A Phase 3 interventional study of Mepolizumab in Hypereosinophilic Syndrome, sponsored by GlaxoSmithKline. Completed at 36 sites in 13 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2020-06-23.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
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Among 23 studies in Hypereosinophilic Syndrome with a site in United States — 3 open to participants now, 8 under way, 3 of them phase 3. Hypereosinophilic Syndrome · United States.
Among the 23 studies in Hypereosinophilic Syndrome with a site in United States, this one is the 7th largest by enrollment of the 21 interventional ones that give a count, is one of 2 that started in 2017, is one of 8 in phase 3, and was the 15th registered.
40 studies on the registry are indexed under Hypereosinophilic Syndrome; 8 are open to participants now.
Browse Hypereosinophilic Syndrome studies →3 of the 23 studies in Hypereosinophilic Syndrome with a site in United States are open now. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Argentina, Austria and 11 more countries
Ages 6+
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–99
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 1–100 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 7 Hypereosinophilic Syndrome studies recruiting now, 5 set no upper age limit and none stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 11 · Phase 3 8 · Phase 4 1
First in 1998; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 102 is above the median of 41 across 31 interventional studies indexed under Hypereosinophilic Syndrome.
Median enrollment 68 across the 21 interventional studies, 150 across the 2 observational. Of the 14 that completed or were terminated, 8 (57%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 23 have an industry lead sponsor. The 9 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
GlaxoSmithKline has 7 studies filed under Hypereosinophilic Syndrome — fewer than ten, so there is no comparison to draw.
3 of the studies in Hypereosinophilic Syndrome with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05334368Phase 3GlaxoSmithKlineDepemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial | 2027-10-29 |
| NCT06477653National Institute of Allergy and Infectious Diseases (NIAID)Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents | 2026-12-30 |
| NCT03862157M.D. Anderson Cancer CenterAzacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia | 2027-01-31 |
Add all 3 to your calendar (.ics) → With an account.
Among the 23 studies in Hypereosinophilic Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is an open-label extension study to Study 200622.In this study subjects from Study 200622 will be continued on 4-weekly dosing with open-label mepolizumab 300 milligram (mg) subcutaneously (SC) for an additional 20 Weeks after completing the 32 Week study assessments post-randomization, while they continue with their background HES therapy per standard of care (SoC). Subjects from study 200622 will participate in this extension study if they had completed the 32-Week treatment period in study 200622 or if they were withdrawn from the study pre-maturely, but were continued in the study per protocol until 32 Weeks from randomization. Data from this study (205203) and 200622 will be combined to provide up to 52-Week exposure data to further characterize the long-term safety profile of mepolizumab and provide additional data on the clinical benefit in HES subjects beyond 32 Weeks. The duration of the study participation will be 20 Weeks for subjects who continue with mepolizumab treatment via MHE104317/MHE112562 after this open-label extension study; and 28 Weeks for subjects who do not continue with MHE104317/MHE112562.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who were part of study 200622 and were randomized to receive either placebo or mepolizumab will be enrolled in this study as per study eligibility criteria. In this study, subjects will receive 300 mg of mepolizumab SC (three 100 mg SC injections) every 4 Weeks for a total of 5 doses during 20-Week treatment period.
Drug: Mepolizumab
Mepolizumab will be available as 100 mg vial for injection. Subjects will receive three 100 mg SC injections for every 4 Weeks for a total of 5 doses during 20 Week treatment period.
Number of Participants With Common (>=3%) Non-serious Adverse Events (AEs)
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.
Time frame: Up to Week 20
Number of Participants With Serious AEs
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.
Time frame: Up to Week 28
Number of Participants With the Presence of Anti-drug Antibody
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.
Time frame: Baseline (Day 1), Week 20 and Week 28
This was a multi-center, open-label extension study to evaluate the long-term safety profile of mepolizumab in participants with Hypereosinophilic Syndrome (HES). In this study, participants received open-label mepolizumab 300 milligram (mg) subcutaneously (SC).
| Milestone | Mepolizumab 300 mg SC |
|---|---|
| Started | 102 |
| Completed | 98 |
| Not completed | 4 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 2 |
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.
| Participants | Mepolizumab 300 mg SC |
|---|---|
| Number of Participants With Common (>=3%) Non-serious Adverse Events (AEs) | 34 |
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.
| Participants | Mepolizumab 300 mg SC |
|---|---|
| Number of Participants With Serious AEs | 9 |
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.
| Participants | Mepolizumab 300 mg SC |
|---|---|
| Baseline, Negative, n=102 | 101 |
| Baseline, Positive, n=102 | 1 |
| Week 20, Negative, n=101 | 101 |
| Week 20, Positive, n=101 | 0 |
| Week 28, Negative, n=14 | 14 |
| Week 28, Positive, n=14 | 0 |
Collected over Serious AEs were reported from start of study (Week 0) up to end of study (up to Week 28) and non-serious AEs were reported from start of study treatment until 28 days after last dose (up to Week 20). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mepolizumab 300 mg SC | 0/102 (0%) | 9/102 (8.8%) | 34/102 (33.3%) |
| Event | Mepolizumab 300 mg SC |
|---|---|
| BacteraemiaInfections and infestations | 1/102 |
| Clostridium difficile colitisInfections and infestations | 1/102 |
| DiverticulitisInfections and infestations | 1/102 |
| Gastrointestinal infectionInfections and infestations | 1/102 |
| Infective exacerbation of bronchiectasisInfections and infestations | 1/102 |
| Mycobacterium abscessus infectionInfections and infestations | 1/102 |
| Perihepatic abscessInfections and infestations | 1/102 |
| PneumoniaInfections and infestations | 1/102 |
| SinusitisInfections and infestations | 1/102 |
| Hypereosinophilic syndromeBlood and lymphatic system disorders | 1/102 |
| Event | Mepolizumab 300 mg SC |
|---|---|
| DiarrhoeaGastrointestinal disorders | 12/102 |
| PruritusSkin and subcutaneous tissue disorders | 7/102 |
| VomitingGastrointestinal disorders | 6/102 |
| HeadacheNervous system disorders | 6/102 |
| ConstipationGastrointestinal disorders | 5/102 |
| NauseaGastrointestinal disorders | 5/102 |
| NasopharyngitisInfections and infestations | 5/102 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/102 |
| BronchitisInfections and infestations | 4/102 |
| SinusitisInfections and infestations | 4/102 |
| Age, Continuous(Years) | Mepolizumab 300 mg SC |
|---|---|
| Mean | 46.0 ± 15.54 |
| Sex: Female, Male(Participants) | Mepolizumab 300 mg SC |
|---|---|
| Female | 55 |
| Male | 47 |
| Race/Ethnicity, Customized(Participants) | Mepolizumab 300 mg SC |
|---|---|
| Asian-East Asian Heritage | 1 |
| Black or African American | 2 |
| White-White/Caucasian/European Heritage | 79 |
| American Indian or Alaskan Native | 3 |
| Unknown | 17 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Nov 2017 to primary completion in Dec 2019, 25 months.
Results were first posted in Jun 2020, 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mepolizumab