Trial · NCT04607005
Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)
NCT04607005, Phase 3, Completed, GlaxoSmithKline; results first posted 2024-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS). Trials, record NCT04607005. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04607005
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)
- NCT number
- NCT04607005
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 169 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Nasal Polyps
- Interventions
- Mepolizumab, Placebo, Standard of care
- First posted
- 2020-10-28
- Last updated
- 2026-07-22
- Results first posted
- 2024-11-25
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites | Baseline (Day 1) up to week 52 | Total endoscopic nasal polyp score is collected at clinical visits. 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 (calculated by summing the scores \[0 to 4\] in each nostril), higher scores indicate worse status. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value. |
| Primary | Mean Change From Baseline in Total Endoscopic NP Score at Week 52 - Intent-to-Treat (ITT) Population | Baseline (Day 1) up to Week 52 | Total endoscopic nasal polyp score is collected at clinical visits. The assessments were performed by central video image recordings of nasal endoscopy (NE). 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 (calculated by summing the scores \[0 to 4\] in each nostril), "0" score represents better status while "8" represents worse status. Baseline was defined as last value prior to first dose (Day 1). Change from Baseline = Post-baseline value minus Baseline value. |
| Primary | Mean Change From Baseline in Mean Nasal Obstruction Visual Analogue Scale (VAS) Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites | Baseline (Day 1) up to 4 weeks prior to week 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 (none) and 10 (worst), with higher scores indicating greater disease severity. 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. |
| Primary | Mean Change From Baseline in Mean Nasal Obstruction VAS Score During the 4 Weeks Prior to Week 52 - ITT Population | Baseline (Day 1) up to 4 weeks prior to week 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 dividing by 10. The final nasal obstruction VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. 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 | Mean Change From Baseline in Mean Overall VAS Symptom Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites | Baseline (Day 1) up to 4 weeks prior to week 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 (none) and 10 (worst), with higher scores indicating greater disease severity. 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 | Mean Change From Baseline in Mean Overall VAS Symptom Score During the 4 Weeks Prior to Week 52 - ITT Population | Baseline (Day 1) up to 4 weeks prior to week 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 (none) and 10 (worst), with higher scores indicating greater disease severity. 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 | Mean Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites | Baseline (Day 1) and Week 52 | The LMK CT scoring system is based on localization with points given for degree of opacification: 0 =normal, 1 = partial opacification, 2 = total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side. The osteomeatal complex (OC) was graded as 0 = not occluded, or 2 = occluded deriving a maximum score of 12 per side. The range for the LMK CT score is therefore 0-24 (higher scores indicating more opacification) when summed across both sides. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Mean Change From Baseline in LMK CT Score at Week 52 - ITT Population | Baseline (Day 1) and Week 52 | The LMK CT scoring system is based on localization with points given for degree of opacification: 0 =normal, 1 = partial opacification, 2 = total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side of the nostril. The osteomeatal complex (OC) was graded as 0 = not occluded, or 2 = occluded deriving a maximum score of 12 per side. The range for the LMK CT score is therefore 0-24 (higher scores indicating more opacification) when summed across both sides. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value. |
| Secondary | Mean Change From Baseline in the Mean 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 - ITT Population Excluding Medipharma Managed Sites | Baseline (Day 1) up to 4 weeks prior to week 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 (none) and 10 (worst), with higher scores indicating greater disease severity. 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 | Mean Change From Baseline in the Mean 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 - ITT Population | Baseline (Day 1) up to 4 weeks prior to week 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 (none) and 10 (worst), with higher scores indicating greater disease severity. 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites | Baseline (Day 1) up to week 52 | The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using missing at random (MAR) assumption to handle missing data. | Scores on a Scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Change From Baseline in Total Endoscopic NP Score at Week 52 - Intent-to-Treat (ITT) Population | Baseline (Day 1) up to Week 52 | The analysis was performed on the Intent to Treat (ITT) Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using missing at random (MAR) assumption to handle missing data. | Scores on a Scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Change From Baseline in Mean Nasal Obstruction Visual Analogue Scale (VAS) Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites | Baseline (Day 1) up to 4 weeks prior to week 52 | The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data. | Scores on a Scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Change From Baseline in Mean Nasal Obstruction VAS Score During the 4 Weeks Prior to Week 52 - ITT Population | Baseline (Day 1) up to 4 weeks prior to week 52 | The analysis was performed on the ITT Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Mean Overall VAS Symptom Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites | Baseline (Day 1) up to 4 weeks prior to week 52 | The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Mean Overall VAS Symptom Score During the 4 Weeks Prior to Week 52 - ITT Population | Baseline (Day 1) up to 4 weeks prior to week 52 | The analysis was performed on the ITT Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites | Baseline (Day 1) and Week 52 | The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in LMK CT Score at Week 52 - ITT Population | Baseline (Day 1) and Week 52 | The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Mean 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 - ITT Population Excluding Medipharma Managed Sites | Baseline (Day 1) up to 4 weeks prior to week 52 | The analysis was performed on the ITT Set (randomized participants who received at least 1 dose of study treatment) excluding participants from Medipharma managed sites. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in the Mean 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 - ITT Population | Baseline (Day 1) up to 4 weeks prior to week 52 | The analysis was performed on the ITT Set that included all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they were allocated at randomization. Analysis was performed using MAR assumption to handle missing data. | Scores on a Scale | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites | Mepolizumab | -0.62 | Standard Error 0.164 | Scores on a Scale | |
| Mean Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites | Placebo | -0.19 | Standard Error 0.164 | Scores on a Scale | |
| Mean Change From Baseline in Total Endoscopic NP Score at Week 52 - Intent-to-Treat (ITT) Population | Mepolizumab | -0.65 | Standard Error 0.160 | Scores on a Scale | |
| Mean Change From Baseline in Total Endoscopic NP Score at Week 52 - Intent-to-Treat (ITT) Population | Placebo | -0.19 | Standard Error 0.162 | Scores on a Scale | |
| Mean Change From Baseline in Mean Nasal Obstruction Visual Analogue Scale (VAS) Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites | Mepolizumab | -3.23 | Standard Error 0.336 | Scores on a Scale | |
| Mean Change From Baseline in Mean Nasal Obstruction Visual Analogue Scale (VAS) Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites | Placebo | -1.80 | Standard Error 0.333 | Scores on a Scale | |
| Mean Change From Baseline in Mean Nasal Obstruction VAS Score During the 4 Weeks Prior to Week 52 - ITT Population | Mepolizumab | -3.20 | Standard Error 0.328 | Scores on a Scale | |
| Mean Change From Baseline in Mean Nasal Obstruction VAS Score During the 4 Weeks Prior to Week 52 - ITT Population | Placebo | -1.77 | Standard Error 0.331 | Scores on a Scale | |
| Mean Change From Baseline in Mean Overall VAS Symptom Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites | Mepolizumab | -3.33 | Standard Error 0.354 | Scores on a Scale | |
| Mean Change From Baseline in Mean Overall VAS Symptom Score During the 4 Weeks Prior to Week 52 - ITT Population Excluding Medipharma Managed Sites | Placebo | -1.80 | Standard Error 0.352 | Scores on a Scale |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mepolizumab | 84 | |
| Overall Study | STARTED | Placebo | 85 | |
| Overall Study | Intent-to-Treat Population | Mepolizumab | 84 | |
| Overall Study | Intent-to-Treat Population | Placebo | 85 | |
| Overall Study | Intent-to-Treat Population Excluding Non GCP Sites | Mepolizumab | 80 | |
| Overall Study | Intent-to-Treat Population Excluding Non GCP Sites | Placebo | 83 | |
| Overall Study | COMPLETED | Mepolizumab | 78 | |
| Overall Study | COMPLETED | Placebo | 69 | |
| Overall Study | NOT COMPLETED | Mepolizumab | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events48
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 | Diarrhoea | Gastrointestinal disorders | Mepolizumab | 4 | 84 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1 | 85 | 1 |
| other | Stomatitis | Gastrointestinal disorders | Mepolizumab | 0 | 84 | 0 |
| other | Stomatitis | Gastrointestinal disorders | Placebo | 3 | 85 | 3 |
| other | Pyrexia | General disorders | Mepolizumab | 3 | 84 | 3 |
| other | Pyrexia | General disorders | Placebo | 4 | 85 | 5 |
| other | Vaccination site pain | General disorders | Mepolizumab | 3 | 84 | 5 |
| other | Vaccination site pain | General disorders | Placebo | 2 | 85 | 4 |
| other | Acute sinusitis | Infections and infestations | Mepolizumab | 0 | 84 | 0 |
| other | Acute sinusitis | Infections and infestations | Placebo | 3 | 85 | 4 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mepolizumab | 0 | 84 |
| Total, all-cause mortality | Placebo | 0 | 85 |
| Total, other adverse events | Mepolizumab | 47 | 84 |
| Total, other adverse events | Placebo | 52 | 85 |
| Total, serious adverse events | Mepolizumab | 0 | 84 |
| Total, serious adverse events | Placebo | 3 | 85 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39058315 | BACKGROUND |
Source PubMed
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 |
|---|---|
| Mepolizumab vs Placebo: deaths from any cause | Trial comparisons |
| Mepolizumab 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/NCT04607005
GET https://conductscience.org/api/trials/v1/NCT04607005/results?page=2