Study of mepolizumab in patients with HES from Study 200622
- Conditions
- Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]MedDRA version: 20.0Level: PTClassification code 10048643Term: Hypereosinophilic syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disordersHypereosinophilic syndrome (HES)
- Registration Number
- EUCTR2017-000184-32-BE
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 102
Participants are eligible to be included in the study only if all of the following criteria apply:
Study 200622 requirements
1. Age 12 years and older participants who were enrolled in Study 200622.
To be considered for Study 205203, Study 200622 participants must have completed 32-week assessments since randomization:
(i) Completion of the 32-week treatment period in Study 200622
OR
(ii) If the participant was withdrawn from study treatment prematurely during the 200622 study, but continued in the study per protocol(including HES flare related assessments) until 32 weeks from randomization.
Sex
2. Male or female
Female participants:
A female participant who meets one of the following conditions:
(i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5
OR
(ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 at least 30 days prior to the first dose of study treatment and until 16 weeks after the last dose of study treatment.
Positive benefit: risk ratio
3. The treating physician must confirm a positive benefit/risk ratio. The anticipated clinical benefit from mepolizumab must outweigh any potential safety or tolerability risk in Study 205203.
Informed consent
4. Capable of giving signed informed consent as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 8
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 104
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
Participants are excluded from the study if any of the following criteria apply:
Medical conditions
1. Participants with any history of hypersensitivity to any monoclonal antibody (including mepolizumab)
2. Participants with current malignancy or malignancy that developed during Study 200622.
NOTE:
Participants who had localized localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded.
3. Participant who is pregnant or breastfeeding.
NOTE:
Participants should not be considered for continued treatment if they plan to become pregnant during the course of treatment with mepolizumab.
4. Participant who has other clinically significant medical conditions uncontrolled with SoC therapy not associated with HES, e.g., unstable liver disease, uncontrolled cardiovascular disease, ongoing active infectious disease.
NOTE:
-Participants with recent parasitic (helminth) infections will be excluded from the study or required to be adequately treated for helminth infections before initiation of mepolizumab.
5. Participants with QTc >450 msec or QTc > 480 msec in participants with bundle branch block based on local EGC reading
NOTES:
-The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method. It is either machine-read or manually over-read.
- The specific formula used to determine eligibility and discontinuation for an individual participant should be determined prior to initiation of the study. In other words, several different formulas cannot be used to calculate the QTc for an individual participant and then the lowest QTc value used to include or discontinue the participant from the trial.
6. Liver abnormality/disease:
- Participants who discontinue study treatment based on liver chemistry stopping
criteria during Study 200622
-Current active liver or biliary disease (with the exception of Gilbert’s syndrome
or asymptomatic gallstones or otherwise stable chronic liver disease per
investigator assessment).
NOTE: Stable chronic liver disease should generally be defined by the absence
of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or
gastric varices, or persistent jaundice, or cirrhosis.
Prior/concurrent clinical study experience
7. Other investigational product/clinical study:
-Participants who have received treatment with an investigational agent (biologic
or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer,
prior to the first dose, other than Study 200622 study treatment. The term investigational” applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or
investigational formulations of marketed products
-Participants who are currently participating in any other interventional clinical
study
8. Participant had an adverse event (serious or non-serious) considered related to study treatment while participating in Study 200622 which resulted in permanent withdrawal of study treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe the long-term safety profile of mepolizumab in participants with HES who took part in Study 200622.;Secondary Objective: Not Applicable;Primary end point(s): • Adverse events (AEs) [serious and non- serious]<br>• Anti-drug antibody<br>;Timepoint(s) of evaluation of this end point: During 20 weeks starting randomization<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): No secondary endpoints;Timepoint(s) of evaluation of this end point: Not applicable