A Phase 3a, Repeat Dose, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02135692 |
Recruitment Status :
Completed
First Posted : May 12, 2014
Results First Posted : May 2, 2018
Last Update Posted : December 3, 2019
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Asthma |
Interventions |
Biological: Mepolizumab Drug: SOC |
Enrollment | 339 |
Participant Flow
Recruitment Details | This was an open-label, long-term study of mepolizumab 100 milligram (mg) administered subcutaneously (SC), in addition to standard of care (SOC), in eligible participants with severe eosinophilic asthma, who completed the MEA115661 Exit Visit (Visit 14). The study enrolled participants across 18 countries. |
Pre-assignment Details | A total of 340 participants were screened for the study, of which one participant was screening failure, and 339 participants received the study treatment. |
Arm/Group Title | Mepolizumab 100 mg SC |
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Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician. |
Period Title: Overall Study | |
Started | 339 |
Completed | 0 |
Not Completed | 339 |
Reason Not Completed | |
Adverse Event | 3 |
Lack of Efficacy | 2 |
Protocol Violation | 2 |
Subject met Liver Stopping Criteria | 1 |
Product commercially available | 159 |
Study closed/terminated | 153 |
Lost to Follow-up | 4 |
Withdrawal by Subject | 15 |
Baseline Characteristics
Arm/Group Title | Mepolizumab 100 mg SC | |
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Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician. | |
Overall Number of Baseline Participants | 339 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 339 participants | |
52.9 (13.08) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 339 participants | |
Female |
178 52.5%
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Male |
161 47.5%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Race/ Ethnicity | Number Analyzed | 339 participants |
Asian-Central/South Asian Heritage |
2 0.6%
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Asian-East Asian Heritage |
19 5.6%
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Asian-Japanese Heritage |
26 7.7%
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Asian-South East Asian Heritage |
4 1.2%
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Black or African American |
4 1.2%
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White-Arabic/North African Heritage |
7 2.1%
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White-White/Caucasian/European Heritage |
277 81.7%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
EMail: | GSKClinicalSupportHD@gsk.com |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT02135692 |
Other Study ID Numbers: |
201312 2014-000314-54 ( EudraCT Number ) |
First Submitted: | May 8, 2014 |
First Posted: | May 12, 2014 |
Results First Submitted: | March 29, 2018 |
Results First Posted: | May 2, 2018 |
Last Update Posted: | December 3, 2019 |