Trial · NCT03401229
Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis
NCT03401229, Phase 3, Completed, AstraZeneca; results first posted 2021-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis. Trials, record NCT03401229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03401229
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis
- NCT number
- NCT03401229
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 413 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Nasal Polyposis
- Interventions
- Benralizumab 30 mg SC + Mometasone Furoate, Matching placebo SC + Mometasone Furoate
- First posted
- 2018-01-17
- Last updated
- 2021-10-12
- Other registries' IDs
- eudract:2017-003675-61
- Results first posted
- 2021-10-12
- Limitations and caveats
During COVID-19 pandemic, for ongoing patients, patient dosing, scheduled visits, and nasal endoscopies are inevitable impacted. Week 40 was made as the primary timepoint to mitigate the impact of COVID disruptions on the primary endpoint.
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total NPS at Week 40 | Baseline to week 40 | Change from baseline in total nasal polyps score (NPS) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The total NPS was the sum of the right and left nostril scores and maximum total NPS is 8, as evaluated by nasal endoscopy and the left and right score were based on central read with scale from 0 to 4 where higher score reflects heavier bilateral nasal polyp burden. Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. |
| Primary | Change From Baseline in NBS at Week 40 | Baseline to week 40 | Change from baseline in nasal blockage score (NBS) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The NBS was captured by an item in NPSD. Patients were asked to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0-none; 1-mild; 2-moderate; 3-severe. The NBS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. |
| Secondary | Change From Baseline in SNOT-22 at Week 40 | Baseline to week 40 | Change from baseline in SinoNasal outcome test (SNOT-22) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The SNOT-22 is a condition specific health-related quality of life assessment which captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal conditions. The total score is the sum of item scores and has a range from 0 to 110 (higher scores indicate poorer outcomes). Baseline was the last valid value on or prior to the date of randomization. Data collected after NP surgery and/or SCS\_NP were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. |
| Secondary | Time to First NP Surgery and/or SCS Use for NP to Week 56 | Baseline to week 56 | The cumulative percentage and the corresponding 95% CI are based on the Kaplan-Meier estimates. Patients can have more than 1 rescue category during the study, and the first rescue per patient is considered. The time to first nasal polyposis (NP) surgery and/or systemic corticosteroids (SCS) use for NP up to week 56 was calculated based on the earliest occurrence of NP surgery and/or SCS use for NP and was calculated as follows: Time to first NP surgery and/or SCS use for NP = Earlier of (Start date of first NP surgery, Start date of first SCS use for NP) - date of randomization + 1. For patients who did not experience any surgery or SCS use for NP, the time to event was censored at earlier of (date of their week 56 visit, date of discontinuation). |
| Secondary | Time to the First NP Surgery up to Week 56 | Baseline to week 56 | The cumulative percentage and the corresponding 95% CI are based on the Kaplan-Meier estimates. Patients can have more than 1 rescue category during the study, and the first rescue per patient is considered. The time to first nasal polyposis (NP) surgery up to week 56 was calculated based on the earliest occurrence of NP surgery and was calculated as follows: Time to first NP surgery=Start date of first NP surgery - date of randomization + 1. For patients who did not experience any surgery, the time to event was censored at earlier of (date of their week 56 visit, date of discontinuation). |
| Secondary | Change From Baseline in DSS at Week 40 | Baseline to week 40 | Change from baseline in difficulty with sense of smell (DSS) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The DSS is captured by an item in the NPSD. Severity of worst difficulty with sense of smell over the past 24 hours was rated with response options: 0-none; 1-mild; 2-moderate; 3-severe. The DSS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids use for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. |
| Secondary | Change From Baseline in NPS at Week 56 | Baseline to week 56 | Change from baseline in total nasal polyps score (NPS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The total NPS is the sum of the right and left nostril scores, as evaluated by nasal endoscopy and the left and right score are based on central read with scale from 0 to 4 where higher score reflects heavier bilateral nasal polyp burden. Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. |
| Secondary | Change From Baseline in NBS at Week 56 | Baseline to week 56 | Change from baseline in nasal blockage score (NBS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The NBS is captured by an item in the NPSD. Patients were asked to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0-none; 1-mild; 2-moderate; 3-severe. The NBS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. |
| Secondary | Change From Baseline in SNOT-22 at Week 56 | Baseline to week 56 | Change from baseline in SinoNasal outcome test (SNOT-22) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The SNOT-22 is a condition specific health-related quality of life assessment which captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal conditions. The total score is range from 0 to 110 (higher scores indicate poorer outcomes). Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. |
| Secondary | Change From Baseline in DSS at Week 56 | Baseline to week 56 | Change from baseline in difficulty with sense of smell (DSS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The DSS is captured by an item in the NPSD with response options: 0-none; 1-mild; 2-moderate; 3-severe to rate the severity of their worst difficulty with sense of smell over past 24 hours. The DSS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS\_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS\_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS\_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
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 Total NPS at Week 40 | Baseline to week 40 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| PRIMARY | Change From Baseline in NBS at Week 40 | Baseline to week 40 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in SNOT-22 at Week 40 | Baseline to week 40 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Time to First NP Surgery and/or SCS Use for NP to Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Number of patients analyzed is number of patients who had NP surgery and/or SCS use. | months | NUMBER |
| SECONDARY | Time to the First NP Surgery up to Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Number of patients analyzed is number of patients who had NP surgery. | months | NUMBER |
| SECONDARY | Change From Baseline in DSS at Week 40 | Baseline to week 40 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in NPS at Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in NBS at Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in SNOT-22 at Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in DSS at Week 56 | Baseline to week 56 | Full analysis set: All patients randomized and receiving any IP are included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients are analyzed according to their randomized treatment. Patients who had not been rescued and whose post-baseline observation was missing at the timepoint of interest are excluded from this analysis. | Score on a scale | MEAN |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group70
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 Total NPS at Week 40 | Benra 30 mg | -0.36 | Standard Deviation 1.66 | Score on a scale | |
| Change From Baseline in Total NPS at Week 40 | Placebo | 0.17 | Standard Deviation 1.18 | Score on a scale | |
| Change From Baseline in NBS at Week 40 | Benra 30 mg | -0.68 | Standard Deviation 1.02 | Score on a scale | |
| Change From Baseline in NBS at Week 40 | Placebo | -0.41 | Standard Deviation 0.89 | Score on a scale | |
| Change From Baseline in SNOT-22 at Week 40 | Benra 30 mg | -15.2 | Standard Deviation 30.47 | Score on a scale | |
| Change From Baseline in SNOT-22 at Week 40 | Placebo | -10.7 | Standard Deviation 31.64 | Score on a scale | |
| Time to First NP Surgery and/or SCS Use for NP to Week 56 | Benra 30 mg | 35.5 | 95% Confidence Interval 29.3 to 42.5 | months | |
| Time to First NP Surgery and/or SCS Use for NP to Week 56 | Placebo | 46.5 | 95% Confidence Interval 39.7 to 53.8 | months | |
| Time to the First NP Surgery up to Week 56 | Benra 30 mg | 16.6 | 95% Confidence Interval 12.1 to 22.5 | months | |
| Time to the First NP Surgery up to Week 56 | Placebo | 19.5 | 95% Confidence Interval 14.5 to 25.9 | months |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benra 30 mg | 207 | |
| Overall Study | STARTED | Placebo | 203 | |
| Overall Study | COMPLETED | Benra 30 mg | 167 | |
| Overall Study | COMPLETED | Placebo | 166 | |
| Overall Study | NOT COMPLETED | Benra 30 mg | 40 | |
| Overall Study | NOT COMPLETED | Placebo | 37 |
Source ClinicalTrials.gov
Adverse events104
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 | Benra 30 mg | 37 | 207 | 57 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 43 | 203 | 54 |
| other | Viral upper respiratory tract infection | Infections and infestations | Benra 30 mg | 7 | 207 | 9 |
| other | Viral upper respiratory tract infection | Infections and infestations | Placebo | 14 | 203 | 15 |
| other | Headache | Nervous system disorders | Benra 30 mg | 7 | 207 | 9 |
| other | Headache | Nervous system disorders | Placebo | 16 | 203 | 18 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Benra 30 mg | 21 | 207 | 30 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Placebo | 30 | 203 | 54 |
| serious | Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | Benra 30 mg | 1 | 207 | 1 |
| serious | Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | Placebo | 0 | 203 | 0 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benra 30 mg | 0 | 207 |
| Total, all-cause mortality | Placebo | 0 | 203 |
| Total, other adverse events | Benra 30 mg | 64 | 207 |
| Total, other adverse events | Placebo | 83 | 203 |
| Total, serious adverse events | Benra 30 mg | 25 | 207 |
| Total, serious adverse events | Placebo | 19 | 203 |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Benra 30 mg vs Placebo: Percentage of Subjects With NP Surgery or SCS_NP | Trial comparisons |
| Benra 30 mg vs Placebo: Percentage of Subjects With NP Surgery | Trial comparisons |
| Benra 30 mg vs Placebo: deaths from any cause | Trial comparisons |
| Benra 30 mg vs Placebo: Percentage of Subjects With SCS_NP | Trial comparisons |
| Benra 30 mg vs Placebo: 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03401229
GET https://conductscience.org/api/trials/v1/NCT03401229/registered?page=2