52, 64, and 76
| Milestone | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Started | 126 | 123 |
| Completed | 117 | 114 |
| Not completed | 9 | 9 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lack of efficacy | 3 | 3 |
| Withdrew: Withdrawal by subject | 6 | 5 |
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.
| Sore on a scale | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 4 | -0.17 (-0.38 to 0.05) | -0.85 (-1.07 to -0.63) |
| Week 8 | -0.26 (-0.49 to -0.02) | -1.06 (-1.30 to -0.82) |
| Week 16 | -0.17 (-0.38 to 0.05) | -1.09 (-1.31 to -0.87) |
| Week 24 | -0.19 (-0.42 to 0.03) | -1.01 (-1.24 to -0.78) |
| Week 36 | -0.83 (-1.07 to -0.59) | -1.09 (-1.32 to -0.85) |
| Week 52 | -0.97 (-1.25 to -0.69) | -1.31 (-1.60 to -1.03) |
| Week 64 | -0.40 (-0.66 to -0.13) | -0.85 (-1.12 to -0.58) |
| Week 76 | -0.48 (-0.76 to -0.20) | -0.54 (-0.83 to -0.25) |
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.
| Score on a scale | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 4 | -0.17 (-0.27 to -0.07) | -0.39 (-0.50 to -0.29) |
| Week 8 | -0.25 (-0.38 to -0.13) | -0.73 (-0.85 to -0.60) |
| Week 12 | -0.31 (-0.44 to -0.18) | -0.81 (-0.94 to -0.68) |
| Week 16 | -0.32 (-0.46 to -0.19) | -0.88 (-1.02 to -0.74) |
| Week 20 | -0.34 (-0.48 to -0.20) | -0.85 (-1.00 to -0.71) |
| Week 24 | -0.31 (-0.46 to -0.16) | -0.85 (-1.00 to -0.70) |
| Week 28 | -0.61 (-0.76 to -0.47) | -0.88 (-1.03 to -0.73) |
| Week 32 | -0.72 (-0.87 to -0.57) | -0.90 (-1.05 to -0.75) |
| Week 36 | -0.74 (-0.89 to -0.59) | -0.98 (-1.13 to -0.82) |
| Week 40 | -0.73 (-0.88 to -0.59) | -1.02 (-1.17 to -0.87) |
| Week 44 | -0.89 (-1.05 to -0.73) | -1.04 (-1.20 to -0.88) |
| Week 48 | -0.94 (-1.10 to -0.79) | -1.04 (-1.20 to -0.88) |
| Week 52 | -0.99 (-1.14 to -0.83) | -1.12 (-1.28 to -0.96) |
| Week 56 | -0.80 (-0.97 to -0.64) | -0.98 (-1.14 to -0.81) |
| Week 60 | -0.71 (-0.87 to -0.54) | -0.88 (-1.05 to -0.71) |
| Week 64 | -0.63 (-0.80 to -0.46) | -0.88 (-1.05 to -0.71) |
| Week 68 | -0.64 (-0.80 to -0.47) | -0.78 (-0.95 to -0.62) |
| Week 72 | -0.56 (-0.73 to -0.40) | -0.71 (-0.87 to -0.54) |
| Week 76 | -0.58 (-0.76 to -0.41) | -0.65 (-0.83 to -0.48) |
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.
| Percentage of Participants | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| With at least one AE | 49.6 | 43.5 |
| With at least one SAE | 4.8 | 2.4 |
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.
| Percentage of Participants | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab | 0.8 | 0.0 |
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.
| Score on a Scale | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 4 | -0.50 (-0.80 to -0.19) | -1.44 (-1.75 to -1.13) |
| Week 8 | -0.72 (-1.09 to -0.34) | -2.44 (-2.82 to -2.06) |
| Week 12 | -0.82 (-1.22 to -0.41) | -2.73 (-3.14 to -2.32) |
| Week 16 | -0.87 (-1.30 to -0.43) | -2.84 (-3.29 to -2.40) |
| Week 20 | -0.93 (-1.36 to -0.49) | -2.84 (-3.27 to -2.40) |
| Week 24 | -0.92 (-1.37 to -0.47) | -2.82 (-3.27 to -2.36) |
| Week 28 | -1.80 (-2.25 to -1.34) | -2.94 (-3.40 to -2.48) |
| Week 32 | -2.19 (-2.64 to -1.74) | -3.14 (-3.60 to -2.68) |
| Week 36 | -2.22 (-2.69 to -1.76) | -3.24 (-3.71 to -2.77) |
| Week 40 | -2.32 (-2.77 to -1.86) | -3.40 (-3.87 to -2.94) |
| Week 44 | -2.72 (-3.21 to -2.24) | -3.52 (-4.02 to -3.03) |
| Week 48 | -2.84 (-3.32 to -2.36) | -3.49 (-3.98 to -3.00) |
| Week 52 | -3.01 (-3.49 to -2.53) | -3.83 (-4.31 to -3.34) |
| Week 56 | -2.54 (-3.04 to -2.04) | -3.23 (-3.74 to -2.72) |
| Week 60 | -2.27 (-2.78 to -1.76) | -2.90 (-3.42 to -2.38) |
| Week 64 | -1.94 (-2.44 to -1.43) | -2.97 (-3.49 to -2.46) |
| Week 68 | -1.83 (-2.33 to -1.33) | -2.59 (-3.09 to -2.08) |
| Week 72 | -1.59 (-2.10 to -1.08) | -2.37 (-2.88 to -1.85) |
| Week 76 | -1.63 (-2.19 to -1.08) | -2.18 (-2.74 to -1.62) |
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.
| Score on a Scale | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 4 | -0.07 (-0.16 to 0.02) | -0.22 (-0.31 to -0.13) |
| Week 8 | -0.14 (-0.25 to -0.03) | -0.43 (-0.55 to -0.32) |
| Week 12 | -0.14 (-0.27 to -0.02) | -0.57 (-0.70 to -0.45) |
| Week 16 | -0.19 (-0.33 to -0.06) | -0.58 (-0.72 to -0.44) |
| Week 20 | -0.21 (-0.35 to -0.08) | -0.58 (-0.72 to -0.45) |
| Week 24 | -0.23 (-0.36 to -0.09) | -0.56 (-0.70 to -0.43) |
| Week 28 | -0.26 (-0.40 to -0.12) | -0.58 (-0.72 to -0.44) |
| Week 32 | -0.39 (-0.54 to -0.24) | -0.65 (-0.80 to -0.50) |
| Week 36 | -0.39 (-0.54 to -0.25) | -0.63 (-0.77 to -0.48) |
| Week 40 | -0.42 (-0.57 to -0.27) | -0.66 (-0.81 to -0.51) |
| Week 44 | -0.51 (-0.67 to -0.36) | -0.70 (-0.85 to -0.54) |
| Week 48 | -0.54 (-0.70 to -0.38) | -0.70 (-0.86 to -0.54) |
| Week 52 | -0.60 (-0.76 to -0.43) | -0.76 (-0.92 to -0.59) |
| Week 56 | -0.54 (-0.69 to -0.38) | -0.62 (-0.78 to -0.46) |
| Week 60 | -0.50 (-0.65 to -0.34) | -0.56 (-0.71 to -0.40) |
| Week 64 | -0.41 (-0.57 to -0.26) | -0.53 (-0.68 to -0.37) |
| Week 68 | -0.39 (-0.53 to -0.24) | -0.44 (-0.59 to -0.30) |
| Week 72 | -0.35 (-0.49 to -0.21) | -0.42 (-0.56 to -0.28) |
| Week 76 | -0.35 (-0.50 to -0.20) | -0.39 (-0.54 to -0.24) |
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.
| Score on a Scale | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 4 | -0.13 (-0.23 to -0.03) | -0.35 (-0.44 to -0.25) |
| Week 8 | -0.13 (-0.24 to -0.02) | -0.58 (-0.70 to -0.47) |
| Week 12 | -0.14 (-0.25 to -0.02) | -0.60 (-0.72 to -0.48) |
| Week 16 | -0.11 (-0.24 to 0.02) | -0.63 (-0.76 to -0.50) |
| Week 20 | -0.14 (-0.27 to -0.02) | -0.64 (-0.77 to -0.51) |
| Week 24 | -0.15 (-0.29 to -0.02) | -0.66 (-0.79 to -0.52) |
| Week 28 | -0.36 (-0.49 to -0.22) | -0.67 (-0.81 to -0.53) |
| Week 32 | -0.46 (-0.60 to -0.32) | -0.72 (-0.86 to -0.58) |
| Week 36 | -0.46 (-0.60 to -0.32) | -0.76 (-0.90 to -0.62) |
| Week 40 | -0.49 (-0.62 to -0.36) | -0.77 (-0.91 to -0.64) |
| Week 44 | -0.58 (-0.72 to -0.44) | -0.80 (-0.94 to -0.65) |
| Week 48 | -0.60 (-0.74 to -0.46) | -0.77 (-0.91 to -0.62) |
| Week 52 | -0.62 (-0.75 to -0.48) | -0.87 (-1.00 to -0.73) |
| Week 56 | -0.52 (-0.66 to -0.38) | -0.74 (-0.88 to -0.59) |
| Week 60 | -0.47 (-0.62 to -0.33) | -0.70 (-0.85 to -0.55) |
| Week 64 | -0.38 (-0.52 to -0.23) | -0.78 (-0.93 to -0.63) |
| Week 68 | -0.37 (-0.52 to -0.21) | -0.66 (-0.81 to -0.50) |
| Week 72 | -0.27 (-0.42 to -0.11) | -0.61 (-0.76 to -0.45) |
| Week 76 | -0.28 (-0.44 to -0.12) | -0.53 (-0.70 to -0.37) |
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.
| Score on a Scale | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 4 | -0.13 (-0.23 to -0.03) | -0.47 (-0.57 to -0.37) |
| Week 8 | -0.21 (-0.32 to -0.09) | -0.68 (-0.80 to -0.57) |
| Week 12 | -0.24 (-0.36 to -0.13) | -0.73 (-0.85 to -0.61) |
| Week 16 | -0.26 (-0.38 to -0.13) | -0.74 (-0.87 to -0.61) |
| Week 20 | -0.24 (-0.37 to -0.11) | -0.74 (-0.87 to -0.61) |
| Week 24 | -0.24 (-0.38 to -0.11) | -0.73 (-0.87 to -0.59) |
| Week 28 | -0.58 (-0.71 to -0.45) | -0.80 (-0.93 to -0.66) |
| Week 32 | -0.65 (-0.77 to -0.52) | -0.84 (-0.97 to -0.71) |
| Week 36 | -0.66 (-0.79 to -0.52) | -0.85 (-0.99 to -0.71) |
| Week 40 | -0.71 (-0.85 to -0.57) | -0.93 (-1.07 to -0.79) |
| Week 44 | -0.77 (-0.91 to -0.63) | -0.96 (-1.10 to -0.82) |
| Week 48 | -0.80 (-0.95 to -0.66) | -0.94 (-1.09 to -0.80) |
| Week 52 | -0.85 (-0.98 to -0.71) | -1.06 (-1.19 to -0.92) |
| Week 56 | -0.71 (-0.85 to -0.56) | -0.89 (-1.03 to -0.74) |
| Week 60 | -0.61 (-0.76 to -0.46) | -0.75 (-0.90 to -0.60) |
| Week 64 | -0.54 (-0.69 to -0.39) | -0.77 (-0.92 to -0.61) |
| Week 68 | -0.47 (-0.62 to -0.32) | -0.69 (-0.84 to -0.54) |
| Week 72 | -0.43 (-0.59 to -0.28) | -0.62 (-0.77 to -0.46) |
| Week 76 | -0.45 (-0.62 to -0.29) | -0.57 (-0.74 to -0.40) |
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.
| Score on a Scale | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 4 | -8.43 (-10.82 to -6.04) | -17.86 (-20.28 to -15.44) |
| Week 8 | -8.85 (-11.56 to -6.15) | -21.74 (-24.47 to -19.01) |
| Week 16 | -8.52 (-11.32 to -5.72) | -24.56 (-27.40 to -21.73) |
| Week 24 | -7.76 (-10.73 to -4.80) | -23.56 (-26.55 to -20.57) |
| Week 36 | -17.87 (-20.91 to -14.83) | -25.42 (-28.51 to -22.34) |
| Week 52 | -22.39 (-25.39 to -19.40) | -28.47 (-31.52 to -25.42) |
| Week 64 | -17.02 (-20.31 to -13.72) | -22.66 (-26.01 to -19.31) |
| Week 76 | -15.37 (-18.79 to -11.95) | -19.44 (-22.89 to -15.99) |
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.
| Score on a Scale | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 16 | -0.6 ± 20.8 | 6.4 ± 16.7 |
| Week 24 | 2.3 ± 19.6 | 7.9 ± 16.9 |
| Week 36 | 7.4 ± 20.0 | 9.3 ± 16.1 |
| Week 52 | 8.5 ± 22.2 | 10.8 ± 17.9 |
| Week 64 | 5.3 ± 21.4 | 5.3 ± 18.4 |
| Week 76 | 2.8 ± 20.4 | 4.4 ± 20.8 |
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.
| Percentage of Participants | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Baseline Usual activities | 57.9 | 59.5 |
| Baseline Mobility | 67.5 | 68.6 |
| Baseline Self-care | 83.3 | 90.9 |
| Baseline Pain/Discomfort | 27.0 | 27.3 |
| Baseline Anxiety/Depression | 49.2 | 47.9 |
| Week 16 Usual activities | 54.0 | 75.6 |
| Week 16 Mobility | 60.5 | 79.7 |
| Week 16 Self-care | 84.7 | 91.1 |
| Week 16 Pain/Discomfort | 32.3 | 48.0 |
| Week 16 Anxiety/Depression | 48.4 | 57.7 |
| Week 24 Usual activities | 60.8 | 69.9 |
| Week 24 Mobility | 66.4 | 74.0 |
| Week 24 Self-care | 87.2 | 89.4 |
| Week 24 Pain/Discomfort | 29.6 | 51.2 |
| Week 24 Anxiety/Depression | 47.2 | 60.2 |
| Week 36 Usual activities | 60.3 | 74.8 |
| Week 36 Mobility | 69.4 | 75.6 |
| Week 36 Self-care | 83.5 | 90.8 |
| Week 36 Pain/Discomfort | 40.5 | 48.7 |
| Week 36 Anxiety/Depression | 55.4 | 68.9 |
| Week 52 Usual activities | 65.5 | 74.6 |
| Week 52 Mobility | 72.3 | 71.9 |
| Week 52 Self-care | 87.4 | 91.2 |
| Week 52 Pain/Discomfort | 40.3 | 56.1 |
| Week 52 Anxiety/Depression | 62.2 | 70.2 |
| Week 64 Usual activities | 62.9 | 72.1 |
| Week 64 Mobility | 62.1 | 70.3 |
| Week 64 Self-care | 84.5 | 90.1 |
| Week 64 Pain/Discomfort | 32.8 | 47.7 |
| Week 64 Anxiety/Depression | 50.9 | 61.3 |
| Week 76 Usual activities | 64.6 | 71.4 |
| Week 76 Mobility | 66.4 | 76.8 |
| Week 76 Self-care | 85.0 | 89.3 |
| Week 76 Pain/Discomfort | 34.5 | 48.2 |
| Week 76 Anxiety/Depression | 51.3 | 58.0 |
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.
| Score on a Scale | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 16 | 0.05 ± 1.14 | 0.77 ± 1.15 |
| Week 24 | -0.01 ± 0.94 | 0.84 ± 1.25 |
| Week 36 | 0.50 ± 1.05 | 0.84 ± 1.27 |
| Week 52 | 0.52 ± 1.10 | 0.95 ± 1.23 |
| Week 64 | 0.34 ± 1.12 | 0.66 ± 1.35 |
| Week 76 | 0.27 ± 1.15 | 0.42 ± 1.57 |
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.
| Score on a Scale | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 8 | 0.49 (-0.69 to 1.67) | 5.04 (3.85 to 6.23) |
| Week 16 | 0.83 (-0.33 to 1.99) | 4.31 (3.14 to 5.48) |
| Week 24 | 0.46 (-0.71 to 1.64) | 4.24 (3.04 to 5.43) |
| Week 36 | 3.47 (2.10 to 4.84) | 4.27 (2.90 to 5.65) |
| Week 52 | 3.88 (2.57 to 5.20) | 4.13 (2.78 to 5.47) |
| Week 64 | 1.81 (0.56 to 3.06) | 2.77 (1.49 to 4.05) |
| Week 76 | 0.62 (-0.47 to 1.71) | 1.42 (0.32 to 2.52) |
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.
| Percentage of Participants | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Baseline OLE (Week 24) | 0.0 | 0.0 |
| Week 36 | 0.0 | 0.0 |
| Week 52 | 0.0 | 0.0 |
| Week 64 | 0.0 | 0.0 |
| Week 76 | 0.0 | 0.0 |
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.
| ng/mL | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 36 | 33100 ± 83.8 | 34500 ± 95.7 |
| Week 52 | 29700 ± 133.4 | 27700 ± 158.5 |
| Week 64 | 1650 ± 199.8 | 1780 ± 214.2 |
| Week 76 | 93.3 ± 352.7 | 109 ± 246.4 |
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.
| IU/mL | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 36 | 665 ± 530 | 522 ± 367 |
| Week 52 | 635 ± 463 | 532 ± 424 |
| Week 64 | 390 ± 366 | 335 ± 342 |
| Week 76 | 231 ± 226 | 196 ± 191 |
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)
| IU/mL | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Week 36 | 8.08 ± 4.73 | 7.73 ± 6.37 |
| Week 52 | 9.09 ± 8.81 | 9.52 ± 10.8 |
| Week 64 | NA ± NA | NA ± NA |
| Week 76 | NA ± NA | NA ± NA |
Collected over From Start to End (Weeks 24 to 76) of OLE Study. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Received Placebo in GA39688 or GA39855 | 0/125 (0%) | 12/125 (9.6%) | 28/125 (22.4%) |
| Received Omalizumab in GA39688 or GA39855 | 0/124 (0%) | 8/124 (6.5%) | 19/124 (15.3%) |
| Event | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| Femur fractureInjury, poisoning and procedural complications | 1/25 | 0/124 |
| PneumoniaInfections and infestations | 2/125 | 0/124 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 2/125 | 1/124 |
| Gastrointestinal inflammationGastrointestinal disorders | 0/125 | 1/124 |
| Ileus paralyticGastrointestinal disorders | 0/125 | 1/124 |
| Rectal abscessInfections and infestations | 0/125 | 1/124 |
| Testicular abscessInfections and infestations | 0/125 | 1/124 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 0/125 | 1/124 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/125 | 1/124 |
| Bipolar disorderPsychiatric disorders | 0/125 | 1/124 |
| Event | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 |
|---|---|---|
| NasopharyngitisInfections and infestations | 13/125 | 19/124 |
| SinusitisInfections and infestations | 13/125 | 9/124 |
| Nasal polypsRespiratory, thoracic and mediastinal disorders | 13/125 | 4/124 |
| Age, Continuous(years) | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 | Total |
|---|---|---|---|
| Mean | 51.6 ± 11.9 | 49.9 ± 13.1 | 50.8 ± 12.5 |
| Sex: Female, Male(Participants) | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 | Total |
|---|---|---|---|
| Female | 44 | 45 | 89 |
| Male | 82 | 78 | 160 |
| Ethnicity (NIH/OMB)(Participants) | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 11 | 19 |
| Not Hispanic or Latino | 117 | 110 | 227 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | Received Placebo in GA39688 or GA39855 | Received Omalizumab in GA39688 or GA39855 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 |
| White | 126 | 117 | 243 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in Mar 2020, 22 months.
Results were first posted in May 2021, 1 year 1 month after primary completion.
Of 30 industry-sponsored phase 3 interventional studies under Nasal Polyps, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 26. This study's 22 months is close to that.
Counting every sponsor, half of 34 studies reached it within 22 months; a quarter within 19 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Omalizumab