18 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE)Primary· Baseline (Week 0) to Week 240
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly
AE
Group
Value
95% CI
Mepolizumab 100 mg
326
SAE
Group
Value
95% CI
Mepolizumab 100 mg
79
Number of Participants Who Experienced On-treatment Systemic (i.e., Allergic/Immunoglobulin E [IgE]-Mediated and Non-allergic) and On-treatment Local Site ReactionsSecondary· Baseline (Week 0) to Week 240
Systemic and local site reactions following mepolizumab dosing as identified by the investigator and the number of participants who experienced systemic and/or local site reactions are presented. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.
Systemic reactions
Group
Value
95% CI
Mepolizumab 100 mg
9
Local site reactions
Group
Value
95% CI
Mepolizumab 100 mg
42
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B])Secondary· Baseline (Week 0) to Week 240
Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Week 24, n=330
Group
Value
95% CI
Mepolizumab 100 mg
4.2
± 18.57
Week 48, n=319
Group
Value
95% CI
Mepolizumab 100 mg
3.2
± 17.19
Week 72, n=307
Group
Value
95% CI
Mepolizumab 100 mg
-0.5
± 16.76
Week 96, n=293
Group
Value
95% CI
Mepolizumab 100 mg
1.3
± 17.92
Week 124, n=292
Group
Value
95% CI
Mepolizumab 100 mg
1.5
± 19.69
Week 148, n=275
Group
Value
95% CI
Mepolizumab 100 mg
1.6
± 17.84
Week 176, n=201
Group
Value
95% CI
Mepolizumab 100 mg
0.6
± 18.02
Week 200, n=149
Group
Value
95% CI
Mepolizumab 100 mg
3.3
± 17.02
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F])Secondary· Baseline (Week 0) to Week 240
Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Week 24, n=330
Group
Value
95% CI
Mepolizumab 100 mg
5.1
± 17.00
Week 48, n=319
Group
Value
95% CI
Mepolizumab 100 mg
4.1
± 15.72
Week 72, n=307
Group
Value
95% CI
Mepolizumab 100 mg
0.2
± 15.11
Week 96, n=293
Group
Value
95% CI
Mepolizumab 100 mg
2.2
± 15.37
Week 124, n=292
Group
Value
95% CI
Mepolizumab 100 mg
3.2
± 16.77
Week 148, n=275
Group
Value
95% CI
Mepolizumab 100 mg
2.9
± 15.49
Week 176, n=201
Group
Value
95% CI
Mepolizumab 100 mg
2.0
± 15.97
Week 200, n=149
Group
Value
95% CI
Mepolizumab 100 mg
4.3
± 14.52
Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B)Secondary· Baseline (Week 0) to Week 240
Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Number of participants with a maximum change from Baseline for QTc(F) and QTc(B) at any time post Baseline are presented. Only those participants who provided ECG data at
QTc(F): < -60
Group
Value
95% CI
Mepolizumab 100 mg
0
QTc(F): >= -60 - < -30
Group
Value
95% CI
Mepolizumab 100 mg
1
QTc(F): >= -30 - < 0
Group
Value
95% CI
Mepolizumab 100 mg
31
QTc(F): >= 0 - < 30
Group
Value
95% CI
Mepolizumab 100 mg
252
QTc(F): >= 30 - < 60
Group
Value
95% CI
Mepolizumab 100 mg
55
QTc(F): >= 60
Group
Value
95% CI
Mepolizumab 100 mg
3
QTc(B): < -60
Group
Value
95% CI
Mepolizumab 100 mg
0
QTc(B): >= -60 - < -30
Group
Value
95% CI
Mepolizumab 100 mg
1
Number of Participants With Clinical Chemistry Data of Potential Clinical ConcernSecondary· Baseline (Week 0) to Week 240
Clinical chemistry analytes with laboratory ranges defining values of potential clinical concern included sodium, potassium, calcium, phosphate, serum glucose and alanine aminotransferase. Number of participants with clinical chemistry abnormalities of potential clinical concern anytime post baseline are presented. Only those participants who provided lab data post-baseline were analyzed represented by n=X in the category titles.
Potassium high, n=346
Group
Value
95% CI
Mepolizumab 100 mg
1
Serum glucose high, n=346
Group
Value
95% CI
Mepolizumab 100 mg
1
Serum glucose low, n=346
Group
Value
95% CI
Mepolizumab 100 mg
7
Number of Participants With Hematology Data of Potential Clinical ConcernSecondary· Baseline (Week 0) to Week 240
Hematology parameters with laboratory ranges defining values of potential clinical concern included hemoglobin, hematocrit, platelet count, white blood cell count. Number of participants with clinical hematology abnormalities of potential clinical concern anytime post baseline are presented, which only included participants with low hemoglobin values. Only those participants who provided lab data post-baseline were analyzed.
Group
Value
95% CI
Mepolizumab 100 mg
1
Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood PressureSecondary· Baseline (Week 0) to Week 240
Vital signs included sitting pulse rate and sitting blood pressure (diastolic and systolic). Measurements were done pre injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Sitting Diastolic Blood Pressure: Week 4, n=346
Group
Value
95% CI
Mepolizumab 100 mg
-1.0
± 8.71
Sitting Diastolic Blood Pressure: Week 8, n=345
Group
Value
95% CI
Mepolizumab 100 mg
-1.5
± 8.85
Sitting Diastolic Blood Pressure: Week 12, n=342
Group
Value
95% CI
Mepolizumab 100 mg
-0.7
± 9.67
Sitting Diastolic Blood Pressure: Week 16, n=341
Group
Value
95% CI
Mepolizumab 100 mg
-1.6
± 9.27
Sitting Diastolic Blood Pressure: Week 20, n=338
Group
Value
95% CI
Mepolizumab 100 mg
-1.6
± 9.17
Sitting Diastolic Blood Pressure: Week 24, n=336
Group
Value
95% CI
Mepolizumab 100 mg
-0.7
± 9.27
Sitting Diastolic Blood Pressure: Week 28, n=332
Group
Value
95% CI
Mepolizumab 100 mg
-1.3
± 8.90
Sitting Diastolic Blood Pressure: Week 32, n=333
Group
Value
95% CI
Mepolizumab 100 mg
-1.0
± 9.62
Mean Change From Baseline in Vital Signs-Sitting Pulse RateSecondary· Baseline (Week 0) to Week 240
Vital signs included sitting pulse rate and blood pressure (diastolic and systolic). Measurements were done pre injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Sitting Pulse Rate: Week 4, n=346
Group
Value
95% CI
Mepolizumab 100 mg
-0.3
± 8.94
Sitting Pulse Rate: Week 8, n=345
Group
Value
95% CI
Mepolizumab 100 mg
1.0
± 9.98
Sitting Pulse Rate: Week 12, n=342
Group
Value
95% CI
Mepolizumab 100 mg
0.0
± 9.52
Sitting Pulse Rate: Week 16, n=341
Group
Value
95% CI
Mepolizumab 100 mg
-0.1
± 10.08
Sitting Pulse Rate: Week 20, n=338
Group
Value
95% CI
Mepolizumab 100 mg
-0.3
± 9.44
Sitting Pulse Rate: Week 24, n=337
Group
Value
95% CI
Mepolizumab 100 mg
-1.6
± 9.83
Sitting Pulse Rate: Week 28, n=332
Group
Value
95% CI
Mepolizumab 100 mg
-0.2
± 9.58
Sitting Pulse Rate: Week 32, n=333
Group
Value
95% CI
Mepolizumab 100 mg
-0.2
± 9.74
Annualized Rate of On-treatment ExacerbationsSecondary· Baseline (Week 0) to Week 240
Exacerbations were defined as worsening of asthma which required use of systemic corticosteroids and/or hospitalization and/or Emergency Department visits. Data is presented as mean which is exacerbation rate/year. Exacerbation data are performed using a negative binomial model with covariates of region, annualized rate of exacerbations in the interval between MEA112997 and MEA115666 (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.
Group
Value
95% CI
Mepolizumab 100 mg
0.68
0.60 – 0.78
Mean Change From Baseline in Asthma Control Questionnaire (ACQ) ScoreSecondary· Baseline (Week 0) to Week 240
The ACQ-5 is a five-item questionnaire, which was developed as a measure of participant' asthma control that was completed by the participant. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze). The ACQ consists of 5 questions that are scored on a 7 point scale from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ score was derived as mean of five questions: ACQ score = Question 1 (Q1)+Q2+Q3+Q4+Q5 divided by 5 where Q1, Q2,... Q5 are the scores of Q1, Q2, ...
Week 12, n=341
Group
Value
95% CI
Mepolizumab 100 mg
-0.47
± 0.991
Week 24, n=335
Group
Value
95% CI
Mepolizumab 100 mg
-0.55
± 1.037
Week 36, n=327
Group
Value
95% CI
Mepolizumab 100 mg
-0.56
± 1.088
Week 48, n=324
Group
Value
95% CI
Mepolizumab 100 mg
-0.55
± 1.098
Week 60, n=317
Group
Value
95% CI
Mepolizumab 100 mg
-0.58
± 1.126
Week 72, n=311
Group
Value
95% CI
Mepolizumab 100 mg
-0.51
± 1.054
Week 84, n=308
Group
Value
95% CI
Mepolizumab 100 mg
-0.54
± 1.090
Week 96, n=301
Group
Value
95% CI
Mepolizumab 100 mg
-0.44
± 1.171
Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)Secondary· Baseline (Week 0) to Week 240
FEV1 is forced expiratory volume in the first second. The volume of air that can be forced out in one second after taking a deep breath, an important measure of pulmonary function. Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. FEV1 was measured by clinic spirometry. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Week 12, n=340
Group
Value
95% CI
Mepolizumab 100 mg
124
± 346.9
Week 24, n=334
Group
Value
95% CI
Mepolizumab 100 mg
144
± 335.0
Week 48, n=325
Group
Value
95% CI
Mepolizumab 100 mg
98
± 395.2
Week 72, n=312
Group
Value
95% CI
Mepolizumab 100 mg
91
± 405.5
Week 96, n=301
Group
Value
95% CI
Mepolizumab 100 mg
51
± 385.8
Week 124, n=292
Group
Value
95% CI
Mepolizumab 100 mg
85
± 395.5
Week 148, n=281
Group
Value
95% CI
Mepolizumab 100 mg
17
± 370.2
Week 176, n=210
Group
Value
95% CI
Mepolizumab 100 mg
45
± 352.2
Adverse events — posted to ClinicalTrials.gov
Time frame: The on-treatment AEs and on-treatment SAEs are the events which happened on/after the first dose of open label mepolizumab date and before/on last dose of mepolizumab date + 28 days (up to 240 weeks).
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Mepolizumab
Serious: 79/347 (23%)
Deaths: 6/347
Serious adverse events (87 terms)
Reaction
System
Mepolizumab
Asthma
Respiratory, thoracic and mediastinal disorders
—
Pneumonia
Infections and infestations
—
Cellulitis
Infections and infestations
—
Respiratory tract infection
Infections and infestations
—
Bursitis
Musculoskeletal and connective tissue disorders
—
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
—
Epilepsy
Nervous system disorders
—
Sciatica
Nervous system disorders
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06041386 — REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEcti
· Phase 4
· active not recruiting
NCT05923047 — Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.
· Phase 4
· unknown
NCT05642806 — Comparison of Immune Profiles in Chronic Rhinosinusitis Patients After Mepolizumab Treatment
· Phase 4
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 28 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01691859.