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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03099096
Registration number
NCT03099096
Ethics application status
Date submitted
29/03/2017
Date registered
4/04/2017
Date last updated
28/06/2023
Titles & IDs
Public title
Study of Mepolizumab Autoinjector in Asthmatics
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Scientific title
An Open-label, Single Arm, Repeat Dose, Multi-centre Study to Evaluate the Use of an Autoinjector for the Subcutaneous Administration of Mepolizumab in Subjects With Severe Eosinophilic Asthma (Study 204959)
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Secondary ID [1]
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2016-001832-36
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Secondary ID [2]
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204959
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Mepolizumab
Experimental: Mepolizumab SC 100 mg/milliliter (mL) in autoinjector - Three doses of mepolizumab liquid drug product in autoinjector will be self-administered by the subject/caregiver at 4-weekly intervals; 2 doses will be administered under observation in the clinic (at Week 0 and 8). One dose will be administered outside the clinic and without observation (within 24 hours after attending the clinic at Week 4).
Treatment: Drugs: Mepolizumab
It is a clear to opalescent, colorless to pale yellow sterile solution for SC injection, supplied in a single-use, prefilled syringe containing 100 mg/mL mepolizumab with sodium phosphate, citric acid, sucrose EDTA and polysorbate 80 within an autoinjector.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Successful Self-administration of Their Observed Third Dose at Week 8 - Autoinjector With Standard Label + Pictogram
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Assessment method [1]
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Due to differences in the labelling requirements among regulatory authorities around the world, two different labelling approaches were included in this global study: labelling that includes a pictogram plus standard labelling elements, or a standard labelling without the pictogram. Participants (and/or their caregiver) attended three on treatment visits at Week 0, 4, 8, and End of Study Visit. Training on the study treatment, device handling and administration technique was provided by the investigator or qualified site staff at Week 0 and then first dose was self-administered under observation of investigator/site staff in clinic. Second dose self-administered unobserved, at home (Week 4) and third dose was self-administered under the observation of investigator/site staff in clinic (Week 8). All Subjects (Safety) Population included all enrolled participants attempting at least one self-administration of mepolizumab. Only participants with data available at Week 8 were analyzed.
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Timepoint [1]
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Week 8
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Primary outcome [2]
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Percentage of Participants With Successful Self-administration of Their Observed Third Dose at Week 8 - Autoinjector With Standard Label Only
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Assessment method [2]
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Due to differences in the labeling requirements among regulatory authorities around the world, two different labeling approaches were included in this global study: labeling that includes a pictogram plus standard labeling elements, or a standard labeling without the pictogram. Participants (and/or their caregiver) attended three on treatment visits at Week 0, Week 4, Week 8, and the End of Study Visit. Training on the study treatment, device handling and administration techniques was provided by the investigator or qualified site staff at Week 0 and then first dose was self-administered under observation of investigator/site staff in clinic. Second dose self-administered unobserved, at home (Week 4) and third dose was self-administered under the observation of investigator/site staff in clinic (Week 8). Only participants with data available at Week 8 were analyzed.
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Timepoint [2]
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Week 8
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Secondary outcome [1]
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Percentage of Participants With Successful Self-administration of Their Unobserved Dose at Week 4 - Autoinjector With Standard Label + Pictogram
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Assessment method [1]
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Due to differences in the labeling requirements among regulatory authorities around the world, two different labeling approaches were included in this global study: labeling that includes a pictogram plus standard labeling elements, or a standard labeling without the pictogram. Data for participants (and/or their caregiver) self-administering the second dose unobserved, at home (Week 4) using Autoinjector with Standard Label + Pictogram has been presented. Only participants with data available at Week 4 were analyzed.
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Timepoint [1]
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Week 4
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Secondary outcome [2]
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Percentage of Participants With Successful Self-administration of Their Unobserved Dose at Week 4 - Autoinjector With Standard Label Only
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Assessment method [2]
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Due to differences in the labeling requirements among regulatory authorities around the world, two different labeling approaches were included in this global study: labeling that includes a pictogram plus standard labeling elements, or a standard labeling without the pictogram. Data for participants (and/or their caregiver) self-administering the second dose unobserved, at home (Week 4) using Autoinjector with Standard Label has been presented. Only participants with data available at Week 4 were analyzed.
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Timepoint [2]
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Week 4
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Eligibility
Key inclusion criteria
- 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.
- Asthma: A physician diagnosis of asthma for >=2 years that meets the National Heart,
Lung and Blood Institute guidelines or Global Initiative for Asthma guidelines.
- Mepolizumab treatment:
a. Not receiving mepolizumab treatment at Visit 1. These subjects must also meet
following inclusion criteria related to eosinophilic asthma, inhaled corticosteroid,
controller medication and exacerbation history):
- Eosinophilic asthma: A high likelihood of eosinophilic asthma as per the required
'Continuation to Treatment'-criterion,
- 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 micrograms (mcg)/day fluticasone propionate (FP) (ex-actuator) 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 mcg/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. (Subjects will be
permitted to be enrolled without continuous high dose ICS providing the subject was
receiving continuous ICS and the Investigator attest that the subject should have been
treated with high dose ICS to mitigate the risk of exacerbations, or the subject has
financial or tolerance issues that prevent the use of high-dose ICS. Such subjects
should be discussed with GSK Medical Monitor prior to enrolment)
- 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., LABA, leukotriene receptor antagonist [LTRA],
or theophylline) for at least 3 successive months.
- 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.
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.
- Body weight: A minimum body weight >=40 kilograms (kg) at Visit 1
- Gender: Male or female. 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: Non-reproductive potential defined as: pre-menopausal females with documented
tubal ligation or documented hysteroscopic tubal occlusion procedure with follow-up
confirmation of bilateral tubal occlusion or hysterectomy or documented bilateral
oophorectomy, postmenopausal female, reproductive potential and agrees to follow
highly effective methods for avoiding pregnancy in females of reproductive potential
from 30 days prior to the first dose of study medication and until 16 weeks after the
last dose of study medication and completion of the end of study/early withdrawal
visit. The investigator is responsible for ensuring that subjects understand how to
properly use these methods of contraception.
- Informed consent: Capable of giving signed informed consent.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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.
- 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 will also be excluded.
- 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.
- Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus [HIV]),
other than that explained by the use of corticosteroids taken as therapy for asthma.
- 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.
- 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).
- ECG assessment: QT interval corrected for heart rate by either Fridericia's or
Bazett's formula (QTc[F] or QTc[B]) >=450 milliseconds (msec) or QTc(F) or QTc(B)
>=480 msec for subjects with bundle branch block at Visit 1.
- Xolair: Subjects who have received omalizumab within 130 days of Visit 1.
- Other monoclonal antibodies not including mepolizumab: Subjects who have received any
monoclonal antibody to treat inflammatory disease within 5 half-lives of Visit 1.
- 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.
- Chemotherapy: Subjects who have received chemotherapy within 12 months prior to Visit
1.
- Alcohol/substance abuse: A history (or suspected history) of alcohol misuse or
substance abuse within 2 years prior to Visit 1.
- Hypersensitivity: Subjects with hypersensitivity to mepolizumab or to any of the
excipients (sodium phosphate, citric acid, sucrose, ethylenediaminetetraacetic acid
[EDTA], polysorbate 80).
- Adherence: Subjects who have known evidence of lack of adherence to controller
medications and/or ability to follow physician's recommendations.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/11/2017
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Sample size
Target
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Accrual to date
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Final
159
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Woodville South
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Recruitment hospital [2]
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GSK Investigational Site - Clayton
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GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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5011 - Woodville South
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Recruitment postcode(s) [2]
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3169 - Clayton
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Georgia
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Indiana
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Maryland
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Brandenburg
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Hessen
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Sachsen
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Berlin
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Chelyabinsk
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Voronezh
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Linköping
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Lund
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Leicestershire
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Bradford
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Oxford
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Plymouth
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is aimed to assess the correct real-world use of an autoinjector for the repeat
self-administration of mepolizumab SC, so to improve subject / physician convenience and to
enable repeat dose self injection themselves or via caregivers. This Phase III study will be
an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product
in autoinjector (100 milligrams [mg]) administered subcutaneously (SC) every 4 weeks (3
doses) in subjects with severe eosinophilic asthma. Subjects will receive 100 mg mepolizumab
SC as a single injection that is self-administered in the thigh, abdomen or administered in
the upper arm (caregiver only). Each subject will participate in the study for up to 18 weeks
including pre-screening visit, a screening visit and a 12-week treatment period which
concludes with end of study assessments (Visit 5) 4 weeks after the last dose of mepolizumab.
Approximately 158 subjects will be enrolled in the study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03099096
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Trial related presentations / publications
Bernstein D, Pavord ID, Chapman KR, Follows R, Bentley JH, Pouliquen I, Bradford E. Usability of mepolizumab single-use prefilled autoinjector for patient self-administration. J Asthma. 2020 Sep;57(9):987-998. doi: 10.1080/02770903.2019.1630641. Epub 2019 Jun 28.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03099096
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