Trial · NCT02020889
A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
NCT02020889, Phase 3, Completed, GlaxoSmithKline; results first posted 2018-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis. Trials, record NCT02020889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02020889
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
- NCT number
- NCT02020889
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 136 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Churg-Strauss Syndrome
- Interventions
- Mepolizumab, Placebo
- First posted
- 2013-12-25
- Last updated
- 2018-01-31
- Results first posted
- 2018-01-26
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants in Each Category of Accrued Duration of Remission | Up to Week 52 | Total accrued duration of remission is the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose \<=4 mg/day over the 52 week study treatment period was reported. The accrued duration was categorized into zero, \>0 to \<12 weeks, 12 to \<24 weeks, 24 to \<36 weeks and \>=36 weeks. Statistical analysis was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. Intent-to-Treat (ITT) Population was used for the analysis and was defined as all participants who were randomized and received at least one dose of trial medication. Randomized participants were assumed to have received study treatment unless definitive evidence to the contrary exists. The odds ratio for treatment difference and associated probability (p)-value and 95 percent confidence interval (CI) were calculated. |
| Primary | Number of Participants Who Are in Remission at 36 and 48 Weeks | Week 36 and Week 48 | The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=4 mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated. |
| Secondary | Time to First EGPA Relapse | Up to Week 52 | EGPA relapse was defined as worsening or persistence of active disease since the last visit characterized by active vasculitis or active asthma symptoms and/or signs with a corresponding worsening in Asthma Control Questionnaire-6 (ACQ-6) score or active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions warranting: i) an increased dose of OCS therapy (or other systemic corticosteroid therapy) to \>4 mg/day prednisolone total daily dose or equivalent; OR ii) an increased dose or addition of immunosuppressive therapy; OR iii) hospitalization related to EGPA worsening. Participants who completed study, or withdrawn prematurely from the study without experiencing the event were censored. The number of participants with at least one EGPA relapse during the planned study treatment period are presented. |
| Secondary | Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period. | Week 48 and Week52 | The number of participants with an average daily prednisolone/prednisone dose during the last 4 weeks of the Study Treatment Period (48 through 52) was calculated. The average dose was categorized into zero, \>0 to \<=4.0mg, \>4.0 to \<=7.5mg and \>7.5mg. The statistical analysis was performed using a proportional odds regression model with Baseline covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region and the comparison between treatment groups was presented as an odds ratio, p-value and 95 percent CI. |
| Secondary | Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period | Up to Week 52 | The number of participants who achieved remission (i.e., BVAS=0 and prednisolone/prednisone\<=4 mg/day) within the first 24 weeks and remain in remission for the remainder of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated. |
| Secondary | Number of Participants in Each Category of Accrued Duration of Remission | Up to Week 52 | Total accrued duration of remission, i.e., the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose \<=7.5mg/day over the 52 week study treatment period was reported. BVAS is a validated, clinician-completed tool used for the comprehensive multisystem clinical assessment of disease activity in systemic vasculitis. The duration was categorized into zero, \>0 to \<12 weeks, 12 to \<24 weeks, 24 to \<36 weeks and \>=36 weeks. Statistical analysis was performed on ITT Population and was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated. |
| Secondary | Number of Participants Who Are in Remission at 36 and 48 Weeks | Week 36 and Week 48 | The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated. |
| Secondary | Number of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period | Up to Week 52 | The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated. |
| Secondary | Number of Participants With Local and Systemic Adverse Events (AEs) | Up to Week 52 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included Facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on Safety Population which comprised of all participants who receive at least one dose of study treatment. |
| Secondary | Change From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) Levels | Baseline and up to Week 60 | Blood samples were collected to evaluate change from Baseline in ALT, Alk.phosph., AST, creatinine kinase, GGT and lactate dehydro values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants in Each Category of Accrued Duration of Remission | Up to Week 52 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Are in Remission at 36 and 48 Weeks | Week 36 and Week 48 | ITT Population | Participants | NUMBER |
| SECONDARY | Time to First EGPA Relapse | Up to Week 52 | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period. | Week 48 and Week52 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period | Up to Week 52 | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants in Each Category of Accrued Duration of Remission | Up to Week 52 | ITT Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Are in Remission at 36 and 48 Weeks | Week 36 and Week 48 | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period | Up to Week 52 | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Local and Systemic Adverse Events (AEs) | Up to Week 52 | Safety Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) Levels | Baseline and up to Week 60 | Safety population | International Unit per Liter (IU/L) | MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group1,300
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants in Each Category of Accrued Duration of Remission | Placebo | Zero | 55 | Participants | |
| Number of Participants in Each Category of Accrued Duration of Remission | Mepolizumab 300mg | Zero | 32 | Participants | |
| Number of Participants in Each Category of Accrued Duration of Remission | Placebo | >0 to <12 weeks | 8 | Participants | |
| Number of Participants in Each Category of Accrued Duration of Remission | Mepolizumab 300mg | >0 to <12 weeks | 8 | Participants | |
| Number of Participants in Each Category of Accrued Duration of Remission | Placebo | 12 to <24 weeks | 3 | Participants | |
| Number of Participants in Each Category of Accrued Duration of Remission | Mepolizumab 300mg | 12 to <24 weeks | 9 | Participants | |
| Number of Participants in Each Category of Accrued Duration of Remission | Placebo | 24 to <36 weeks | 0 | Participants | |
| Number of Participants in Each Category of Accrued Duration of Remission | Mepolizumab 300mg | 24 to <36 weeks | 10 | Participants | |
| Number of Participants in Each Category of Accrued Duration of Remission | Placebo | >=36 weeks | 2 | Participants | |
| Number of Participants in Each Category of Accrued Duration of Remission | Mepolizumab 300mg | >=36 weeks | 9 | Participants |
1 to 10 of 1,300Source ClinicalTrials.gov
See all 1,300 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 68 | |
| Overall Study | STARTED | Mepolizumab 300mg | 68 | |
| Overall Study | COMPLETED | Placebo | 61 | |
| Overall Study | COMPLETED | Mepolizumab 300mg | 65 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Mepolizumab 300mg | 3 |
Source ClinicalTrials.gov
Adverse events232
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 | 16 | 68 | |
| other | Nasopharyngitis | Infections and infestations | Mepolizumab 300mg | 12 | 68 | |
| other | Sinusitis | Infections and infestations | Placebo | 11 | 68 | |
| other | Sinusitis | Infections and infestations | Mepolizumab 300mg | 14 | 68 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 11 | 68 | |
| other | Upper respiratory tract infection | Infections and infestations | Mepolizumab 300mg | 14 | 68 | |
| other | Bronchitis | Infections and infestations | Placebo | 8 | 68 | |
| other | Bronchitis | Infections and infestations | Mepolizumab 300mg | 7 | 68 | |
| other | Influenza | Infections and infestations | Placebo | 6 | 68 | |
| other | Influenza | Infections and infestations | Mepolizumab 300mg | 7 | 68 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 68 |
| Total, all-cause mortality | Mepolizumab 300mg | 1 | 68 |
| Total, other adverse events | Placebo | 61 | 68 |
| Total, other adverse events | Mepolizumab 300mg | 65 | 68 |
| Total, serious adverse events | Placebo | 18 | 68 |
| Total, serious adverse events | Mepolizumab 300mg | 12 | 68 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28514601 | DERIVED |
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mepolizumab 300mg vs Placebo: Number of Participants Who Are in Remission at 36 and 48 Weeks | Trial comparisons |
| Mepolizumab 300mg vs Placebo: Number of Participants Who Are in Remission at 36 and 48 Weeks | Trial comparisons |
| Mepolizumab 300mg vs Placebo: Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period | Trial comparisons |
| Mepolizumab 300mg vs Placebo: Time to First EGPA Relapse | Trial comparisons |
| Mepolizumab 300mg vs Placebo: deaths from any cause | Trial comparisons |
Mepolizumab 300mg vs Placebo: Number of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period | Trial comparisons |
| Mepolizumab 300mg 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/NCT02020889
GET https://conductscience.org/api/trials/v1/NCT02020889/registered?page=2