Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02135692 · ClinicalTrials.gov registry record · Phase 3
A Phase 3a, Repeat Dose, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects
A Phase 3 study of Asthma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 339
- Enrollment target
- 20
- Study locations
NCT02135692 is a Phase 3 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 339 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT02135692, a Phase 3 study of Asthma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 339 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multi-center, open-label, long-term study of subcutaneously (SC) administered mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic asthma. This study will enroll a subset of subjects from Study MEA115661 who have demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy are individuals at greatest risk of serious deterioration of their health status. In order to target individuals at greatest risk for serious deterioration of their health status, only subjects from the MEA115661 study with a history of life-threatening or seriously debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility criteria for the study will be offered the opportunity to consent for this study of up to 128 weeks in length (including the Follow-Up Visit). This study will give opportunity to extend the collection of clinical data for long-term use and further assess the sustainability of efficacy in a population likely to experience significant loss of asthma control and the need for higher doses of systemic steroids if returned to SOC only.
Conditions Studied
Interventions
- BIOLOGICAL Mepolizumab
- DRUG SOC
Study Locations (20)
California
- GSK Investigational Site - Newport Beach
- GSK Investigational Site - Riverside
- GSK Investigational Site - Rolling Hills Estates
New York
- GSK Investigational Site - New York
- GSK Investigational Site - Rochester
North Carolina
- GSK Investigational Site - Durham
- GSK Investigational Site - Winston-Salem
Pennsylvania
- GSK Investigational Site - Hershey
- GSK Investigational Site - Pittsburgh
Colorado
- GSK Investigational Site - Denver
Connecticut
- GSK Investigational Site - New Haven
Georgia
- GSK Investigational Site - Albany
Maryland
- GSK Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 339 participants |
| Start Date | 2014-05-29 |
| Est. Completion | 2017-10-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02135692
The ClinicalTrials.gov registry entry for NCT02135692 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 339 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (78% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Mepolizumab is the first listed.
NCT02135692 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02135692 about?
NCT02135692 is a clinical study titled "A Phase 3a, Repeat Dose, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects". This is a multi-center, open-label, long-term study of subcutaneously (SC) administered mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic asthma. This study will enroll a subset of subjects from Study MEA115661 who have demonstrated clear benefit from ther...
What is the current status of trial NCT02135692?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 339 participants. The study started on 2014-05-29. Estimated completion is 2017-10-05.
What conditions does trial NCT02135692 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT02135692?
The interventions under investigation include: Mepolizumab (BIOLOGICAL), SOC (DRUG).
Who is sponsoring clinical trial NCT02135692?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02135692 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Depemokimab Asthma Imaging and Bronchoscopy Sub-Study
RECRUITING · Phase 3
-
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
RECRUITING · Phase 3
-
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
RECRUITING · Phase 3
-
A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
RECRUITING · Phase 3
-
Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
RECRUITING · Phase 3
-
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.