AsthmaPhase 3NCT03021304
Study of Mepolizumab Safety Syringe in Asthmatics
A Phase 3 study testing Mepolizumab in people with Asthma, run by GlaxoSmithKline at 15 sites in 5 countries.
Trial summary
This study is aimed to assess the correct real-world use of a safety syringe for the repeat self-administration of mepolizumab SC. This Phase III study will be an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in a safety syringe (100 milligrams [mg]) administered… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Mepolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 1 Feb 2017to 8 Aug 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- 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.
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- 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.
Who cannot join
- 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.
- 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.
- 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).
- A known immunodeficiency (e.g. human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids taken as therapy for asthma.
- 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.
- 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)
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- QT interval corrected for heart rate by either Fridericia's or Bazett's formula QTc(F)/QTc(B) ≥450milliseconds (msec) or QTc(F)/QTc(B) ≥480 msec for subjects with Bundle Branch Block at Visit 1 confirmed by electrocardiogram (ECG).
- Subjects who have received omalizumab within 130 days of Visit 1.
- Subjects who have received any monoclonal antibody (other than Xolair) to treat inflammatory disease within 5 half-lives of Visit 1.
- 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.
- Subjects who have received chemotherapy within 12 months prior to Visit 1.
- A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
- Subjects with hypersensitivity to mepolizumab or to any of the excipients (sodium phosphate, citric acid, sucrose, ethylenediamine tetraacetic acid (EDTA), polysorbate 80).
- Subjects who have known evidence of lack of adherence to controller medications and/or ability to follow physician's recommendations.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
United States4 sites
GSK Investigational Site
Birmingham, Alabama, 35243
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Los Angeles, California, 90025
GSK Investigational Site
Orangeburg, South Carolina, 29118-2040
Netherlands3 sites
GSK Investigational Site
Amsterdam, 1105 AZ
GSK Investigational Site
Leeuwarden, 8934 AD
GSK Investigational Site
Zwolle, 8025 AB
Russia3 sites
GSK Investigational Site
Moscow, 123095
GSK Investigational Site
Saint Petersburg, 198328
GSK Investigational Site
Yekaterinburg, 620109
Sweden3 sites
GSK Investigational Site
Linköping, SE-581 85
GSK Investigational Site
Lund, SE-221 85
GSK Investigational Site
Stockholm, SE-141 86
Canada2 sites
GSK Investigational Site
Saint-Charles-Borromée, Quebec, J6E 2B4
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5
About this study
Official title: An Open-label, Single Arm, Repeat Dose, Multi-centre Study to Evaluate the Use of a Safety Syringe for the Subcutaneous Administration of Mepolizumab in Subjects With Severe Eosinophilic Asthma (Study 205667)
This study is aimed to assess the correct real-world use of a safety syringe for the repeat self-administration of mepolizumab SC. This Phase III study will be an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in a safety syringe (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 55 Subjects will be enrolled in the study.
- Conditions
- Asthma
- Being tested
- Mepolizumab
- Keywords
- SB240563, self-administration, Mepolizumab, safety syringe, Eosinophilic asthma
- Medical subject headings
- Asthma, Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepolizumabDrug
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 a safety syringe.
| Study group | Role | What they receive |
|---|---|---|
| Mepolizumab SC 100 mg/milliliter (mL) in Safety syringe | Experimental | Subjects will receive 3 doses of 100 mg mepolizumab, liquid drug product in safety syringe, subcutaneously as a single injection that is self-administered in the thigh, abdomen or administered in the upper arm (by caregiver only) 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). Receives: Drug: Mepolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Successful Self-administration of Their Observed Third Dose at Week 8
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.
Measured: Week 8
Secondary outcomes (1)
Percentage of Participants With Successful Self-administration of Their Unobserved Second Dose Outside the Clinic Setting at Week 4
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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion8 Aug 2017
- Study completion8 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021304
- Sponsor's protocol ID
- 205667
- Other IDs
- 2016-001831-10, 2016
- Status last verified
- Jul 2019
- First submitted
- 12 Jan 2017
- Last updated
- 23 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
- Expanded access
- Available
Publications
Bel EH, I Bernstein D, Bjermer L, Follows R, Bentley JH, Pouliquen I, Bradford E. Usability of mepolizumab single-use prefilled syringe for patient self-administration. J Asthma. 2020 Jul;57(7):755-764. doi: 10.1080/02770903.2019.1604745. Epub 2019 Apr 24.
PubMed 31017022
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Arm, Repeat Dose, Multi-centre Study to Evaluate the Use of a Safety Syringe for the Subcutaneous Administration of Mepolizumab in Subjects With Severe Eosinophilic Asthma (Study 205667)
- ClinicalTrials.gov ID
- NCT03021304
- Acronym / sponsor ID
- 205667
- Conditions
- Asthma
- Keywords
- SB240563, self-administration, Mepolizumab, safety syringe, Eosinophilic asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Posted 31 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed to assess the correct real-world use of a safety syringe for the repeat self-administration of mepolizumab SC. This Phase III study will be an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in a safety syringe (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 55 Subjects will be enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mepolizumab SC 100 mg/milliliter (mL) in Safety syringe | Experimental | Drug: MepolizumabSubjects will receive 3 doses of 100 mg mepolizumab, liquid drug product in safety syringe, subcutaneously as a single injection that is self-administered in the thigh, abdomen or administered in the upper arm (by caregiver only) 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). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (14 listed)
- 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.
- 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.
- 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).
- A known immunodeficiency (e.g. human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids taken as therapy for asthma.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MepolizumabIt 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 a safety syringe. | Drug | Mepolizumab SC 100 mg/milliliter (mL) in Safety syringe |
Primary outcome
Percentage of Participants With Successful Self-administration of Their Observed Third Dose at Week 8
Time frame: Week 8
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.
1 secondary outcome
Percentage of Participants With Successful Self-administration of Their Unobserved Second Dose Outside the Clinic Setting at Week 4
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31017022Bel EH, I Bernstein D, Bjermer L, Follows R, Bentley JH, Pouliquen I, Bradford E. Usability of mepolizumab single-use prefilled syringe for patient self-administration. J Asthma. 2020 Jul;57(7):755-764. doi: 10.1080/02770903.2019.1604745. Epub 2019 Apr 24.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mepolizumab in people with Asthma, run by GlaxoSmithKline at 15 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Netherlands, Russia, Sweden, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Successful Self-administration of Their Observed Third Dose at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03021304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.