Trial Outcomes & Findings for Study of Mepolizumab Safety Syringe in Asthmatics (NCT NCT03021304)
NCT ID: NCT03021304
Last Updated: 2019-07-23
Results Overview
During the clinic visits the Investigator or designee evaluated if the participants were able to self-administer the third dose at Week 8 by visual inspection immediately following injection and by using an 'Observer checklist' based on the safety syringe Instructions for Use (IFU). The 'self-administration' was defined as administration of mepolizumab liquid drug product in safety syringe either by the participants themselves or by their caregiver. Failure to perform one of the critical steps was deemed to be failure to successfully administer the injection. Participants with data available at Week 8 have been analyzed. Analysis was performed on All Subjects (Safety) Population which comprised of all enrolled participants attempting at least one self administration of mepolizumab liquid drug product in a safety syringe.
COMPLETED
PHASE3
56 participants
Week 8
2019-07-23
Participant Flow
Participants with severe eosinophilic asthma, were enrolled at 4 sites in the United States of America, 3 sites in the Netherlands, 3 sites in the Russian Federation, 3 sites in Sweden, and 2 sites in Canada. The study duration lasted from 01 February 2017 to 08 August 2017.
Of the total 58 participants screened, 2 were screen failures and 56 were enrolled in this open-label, single arm, repeat dose study of mepolizumab and attempted to self-administer at least one dose of study treatment.
Participant milestones
| Measure |
Mepolizumab Liquid Safety Syringe
The participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4-weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12-weeks.
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Mepolizumab Liquid Safety Syringe
The participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4-weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12-weeks.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Study of Mepolizumab Safety Syringe in Asthmatics
Baseline characteristics by cohort
| Measure |
Mepolizumab Liquid Safety Syringe
n=56 Participants
The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4-weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12-weeks.
|
|---|---|
|
Age, Continuous
|
50.8 Years
STANDARD_DEVIATION 12.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian- Central/South Asian Heritage
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Or African American Heritage
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Heritage
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: All Subjects (Safety) Population
During the clinic visits the Investigator or designee evaluated if the participants were able to self-administer the third dose at Week 8 by visual inspection immediately following injection and by using an 'Observer checklist' based on the safety syringe Instructions for Use (IFU). The 'self-administration' was defined as administration of mepolizumab liquid drug product in safety syringe either by the participants themselves or by their caregiver. Failure to perform one of the critical steps was deemed to be failure to successfully administer the injection. Participants with data available at Week 8 have been analyzed. Analysis was performed on All Subjects (Safety) Population which comprised of all enrolled participants attempting at least one self administration of mepolizumab liquid drug product in a safety syringe.
Outcome measures
| Measure |
Mepolizumab Liquid Safety Syringe
n=55 Participants
The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4 weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12 weeks.
|
|---|---|
|
Percentage of Participants With Successful Self-administration of Their Observed Third Dose at Week 8
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: All Subjects (Safety) Population
The participant (or caregiver), self-administered the dose of study treatment outside the clinic and without observation during Week 4, up to 24 hours after attending clinic Visit 3. The 'self-administration' was defined as either administration of mepolizumab liquid drug product in safety syringe by the participants themselves or by their caregiver. The participant/caregiver completed an 'At home Checklist' outlining the various steps in the IFU to use the safety syringe. On returning to clinic the investigator inspected whether the returned safety syringe showed any signs that the full dose had not been administered.
Outcome measures
| Measure |
Mepolizumab Liquid Safety Syringe
n=56 Participants
The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4 weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12 weeks.
|
|---|---|
|
Percentage of Participants With Successful Self-administration of Their Unobserved Second Dose Outside the Clinic Setting at Week 4
|
100 Percentage of participants
|
Adverse Events
Mepolizumab Liquid Safety Syringe
Serious adverse events
| Measure |
Mepolizumab Liquid Safety Syringe
n=56 participants at risk
The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4-weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12-weeks.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.6%
2/56 • On-treatment adverse events (AEs) and serious AEs (SAEs) were collected from time of study treatment administration (Week 0) up to Week 12
AEs and SAEs were collected in All Subjects Population which comprised of all enrolled participants attempting at least one self administration of mepolizumab liquid drug product in a safety syringe.
|
|
Infections and infestations
Diverticulitis
|
1.8%
1/56 • On-treatment adverse events (AEs) and serious AEs (SAEs) were collected from time of study treatment administration (Week 0) up to Week 12
AEs and SAEs were collected in All Subjects Population which comprised of all enrolled participants attempting at least one self administration of mepolizumab liquid drug product in a safety syringe.
|
Other adverse events
| Measure |
Mepolizumab Liquid Safety Syringe
n=56 participants at risk
The participants (or their caregivers) self-administered, 100 mg mepolizumab liquid drug product subcutaneously every 4-weeks (3-doses) as a single injection using safety syringe, in the thigh, abdomen or upper arm (caregiver only), for 12-weeks.
|
|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.1%
4/56 • On-treatment adverse events (AEs) and serious AEs (SAEs) were collected from time of study treatment administration (Week 0) up to Week 12
AEs and SAEs were collected in All Subjects Population which comprised of all enrolled participants attempting at least one self administration of mepolizumab liquid drug product in a safety syringe.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER