Trial · NCT02836496
Efficacy and Safety Study of Mepolizumab in Subjects With Severe Hypereosinophilic Syndrome (HES)
NCT02836496, Phase 3, Completed, GlaxoSmithKline; results first posted 2020-02-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Mepolizumab in Subjects With Severe Hypereosinophilic Syndrome (HES). Trials, record NCT02836496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02836496
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Mepolizumab in Subjects With Severe Hypereosinophilic Syndrome (HES)
- NCT number
- NCT02836496
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 108 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypereosinophilic Syndrome
- Interventions
- Mepolizumab 300 mg, Placebo matching mepolizumab, Active OCS capsules (5 mg prednisolone or prednisone), Placebo matching OCS capsules
- First posted
- 2016-07-19
- Last updated
- 2020-02-21
- Results first posted
- 2020-02-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period | Up to Week 32 | Percentage of participants who experienced \>=1 HES flare during the 32-Week treatment period or who withdrew from the study has been presented. A HES flare is defined as a HES related clinical manifestation based on a physician-documented change in clinical signs or symptoms which resulted in need for an increase in the maintenance Oral Corticosteroid (OCS) dose by at least 10 mg per day for 5 days or an increase in or addition of any cytotoxic or immunosuppressive HES therapy. HES flare is also defined as receipt of two or more courses of blinded active OCS during the treatment period. Intent-to-treat (ITT) Population comprises of all randomized participants. This population was based on the treatment to which the participants were randomized. Any participant who received a treatment randomization number were considered to be randomized. |
| Secondary | Percentage of Participants Who Experienced a HES Flare or Who Withdrew From the Study During Week 20 Through Week 32 | Week 20 to Week 32 | HES flare during Week 20 through Week 32 was defined as a HES flare starting or ongoing on or after the date of the Week 20 visit up to and including the date of the Week 32 visit. Percentage of participants who experienced \>=1 HES flare during Week 20 through Week 32 or who withdrew from the study has been presented. |
| Secondary | Time to First HES Flare | Weeks 4, 8, 12, 16, 20, 24, 28 and 32 | The time to first HES flare was calculated as (onset date of first HES flare minus date of first dose of study treatment) plus 1. Probability of first flare (by week 4, 8, 12, 16, 20, 24, 28, and 32) and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method. |
| Secondary | Number of HES Flares Per Participant Per Year | Up to Week 32 | The rate of HES flares for each participant was calculated as the number of observed HES flares divided by the time (expressed in years) between randomization and either the week 32 visit date if available, or the study withdrawal date. Negative binomial generalized linear model including Baseline OCS dose, region, treatment and observed time (offset variable). Wilcoxon test stratified by Baseline OCS (0-\<=20mg/day, \>20mg/day prednisone or equivalent) and region. Adjusted mean and 95% CI rate/year has been presented. |
| Secondary | Number of Participants With Change From Baseline in Fatigue Severity Based on Brief Fatigue Inventory (BFI) in Item 3 (Worst Level of Fatigue During Past 24 Hours) at Week 32 by Category | Baseline (Week 0) and at Week 32 | The change from Baseline in fatigue severity (worst level of fatigue during past 24 hours) at Week 32 was calculated using the mean of the 7 daily assessments of BFI item 3 up to and including the date of the Week 32 visit as the Week 32 assessment, and the mean of the 7 daily assessments of BFI item 3 up to but not including the date of first dose of study treatment as the Baseline assessment. Wilcoxon Rank Sum test stratified by Baseline fatigue severity ("severe" defined as BFI item 3\>=7 and "not severe" defined as BFI item 3\<7), Baseline OCS (0-\<=20mg/day and \>20mg/day prednisone or equivalent) and region. Participants with missing change from Baseline at Week 32 were included in the worst category (\>=4 point increase). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period | Up to Week 32 | ITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced a HES Flare or Who Withdrew From the Study During Week 20 Through Week 32 | Week 20 to Week 32 | ITT Population. | Percentage of participants | NUMBER |
| SECONDARY | Time to First HES Flare | Weeks 4, 8, 12, 16, 20, 24, 28 and 32 | ITT Population. | Probability expressed as percentage | NUMBER |
| SECONDARY | Number of HES Flares Per Participant Per Year | Up to Week 32 | ITT Population. | Flares per participant per year | MEAN |
| SECONDARY | Number of Participants With Change From Baseline in Fatigue Severity Based on Brief Fatigue Inventory (BFI) in Item 3 (Worst Level of Fatigue During Past 24 Hours) at Week 32 by Category | Baseline (Week 0) and at Week 32 | ITT Population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period | Placebo | 56 | Percentage of participants | ||
| Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period | Mepolizumab 300 mg SC | 28 | Percentage of participants | ||
| Percentage of Participants Who Experienced a HES Flare or Who Withdrew From the Study During Week 20 Through Week 32 | Placebo | 35 | Percentage of participants | ||
| Percentage of Participants Who Experienced a HES Flare or Who Withdrew From the Study During Week 20 Through Week 32 | Mepolizumab 300 mg SC | 17 | Percentage of participants | ||
| Time to First HES Flare | Placebo | Flares by Week 4 | 7.4 | 95% Confidence Interval 2.8 to 18.5 | Probability expressed as percentage |
| Time to First HES Flare | Mepolizumab 300 mg SC | Flares by Week 4 | 5.6 | 95% Confidence Interval 1.8 to 16.2 | Probability expressed as percentage |
| Time to First HES Flare | Placebo | Flares by Week 8 | 14.9 | 95% Confidence Interval 7.7 to 27.5 | Probability expressed as percentage |
| Time to First HES Flare | Mepolizumab 300 mg SC | Flares by Week 8 | 7.4 | 95% Confidence Interval 2.8 to 18.5 | Probability expressed as percentage |
| Time to First HES Flare | Placebo | Flares by Week 12 | 26.2 | 95% Confidence Interval 16.4 to 40.2 | Probability expressed as percentage |
| Time to First HES Flare | Mepolizumab 300 mg SC | Flares by Week 12 | 9.3 | 95% Confidence Interval 4.0 to 20.8 | Probability expressed as percentage |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 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 | 54 | |
| Overall Study | STARTED | Mepolizumab 300 mg SC | 54 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | COMPLETED | Mepolizumab 300 mg SC | 52 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | Mepolizumab 300 mg SC | 2 |
Source ClinicalTrials.gov
Adverse events184
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 | Bronchitis | Infections and infestations | Placebo | 10 | 54 | |
| other | Bronchitis | Infections and infestations | Mepolizumab 300 mg SC | 7 | 54 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 7 | 54 | |
| other | Nasopharyngitis | Infections and infestations | Mepolizumab 300 mg SC | 7 | 54 | |
| other | Rhinitis | Infections and infestations | Placebo | 6 | 54 | |
| other | Rhinitis | Infections and infestations | Mepolizumab 300 mg SC | 5 | 54 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 2 | 54 | |
| other | Upper respiratory tract infection | Infections and infestations | Mepolizumab 300 mg SC | 8 | 54 | |
| other | Sinusitis | Infections and infestations | Placebo | 4 | 54 | |
| other | Sinusitis | Infections and infestations | Mepolizumab 300 mg SC | 2 | 54 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 54 |
| Total, all-cause mortality | Mepolizumab 300 mg SC | 1 | 54 |
| Total, other adverse events | Placebo | 43 | 54 |
| Total, other adverse events | Mepolizumab 300 mg SC | 41 | 54 |
| Total, serious adverse events | Placebo | 9 | 54 |
| Total, serious adverse events | Mepolizumab 300 mg SC | 10 | 54 |
Source ClinicalTrials.gov
Papers6
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 300 mg SC vs Placebo: deaths from any cause | Trial comparisons |
| Mepolizumab 300 mg SC 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/NCT02836496
GET https://conductscience.org/api/trials/v1/NCT02836496/results?page=2