Trial · NCT03085797
Effect of Mepolizumab in Severe Bilateral Nasal Polyps
NCT03085797, Phase 3, Completed, GlaxoSmithKline; results first posted 2020-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Mepolizumab in Severe Bilateral Nasal Polyps. Trials, record NCT03085797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03085797
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Mepolizumab in Severe Bilateral Nasal Polyps
- NCT number
- NCT03085797
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 414 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Nasal Polyps
- Interventions
- Mepolizumab, Placebo, Mometasone furoate
- First posted
- 2017-03-21
- Last updated
- 2026-07-22
- Other registries' IDs
- eudract:2016-004255-70
- Results first posted
- 2020-12-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Endoscopic Nasal Polyps Score at Week 52 | Baseline (Day 1) and Week 52 | Independent reviewers, blinded to treatment, reviewed image recordings of nasal endoscopies to determine total endoscopic NP score based on NP size. The right and left nostrils were scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction/congestion of the inferior meatus). The total score is the sum of the right and left nostril scores and ranges from 0 to 8, higher scores indicate greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value. |
| Primary | Change From Baseline in Nasal Obstruction Visual Analog Scale (VAS) Score During the 4 Weeks Prior to Week 52 | Baseline and Weeks 49 to 52 | Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale (VAS) using an electronic diary (eDiary). Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final nasal obstruction VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Percentage of Participants With Nasal Surgery Over Time | Weeks 8, 16, 24, 32, 40, 48 and 52 | The percentage of participants with nasal surgery over time (by Weeks 8, 16, 24, 32, 40, 48 and 52) was derived from Kaplan-Meier time-to-event analyses for the event 'first nasal surgery'. Nasal surgery was defined as any procedure involving instruments resulting in incision and removal of tissue (polypectomy) in the nasal cavity. Time to first nasal surgery was defined as (Date of first nasal surgery - Date of first dose of study treatment) + 1. Percentage of participants with nasal surgery over time (by Weeks 8, 16, 24, 32, 40, 48 and 52) and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method. Analysis included surgeries occurring up to Week 52, reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study. |
| Secondary | Change From Baseline in Overall VAS Score During the 4 Weeks Prior to Week 52 | Baseline and Weeks 49 to 52 | Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final overall VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52 | Baseline (Day 1) and Week 52 | The SNOT-22 is a 22-item self-reported questionnaire developed to measure symptoms and impacts related to chronic rhinosinusitis. The 22 questions are self-completed by participants based on their recall of their symptoms over the previous 2 weeks using a 6-point rating scale (0 = Not present/no problem; 1 = Very mild problem; 2 = Mild or slight problem; 3 = Moderate problem; 4 = Severe problem; 5 = Problem as "bad as it can be"). Scores for each question are summed to derive the total score. The SNOT-22 total score ranges from 0 to 110, with higher scores representing worse quality of life. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Percentage of Participants Requiring at Least One Course of Systemic Steroids for Nasal Polyps up to Week 52 | Up to Week 52 | The number of courses of systemic steroids received by participants were recorded. For the purpose of this study, a course of systemic corticosteroid separated by less than 7 days was considered as a continuation of the same course. Percentage of participants requiring at least one course of systemic steroids for nasal polyps up to Week 52 is presented. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. |
| Secondary | Change From Baseline in the Composite VAS Score (Combining VAS Scores for Nasal Obstruction, Nasal Discharge, Mucus in the Throat and Loss of Smell) During the 4 Weeks Prior to Week 52 | Baseline and Weeks 49 to 52 | Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from electronically captured scores by dividing by 10. The composite VAS score was calculated as average of individual scores of nasal obstruction, nasal discharge, mucus in the throat and loss of smell and ranged between 0 and 10, with higher scores indicating greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Change From Baseline in Individual VAS Symptom Score: Loss of Smell During the 4 Weeks Prior to Week 52 | Baseline and Weeks 49 to 52 | Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final loss of smell VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value. |
Source ClinicalTrials.gov
Outcomes8
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 Endoscopic Nasal Polyps Score at Week 52 | Baseline (Day 1) and Week 52 | ITT Population which included all randomized participants who took at least 1 dose of study treatment. | Scores on a scale | MEDIAN |
| PRIMARY | Change From Baseline in Nasal Obstruction Visual Analog Scale (VAS) Score During the 4 Weeks Prior to Week 52 | Baseline and Weeks 49 to 52 | ITT Population | Scores on a scale | MEDIAN |
| SECONDARY | Percentage of Participants With Nasal Surgery Over Time | Weeks 8, 16, 24, 32, 40, 48 and 52 | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Overall VAS Score During the 4 Weeks Prior to Week 52 | Baseline and Weeks 49 to 52 | ITT Population | Scores on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52 | Baseline (Day 1) and Week 52 | ITT Population. Only those participants with data available at the specified data point were analyzed. | Scores on a scale | MEDIAN |
| SECONDARY | Percentage of Participants Requiring at Least One Course of Systemic Steroids for Nasal Polyps up to Week 52 | Up to Week 52 | ITT Population | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Composite VAS Score (Combining VAS Scores for Nasal Obstruction, Nasal Discharge, Mucus in the Throat and Loss of Smell) During the 4 Weeks Prior to Week 52 | Baseline and Weeks 49 to 52 | ITT Population | Scores on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Individual VAS Symptom Score: Loss of Smell During the 4 Weeks Prior to Week 52 | Baseline and Weeks 49 to 52 | ITT Population | Scores on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group28
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 Endoscopic Nasal Polyps Score at Week 52 | Placebo | 0.0 | Full Range -5 to 3 | Scores on a scale | |
| Change From Baseline in Total Endoscopic Nasal Polyps Score at Week 52 | Mepolizumab 100 mg SC | -1.0 | Full Range -6 to 3 | Scores on a scale | |
| Change From Baseline in Nasal Obstruction Visual Analog Scale (VAS) Score During the 4 Weeks Prior to Week 52 | Placebo | -0.82 | Full Range -9.23 to 2.58 | Scores on a scale | |
| Change From Baseline in Nasal Obstruction Visual Analog Scale (VAS) Score During the 4 Weeks Prior to Week 52 | Mepolizumab 100 mg SC | -4.41 | Full Range -9.90 to 1.54 | Scores on a scale | |
| Percentage of Participants With Nasal Surgery Over Time | Placebo | Week 8 | 1.0 | 95% Confidence Interval 0.3 to 3.9 | Percentage of participants |
| Percentage of Participants With Nasal Surgery Over Time | Mepolizumab 100 mg SC | Week 8 | 0.5 | 95% Confidence Interval 0.1 to 3.4 | Percentage of participants |
| Percentage of Participants With Nasal Surgery Over Time | Placebo | Week 16 | 3.5 | 95% Confidence Interval 1.7 to 7.2 | Percentage of participants |
| Percentage of Participants With Nasal Surgery Over Time | Mepolizumab 100 mg SC | Week 16 | 1.0 | 95% Confidence Interval 0.2 to 3.8 | Percentage of participants |
| Percentage of Participants With Nasal Surgery Over Time | Placebo | Week 24 | 9.1 | 95% Confidence Interval 5.8 to 14.0 | Percentage of participants |
| Percentage of Participants With Nasal Surgery Over Time | Mepolizumab 100 mg SC | Week 24 | 4.0 | 95% Confidence Interval 2.0 to 7.8 | Percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (TP) (52 Weeks) | STARTED | Placebo | 201 | |
| Treatment Period (TP) (52 Weeks) | STARTED | Mepolizumab 100 mg SC | 206 | |
| Treatment Period (TP) (52 Weeks) | Completed Investigational Product (IP) | Placebo | 167 | |
| Treatment Period (TP) (52 Weeks) | Completed Investigational Product (IP) | Mepolizumab 100 mg SC | 183 | |
| Treatment Period (TP) (52 Weeks) | Not Completed IP | Placebo | 34 | |
| Treatment Period (TP) (52 Weeks) | Not Completed IP | Mepolizumab 100 mg SC | 23 | |
| Treatment Period (TP) (52 Weeks) | Withdrew IP Due to: Adverse Event | Placebo | 4 | |
| Treatment Period (TP) (52 Weeks) | Withdrew IP Due to: Adverse Event | Mepolizumab 100 mg SC | 4 | |
| Treatment Period (TP) (52 Weeks) | Withdrew IP Due to: Lack of Efficacy | Placebo | 11 | |
| Treatment Period (TP) (52 Weeks) | Withdrew IP Due to: Lack of Efficacy | Mepolizumab 100 mg SC | 5 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events276
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 | Placebo (Treatment Period) | 46 | 201 | 64 |
| other | Nasopharyngitis | Infections and infestations | Mepolizumab 100 mg SC (Treatment Period) | 52 | 206 | 83 |
| other | Nasopharyngitis | Infections and infestations | Placebo (Follow-up) | 4 | 65 | 6 |
| other | Nasopharyngitis | Infections and infestations | Mepolizumab 100 mg SC (Follow-up) | 6 | 69 | 8 |
| other | Headache | Nervous system disorders | Placebo (Treatment Period) | 44 | 201 | 141 |
| other | Headache | Nervous system disorders | Mepolizumab 100 mg SC (Treatment Period) | 37 | 206 | 114 |
| other | Headache | Nervous system disorders | Placebo (Follow-up) | 5 | 65 | 14 |
| other | Headache | Nervous system disorders | Mepolizumab 100 mg SC (Follow-up) | 5 | 69 | 8 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo (Treatment Period) | 18 | 201 | 20 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Mepolizumab 100 mg SC (Treatment Period) | 17 | 206 | 24 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Treatment Period) | 0 | 201 |
| Total, all-cause mortality | Mepolizumab 100 mg SC (Treatment Period) | 0 | 206 |
| Total, all-cause mortality | Placebo (Follow-up) | 1 | 65 |
| Total, all-cause mortality | Mepolizumab 100 mg SC (Follow-up) | 0 | 69 |
| Total, other adverse events | Placebo (Treatment Period) | 141 | 201 |
| Total, other adverse events | Mepolizumab 100 mg SC (Treatment Period) | 139 | 206 |
| Total, other adverse events | Placebo (Follow-up) | 13 | 65 |
| Total, other adverse events | Mepolizumab 100 mg SC (Follow-up) | 14 | 69 |
| Total, serious adverse events | Placebo (Treatment Period) | 14 | 201 |
| Total, serious adverse events | Mepolizumab 100 mg SC (Treatment Period) | 12 | 206 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers7
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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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