Churg Strauss SyndromePhase 2MEPOCHUSSNCT00716651
Safety and Efficacy Study of Mepolizumab in Churg Strauss Syndrome
A Phase 2 study testing mepolizumab in people with Churg Strauss Syndrome, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Churg-Strauss syndrome is a rare type of systemic vasculitis which occurs almost exclusively in patients with asthma and which is characterized by prominent blood and tissue eosinophilia. The disease has a chronic smoldering course with a permanent need for medium to high corticosteroid doses. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Churg Strauss Syndrome
- What is being tested?
- mepolizumab
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Jul 2010
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- documented history of Churg Strauss Syndrome
- active disease
- subjects must complete screening and baseline assessment
- stable corticosteroid dose of > 12.5 mg prednisolone for at least one week
- treatment with cyclophosphamide (pulse or daily oral) or methotrexate or azathioprin or leflunomide in a stable dose for at least 4 weeks
- not pregnant or nursing
- negative pregnancy test and agree to practice birth control
Who cannot join
- life threatening disease or other critical illness deemed inappropriate for inclusion in the study by the principal investigator
- treatment with other immunosuppressive agents within 4 weeks prior to randomisation
- corticosteroid pulse of > 60 mg within the last three weeks prior to randomisation
- known secondary cause of eosinophilia
- no history or clinical features of vasculitis
- diagnosis of other primary systemic vasculitis
Show all 13Show fewer
- currently active malignant disease
- abnormal laboratory values
- impaired cardiac function
- history of allergic reaction due to monoclonal antibodies
- prior treatment with anti-hIL-5 monoclonal antibody
- exposure to investigational drug within 30 days prior to randomisation
- positive pregnancy test
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig Holstein, Rheumaklinik Bad Bramstetd
Bad Bramstedt, Schleswig-Holstein, 24576
About this study
Official title: A Phase II, Single Center Open Label, Prospective Trial to Evaluate the Efficacy and Safety of Mepolizumab for Patients With Refractory or Relapsing Churg Strauss Syndrome
Churg-Strauss syndrome is a rare type of systemic vasculitis which occurs almost exclusively in patients with asthma and which is characterized by prominent blood and tissue eosinophilia. The disease has a chronic smoldering course with a permanent need for medium to high corticosteroid doses. Available unselective immunosuppressive agents are often insufficient to reduce corticosteroid doses, to induce complete remission and to protect patients from disease flares which occur in more than 50 % of cases.
Interleukin-5 is the most potent cytokine regulating the production of eosinophil granulocytes which are the major effector cells in Churg-Strauss syndrome. Recently, an increased production of interleukin-5 was demonstrated in Churg-Strauss syndrome. Mepolizumab is a monoclonal IgG antibody targeting interleukin-5 and is effective in the treatment of the HES. The hypothesis of this study is, that mepolizumab will induce remission and allow for steroid reduction.
- Conditions
- Churg Strauss Syndrome
- Being tested
- mepolizumab
- Medical subject headings
- Churg-Strauss Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mepolizumabDrug
750 mg mepolizumab iv q4wk until week 32
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is the percentage of patients with Churg-Strauss Syndrome that attain remission
Measured: 52 weeks
Secondary outcomes (9)
Change in BVAS score
Measured: 52 weeks
Change in Disease Extent Index score
Measured: 52 weeks
Permanent End organ damage assessed by the Vasculitis Damage Index
Measured: 52 weeks
Time to remission
Measured: 52 weeks
Response, defined as a 50 % reduction of the BVAS score
Measured: 52 weeks
Time to response
Measured: 52 weeks
The frequency of relapses
Measured: 52 weeks
Blood eosinophil count
Measured: 52 weeks
Frequency of all AEs and SAEs
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Churg Strauss SyndromeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Moosig, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716651
- Sponsor's protocol ID
- RBB1
- Other IDs
- EudraCT 2006-001791-20
- Acronym
- MEPOCHUSS
- Status last verified
- Jun 2012
- First submitted
- 14 Jul 2008
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single Center Open Label, Prospective Trial to Evaluate the Efficacy and Safety of Mepolizumab for Patients With Refractory or Relapsing Churg Strauss Syndrome
- ClinicalTrials.gov ID
- NCT00716651
- Acronym / sponsor ID
- MEPOCHUSS / RBB1
- Conditions
- Churg Strauss Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (actual)
- First posted
- 16 Jul 2008 (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.
Churg-Strauss syndrome is a rare type of systemic vasculitis which occurs almost exclusively in patients with asthma and which is characterized by prominent blood and tissue eosinophilia. The disease has a chronic smoldering course with a permanent need for medium to high corticosteroid doses. Available unselective immunosuppressive agents are often insufficient to reduce corticosteroid doses, to induce complete remission and to protect patients from disease flares which occur in more than 50 % of cases.
Interleukin-5 is the most potent cytokine regulating the production of eosinophil granulocytes which are the major effector cells in Churg-Strauss syndrome. Recently, an increased production of interleukin-5 was demonstrated in Churg-Strauss syndrome. Mepolizumab is a monoclonal IgG antibody targeting interleukin-5 and is effective in the treatment of the HES. The hypothesis of this study is, that mepolizumab will induce remission and allow for steroid reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- informed consent
- documented history of Churg Strauss Syndrome
- active disease
- subjects must complete screening and baseline assessment
- stable corticosteroid dose of > 12.5 mg prednisolone for at least one week
Key exclusion criteria (13 listed)
- life threatening disease or other critical illness deemed inappropriate for inclusion in the study by the principal investigator
- treatment with other immunosuppressive agents within 4 weeks prior to randomisation
- corticosteroid pulse of > 60 mg within the last three weeks prior to randomisation
- known secondary cause of eosinophilia
- no history or clinical features of vasculitis
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 |
|---|---|---|
| mepolizumab750 mg mepolizumab iv q4wk until week 32 | Drug | – |
Primary outcome
Primary endpoint is the percentage of patients with Churg-Strauss Syndrome that attain remission
Time frame: 52 weeks
9 secondary outcomes
Change in BVAS score
Time frame: 52 weeks
Change in Disease Extent Index score
Time frame: 52 weeks
Permanent End organ damage assessed by the Vasculitis Damage Index
Time frame: 52 weeks
Time to remission
Time frame: 52 weeks
Response, defined as a 50 % reduction of the BVAS score
Time frame: 52 weeks
Time to response
Time frame: 52 weeks
The frequency of relapses
Time frame: 52 weeks
Blood eosinophil count
Time frame: 52 weeks
Frequency of all AEs and SAEs
Time frame: 52 weeks
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 15 Jun 2012.
Related trials for Churg Strauss Syndrome
RecruitingPhase 3
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilia Syndrome (HES)
RecruitingPhase 3
Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
Asthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Active, not recruitingPhase 1/2
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
Lupus Nephritis, Immunoglobulin A Nephropathy
RecruitingObservational study
Benralizumab Effectiveness in EGPA
Eosinophilic Granulomatosis With Polyangiitis (EGPA)
RecruitingObservational study
Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis
Eosinophilic Granulomatosis With Polyangiitis, Churg-Strauss Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mepolizumab in people with Churg Strauss Syndrome, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 8 inclusion and 13 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 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Primary endpoint is the percentage of patients with Churg-Strauss Syndrome that attain remission (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2012.