A Real-World Use Study of Safety Syringe for the Administration of Mepolizumab in Severe Asthma
- Conditions
- severe eosinophilic asthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-001831-10-SE
- Lead Sponsor
- GlaxoSmithKline Research & Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 55
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
AGE
1. Age: At least 12 years of age inclusive, at the time of signing the informed consent. [For those countries where local regulations permit enrolment of adults only, subject recruitment will be restricted to those who are =18 years of age]
TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
2. Asthma: A physician diagnosis of asthma for =2 years that meets the National Heart, Lung and Blood Institute guidelines [National heart, lung and blood institute (NIH), 2007] or Global Initiative for Asthma (GINA) guidelines [GINA, 2015]
3. Mepolizumab treatment:
a. Not receiving mepolizumab treatment at Visit 1 (NB: these subjects must also meet inclusion criteria 4, 5, 6 and 7).
OR
b. Receiving 100 mg SC mepolizumab administered for the treatment of severe eosinophilic asthma every 4 weeks for at least 12 weeks prior to Visit 1.
The following inclusion criteria are only applicable to those subjects NOT receiving mepolizumab treatment at Visit 1:
4. Eosinophilic asthma: A high likelihood of eosinophilic asthma as per the required
‘Continuation to Treatment’ - Criterion 2.
5. Inhaled Corticosteroid: A well-documented requirement for regular treatment with high dose inhaled corticosteroid (ICS) in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids (OCS).
-For subjects =18 years old:
-ICS dose must be =880 mcg/day fluticasone propionate (FP) (exactuator) or equivalent daily.
-For ICS/long-acting-beta-2-agonist (LABA) combination
preparations, the highest approved maintenance dose in the local
country will meet this ICS criterion.
- For subjects =12 to =17 years old:
-ICS dose must be =440 µg/day FP (ex-actuator) or equivalent daily.
-For ICS/LABA combination preparations, the mid-strength approved
maintenance dose in the local country will meet this ICS criterion.
6. Controller Medication: Current treatment with an additional controller medication, besides ICS, for at least 3 months or a documented failure in the past 12 months of an additional controller medication [e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline] for at least 3 successive
months.
7. Exacerbation history: Previously confirmed history of one or more exacerbations requiring treatment with systemic corticosteroid (CS) [intramuscular (IM), intravenous, or oral] in the 12 months prior to Visit 1, despite the use of high-dose ICS. For subjects receiving maintenance CS, the CS treatment for an exacerbation must have been a two-fold dose increase or greater.
WEIGHT
8. Body weight: A minimum =40 kg at Visit 1
SEX
9. Gender: Male or Female
Females:
A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test), planning to become pregnant during the time of study participation (and up to 16 weeks after the last dose), not
lactating, and at least one of the following conditions applies:
a. Non-reproductive potential defined as:
-Pre-menopausal females with one of the following:
-Documented tubal ligation
-Documented hysteroscopic tubal occlusion procedure with follow-up
confirmation of bilateral tubal occlusion
-Hysterectomy
-Documented Bilateral Oophorectomy
-Postmenopausal female (see Appendix 3 for specific criteria).
b. Reproductive potential and agrees to follow one of the op
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER
FUNCTION AND QTc INTERVAL)
1. Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than asthma. This includes current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than
asthma) or a history of lung cancer.
2. Eosinophilic Diseases: Subjects with other conditions that could lead to elevated eosinophils such as Hypereosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis. Subjects with a known, pre-existing parasitic infestation within 6 months prior to Visit 1 are also to be excluded.
3. Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening (Subjects that had localized carcinoma of the skin which was resected for cure will not be excluded).
4. Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus – HIV), other than that explained by the use of corticosteroids taken as therapy for asthma.
5. Other Concurrent Medical Conditions: Subjects who have known, pre-existing, clinically significant cardiovascular, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
6. Liver Disease: Known, pre-existing, unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
7. ECG Assessment: QT interval corrected for heart rate by either Fridericia’s or Bazett’s formula QTc(F)/QTc(B) =450msec or QTc(F)/QTc(B) =480 msec for subjects with Bundle Branch Block at Visit 1.
CONCOMITANT MEDICATIONS
8. Xolair: Subjects who have received omalizumab within 130 days of Visit 1.
9. Other Monoclonal Antibodies not including mepolizumab: Subjects who have received any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1.
10. Investigational Medications: Subjects who have received treatment with an investigational drug, other than mepolizumab within the past 30 days or five terminal phase half-lives of the drug whichever is longer, prior to visit 1 (this also includes investigational formulations of marketed products) or experimental anti-inflammatory drugs (non biologicals) in the past 3 months.
11. Chemotherapy: Subjects who have received chemotherapy within 12 months prior to Visit 1.
CONTRAINDICATIONS
13. Hypersensitivity: Subjects with hypersensitivity to mepolizumab or to any of the excipients (sodium phosphate, citric acid, sucrose, EDTA, polysorbate 80).
DIAGNOSTIC ASSESSMENTS AND OTHER CRITERIA
14. Adherence: Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician’s recommendations.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the use of the combination product, mepolizumab liquid drug product in safety syringe for the subcutaneous self-administration of mepolizumab by subjects with severe eosinophilic asthma;Secondary Objective: To assess the use of mepolizumab liquid drug product in safety syringe<br>outside the clinic setting.;Primary end point(s): Proportion of subjects successfully able to self-administer their observed third dose;Timepoint(s) of evaluation of this end point: Week 8
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Proportion of subjects successfully able to self-administer their unobserved second dose outside the clinic setting;Timepoint(s) of evaluation of this end point: Week 4