Cessation Versus Continuation of Long-term Mepolizumab in Severe Eosinophilic Asthma Patients
Public ClinicalTrials.gov record NCT02555371. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Compare Cessation Versus Continuation of Long-term Mepolizumab Treatment in Patients With Severe Eosinophilic Asthma (201810)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary objective of the study is to evaluate whether patients with severe eosinophilic asthma who have received long-term treatment with mepolizumab (at least 3 years) need to maintain treatment with mepolizumab to continue to receive benefit. Subjects who participated in the open-label studies MEA115666 or 201312 with at least 6 months of treatment with mepolizumab prior to Visit 1 and who have no more than 2 consecutive missed doses of mepolizumab treatment will be eligible to participate in this study. This study will be conducted in 4 parts in approximately 300 subjects. Part A will be Variable Open-Label Run-in (for subjects with less than 3 years of mepolizumab treatment). Once the required 3 year exposure is reached, subjects will enter Part B- Fixed Open-Label Run-In (4 weeks to 8 weeks). During Part A and B subjects will be administered Open-label mepolizumab (100 milligram \[mg\] Subcutaneous \[SC\]) every 4 weeks. Part C will be the randomized double-blinded part. Upon completion of Part B, eligible subjects will be randomized to mepolizumab (100 mg SC) every 4 weeks or placebo administered SC every 4 weeks for 52 weeks. Subjects discontinuing investigational product (IP) due to a clinically significant asthma exacerbation will then enter optional Part D of the study. During Part D, subjects receive open-label mepolizumab in addition to their standard of care therapy for the remainder of the study, through Part D up to 52-weeks post-randomization. An Exit Visit will be conducted 52 weeks after randomization in order to assess subject's efficacy parameters, immunogenicity status, and to conduct additional safety assessments. Eligible subjects will participate in the study ranging from 56 to192 weeks, depending on the duration of Part A (0 to 132 weeks) and Part B (4 to 8 weeks).
Study identification
- NCT ID
- NCT02555371
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 306 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 7, 2016 (Actual)
- Primary completion
- Jul 24, 2019 (Actual)
- Completion
- Jul 24, 2019 (Actual)
- Last update posted
- Feb 5, 2020
2016 – 2019
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Long Beach | California | 90808 | — |
| GSK Investigational Site | Riverside | California | 92506 | — |
| GSK Investigational Site | Denver | Colorado | 80206 | — |
| GSK Investigational Site | New Haven | Connecticut | 6504 | — |
| GSK Investigational Site | Albany | Georgia | 31707 | — |
| GSK Investigational Site | Baltimore | Maryland | 21224 | — |
| GSK Investigational Site | Rochester | Minnesota | 55905 | — |
| GSK Investigational Site | Rochester | New York | 14642 | — |
| GSK Investigational Site | Durham | North Carolina | 27705 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27104 | — |
| GSK Investigational Site | Hershey | Pennsylvania | 17033 | — |
| GSK Investigational Site | Nashville | Tennessee | 37212 | — |
| GSK Investigational Site | Murray | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 60 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02555371, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 5, 2020 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02555371 live on ClinicalTrials.gov.