HypereosinophiliaPhase 3NCT00086658
Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)
A Phase 3 study testing mepolizumab in people with Hypereosinophilia and Hypereosinophilic Syndrome, run by GlaxoSmithKline at 29 sites in 8 countries.
Trial summary
Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypereosinophilia, Hypereosinophilic Syndrome
- What is being tested?
- mepolizumab
- How many people
- 86 participants
- Where
- 29 sitesin 8 countries
- Study dates
- 23 Mar 2004to 1 May 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented history of Hypereosinophilic Syndrome (HES)
- Eosinophil count greater than 1500 cells for 6 months
- Signs and symptoms of organ system involvement
- No evidence of parasitic, allergic or other causes of eosinophilia after comprehensive evaluation.
- Achieve and maintain a stable prednisone (corticosteroid) dose prior to starting study medication.
- Not pregnant or nursing.
Who cannot join
- Churg-Strauss Syndrome
- Wegener's Granulomatosis
- Lymphoma, hematological malignancy, advanced and metastatic solid tumors
- Chemotherapy, radiotherapy or interleukin 2 treatment.
Trial locations and contacts
29 sites in 8 countries.
29 sites in 8 countries
United States11 sites
GSK Investigational Site
Bethesda, Maryland, 20892
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Cincinnati, Ohio, 45229
GSK Investigational Site
Denver, Colorado, 80206
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Nashville, Tennessee, 37203-1424
GSK Investigational Site
Richmond, Virginia, 23298-0568
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
Salt Lake City, Utah, 84132
GSK Investigational Site
San Diego, California, 92103
Canada6 sites
GSK Investigational Site
Edmonton, Alberta, T6G 1Z2
GSK Investigational Site
Halifax, Nova Scotia, B3H 1V7
GSK Investigational Site
Hamilton, Ontario, L8N 3Z5
GSK Investigational Site
Montreal, Quebec, H3A 1A1
GSK Investigational Site
Toronto, Ontario, M5V 2T3
GSK Investigational Site
Winnipeg, Manitoba, R3C 0N2
Australia4 sites
GSK Investigational Site
Melbourne, Victoria, 3050
GSK Investigational Site
South Brisbane, Queensland, 4101
GSK Investigational Site
St Leonards, New South Wales, 2065
GSK Investigational Site
West Perth, Western Australia, 6005
Germany3 sites
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, 24576
GSK Investigational Site
Hanover, Lower Saxony, 30625
GSK Investigational Site
Munich, Bavaria, 80802
France2 sites
GSK Investigational Site
Lille, 59000
GSK Investigational Site
Suresnes, 92150
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- Sparing Effects of Mepolizumab in Subjects With Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of Subjects With HES
Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary causes of hypereosinophilia.
HES has a high morbidity/mortality rate. The major treatment of HES has been systemic corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon) with the intention to lower eosinophil counts and therefore to slow down the progression of disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia in some patients, some may eventually become nonresponsive and intolerable to the amount of side effects of the long-term therapy with these medications.
Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES clinical signs and symptoms. This study intends to further evaluate the corticosteroid-sparing and clinical benefit of mepolizumab in HES.
Read the detailed description
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase III Study to Evaluate Corticosteroid-reduction and -sparing effects of Mepolizumab 750 mg intravenously in Subjects with Hypereosinophilic Syndromes (HES) and to evaluate the Efficacy and Safety of Mepolizumab in controlling the Clinical Signs and Symptoms of HES over Nine Months
- Conditions
- Hypereosinophilia, Hypereosinophilic Syndrome
- Being tested
- mepolizumab
- Keywords
- Hypereosinophilic Syndrome Hypereosinophilia, mepolizumab, anti IL-5
- Medical subject headings
- Eosinophilia, Hypereosinophilic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mepolizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve a total daily prednisone dose of </=10 mg for a period of 8 consecutive weeks
Secondary outcomes (1)
Assess the effect of mepo in lowering prednisone dose and blood eosinophil count, improving HES-associated skin manifestations, improving quality of life (QoL), safety and tolerability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2004 (estimated)
- Study start23 Mar 2004
- Primary completion1 May 2006
- Study completion1 May 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypereosinophiliaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086658
- Sponsor's protocol ID
- 100185
- Status last verified
- May 2020
- First submitted
- 7 Jul 2004
- Last updated
- 5 May 2020
- Results posted
- No
Publications
Roufosse F, de Lavareille A, Schandene L, Cogan E, Georgelas A, Wagner L, Xi L, Raffeld M, Goldman M, Gleich GJ, Klion A. Mepolizumab as a corticosteroid-sparing agent in lymphocytic variant hypereosinophilic syndrome. J Allergy Clin Immunol. 2010 Oct;126(4):828-835.e3. doi: 10.1016/j.jaci.2010.06.049.
PubMed 20810155Rothenberg ME, Klion AD, Roufosse FE, Kahn JE, Weller PF, Simon HU, Schwartz LB, Rosenwasser LJ, Ring J, Griffin EF, Haig AE, Frewer PI, Parkin JM, Gleich GJ; Mepolizumab HES Study Group. Treatment of patients with the hypereosinophilic syndrome with mepolizumab. N Engl J Med. 2008 Mar 20;358(12):1215-28. doi: 10.1056/NEJMoa070812. Epub 2008 Mar 16.
PubMed 18344568
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- Sparing Effects of Mepolizumab in Subjects With Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of Subjects With HES
- ClinicalTrials.gov ID
- NCT00086658
- Acronym / sponsor ID
- 100185
- Conditions
- Hypereosinophilia, Hypereosinophilic Syndrome
- Keywords
- Hypereosinophilic Syndrome Hypereosinophilia, mepolizumab, anti IL-5
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2004 (actual)
- Primary completion
- 1 May 2006 (actual)
- Study completion
- 1 May 2006 (actual)
- First posted
- 9 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells, various end-organ damages (including skin, heart, lung, nervous system and digestive system etc.), and with exclusion of known secondary causes of hypereosinophilia.
HES has a high morbidity/mortality rate. The major treatment of HES has been systemic corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon) with the intention to lower eosinophil counts and therefore to slow down the progression of disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia in some patients, some may eventually become nonresponsive and intolerable to the amount of side effects of the long-term therapy with these medications.
Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5 (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES clinical signs and symptoms. This study intends to further evaluate the corticosteroid-sparing and clinical benefit of mepolizumab in HES.
Detailed description
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase III Study to Evaluate Corticosteroid-reduction and -sparing effects of Mepolizumab 750 mg intravenously in Subjects with Hypereosinophilic Syndromes (HES) and to evaluate the Efficacy and Safety of Mepolizumab in controlling the Clinical Signs and Symptoms of HES over Nine Months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented history of Hypereosinophilic Syndrome (HES)
- Eosinophil count greater than 1500 cells for 6 months
- Signs and symptoms of organ system involvement
- No evidence of parasitic, allergic or other causes of eosinophilia after comprehensive evaluation.
- Achieve and maintain a stable prednisone (corticosteroid) dose prior to starting study medication.
Key exclusion criteria (4 listed)
- Churg-Strauss Syndrome
- Wegener's Granulomatosis
- Lymphoma, hematological malignancy, advanced and metastatic solid tumors
- Chemotherapy, radiotherapy or interleukin 2 treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mepolizumab | Drug | – |
Primary outcome
Proportion of subjects who achieve a total daily prednisone dose of </=10 mg for a period of 8 consecutive weeks
1 secondary outcome
Assess the effect of mepo in lowering prednisone dose and blood eosinophil count, improving HES-associated skin manifestations, improving quality of life (QoL), safety and tolerability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Derived from this study: PubMed 20810155Roufosse F, de Lavareille A, Schandene L, Cogan E, Georgelas A, Wagner L, Xi L, Raffeld M, Goldman M, Gleich GJ, Klion A. Mepolizumab as a corticosteroid-sparing agent in lymphocytic variant hypereosinophilic syndrome. J Allergy Clin Immunol. 2010 Oct;126(4):828-835.e3. doi: 10.1016/j.jaci.2010.06.049.
- Derived from this study: PubMed 18344568Rothenberg ME, Klion AD, Roufosse FE, Kahn JE, Weller PF, Simon HU, Schwartz LB, Rosenwasser LJ, Ring J, Griffin EF, Haig AE, Frewer PI, Parkin JM, Gleich GJ; Mepolizumab HES Study Group. Treatment of patients with the hypereosinophilic syndrome with mepolizumab. N Engl J Med. 2008 Mar 20;358(12):1215-28. doi: 10.1056/NEJMoa070812. Epub 2008 Mar 16.
Related trials for Hypereosinophilia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
29 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mepolizumab in people with Hypereosinophilia and Hypereosinophilic Syndrome, run by GlaxoSmithKline at 29 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Canada, Australia, Germany, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who achieve a total daily prednisone dose of </=10 mg for a period of 8 consecutive weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00086658, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.