Clinical Trial Results:
An open-label, single arm, repeat dose, multi-center study to evaluate the use of a safety syringe for the subcutaneous administration of mepolizumab in subjects with severe eosinophilic asthma (Study 205667)
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Summary
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EudraCT number |
2016-001831-10 |
Trial protocol |
SE NL Outside EU/EEA |
Global end of trial date |
08 Aug 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Jan 2018
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First version publication date |
26 Jan 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
205667
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline
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Sponsor organisation address |
980 Great West Road, Brentford, Middlesex, United Kingdom,
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Public contact |
GSK Response Center, GlaxoSmithKline, 866 4357343,
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Scientific contact |
GSK Response Center, GlaxoSmithKline, 866 4357343,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Nov 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Aug 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the use of the combination product, mepolizumab liquid drug product in safety syringe for the subcutaneous self-administration of mepolizumab by participants with severe eosinophilic asthma
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Protection of trial subjects |
The participants were educated by the staff prior to self-administration and their first scheduled dose was supervised in the clinic by the staff. Additionally, the IFU instructed the participants on the safe use of the device. A plastic/rubber needle shield protects the needle before injection to minimize the potential for needle stick injuries. The needle automatically retracted into the syringe body after the injection.”
The risk of systemic reactions associated with a mAb therapy was mitigated with AE monitoring, subject monitoring for 1 h following in clinic injections, and subject instructions to call the investigator and/or go to an Emergency Department for any unusual symptoms.
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Canada: 10
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Country: Number of subjects enrolled |
Netherlands: 13
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Country: Number of subjects enrolled |
Russian Federation: 10
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Country: Number of subjects enrolled |
Sweden: 9
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Country: Number of subjects enrolled |
United States: 16
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Worldwide total number of subjects |
58
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EEA total number of subjects |
22
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
2
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Adults (18-64 years) |
48
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From 65 to 84 years |
8
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85 years and over |
0
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Recruitment
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Recruitment details |
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. | ||||||||||
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Pre-assignment
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Screening details |
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. | ||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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Mepolizumab Liquid Safety Syringe | ||||||||||
Arm description |
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. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Mepolizumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Dose of 100 mg per milliliter (mL); 1.0 mL (deliverable) as subcutaneous injection every 4 weeks
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 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. |
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Baseline characteristics reporting groups
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Reporting group title |
Mepolizumab Liquid Safety Syringe
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Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Mepolizumab Liquid Safety Syringe
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Reporting group description |
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. | ||
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End point title |
Percentage of participants with successful self-administration of their observed third dose at Week 8 [1] | ||||||||
End point description |
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 presented. 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.
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End point type |
Primary
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End point timeframe |
Week 8
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There are no statistical data to report. |
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| Notes [2] - All Subjects (Safety) Population |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of participants with successful self-administration of their unobserved second dose outside the clinic setting at Week 4 | ||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
Week 4
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| Notes [3] - All Subjects (Safety) Population |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
On-treatment adverse events (AEs) and serious AEs (SAEs) were collected from time of study treatment administration (Week 0) to up to Week 12
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Adverse event reporting additional description |
AEs and SAEs were collected in All subject Population which comprised of all enrolled participants attempting at least one self administration of mepolizumab liquid drug product in a safety syringe.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
20.0
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Reporting groups
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Reporting group title |
Mepolizumab Liquid Safety Syringe
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Reporting group description |
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. | ||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 3% | |||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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06 Oct 2016 |
1. To refine the criteria for a successful injection following a use-related risk review
2. To amend Exclusion Criterion 7 to allow either Fridericia’s or Bazett’s to be used as the correction formula for heart rate when measuring the QT interval
3. To remove Exclusion Criterion 15 as the exclusion of pregnant or lactating females is covered in Inclusion Criterion 9
4. To correct the EudraCT No.
5. To correct minor typographical errors |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
