Trial · NCT01362244
Mepolizumab in Nasal Polyposis
NCT01362244, Phase 2, Completed, GlaxoSmithKline; results first posted 2016-03-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Mepolizumab in Nasal Polyposis. Trials, record NCT01362244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01362244
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mepolizumab in Nasal Polyposis
- NCT number
- NCT01362244
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Nasal Polyps
- Interventions
- Mepolizumab, Placebo, Run In Medication
- First posted
- 2011-05-30
- Last updated
- 2021-04-12
- Other registries' IDs
- eudract:2008-003772-21
- Results first posted
- 2016-03-28
- Limitations and caveats
Part B was removed due to the low numbers of participants enrolling into Part B. GSK determined it was no longer feasible to achieve a meaningful number of participants and therefore recruitment into this portion of the study was stopped.
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Reduced Need for Surgery at Week 25 | Week 25 | Assessment of the nasal polyposis condition was performed after six months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp (ENP) scores and a severity of condition as measured by a visual analogue scale (VAS). Surgery was still deemed required for a participant with an ENP score of \>=3, or an ENP score of 2 and a VAS symptom score of \>7. The number of participants with reduced need for polyp surgery are presented as missing data set to non-responders (NR) and missing data last observation carry forward (LOCF). LOCF is defined as missing responses at Week 25 imputed with the last non-missing post-dose observation for that participant. |
| Secondary | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Each nostril was assessed for polyps and graded at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. The right and left nostrils were scored from 0 to 4, where, 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 ENP score was recorded for both the right and the left nostril. The higher of the two scores was derived and used for the analysis. The ENP score ranges from 0 to 4, with a higher score indicating a larger polyp. |
| Secondary | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Assessment of the nasal polyposis condition was performed after 6 months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp scores and a severity of condition as measured by a VAS. Surgery was required for participants with ENP scores of \>=3, or ENP scores of 2 and a VAS symptom score of \>7. |
| Secondary | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP and DBP were measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. |
| Secondary | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25 | Pulse rate was measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. |
| Secondary | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. Any abnormal clinically significant (CS) and not clinically significant (NCS) findings were identified. ECG abnormaility with respect to CS and NCS findings were judged by the investigator or appropriately qualified designee. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. |
| Secondary | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | BUN, glucose fasting, chloride, sodium, potassium, carbon dioxide (CO2), and calcium were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Secondary | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | ALT, AST, ALP, and GGT were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Secondary | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | Albumin and protein were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Secondary | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | Total bilirubin (TB) and direct bilirubin (DB), creatinine, and uric acid were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Reduced Need for Surgery at Week 25 | Week 25 | Per Protocol Population: all randomized participants who received at least one dose of study treatment and who complied with the protocol. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | PP Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | PP Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25 | Safety Population: participants who received \>=1 dose of study treatment (based on actual treatment received). One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Participants available at the specified time points (represented by n=X, X) were analyzed. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25 | Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed. | beats per minute | MEAN |
| SECONDARY | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed. | International units per liter (IU/L) | MEAN |
| SECONDARY | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed. | Grams per liter (g/L) | MEAN |
| SECONDARY | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed. | Micromoles per liter | MEAN |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group872
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Reduced Need for Surgery at Week 25 | Mepolizumab 750 mg | NR, Responders | 16 | Participants | |
| Number of Participants With a Reduced Need for Surgery at Week 25 | Placebo | NR, Responders | 5 | Participants | |
| Number of Participants With a Reduced Need for Surgery at Week 25 | Mepolizumab 750 mg | NR, Non-Responders | 33 | Participants | |
| Number of Participants With a Reduced Need for Surgery at Week 25 | Placebo | NR, Non-Responders | 46 | Participants | |
| Number of Participants With a Reduced Need for Surgery at Week 25 | Mepolizumab 750 mg | LOCF, Responders | 17 | Participants | |
| Number of Participants With a Reduced Need for Surgery at Week 25 | Placebo | LOCF, Responders | 8 | Participants | |
| Number of Participants With a Reduced Need for Surgery at Week 25 | Mepolizumab 750 mg | LOCF, Non- Responders | 32 | Participants | |
| Number of Participants With a Reduced Need for Surgery at Week 25 | Placebo | LOCF, Non- Responders | 43 | Participants | |
| Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mepolizumab 750 mg | Week 1, ENP score 0, n=49, 51 | 0 | Participants | |
| Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Placebo | Week 1, ENP score 0, n=49, 51 | 0 | Participants |
1 to 10 of 872Source ClinicalTrials.gov
See all 872 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mepolizumab 750 mg | 54 | |
| Overall Study | STARTED | Placebo | 51 | |
| Overall Study | COMPLETED | Mepolizumab 750 mg | 22 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | Mepolizumab 750 mg | 32 | |
| Overall Study | NOT COMPLETED | Placebo | 32 |
Source ClinicalTrials.gov
Adverse events38
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 | Ear pain | Ear and labyrinth disorders | Mepolizumab 750 mg | 1 | 53 | |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 6 | 52 | |
| other | Nausea | Gastrointestinal disorders | Mepolizumab 750 mg | 2 | 53 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 52 | |
| other | Fatigue | General disorders | Mepolizumab 750 mg | 1 | 53 | |
| other | Fatigue | General disorders | Placebo | 5 | 52 | |
| other | Influenza | Infections and infestations | Mepolizumab 750 mg | 4 | 53 | |
| other | Influenza | Infections and infestations | Placebo | 2 | 52 | |
| other | Nasopharyngitis | Infections and infestations | Mepolizumab 750 mg | 10 | 53 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 14 | 52 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mepolizumab 750 mg | 0 | 53 |
| Total, all-cause mortality | Placebo | 0 | 52 |
| Total, other adverse events | Mepolizumab 750 mg | 32 | 53 |
| Total, other adverse events | Placebo | 38 | 52 |
| Total, serious adverse events | Mepolizumab 750 mg | 0 | 53 |
| Total, serious adverse events | Placebo | 0 | 52 |
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 |
|---|---|
| Mepolizumab 750 mg vs Placebo: deaths from any cause | Trial comparisons |
| Mepolizumab 750 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/NCT01362244
GET https://conductscience.org/api/trials/v1/NCT01362244/registered?page=2