Trial · NCT03478930
An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
NCT03478930, Phase 3, Completed, Hoffmann-La Roche; results first posted 2021-05-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps. Trials, record NCT03478930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03478930
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
- NCT number
- NCT03478930
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 249 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Nasal Polyps, Chronic Rhinosinusitis
- Interventions
- Omalizumab, Placebo
- First posted
- 2018-03-27
- Last updated
- 2022-04-04
- Other registries' IDs
- eudract:2017-003450-16
- Results first posted
- 2021-05-11
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Nasal Polyp Score (NPS) | Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76 | 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. |
| Primary | Change From Baseline in Average Daily Nasal Congestion Score (NCS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76 | 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. |
| Primary | Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | From Start to End (Weeks 24 to 52) of OLE Study | 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. |
| Primary | Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab | From Start to End (Weeks 24 to 76) of OLE Study | 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. |
| Secondary | Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) | 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. |
| Secondary | Change From Baseline in Loss of Sense of Smell Score | 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. |
| Secondary | Change From Baseline in Average Daily Posterior Rhinorrhea Score | 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. |
| Secondary | Change From Baseline in Average Daily Anterior Rhinorrhea Score | 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. |
| Secondary | Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score | 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. |
| Secondary | Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Nasal Polyp Score (NPS) | Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76 | 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. | Sore on a scale | MEAN |
| PRIMARY | Change From Baseline in Average Daily Nasal Congestion Score (NCS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76 | 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. | Score on a scale | MEAN |
| PRIMARY | Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | From Start to End (Weeks 24 to 52) 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. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Adverse Events Leading to Discontinuation of Omalizumab | 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. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76 | 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. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline in Loss of Sense of Smell Score | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76 | 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. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline in Average Daily Posterior Rhinorrhea Score | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76 | 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. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline in Average Daily Anterior Rhinorrhea Score | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, and 76 | 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. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Score | Baseline, Weeks 4, 8, 16, 24, 36, 52, 64, and 76 | 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. | Score on a Scale | MEAN |
| SECONDARY | Change From Baseline in European Quality of Life 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score | Baseline, Weeks 16, 24, 36, 52, 64, and 76 | 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. | Score on a Scale | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group370
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Nasal Polyp Score (NPS) | Received Placebo in GA39688 or GA39855 | Week 4 | -0.17 | 95% Confidence Interval -0.38 to 0.05 | Sore on a scale |
| Change From Baseline in Nasal Polyp Score (NPS) | Received Omalizumab in GA39688 or GA39855 | Week 4 | -0.85 | 95% Confidence Interval -1.07 to -0.63 | Sore on a scale |
| Change From Baseline in Nasal Polyp Score (NPS) | Received Placebo in GA39688 or GA39855 | Week 8 | -0.26 | 95% Confidence Interval -0.49 to -0.02 | Sore on a scale |
| Change From Baseline in Nasal Polyp Score (NPS) | Received Omalizumab in GA39688 or GA39855 | Week 8 | -1.06 | 95% Confidence Interval -1.30 to -0.82 | Sore on a scale |
| Change From Baseline in Nasal Polyp Score (NPS) | Received Placebo in GA39688 or GA39855 | Week 16 | -0.17 | 95% Confidence Interval -0.38 to 0.05 | Sore on a scale |
| Change From Baseline in Nasal Polyp Score (NPS) | Received Omalizumab in GA39688 or GA39855 | Week 16 | -1.09 | 95% Confidence Interval -1.31 to -0.87 | Sore on a scale |
| Change From Baseline in Nasal Polyp Score (NPS) | Received Placebo in GA39688 or GA39855 | Week 24 | -0.19 | 95% Confidence Interval -0.42 to 0.03 | Sore on a scale |
| Change From Baseline in Nasal Polyp Score (NPS) | Received Omalizumab in GA39688 or GA39855 | Week 24 | -1.01 | 95% Confidence Interval -1.24 to -0.78 | Sore on a scale |
| Change From Baseline in Nasal Polyp Score (NPS) | Received Placebo in GA39688 or GA39855 | Week 36 | -0.83 | 95% Confidence Interval -1.07 to -0.59 | Sore on a scale |
| Change From Baseline in Nasal Polyp Score (NPS) | Received Omalizumab in GA39688 or GA39855 | Week 36 | -1.09 | 95% Confidence Interval -1.32 to -0.85 | Sore on a scale |
1 to 10 of 370Source ClinicalTrials.gov
See all 370 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Received Placebo in GA39688 or GA39855 | 126 | |
| Overall Study | STARTED | Received Omalizumab in GA39688 or GA39855 | 123 | |
| Overall Study | COMPLETED | Received Placebo in GA39688 or GA39855 | 117 | |
| Overall Study | COMPLETED | Received Omalizumab in GA39688 or GA39855 | 114 | |
| Overall Study | NOT COMPLETED | Received Placebo in GA39688 or GA39855 | 9 | |
| Overall Study | NOT COMPLETED | Received Omalizumab in GA39688 or GA39855 | 9 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Received Placebo in GA39688 or GA39855 | 13 | 125 | 34 |
| other | Nasopharyngitis | Infections and infestations | Received Omalizumab in GA39688 or GA39855 | 19 | 124 | 33 |
| other | Sinusitis | Infections and infestations | Received Placebo in GA39688 or GA39855 | 13 | 125 | 16 |
| other | Sinusitis | Infections and infestations | Received Omalizumab in GA39688 or GA39855 | 9 | 124 | 16 |
| other | Nasal polyps | Respiratory, thoracic and mediastinal disorders | Received Placebo in GA39688 or GA39855 | 13 | 125 | 16 |
| other | Nasal polyps | Respiratory, thoracic and mediastinal disorders | Received Omalizumab in GA39688 or GA39855 | 4 | 124 | 4 |
| serious | Gastrointestinal inflammation | Gastrointestinal disorders | Received Placebo in GA39688 or GA39855 | 0 | 125 | 0 |
| serious | Gastrointestinal inflammation | Gastrointestinal disorders | Received Omalizumab in GA39688 or GA39855 | 1 | 124 | 1 |
| serious | Gastrooesophageal reflux disease | Gastrointestinal disorders | Received Placebo in GA39688 or GA39855 | 1 | 125 | 1 |
| serious | Gastrooesophageal reflux disease | Gastrointestinal disorders | Received Omalizumab in GA39688 or GA39855 | 0 | 124 | 0 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Received Placebo in GA39688 or GA39855 | 0 | 125 |
| Total, all-cause mortality | Received Omalizumab in GA39688 or GA39855 | 0 | 124 |
| Total, other adverse events | Received Placebo in GA39688 or GA39855 | 28 | 125 |
| Total, other adverse events | Received Omalizumab in GA39688 or GA39855 | 19 | 124 |
| Total, serious adverse events | Received Placebo in GA39688 or GA39855 | 12 | 125 |
| Total, serious adverse events | Received Omalizumab in GA39688 or GA39855 | 8 | 124 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Received Omalizumab in GA39688 or GA39855 vs Received Placebo in GA39688 or GA39855: deaths from any cause | Trial comparisons |
| Received Omalizumab in GA39688 or GA39855 vs Received Placebo in GA39688 or GA39855: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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