Trial Outcomes & Findings for Study of Mepolizumab Autoinjector in Asthmatics (NCT NCT03099096)
NCT ID: NCT03099096
Last Updated: 2023-06-28
Results Overview
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.
COMPLETED
PHASE3
159 participants
Week 8
2023-06-28
Participant Flow
Participants with severe eosinophilic asthma, were enrolled at 16 sites in the United States of America, 6 sites in Germany, 5 sites in the United Kingdom, 4 sites in Canada, 3 sites in Australia, 2 sites in Russia and 2 sites in Sweden. The study duration lasted from 04 May 2017 to 30 November 2017.
Of the total 181 participants screened, 22 were screen failures and 159 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 Autoinjector
Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.
|
|---|---|
|
Overall Study
STARTED
|
159
|
|
Overall Study
COMPLETED
|
157
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Mepolizumab Liquid Autoinjector
Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Study of Mepolizumab Autoinjector in Asthmatics
Baseline characteristics by cohort
| Measure |
Mepolizumab Liquid Autoinjector
n=159 Participants
Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.
|
|---|---|
|
Age, Continuous
|
49.3 Years
STANDARD_DEVIATION 16.18 • n=39 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
25 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
2 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
3 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
126 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: All Subjects (Safety) Population
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.
Outcome measures
| Measure |
Mepolizumab Liquid Autoinjector
n=103 Participants
Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, 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 - Autoinjector With Standard Label + Pictogram
|
99 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 8Population: All Subjects (Safety) Population
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.
Outcome measures
| Measure |
Mepolizumab Liquid Autoinjector
n=54 Participants
Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, 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 - Autoinjector With Standard Label Only
|
98 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: All Subjects (Safety) Population
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.
Outcome measures
| Measure |
Mepolizumab Liquid Autoinjector
n=103 Participants
Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.
|
|---|---|
|
Percentage of Participants With Successful Self-administration of Their Unobserved Dose at Week 4 - Autoinjector With Standard Label + Pictogram
|
98 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: All Subjects (Safety) Population
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.
Outcome measures
| Measure |
Mepolizumab Liquid Autoinjector
n=54 Participants
Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.
|
|---|---|
|
Percentage of Participants With Successful Self-administration of Their Unobserved Dose at Week 4 - Autoinjector With Standard Label Only
|
96 Percentage of participants
|
Adverse Events
Mepolizumab Liquid Autoinjector
Serious adverse events
| Measure |
Mepolizumab Liquid Autoinjector
n=159 participants at risk
Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.63%
1/159 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.63%
1/159 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.63%
1/159 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
|
General disorders
Chest discomfort
|
0.63%
1/159 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.63%
1/159 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.63%
1/159 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.63%
1/159 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.63%
1/159 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.63%
1/159 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
Other adverse events
| Measure |
Mepolizumab Liquid Autoinjector
n=159 participants at risk
Participants (or their caregivers) self-administered, 100 milligram (mg) mepolizumab liquid drug product subcutaneously every 4 weeks (3 doses) as a single injection using autoinjector, in the thigh, abdomen or upper arm (caregiver only) for 12 weeks.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.7%
9/159 • Number of events 11 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
6/159 • Number of events 6 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
|
Infections and infestations
Lower respiratory tract infection
|
3.1%
5/159 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
|
Infections and infestations
Urinary tract infection
|
3.1%
5/159 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
|
Nervous system disorders
Headache
|
5.0%
8/159 • Number of events 11 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from start of Study Treatment (Week 0) until the End of Study/Early Withdrawal Visit (Week 12)
On-treatment SAEs and non-serious AEs are reported for All Subjects (Safety) Population
|
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