Phase 3
Completed N=347
MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects
Source: ClinicalTrials.gov NCT01691859 ↗Enrolled (actual)
347
Serious AEs
22.8%
Results posted
May 2018
Primary outcomePrimary: Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE) — 326; 79 Participants
◆ Published Evidence
Highly cited
297citations · ~42 / year
Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma.
Summary
This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.
Linked Publications (2)
-
Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma.
-
Update on immunogenicity in severe asthma: Experience with mepolizumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE) |
326; 79 | — |
| SECONDARY Number of Participants Who Experienced On-treatment Systemic (i.e., Allergic/Immunoglobulin E [IgE]-Mediated and Non-allergic) and On-treatment Local Site Reactions |
9; 42 | — |
| SECONDARY Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B]) |
4.2; 3.2; -0.5; 1.3; 1.5; 1.6 | — |
| SECONDARY Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F]) |
5.1; 4.1; 0.2; 2.2; 3.2; 2.9 | — |
| SECONDARY Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B) |
0; 1; 31; 252; 55; 3 | — |
| SECONDARY Number of Participants With Clinical Chemistry Data of Potential Clinical Concern |
1; 1; 7 | — |
| SECONDARY Number of Participants With Hematology Data of Potential Clinical Concern |
1 | — |
| SECONDARY Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure |
-1.0; -1.5; -0.7; -1.6; -1.6; -0.7 | — |
| SECONDARY Mean Change From Baseline in Vital Signs-Sitting Pulse Rate |
-0.3; 1.0; 0.0; -0.1; -0.3; -1.6 | — |
| SECONDARY Annualized Rate of On-treatment Exacerbations |
0.68 | — |
| SECONDARY Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score |
-0.47; -0.55; -0.56; -0.55; -0.58; -0.51 | — |
| SECONDARY Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) |
124; 144; 98; 91; 51; 85 | — |
| SECONDARY Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb) |
27; 0 | — |
| SECONDARY Number of Participants Who Withdrew Due to Lack of Efficacy |
11 | — |
| SECONDARY Number of Participants Requiring Hospitalizations Due to Adverse Events Including Asthma Exacerbations |
71 | — |
| SECONDARY Number of Participants Who Withdrew Due to AE |
19 | — |
Eligibility Criteria
Inclusion Criteria
- Informed Consent.
- MEA112997 Study Participation: Received at least 2 doses of double-blind investigational product during the MEA112997 trial.
- MEA112997 Treatment Assignment: If the subject received mepolizumab, they must have had a positive risk: benefit ratio.
- Currently being treated with a controller medication and the subject has been on a controller medication for the past 12 weeks.
- Male or Eligible Female Subjects. To be eligible for entry into the study, females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control for the duration of the trial and for 4 months after the last study drug administration.
Exclusion Criteria
- Hypersensitivity related to mepolizumab.
- Clinically significant change in health status since completing participation in the MEA112997 trial.
- A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
- For those subjects who had a SAE in MEA112997 that was assessed as possibly related to mepolizumab by the investigator.
- Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnant during the time of study participation.
- Screening ECG which has a clinically significant abnormality.
- Received Xolair (omalizumab) within the past 130 days.
- Participated in a clinical trial within the past 30 days or have received investigational medication within five terminal half-lives of Screen Visit, whichever is longer.
- Current smokers.
Data sourced from ClinicalTrials.gov (NCT01691859) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.