Trial · NCT03306043
A Multi-center, Open-label Extension, Safety Study of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES) From Study 200622
NCT03306043, Phase 3, Completed, GlaxoSmithKline; results first posted 2020-06-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multi-center, Open-label Extension, Safety Study of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES) From Study 200622. Trials, record NCT03306043. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03306043
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-center, Open-label Extension, Safety Study of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES) From Study 200622
- NCT number
- NCT03306043
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 102 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypereosinophilic Syndrome
- Interventions
- Mepolizumab
- First posted
- 2017-10-10
- Last updated
- 2020-06-23
- Other registries' IDs
- eudract:2017-000184-32
- Results first posted
- 2020-06-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Common (>=3%) Non-serious Adverse Events (AEs) | Up to Week 20 | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Serious AE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Non-serious AEs from start of study treatment until 28 days after last dose (up to Week 20) are reported. Number of participants with common (\>=3% incidence) non-serious AEs are presented. |
| Primary | Number of Participants With Serious AEs | Up to Week 28 | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Serious AE was defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with serious AEs are presented. |
| Primary | Number of Participants With the Presence of Anti-drug Antibody | Baseline (Day 1), Week 20 and Week 28 | Blood samples were analyzed for the presence of anti-mepolizumab antibodies by binding anti-drug antibody (ADA) assay. The binding ADA assay results at each visit were summarized as negative or positive. The binding ADA assay was performed in three steps; screening, confirmation and titration. The screening assay produced a result of positive or negative relative to a screening cut point. Positive samples continued with the confirmation assay, which also produced a result of positive or negative relative to a confirmation cut point. For positive confirmation samples, a titre value was obtained to quantify the degree of binding in a titration assay. Participants were considered 'Positive' if they had a positive confirmation ADA assay result. |
Source ClinicalTrials.gov
Outcomes3
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 Common (>=3%) Non-serious Adverse Events (AEs) | Up to Week 20 | Safety Population comprised of all participants who received at least one dose of open-label mepolizumab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious AEs | Up to Week 28 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With the Presence of Anti-drug Antibody | Baseline (Day 1), Week 20 and Week 28 | Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
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 Common (>=3%) Non-serious Adverse Events (AEs) | Mepolizumab 300 mg SC | 34 | Participants | ||
| Number of Participants With Serious AEs | Mepolizumab 300 mg SC | 9 | Participants | ||
| Number of Participants With the Presence of Anti-drug Antibody | Mepolizumab 300 mg SC | Baseline, Negative, n=102 | 101 | Participants | |
| Number of Participants With the Presence of Anti-drug Antibody | Mepolizumab 300 mg SC | Baseline, Positive, n=102 | 1 | Participants | |
| Number of Participants With the Presence of Anti-drug Antibody | Mepolizumab 300 mg SC | Week 20, Negative, n=101 | 101 | Participants | |
| Number of Participants With the Presence of Anti-drug Antibody | Mepolizumab 300 mg SC | Week 20, Positive, n=101 | 0 | Participants | |
| Number of Participants With the Presence of Anti-drug Antibody | Mepolizumab 300 mg SC | Week 28, Negative, n=14 | 14 | Participants | |
| Number of Participants With the Presence of Anti-drug Antibody | Mepolizumab 300 mg SC | Week 28, Positive, n=14 | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mepolizumab 300 mg SC | 102 | |
| Overall Study | COMPLETED | Mepolizumab 300 mg SC | 98 | |
| Overall Study | NOT COMPLETED | Mepolizumab 300 mg SC | 4 |
Source ClinicalTrials.gov
Adverse events26
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 300 mg SC | 12 | 102 | 13 |
| other | Vomiting | Gastrointestinal disorders | Mepolizumab 300 mg SC | 6 | 102 | 7 |
| other | Constipation | Gastrointestinal disorders | Mepolizumab 300 mg SC | 5 | 102 | 6 |
| other | Nausea | Gastrointestinal disorders | Mepolizumab 300 mg SC | 5 | 102 | 5 |
| other | Nasopharyngitis | Infections and infestations | Mepolizumab 300 mg SC | 5 | 102 | 5 |
| other | Bronchitis | Infections and infestations | Mepolizumab 300 mg SC | 4 | 102 | 4 |
| other | Sinusitis | Infections and infestations | Mepolizumab 300 mg SC | 4 | 102 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | Mepolizumab 300 mg SC | 4 | 102 | 4 |
| other | Fatigue | General disorders | Mepolizumab 300 mg SC | 4 | 102 | 4 |
| other | Injection site reaction | General disorders | Mepolizumab 300 mg SC | 4 | 102 | 11 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mepolizumab 300 mg SC | 0 | 102 |
| Total, other adverse events | Mepolizumab 300 mg SC | 34 | 102 |
| Total, serious adverse events | Mepolizumab 300 mg SC | 9 | 102 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34389506 | 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 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.
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/NCT03306043
GET https://conductscience.org/api/trials/v1/NCT03306043/events?page=2