A Phase 3 interventional study of Mepolizumab and Placebo in Churg-Strauss Syndrome, sponsored by GlaxoSmithKline. Completed at 32 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
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Among 26 studies in Churg-Strauss Syndrome with a site in United States — 8 open to participants now, 12 under way, 4 of them phase 3. Churg-Strauss Syndrome · United States.
Among the 26 studies in Churg-Strauss Syndrome with a site in United States, this one is the 4th largest by enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2014, is one of 6 in phase 3, and was the 9th registered.
61 studies on the registry are indexed under Churg-Strauss Syndrome; 17 are open to participants now.
Browse Churg-Strauss Syndrome studies →8 of the 26 studies in Churg-Strauss Syndrome with a site in United States are open now. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Argentina, Austria and 11 more countries
Ages 6+
AstraZeneca · Sites in United States, Brazil, Canada and 7 more countries
Ages 6–17
Peter Merkel · Sites in United States, Canada
Ages 5+
University of Pennsylvania · Sites in United States, Canada
University of Pennsylvania · Sites in United States
Ages 18–50 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 14 Churg-Strauss Syndrome studies recruiting now, 11 (79%) set no upper age limit and 3 (21%) stop at 75 or younger; 7 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 6 · Phase 3 6
First in 2000; this study’s year is marked. 2 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 136 is above the median of 66 across 30 interventional studies indexed under Churg-Strauss Syndrome.
Median enrollment 60 across the 13 interventional studies, 467 across the 13 observational. Of the 12 that completed or were terminated, 4 (33%) have results posted.
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8 of 26 have an industry lead sponsor. The 10 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
GlaxoSmithKline has 6 studies filed under Churg-Strauss Syndrome — fewer than ten, so there is no comparison to draw.
1 of the studies in Churg-Strauss Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06046222NS Pharma, Inc.Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis | 2026-12 |
Add it to your calendar (.ics) → With an account.
Among the 26 studies in Churg-Strauss Syndrome with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram [mg] administered subcutaneously [SC] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject must have a past history of at least one confirmed EGPA relapse (i.e., requiring increase in oral (OCS) dose, initiation/increased dose of therapy or hospitalisation) within the past 2 years which occurred at least 12 weeks prior to Screening (Visit 1) whilst receiving a dose of prednisolone (or equivalent) of >=7.5 milligram per day (mg/day). Refractory disease: Either: Failure to attain remission (BVAS=0 and OCS dose \<=7.5 mg/day prednisolone or equivalent) within the last 6 months following induction treatment with a standard regimen, administered for at least 3 months. Note: a) Subjects who have received a cyclophosphamide (CYC) induction regimen may be included a minimum of 2 weeks after the last dose of daily oral CYC, or 3 weeks after the last dose of pulsed intravenous CYC prior to Baseline (Visit 2), if their total white blood cells (WBC) is >=4x10\^9/Liter (tested at the local laboratory, if necessary) prior to randomisation. b) Subjects who have received a methotrexate, azathioprine, or mycophenolate mofetil induction regimen may be included if on a stable dose for at least 4 weeks prior to Baseline (Visit 2). c) Subjects who have received an induction regimen comprising corticosteroids alone may be included only if they have failed to attain remission after 3 months of treatment AND the corticosteroid dose is >=15 mg/day prednisolone or equivalent for the 4 weeks prior to Baseline (Visit 2). Or: Within 6 months prior to Screening (Visit 1), recurrence of symptoms of EGPA (not necessarily meeting the protocol definition of relapse) whilst tapering OCS, occurring at any dose level >=7.5 mg/day prednisolone or equivalent.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each subject will receive mepolizumab 300 mg subcutaneous (SC) injection every 4 weeks (13 administrations) along with standard care. It will be administered as 3 separate injections (100 mg each- total dose 300 mg); individual injection sites will be separated by at least 5 cm. It will be administered into any of the upper arm, thigh or anterior abdominal wall.
Biological: Mepolizumab
Each subject will receive placebo (0.9% sodium chloride) SC injection every 4 weeks (13 administrations) along with standard care. It will be administered as 3 separate injections; individual injection sites will be separated by at least 5 cm. It will be administered into any of the upper arm, thigh or anterior abdominal wall.
Drug: Placebo
Mepolizumab will be provided as a lyophilized cake in sterile vials for individual use to be reconstituted with sterile water for Injection, just prior to use.
Placebo will be available as 0.9% sodium chloride
Number of Participants in Each Category of Accrued Duration of Remission
Total accrued duration of remission is the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose \<=4 mg/day over the 52 week study treatment period was reported. The accrued duration was categorized into zero, \>0 to \<12 weeks, 12 to \<24 weeks, 24 to \<36 weeks and \>=36 weeks. Statistical analysis was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. Intent-to-Treat (ITT) Population was used for the analysis and was defined as all participants who were randomized and received at least one dose of trial medication. Randomized participants were assumed to have received study treatment unless definitive evidence to the contrary exists. The odds ratio for treatment difference and associated probability (p)-value and 95 percent confidence interval (CI) were calculated.
Time frame: Up to Week 52
Number of Participants Who Are in Remission at 36 and 48 Weeks
The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=4 mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Time frame: Week 36 and Week 48
Time to First EGPA Relapse
EGPA relapse was defined as worsening or persistence of active disease since the last visit characterized by active vasculitis or active asthma symptoms and/or signs with a corresponding worsening in Asthma Control Questionnaire-6 (ACQ-6) score or active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions warranting: i) an increased dose of OCS therapy (or other systemic corticosteroid therapy) to \>4 mg/day prednisolone total daily dose or equivalent; OR ii) an increased dose or addition of immunosuppressive therapy; OR iii) hospitalization related to EGPA worsening. Participants who completed study, or withdrawn prematurely from the study without experiencing the event were censored. The number of participants with at least one EGPA relapse during the planned study treatment period are presented.
Time frame: Up to Week 52
Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.
The number of participants with an average daily prednisolone/prednisone dose during the last 4 weeks of the Study Treatment Period (48 through 52) was calculated. The average dose was categorized into zero, \>0 to \<=4.0mg, \>4.0 to \<=7.5mg and \>7.5mg. The statistical analysis was performed using a proportional odds regression model with Baseline covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region and the comparison between treatment groups was presented as an odds ratio, p-value and 95 percent CI.
Time frame: Week 48 and Week52
Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period
The number of participants who achieved remission (i.e., BVAS=0 and prednisolone/prednisone\<=4 mg/day) within the first 24 weeks and remain in remission for the remainder of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Time frame: Up to Week 52
Number of Participants in Each Category of Accrued Duration of Remission
Total accrued duration of remission, i.e., the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose \<=7.5mg/day over the 52 week study treatment period was reported. BVAS is a validated, clinician-completed tool used for the comprehensive multisystem clinical assessment of disease activity in systemic vasculitis. The duration was categorized into zero, \>0 to \<12 weeks, 12 to \<24 weeks, 24 to \<36 weeks and \>=36 weeks. Statistical analysis was performed on ITT Population and was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Time frame: Up to Week 52
Number of Participants Who Are in Remission at 36 and 48 Weeks
The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Time frame: Week 36 and Week 48
Number of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period
The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
Time frame: Up to Week 52
Number of Participants With Local and Systemic Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included Facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on Safety Population which comprised of all participants who receive at least one dose of study treatment.
Time frame: Up to Week 52
Change From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) Levels
Blood samples were collected to evaluate change from Baseline in ALT, Alk.phosph., AST, creatinine kinase, GGT and lactate dehydro values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time frame: Baseline and up to Week 60
Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels
Blood samples were collected to evaluate change from Baseline in albumin and protein levels values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time frame: Baseline and up to Week 60
Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels
Blood samples were collected to evaluate change from Baseline in direct, indirect and total bilirubin and creatinine values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time frame: Baseline and up to Week 60
Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol Levels
Blood samples were collected to evaluate change from Baseline in calcium, chloride, cholesterol, glucose, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, phosphorus, potassium, sodium, urea nitrogen and very low density lipoprotein (VLDL) cholesterol values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured. NA indicates that data were not available.
Time frame: Baseline and up to Week 60
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Blood samples were collected to evaluate change from Baseline in troponin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time frame: Baseline and up to Week 60
Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels
Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelet values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time frame: Baseline and up to Week 60
Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels
Blood samples were collected to evaluate change from Baseline in MCHC and hemoglobin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time frame: Baseline and up to Week 60
Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels
Blood samples were collected to evaluate change from Baseline in MCV values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time frame: Baseline and up to Week 60
Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels
Blood samples were collected to evaluate change from Baseline in MCH values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time frame: Baseline and up to Week 60
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Blood samples were collected to evaluate change from Baseline in erythrocytes values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time frame: Baseline and up to Week 60
Number of Participants With Anti-Mepolizumab Antibodies
Blood samples were collected for the determination of anti-Mepolizumab antibodies. Participants who showed presence of anti-Mepolizumab antibody were termed as 'positive' and those who did not have anti-Mepolizumab antibody in blood sample were termed as 'negative'. Participants who did not have a positive ADA assay prior to the first dose of investigational product were included in the analysis.
Time frame: Up to Week 60
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels
SBP and DBP were measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time frame: Baseline up to Week 60
Change From Baseline in Pulse Rate
Pulse rate was measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time frame: Baseline and up to Week 60
Change From Baseline in Body Temperature
Body temperature was measured from Baseline throughout follow-up (till Week 60). The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. The analysis was performed on Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
Time frame: Baseline and up to Week 60
Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values
Single measurements of 12-lead electrocardiogram (ECGs) were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Mean change from Baseline in QTcF and QTcB values were measured. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to Week 60
Maximum Change From Baseline in QTcF and QTcB Values
Single measurements of 12-lead ECGs were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Maximum change from Baseline in QTcF and QTcB values were measured.
Time frame: Baseline and up to Week 60
Eligible participants at screening and run-in visit, entered a 52 week study treatment phase followed by 8-week follow-up phase. The total duration for the study participation was approximately 64 weeks.
| Milestone | Placebo | Mepolizumab 300mg |
|---|---|---|
| Started | 68 | 68 |
| Completed | 61 | 65 |
| Not completed | 7 | 3 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Withdrawal by subject | 3 | 2 |
Total accrued duration of remission is the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose \<=4 mg/day over the 52 week study treatment period was reported. The accrued duration was categorized into zero, \>0 to \<12 weeks, 12 to \<24 weeks, 24 to \<36 weeks and \>=36 weeks. Statistical analysis was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. Intent-to-Treat (ITT) Population was used for the analysis and was defined as all participants who were randomized and received at least one dose of trial medication. Randomized participants were assumed to have received study treatment unless definitive evidence to the contrary exists. The odds ratio for treatment difference and associated probability (p)-value and 95 percent confidence interval (CI) were calculated.
| Participants | Placebo | Mepolizumab 300mg |
|---|---|---|
| Zero | 55 | 32 |
| >0 to <12 weeks | 8 | 8 |
| 12 to <24 weeks | 3 | 9 |
| 24 to <36 weeks | 0 | 10 |
| >=36 weeks | 2 | 9 |
The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=4 mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
| Participants | Placebo | Mepolizumab 300mg |
|---|---|---|
| Number of Participants Who Are in Remission at 36 and 48 Weeks | 2 | 22 |
EGPA relapse was defined as worsening or persistence of active disease since the last visit characterized by active vasculitis or active asthma symptoms and/or signs with a corresponding worsening in Asthma Control Questionnaire-6 (ACQ-6) score or active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions warranting: i) an increased dose of OCS therapy (or other systemic corticosteroid therapy) to \>4 mg/day prednisolone total daily dose or equivalent; OR ii) an increased dose or addition of immunosuppressive therapy; OR iii) hospitalization related to EGPA worsening. Participants who completed study, or withdrawn prematurely from the study without experiencing the event were censored. The number of participants with at least one EGPA relapse during the planned study treatment period are presented.
| Participants | Placebo | Mepolizumab 300mg |
|---|---|---|
| Time to First EGPA Relapse | 56 | 38 |
The number of participants with an average daily prednisolone/prednisone dose during the last 4 weeks of the Study Treatment Period (48 through 52) was calculated. The average dose was categorized into zero, \>0 to \<=4.0mg, \>4.0 to \<=7.5mg and \>7.5mg. The statistical analysis was performed using a proportional odds regression model with Baseline covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region and the comparison between treatment groups was presented as an odds ratio, p-value and 95 percent CI.
| Participants | Placebo | Mepolizumab 300mg |
|---|---|---|
| Zero | 2 | 12 |
| >0 to <=4.0mg | 3 | 18 |
| >4.0 to <=7.5mg | 18 | 10 |
| >7.5mg | 45 | 28 |
The number of participants who achieved remission (i.e., BVAS=0 and prednisolone/prednisone\<=4 mg/day) within the first 24 weeks and remain in remission for the remainder of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
| Participants | Placebo | Mepolizumab 300mg |
|---|---|---|
| Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period | 1 | 13 |
Total accrued duration of remission, i.e., the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose \<=7.5mg/day over the 52 week study treatment period was reported. BVAS is a validated, clinician-completed tool used for the comprehensive multisystem clinical assessment of disease activity in systemic vasculitis. The duration was categorized into zero, \>0 to \<12 weeks, 12 to \<24 weeks, 24 to \<36 weeks and \>=36 weeks. Statistical analysis was performed on ITT Population and was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
| Participants | Placebo | Mepolizumab 300mg |
|---|---|---|
| Zero | 36 | 15 |
| >0 to <12 weeks | 19 | 15 |
| 12 to <24 weeks | 0 | 7 |
| 24 to <36 weeks | 7 | 9 |
| >=36 weeks | 6 | 22 |
The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
| Participants | Placebo | Mepolizumab 300mg |
|---|---|---|
| Number of Participants Who Are in Remission at 36 and 48 Weeks | 7 | 28 |
The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone \<=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.
| Participants | Placebo | Mepolizumab 300mg |
|---|---|---|
| Number of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period | 2 | 16 |
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included Facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on Safety Population which comprised of all participants who receive at least one dose of study treatment.
| Participants | Placebo | Mepolizumab 300mg |
|---|---|---|
| Facial paralysis | 1 | 0 |
| Flushing | 0 | 1 |
| Hypersensitivity | 0 | 1 |
| Rash pruritic | 0 | 1 |
| Injection related reactions | 0 | 1 |
| Injection site bruising | 0 | 1 |
| Injection site erythema | 1 | 1 |
| Injection site pain | 1 | 0 |
| Injection site reaction | 7 | 9 |
Blood samples were collected to evaluate change from Baseline in ALT, Alk.phosph., AST, creatinine kinase, GGT and lactate dehydro values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
| International Unit per Liter (IU/L) | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute ALT; Baseline; n= 68, 68 | 19.9 ± 8.91 | 21.3 ± 14.22 |
| ALT; Week 4; n= 68, 68 | 0.2 ± 6.17 | -2.2 ± 8.59 |
| ALT; Week 8; n= 67, 66 | -0.9 ± 5.66 | -1.7 ± 10.14 |
| ALT; Week 12; n= 65, 68 | -0.9 ± 4.53 | -0.7 ± 12.65 |
| ALT; Week 16; n= 65, 68 | -0.4 ± 6.56 | -2.2 ± 9.73 |
| ALT; Week 20; n= 63, 68 | -0.3 ± 6.25 | -1.2 ± 12.30 |
| ALT; Week 24; n= 63, 66 | -1.3 ± 5.38 | -0.2 ± 15.77 |
| ALT; Week 28; n= 62, 66 | -0.9 ± 6.73 | -0.4 ± 13.62 |
| ALT; Week 32; n= 61, 67 | -0.7 ± 6.79 | -2.4 ± 11.30 |
| ALT; Week 36; n= 60, 67 | -0.1 ± 6.21 | -3.0 ± 11.66 |
| ALT; Week 40; n= 61, 66 | 0.3 ± 9.01 | -2.3 ± 11.70 |
| ALT; Week 44; n= 61, 66 | 0.9 ± 9.68 | -2.7 ± 9.51 |
| ALT; Week 48; n= 61, 64 | 1.7 ± 9.04 | -1.6 ± 15.47 |
| ALT; Week 52; n= 60, 65 | 1.5 ± 10.42 | -2.8 ± 12.87 |
| ALT; Week 56; n= 61, 63 | -0.1 ± 7.35 | -3.6 ± 12.79 |
| ALT; Week 60; n= 60, 65 | -0.3 ± 7.33 | -4.7 ± 14.11 |
| Absolute Alk.phosph.; Baseline; n= 68, 68 | 61.2 ± 17.83 | 60.4 ± 20.90 |
| Alk.phosph.; Week 4; n= 68, 68 | -0.9 ± 6.65 | -3.2 ± 10.01 |
| Alk.phosph.; Week 8; n= 67, 66 | -1.7 ± 9.95 | -1.7 ± 11.56 |
| Alk. phosph.; Week 12; n= 65, 68 | -1.9 ± 8.36 | -1.1 ± 12.99 |
| Alk. phosph.; Week 16; n= 65, 68 | -1.3 ± 9.35 | -1.1 ± 14.61 |
| Alk. phosph.; Week 20; n= 63, 68 | 0.0 ± 11.24 | 4.4 ± 21.90 |
| Alk. phosph.; Week 24; n= 63, 66 | -1.1 ± 10.65 | 2.8 ± 17.64 |
| Alk. phosph.; Week 28; n= 62, 66 | 0.2 ± 10.95 | 4.9 ± 17.17 |
| Alk. phosph.; Week 32; n= 61, 67 | 0.2 ± 11.14 | 4.4 ± 15.83 |
| Alk. phosph.; Week 36; n= 60, 67 | 0.2 ± 10.42 | 4.8 ± 14.71 |
| Alk. phosph.; Week 40; n= 61, 66 | 1.0 ± 10.08 | 6.2 ± 18.43 |
| Alk. phosph.; Week 44; n= 61, 66 | 1.1 ± 12.55 | 5.1 ± 16.53 |
| Alk. phosph.; Week 48; n= 61, 64 | 1.2 ± 11.66 | 5.1 ± 17.56 |
| Alk. phosph.; Week 52; n= 60, 65 | 0.3 ± 12.30 | 2.3 ± 14.47 |
| Alk. phosph.; Week 56; n= 61, 63 | -0.9 ± 12.04 | 1.7 ± 16.42 |
| Alk. phosph.; Week 60; n= 60, 65 | -1.5 ± 13.16 | 1.0 ± 15.08 |
| Absolute AST; Baseline; n= 68, 68 | 19.3 ± 6.11 | 21.8 ± 10.73 |
| AST; Week 4; n= 68, 68 | 0.0 ± 4.41 | -1.7 ± 8.61 |
| AST; Week 8; n= 67, 66 | -0.4 ± 4.77 | -1.0 ± 8.21 |
| AST; Week 12; n= 65, 68 | 0.5 ± 4.41 | -0.7 ± 9.62 |
| AST; Week 16; n= 65, 68 | 0.4 ± 5.48 | -0.6 ± 7.90 |
| AST; Week 20; n= 63, 68 | 0.8 ± 4.66 | -0.6 ± 8.49 |
| AST; Week 24; n= 63, 66 | 0.0 ± 4.46 | -0.4 ± 10.44 |
| AST; Week 28; n= 61, 66 | -0.9 ± 5.34 | -0.4 ± 10.59 |
| AST; Week 32; n= 61, 67 | -0.2 ± 4.91 | -1.3 ± 10.67 |
| AST; Week 36; n= 60, 67 | 0.2 ± 4.68 | -2.2 ± 9.61 |
| AST; Week 40; n= 61, 66 | 0.5 ± 5.51 | -1.6 ± 8.97 |
| AST; Week 44; n= 61, 66 | 0.4 ± 5.77 | -2.4 ± 9.02 |
| AST; Week 48; n= 61, 64 | 1.1 ± 6.86 | -2.3 ± 10.14 |
| AST; Week 52; n= 60, 65 | 0.9 ± 6.84 | -3.0 ± 10.49 |
| AST; Week 56; n= 61, 63 | -0.2 ± 4.92 | -2.8 ± 10.64 |
| AST; Week 60; n= 60, 65 | -0.4 ± 5.24 | -3.7 ± 10.92 |
| Absolute Creatinine kinase; Baseline; n= 68, 68 | 99.0 ± 75.99 | 88.8 ± 75.18 |
| Creatinine kinase; Week 4; n= 68, 68 | -2.4 ± 83.23 | 2.0 ± 60.92 |
| Creatinine kinase; Week 8; n= 67, 66 | -5.0 ± 62.41 | 3.5 ± 50.48 |
| Creatinine kinase; Week 12; n= 65, 68 | 5.4 ± 93.24 | 6.1 ± 40.86 |
| Creatinine kinase; Week 16; n= 65, 68 | 15.8 ± 125.84 | 0.5 ± 49.65 |
| Creatinine kinase; Week 20; n= 63, 68 | 1.3 ± 78.35 | 6.5 ± 54.83 |
| Creatinine kinase; Week 24; n= 63, 66 | -0.6 ± 56.55 | 6.0 ± 66.69 |
| Creatinine kinase; Week 28; n= 62, 66 | -15.9 ± 59.38 | 6.3 ± 55.84 |
| Creatinine kinase; Week 32; n= 61, 67 | -13.1 ± 59.29 | 0.2 ± 49.68 |
| Creatinine kinase; Week 36; n= 60, 67 | -12.0 ± 65.11 | 4.9 ± 52.71 |
| Creatinine kinase; Week 40; n= 61, 66 | 2.6 ± 91.89 | 2.8 ± 62.74 |
| Creatinine kinase; Week 44; n= 61, 66 | 5.8 ± 86.76 | -2.4 ± 62.13 |
| Creatinine kinase; Week 48; n= 61, 64 | -8.1 ± 70.09 | -2.6 ± 90.09 |
| Creatinine kinase; Week 52; n= 60, 65 | 0.9 ± 67.51 | 0.2 ± 53.45 |
| Creatinine kinase; Week 56; n= 61, 63 | -8.7 ± 60.58 | -0.2 ± 62.08 |
| Creatinine kinase; Week 60; n= 60, 65 | -10.3 ± 65.83 | 0.4 ± 61.45 |
| Absolute GGT; Baseline; n= 68, 68 | 30.8 ± 25.49 | 30.1 ± 27.24 |
| GGT; Week 4; n= 68, 68 | 0.2 ± 11.70 | -2.0 ± 9.68 |
| GGT; Week 8; n= 67, 66 | -1.0 ± 8.59 | -0.6 ± 17.99 |
| GGT; Week 12; n= 65, 68 | -2.9 ± 6.68 | -1.9 ± 18.70 |
| GGT; Week 16; n= 65, 68 | -2.1 ± 10.18 | -1.5 ± 21.36 |
| GGT; Week 20; n= 63, 68 | 1.7 ± 19.02 | -1.1 ± 24.50 |
| GGT; Week 24; n= 63, 66 | -1.7 ± 11.83 | -3.3 ± 22.52 |
| GGT; Week 28; n= 62, 66 | -1.9 ± 11.71 | -3.1 ± 16.86 |
| GGT; Week 32; n= 61, 67 | -1.5 ± 15.77 | -3.6 ± 17.87 |
| GGT; Week 36; n= 60, 67 | -2.1 ± 10.64 | -4.7 ± 14.96 |
| GGT; Week 40; n= 61, 66 | -0.2 ± 16.05 | -0.3 ± 19.75 |
| GGT; Week 44; n= 61, 66 | -2.9 ± 8.26 | -2.7 ± 15.25 |
| GGT; Week 48; n= 61, 64 | 0.9 ± 18.91 | -3.0 ± 16.51 |
| GGT; Week 52; n= 60, 65 | -1.6 ± 16.44 | -4.2 ± 13.53 |
| GGT; Week 56; n= 61, 63 | -5.0 ± 16.77 | -3.6 ± 17.02 |
| GGT; Week 60; n= 60, 65 | -4.8 ± 16.45 | -5.6 ± 15.37 |
| Absolute Lactate dehydro; Baseline; n= 68, 68 | 186.5 ± 47.82 | 179.6 ± 38.88 |
| Lactate dehydro; Week 4; n= 68, 68 | -3.6 ± 19.73 | -2.3 ± 27.80 |
| Lactate dehydro; Week 8; n= 67, 66 | -8.2 ± 29.91 | -5.3 ± 24.46 |
| Lactate dehydro; Week 12; n= 65, 68 | -2.2 ± 27.17 | -7.7 ± 25.56 |
| Lactate dehydro; Week 16; n= 65, 68 | -2.6 ± 32.13 | -10.6 ± 26.12 |
| Lactate dehydro; Week 20; n= 63, 68 | 2.2 ± 26.80 | -13.7 ± 25.79 |
| Lactate dehydro; Week 24; n= 63, 66 | -4.3 ± 26.22 | -13.5 ± 26.99 |
| Lactate dehydro; Week 28; n= 61, 66 | -8.5 ± 27.77 | -15.9 ± 30.44 |
| Lactate dehydro; Week 32; n= 61, 67 | -8.3 ± 25.49 | -17.1 ± 24.88 |
| Lactate dehydro; Week 36; n= 60, 67 | -3.6 ± 36.45 | -16.2 ± 30.54 |
| Lactate dehydro; Week 40; n= 61, 66 | -4.5 ± 35.81 | -13.5 ± 36.31 |
| Lactate dehydro; Week 44; n= 61, 66 | -2.7 ± 33.40 | -17.0 ± 31.37 |
| Lactate dehydro; Week 48; n= 61, 64 | 0.8 ± 43.82 | -19.0 ± 30.66 |
| Lactate dehydro; Week 52; n= 60, 65 | -0.1 ± 34.99 | -17.8 ± 33.45 |
| Lactate dehydro; Week 56; n= 61, 63 | -5.2 ± 32.69 | -16.0 ± 30.87 |
| Lactate dehydro; Week 60; n= 60, 65 | -3.5 ± 34.15 | -12.4 ± 33.23 |
Blood samples were collected to evaluate change from Baseline in albumin and protein levels values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
| gram per liter (g/L) | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute Albumin; Baseline; n= 68, 68 | 43.4 ± 2.45 | 43.5 ± 3.01 |
| Albumin; Week 4; n= 68, 68 | -0.6 ± 2.25 | -0.1 ± 2.16 |
| Albumin; Week 8; n= 67, 66 | -0.8 ± 2.16 | -0.6 ± 2.72 |
| Albumin; Week 12; n= 65, 68 | -0.2 ± 2.47 | -0.4 ± 2.64 |
| Albumin; Week 16; n= 65, 68 | -0.6 ± 2.57 | -0.6 ± 2.54 |
| Albumin; Week 20; n= 63, 68 | -0.1 ± 2.35 | -0.2 ± 2.92 |
| Albumin; Week 24; n= 63, 66 | 0.0 ± 2.80 | 0.1 ± 2.72 |
| Albumin; Week 28; n= 62, 66 | -0.2 ± 2.67 | 0.1 ± 2.67 |
| Albumin; Week 32; n= 61, 67 | -0.4 ± 2.71 | -0.1 ± 2.69 |
| Albumin; Week 36; n= 60, 67 | -0.1 ± 2.58 | 0.3 ± 3.01 |
| Albumin; Week 40; n= 61, 66 | -0.2 ± 2.98 | 0.2 ± 2.82 |
| Albumin; Week 44; n= 61, 66 | 0.3 ± 2.95 | -0.3 ± 2.87 |
| Albumin; Week 48; n= 61, 64 | -0.4 ± 2.74 | -0.3 ± 2.77 |
| Albumin; Week 52; n= 60, 65 | -0.5 ± 2.45 | -0.3 ± 3.10 |
| Albumin; Week 56; n= 61, 63 | -0.7 ± 2.84 | -0.5 ± 2.88 |
| Albumin; Week 60; n= 60, 65 | -0.9 ± 2.55 | -0.7 ± 3.04 |
| Absolute Protein; Baseline; n= 68, 68 | 67.7 ± 4.26 | 67.3 ± 4.46 |
| Protein; Week 4; n= 68, 68 | -0.8 ± 3.00 | -0.5 ± 3.19 |
| Protein; Week 8; n= 67, 66 | -1.5 ± 2.97 | -0.9 ± 3.60 |
| Protein; Week 12; n= 65, 68 | -0.6 ± 3.57 | -0.6 ± 3.30 |
| Protein; Week 16; n= 65, 68 | -0.3 ± 3.56 | -0.8 ± 3.93 |
| Protein; Week 20; n= 63, 68 | 0.0 ± 3.21 | 0.1 ± 4.28 |
| Protein; Week 24; n= 63, 66 | 0.2 ± 3.99 | 0.0 ± 3.96 |
| Protein; Week 28; n= 62, 66 | -0.2 ± 4.13 | -0.1 ± 3.59 |
| Protein; Week 32; n= 61, 67 | -0.5 ± 4.09 | -0.4 ± 3.91 |
| Protein; Week 36; n= 60, 67 | -0.2 ± 3.82 | 0.2 ± 4.45 |
| Protein; Week 40; n= 61, 66 | -0.4 ± 3.48 | 0.1 ± 3.98 |
| Protein; Week 44; n= 61, 66 | 0.4 ± 4.43 | -0.6 ± 4.19 |
| Protein; Week 48; n= 61, 64 | -0.5 ± 3.94 | -0.5 ± 4.29 |
| Protein; Week 52; n= 60, 65 | -0.3 ± 3.75 | -0.4 ± 4.08 |
| Protein; week 56; n= 61, 63 | -0.1 ± 4.77 | -0.5 ± 4.21 |
| Protein; Week 60; n= 60, 65 | -0.4 ± 5.88 | -0.7 ± 4.17 |
Blood samples were collected to evaluate change from Baseline in direct, indirect and total bilirubin and creatinine values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
| micromole per liter (µmol/L) | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute Total bilirubin; Baseline; n= 68, 68 | 9.8 ± 6.14 | 8.8 ± 4.10 |
| Total bilirubin; week 4; n= 68, 68 | -0.9 ± 4.02 | 0.1 ± 3.48 |
| Total bilirubin; Week 8; n= 67, 66 | -1.2 ± 4.38 | 0.0 ± 3.50 |
| Total bilirubin; Week 12; n= 65, 68 | -0.3 ± 3.01 | 0.1 ± 3.27 |
| Total bilirubin; Week 16; n= 65, 68 | -1.1 ± 4.15 | 0.0 ± 4.14 |
| Total bilirubin; Week 20; n= 63, 68 | -0.5 ± 2.90 | 0.3 ± 3.57 |
| Total bilirubin; Week 24; n= 63, 66 | -0.3 ± 3.36 | 0.0 ± 2.71 |
| Total bilirubin; Week 28; n= 62, 66 | -0.8 ± 3.13 | 0.3 ± 4.43 |
| Total bilirubin; Week 32; n= 61, 67 | -1.1 ± 3.07 | -0.1 ± 3.63 |
| Total bilirubin; Week 36; n= 60, 67 | -0.7 ± 3.39 | 0.1 ± 4.09 |
| Total bilirubin; Week 40; n= 61, 66 | -0.2 ± 3.22 | -0.3 ± 3.78 |
| Total bilirubin; Week 44; n= 61, 66 | 0.0 ± 2.50 | 0.1 ± 3.64 |
| Total bilirubin; Week 48; n= 61, 64 | -0.2 ± 2.59 | -0.1 ± 3.77 |
| Total bilirubin; Week 52; n= 60, 65 | -0.1 ± 3.41 | 0.7 ± 3.92 |
| Total bilirubin; Week 56; n= 61, 63 | -0.8 ± 3.17 | 0.5 ± 3.24 |
| Total bilirubin; Week 60; n= 60, 65 | -0.5 ± 3.21 | 0.0 ± 3.42 |
| Absolute Creatinine; Baseline; n= 68, 68 | 75.49 ± 12.878 | 73.00 ± 12.289 |
| Creatinine; Week 4; n= 68, 68 | 0.69 ± 7.195 | 2.09 ± 5.533 |
| Creatinine; Week 8; n= 67, 66 | 1.87 ± 7.505 | 1.15 ± 6.737 |
| Creatinine; Week 12; n= 65, 68 | 1.50 ± 9.029 | 0.34 ± 7.006 |
| Creatinine; Week 16; n= 65, 68 | 1.53 ± 10.012 | 2.72 ± 6.702 |
| Creatinine; Week 20; n= 63, 68 | 1.73 ± 6.916 | 2.60 ± 7.739 |
| Creatinine; Week 24; n= 63, 66 | 0.74 ± 7.775 | 0.06 ± 6.538 |
| Creatinine; Week 28; n= 62, 66 | 0.96 ± 7.504 | 1.02 ± 7.764 |
| Creatinine; Week 32; n= 61, 67 | 1.89 ± 9.809 | 1.85 ± 8.589 |
| Creatinine; Week 36; n= 60, 67 | 1.42 ± 6.957 | 0.40 ± 7.839 |
| Creatinine; Week 40; n= 61, 66 | 1.16 ± 8.253 | 0.34 ± 8.119 |
| Creatinine; Week 44; n= 61, 66 | 2.14 ± 8.991 | 0.04 ± 9.070 |
| Creatinine; Week 48; n= 61, 64 | 1.53 ± 7.972 | -2.25 ± 7.398 |
| Creatinine; Week 52; n= 60, 65 | 0.52 ± 7.719 | -1.35 ± 7.182 |
| Creatinine; Week 56; n= 61, 63 | 1.39 ± 7.367 | -0.30 ± 8.695 |
| Creatinine; Week 60; n= 60, 65 | 0.34 ± 7.014 | -1.22 ± 10.896 |
| Absolute Direct bilirubin; Baseline; n= 68, 68 | 2.1 ± 1.33 | 1.9 ± 0.98 |
| Direct bilirubin; Week 4; n= 68, 68 | 0.0 ± 1.06 | 0.0 ± 0.84 |
| Direct bilirubin; Week 8; n= 67, 66 | 0.0 ± 1.01 | 0.1 ± 0.96 |
| Direct bilirubin; Week 12; n= 65, 68 | 0.0 ± 0.97 | 0.0 ± 1.04 |
| Direct bilirubin; Week 16; n= 65, 68 | -0.2 ± 0.96 | -0.1 ± 1.20 |
| Direct bilirubin; Week 20; n= 63, 68 | 0.0 ± 0.86 | 0.1 ± 1.03 |
| Direct bilirubin; Week 24; n= 63, 66 | 0.1 ± 0.90 | 0.0 ± 0.88 |
| Direct bilirubin; Week 28; n= 62, 66 | -0.1 ± 1.20 | 0.2 ± 1.15 |
| Direct bilirubin; Week 32; n= 61, 67 | -0.2 ± 0.99 | 0.1 ± 0.99 |
| Direct bilirubin; Week 36; n= 60, 67 | -0.1 ± 1.11 | 0.1 ± 1.17 |
| Direct bilirubin; Week 40; n= 61, 66 | 0.0 ± 1.11 | 0.0 ± 0.94 |
| Direct bilirubin; Week 44; n= 61, 66 | 0.1 ± 0.93 | 0.0 ± 1.12 |
| Direct bilirubin; Week 48; n= 61, 64 | 0.1 ± 0.99 | 0.0 ± 1.17 |
| Direct bilirubin; Week 52; n= 60, 65 | 0.1 ± 1.05 | 0.2 ± 1.06 |
| Direct bilirubin; Week 56; n= 61, 63 | 0.1 ± 1.08 | 0.1 ± 1.06 |
| Direct bilirubin; Week 60; n= 60, 65 | 0.1 ± 1.10 | 0.1 ± 1.07 |
| Absolute Indirect bilirubin; Baseline; n= 68, 68 | 7.7 ± 5.09 | 6.9 ± 3.38 |
| Indirect bilirubin; Week 4; n= 68, 68 | -0.8 ± 3.68 | 0.0 ± 3.06 |
| Indirect bilirubin; Week 8; n= 67, 66 | -1.2 ± 3.86 | -0.1 ± 2.94 |
| Indirect bilirubin; Week 12; n= 65, 68 | -0.3 ± 2.61 | 0.1 ± 2.79 |
| Indirect bilirubin; Week 16; n= 65, 68 | -0.9 ± 3.67 | 0.1 ± 3.37 |
| Indirect bilirubin; Week 20; n= 63, 68 | -0.5 ± 2.37 | 0.2 ± 3.00 |
| Indirect bilirubin; Week 24; n= 63, 66 | -0.4 ± 2.94 | 0.0 ± 2.37 |
| Indirect bilirubin; Week 28; n= 62, 66 | -0.7 ± 2.60 | 0.1 ± 3.71 |
| Indirect bilirubin; Week 32; n= 61, 66 | -0.9 ± 2.48 | -0.2 ± 3.02 |
| Indirect bilirubin; Week 36; n= 60, 67 | -0.6 ± 2.77 | 0.0 ± 3.30 |
| Indirect bilirubin; Week 40; n= 61, 66 | -0.1 ± 2.56 | -0.2 ± 3.16 |
| Indirect bilirubin; Week 44; n= 61, 66 | -0.1 ± 2.19 | 0.1 ± 2.99 |
| Indirect bilirubin; Week 48; n= 61, 64 | -0.3 ± 2.19 | -0.1 ± 3.13 |
| Indirect bilirubin; Week 52; n= 60, 65 | -0.2 ± 2.84 | 0.5 ± 3.32 |
| Indirect bilirubin; Week 56; n= 61, 63 | -0.9 ± 2.72 | 0.4 ± 2.64 |
| Indirect bilirubin; Week 60; n= 60, 65 | -0.6 ± 2.64 | -0.1 ± 2.81 |
Blood samples were collected to evaluate change from Baseline in calcium, chloride, cholesterol, glucose, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, phosphorus, potassium, sodium, urea nitrogen and very low density lipoprotein (VLDL) cholesterol values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured. NA indicates that data were not available.
| millimoles per liter (mmol/L) | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute Calcium; Baseline; n= 68, 68 | 2.365 ± 0.0864 | 2.382 ± 0.1189 |
| Calcium; Week 4; n= 68, 68 | -0.011 ± 0.0836 | -0.012 ± 0.1200 |
| Calcium; Week 8; n= 67, 66 | -0.013 ± 0.0877 | -0.010 ± 0.1003 |
| Calcium; Week 12; n= 65, 68 | -0.013 ± 0.0844 | -0.026 ± 0.0889 |
| Calcium; Week 16; n= 65, 68 | 0.000 ± 0.1091 | -0.029 ± 0.1018 |
| Calcium; Week 20; n= 63, 68 | 0.002 ± 0.0882 | -0.016 ± 0.1032 |
| Calcium; Week 24; n= 63, 66 | 0.001 ± 0.0901 | -0.013 ± 0.1111 |
| Calcium; Week 28; n= 61, 66 | 0.001 ± 0.0962 | -0.001 ± 0.1039 |
| Calcium; Week 32; n= 61, 67 | -0.000 ± 0.0911 | -0.006 ± 0.0977 |
| Calcium; Week 36; n= 60, 67 | -0.006 ± 0.0931 | -0.006 ± 0.1133 |
| Calcium; Week 40; n= 61, 66 | 0.014 ± 0.1126 | 0.005 ± 0.1115 |
| Calcium; Week 44; n= 61, 66 | 0.016 ± 0.1144 | -0.020 ± 0.1115 |
| Calcium; Week 48; n= 61, 64 | -0.007 ± 0.1007 | -0.018 ± 0.1002 |
| Calcium; Week 52; n= 60, 65 | -0.008 ± 0.1001 | -0.027 ± 0.1110 |
| Calcium; Week 56; n= 61, 63 | -0.008 ± 0.0931 | -0.015 ± 0.0994 |
| Calcium; Week 60; n= 60, 65 | -0.025 ± 0.0946 | -0.019 ± 0.1058 |
| Absolute Chloride; Baseline; n= 68, 68 | 103.4 ± 2.05 | 104.0 ± 2.21 |
| Chloride; Week 4; n= 68, 68 | 0.6 ± 1.97 | 0.2 ± 2.00 |
| Chloride; Week 8; n= 67, 66 | 0.9 ± 2.05 | 0.5 ± 2.06 |
| Chloride; Week 12; n= 65, 68 | 0.7 ± 2.32 | 0.7 ± 2.20 |
| Chloride; Week 16; n= 65, 68 | 0.5 ± 2.08 | 0.8 ± 1.95 |
| Chloride; Week 20; n= 63, 68 | 0.3 ± 2.38 | 0.7 ± 2.04 |
| Chloride; Week 24; n= 63, 66 | 0.6 ± 2.51 | 0.8 ± 2.20 |
| Chloride; Week 28; n= 62, 66 | 0.7 ± 2.17 | 0.8 ± 2.59 |
| Chloride; Week 32; n= 61, 67 | 0.4 ± 2.24 | 0.5 ± 2.32 |
| Chloride; Week 36; n= 60, 67 | 0.8 ± 2.53 | 0.6 ± 2.08 |
| Chloride; Week 40; n= 61, 66 | 0.9 ± 2.22 | 0.7 ± 2.13 |
| Chloride; Week 44; n= 61, 66 | 0.5 ± 2.13 | 0.6 ± 2.55 |
| Chloride; Week 48; n= 61, 64 | 0.5 ± 2.38 | 0.5 ± 2.34 |
| Chloride; Week 52; n= 60, 65 | 0.3 ± 2.26 | 0.4 ± 2.24 |
| Chloride; Week 56; n= 61, 63 | 0.7 ± 2.27 | 0.2 ± 2.06 |
| Chloride; Week 60; n= 60, 65 | 0.4 ± 2.01 | 0.4 ± 2.20 |
| Absolute Cholesterol; Baseline; n= 68, 68 | 5.771 ± 1.2033 | 5.788 ± 1.2386 |
| Cholesterol; Week 8; n= 2, 0 | -0.250 ± 0.1414 | — |
| Cholesterol; Week 12; n= 1, 0 | 0.050 ± NA | — |
| Cholesterol; Week 16; n= 1, 1 | -0.400 ± NA | -0.300 ± NA |
| Cholesterol; Week 20; n= 1, 1 | 0.050 ± NA | -0.300 ± NA |
| Cholesterol; Week 24; n= 0, 1 | — | -0.560 ± NA |
| Cholesterol; Week 36; n= 0, 1 | — | 0.420 ± NA |
| Cholesterol; Week 52; n= 60, 65 | -0.006 ± 0.9364 | -0.384 ± 0.8798 |
| Cholesterol; Week 56; n= 1, 0 | -0.220 ± NA | — |
| Absolute Glucose; Baseline; n= 68, 68 | 5.76 ± 2.000 | 5.35 ± 1.195 |
| Glucose; Week 4; n= 68, 68 | 0.27 ± 1.619 | -0.01 ± 1.050 |
| Glucose; Week 8; n= 67, 66 | 0.09 ± 1.695 | 0.07 ± 0.986 |
| Glucose; Week 12; n= 65, 68 | 0.27 ± 1.961 | 0.26 ± 1.079 |
| Glucose; Week 16; n= 65, 68 | 0.03 ± 1.454 | 0.04 ± 1.077 |
| Glucose; Week 20; n= 63, 68 | 0.25 ± 1.644 | -0.03 ± 1.351 |
| Glucose; Week 24; n= 63, 66 | 0.02 ± 1.588 | 0.16 ± 1.211 |
| Glucose; Week 28; n= 62, 66 | 0.14 ± 1.613 | 0.21 ± 1.551 |
| Glucose; Week 32; n= 61, 67 | -0.03 ± 1.808 | -0.14 ± 1.162 |
| Glucose; Week 36; n= 60, 67 | 0.11 ± 1.525 | 0.03 ± 1.003 |
| Glucose; Week 40; n= 61, 66 | 0.34 ± 1.831 | -0.03 ± 1.305 |
| Glucose; Week 44; n= 61, 66 | 0.21 ± 1.766 | -0.05 ± 0.891 |
| Glucose; Week 48; n= 61, 64 | 0.32 ± 2.065 | 0.21 ± 1.740 |
| Glucose; Week 52; n= 60, 65 | -0.17 ± 1.650 | 0.02 ± 1.258 |
| Glucose; Week 56; n= 61, 63 | 0.01 ± 1.718 | 0.13 ± 1.852 |
| Glucose; Week 60; n= 60, 65 | 0.20 ± 1.664 | 0.11 ± 1.483 |
| Absolute HDL cholesterol; Baseline; n= 68, 68 | 1.837 ± 0.4540 | 1.937 ± 0.5606 |
| HDL cholesterol; Week 8; n= 2, 0 | -0.075 ± 0.0354 | — |
| HDL cholesterol; Week 12; n= 1, 0 | -0.100 ± NA | — |
| HDL cholesterol; Week 16; n= 1, 1 | 0.400 ± NA | -0.150 ± NA |
| HDL cholesterol; Week 20; n= 1, 1 | 0.000 ± NA | -0.250 ± NA |
| HDL cholesterol; Week 24; n= 0, 1 | — | -0.390 ± NA |
| HDL cholesterol; Week 36; n= 0, 1 | — | 0.400 ± NA |
| HDL cholesterol; Week 52; n= 60, 65 | -0.045 ± 0.2832 | -0.150 ± 0.3146 |
| HDL cholesterol; Week 56; n= 1, 0 | -0.060 ± NA | — |
| Absolute LDL cholesterol; Baseline; n= 67, 68 | 3.261 ± 1.0808 | 3.205 ± 1.0992 |
| LDL cholesterol; Week 8; n= 1, 0 | -0.350 ± NA | — |
| LDL cholesterol; Week 12; n= 1, 0 | 0.190 ± NA | — |
| LDL cholesterol; Week 16; n= 1, 1 | -0.730 ± NA | -0.790 ± NA |
| LDL cholesterol; Week 20; n= 1, 1 | -0.150 ± NA | -0.540 ± NA |
| LDL cholesterol; Week 24; n= 0, 1 | — | 0.040 ± NA |
| LDL cholesterol; Week 36; n= 0, 1 | — | 0.250 ± NA |
| LDL cholesterol; Week 52; n= 58, 64 | 0.016 ± 0.7717 | -0.215 ± 0.8079 |
| LDL cholesterol; Week 56; n= 1, 0 | 0.100 ± NA | — |
| Absolute Phosphate; Baseline; n= 68, 68 | 1.068 ± 0.1797 | 1.066 ± 0.1939 |
| Phosphate; Week 4; n= 68, 68 | -0.027 ± 0.2183 | 0.014 ± 0.1833 |
| Phosphate; Week 8; n= 67, 66 | -0.004 ± 0.1577 | 0.024 ± 0.2239 |
| Phosphate; Week 12; n= 65, 68 | 0.003 ± 0.1821 | 0.019 ± 0.2181 |
| Phosphate; Week 16; n= 65, 68 | 0.016 ± 0.1819 | 0.016 ± 0.2205 |
| Phosphate; Week 20; n= 63, 68 | -0.001 ± 0.1611 | 0.019 ± 0.2087 |
| Phosphate; Week 24; n= 63, 66 | -0.042 ± 0.1565 | 0.007 ± 0.2142 |
| Phosphate; Week 28; n= 62, 66 | -0.025 ± 0.1819 | 0.003 ± 0.2539 |
| Phosphate; Week 32; n= 61, 67 | -0.018 ± 0.1975 | 0.040 ± 0.2172 |
| Phosphate; Week 36; n= 60, 67 | -0.038 ± 0.2159 | 0.023 ± 0.2260 |
| Phosphate; Week 40; n= 61, 66 | -0.029 ± 0.1822 | 0.026 ± 0.2213 |
| Phosphate; Week 44; n= 61, 66 | -0.018 ± 0.2104 | 0.041 ± 0.2240 |
| Phosphate; Week 48; n= 61, 64 | -0.053 ± 0.1931 | -0.020 ± 0.2443 |
| Phosphate; Week 52; n= 60, 65 | 0.005 ± 0.1939 | 0.053 ± 0.2988 |
| Phosphate; Week 56; n= 61, 63 | 0.019 ± 0.2962 | 0.043 ± 0.3066 |
| Phosphate; Week 60; n= 60, 65 | -0.035 ± 0.2125 | -0.007 ± 0.2322 |
| Absolute Potassium; Baseline; n= 68, 68 | 4.11 ± 0.348 | 4.10 ± 0.359 |
| Potassium; Week 4; n= 68, 68 | 0.05 ± 0.378 | -0.02 ± 0.345 |
| Potassium; Week 8; n= 67, 66 | 0.01 ± 0.309 | 0.02 ± 0.323 |
| Potassium; Week 12; n= 65, 68 | -0.04 ± 0.318 | 0.01 ± 0.296 |
| Potassium; Week 16; n= 65, 68 | 0.06 ± 0.340 | 0.05 ± 0.317 |
| Potassium; Week 20; n= 63, 68 | 0.08 ± 0.382 | 0.01 ± 0.372 |
| Potassium; Week 24; n= 63, 66 | -0.02 ± 0.298 | 0.04 ± 0.350 |
| Potassium; Week 28; n= 61, 66 | 0.07 ± 0.338 | 0.10 ± 0.382 |
| Potassium; Week 32; n= 61, 67 | 0.04 ± 0.340 | 0.11 ± 0.305 |
| Potassium; Week 36; n= 60, 67 | 0.02 ± 0.291 | 0.01 ± 0.351 |
| Potassium; Week 40; n= 61, 66 | 0.08 ± 0.419 | 0.14 ± 0.313 |
| Potassium; Week 44; n= 61, 66 | 0.08 ± 0.383 | 0.09 ± 0.341 |
| Potassium; Week 48; n= 61, 64 | 0.09 ± 0.367 | 0.05 ± 0.349 |
| Potassium; Week 52; n= 60, 65 | 0.05 ± 0.344 | 0.01 ± 0.329 |
| Potassium; Week 56; n= 61, 63 | 0.08 ± 0.379 | 0.08 ± 0.378 |
| Potassium; Week 60; n= 60, 65 | 0.00 ± 0.358 | 0.10 ± 0.390 |
| Absolute Sodium; Baseline; n= 68, 68 | 139.8 ± 2.03 | 140.3 ± 1.83 |
| Sodium; Week 4; n= 68, 68 | 0.2 ± 1.86 | 0.3 ± 2.03 |
| Sodium; Week 8; n= 67, 66 | 0.4 ± 2.06 | 0.2 ± 1.89 |
| Sodium; Week 12; n= 65, 68 | 0.1 ± 1.99 | -0.1 ± 2.28 |
| Sodium; Week 16; n= 65, 68 | 0.0 ± 1.46 | -0.1 ± 1.91 |
| Sodium; Week 20; n= 63, 68 | 0.0 ± 1.88 | 0.1 ± 2.09 |
| Sodium; Week 24; n= 63, 66 | 0.2 ± 1.94 | 0.0 ± 1.95 |
| Sodium; Week 28; n= 62, 66 | 0.5 ± 1.71 | 0.0 ± 2.23 |
| Sodium; Week 32; n= 61, 67 | 0.3 ± 1.92 | 0.1 ± 2.13 |
| Sodium; Week 36; n= 60, 67 | 0.4 ± 2.10 | 0.0 ± 1.95 |
| Sodium; Week 40; n= 61, 66 | 0.2 ± 2.42 | 0.0 ± 2.18 |
| Sodium; Week 44; n= 61, 66 | 0.1 ± 1.77 | -0.2 ± 2.02 |
| Sodium; Week 48; n= 61, 64 | 0.1 ± 2.03 | -0.4 ± 1.97 |
| Sodium; Week 52; n= 60, 65 | 0.4 ± 1.79 | -0.2 ± 2.17 |
| Sodium; Week 56; n= 61, 63 | 0.4 ± 2.15 | -0.5 ± 2.08 |
| Sodium; Week 60; n= 60, 65 | -0.1 ± 2.04 | -0.3 ± 2.36 |
| Absolute Urea; Baseline; n= 68, 68 | 5.94 ± 1.451 | 5.79 ± 1.629 |
| Urea; Week 4; n= 68, 68 | -0.08 ± 1.412 | 0.09 ± 1.241 |
| Urea; Week 8; n= 67, 66 | -0.23 ± 1.564 | 0.20 ± 1.206 |
| Urea; Week 12; n= 65, 68 | -0.15 ± 1.414 | -0.10 ± 1.217 |
| Urea; Week 16; n= 65, 68 | -0.07 ± 1.569 | 0.00 ± 1.317 |
| Urea; Week 20; n= 63, 68 | -0.21 ± 1.465 | -0.23 ± 1.286 |
| Urea; Week 24; n= 63, 66 | -0.28 ± 1.513 | -0.12 ± 1.172 |
| Urea; Week 28; n= 62, 66 | -0.21 ± 1.525 | -0.22 ± 1.350 |
| Urea; Week 32; n= 61, 67 | -0.11 ± 1.320 | -0.23 ± 1.359 |
| Urea; Week 36; n= 60, 67 | -0.27 ± 1.407 | -0.32 ± 1.391 |
| Urea; Week 40; n= 61, 66 | -0.44 ± 1.377 | -0.23 ± 1.375 |
| Urea; Week 44; n= 61, 66 | -0.32 ± 1.731 | -0.19 ± 1.698 |
| Urea; Week 48; n= 61, 64 | -0.36 ± 1.422 | -0.09 ± 1.429 |
| Urea; Week 52; n= 60, 65 | -0.19 ± 1.737 | -0.18 ± 1.128 |
| Urea; Week 56; n= 61, 63 | -0.11 ± 1.495 | -0.13 ± 1.539 |
| Urea; Week 60; n= 60, 65 | -0.09 ± 1.546 | -0.10 ± 1.170 |
| Absolute VLDL cholesterol; Baseline; n= 67, 68 | 0.680 ± 0.2846 | 0.646 ± 0.2841 |
| VLDL cholesterol; Week 8; n= 1, 0 | 0.100 ± NA | — |
| VLDL cholesterol; Week 12; n= 1, 0 | -0.040 ± NA | — |
| VLDL cholesterol; Week 16; n= 1, 1 | -0.070 ± NA | 0.640 ± NA |
| VLDL cholesterol; Week 20; n= 1, 1 | 0.200 ± NA | 0.490 ± NA |
| VLDL cholesterol; Week 24; n= 0, 1 | — | -0.210 ± NA |
| VLDL cholesterol; Week 36; n= 0, 1 | — | -0.230 ± NA |
| VLDL cholesterol; Week 52; n= 58, 64 | -0.019 ± 0.3229 | -0.051 ± 0.1927 |
| VLDL cholesterol; Week 56; n= 1, 0 | -0.260 ± NA | — |
Blood samples were collected to evaluate change from Baseline in troponin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
| µg/L | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute Troponin; Baseline; n= 68, 68 | 0.013 ± 0.0110 | 0.013 ± 0.0092 |
| Troponin; Week 4; n= 68, 66 | -0.001 ± 0.0106 | 0.008 ± 0.0717 |
| Troponin; Week 8; n= 67, 67 | -0.002 ± 0.0111 | 0.001 ± 0.0089 |
| Troponin; Week 12; n= 64, 67 | -0.002 ± 0.0108 | -0.001 ± 0.0053 |
| Troponin; Week 16; n= 65, 68 | -0.002 ± 0.0104 | 0.002 ± 0.0272 |
| Troponin; Week 20; n= 61, 68 | -0.002 ± 0.0105 | -0.001 ± 0.0089 |
| Troponin; Week 24; n= 62, 67 | -0.002 ± 0.0098 | 0.004 ± 0.0535 |
| Troponin; Week 28; n= 63, 66 | -0.003 ± 0.0102 | -0.002 ± 0.0090 |
| Troponin; Week 32; n= 61, 67 | -0.003 ± 0.0100 | -0.002 ± 0.0092 |
| Troponin; Week 36; n= 61, 67 | -0.002 ± 0.0107 | 0.000 ± 0.0185 |
| Troponin; Week 40; n= 61, 66 | -0.001 ± 0.0117 | -0.002 ± 0.0090 |
| Troponin; Week 44; n= 61, 65 | -0.000 ± 0.0068 | -0.001 ± 0.0095 |
| Troponin; Week 48; n= 60, 65 | 0.017 ± 0.1479 | -0.001 ± 0.0101 |
| Troponin; Week 52; n= 60, 65 | -0.002 ± 0.0114 | -0.001 ± 0.0111 |
| Troponin; Week 56; n= 61, 63 | -0.003 ± 0.0112 | -0.002 ± 0.0086 |
| Troponin; Week 60; n= 59, 65 | -0.003 ± 0.0109 | -0.001 ± 0.0093 |
Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelet values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
| 10^9 cells/L | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute Basophils; Baselin; n= 68, 68 | 0.030 ± 0.0253 | 0.028 ± 0.0236 |
| Basophils; Week 4; n= 66, 66 | -0.002 ± 0.0302 | -0.007 ± 0.0282 |
| Basophils; Week 8; n= 65, 66 | 0.005 ± 0.0285 | -0.002 ± 0.0261 |
| Basophils; Week 12; n= 63, 65 | 0.007 ± 0.0351 | -0.007 ± 0.0222 |
| Basophils; Week 16; n= 64, 68 | 0.005 ± 0.0333 | -0.004 ± 0.0295 |
| Basophils; Week 20; n= 61, 66 | 0.005 ± 0.0338 | -0.002 ± 0.0287 |
| Basophils; Week 24; n= 61, 66 | 0.004 ± 0.0341 | -0.002 ± 0.0328 |
| Basophils; Week 28; n= 62, 65 | 0.006 ± 0.0411 | -0.005 ± 0.0297 |
| Basophils; Week 32; n= 61, 66 | 0.010 ± 0.0467 | 0.002 ± 0.0355 |
| Basophils; Week 36; n= 60, 66 | 0.009 ± 0.0321 | 0.005 ± 0.0424 |
| Basophils; Week 40; n= 61, 65 | 0.005 ± 0.0357 | -0.002 ± 0.0356 |
| Basophils; Week 44; n= 59, 61 | 0.008 ± 0.0328 | 0.000 ± 0.0296 |
| Basophils; Week 48; n= 59, 64 | 0.003 ± 0.0408 | -0.004 ± 0.0300 |
| Basophils; Week 52; n= 60, 64 | 0.004 ± 0.0289 | -0.003 ± 0.0284 |
| Basophils; Week 56; n= 59, 61 | 0.009 ± 0.0381 | -0.003 ± 0.0286 |
| Basophils; Week 60; n= 58, 64 | 0.002 ± 0.0316 | -0.006 ± 0.0248 |
| Absolute Eosinophils; Baseline; n= 68, 68 | 0.362 ± 0.5835 | 0.398 ± 0.8415 |
| Eosinophils; Week 4; n= 66, 66 | -0.054 ± 0.3309 | -0.339 ± 0.6794 |
| Eosinophils; Week 8; n= 65, 66 | 0.103 ± 0.2921 | -0.370 ± 0.8092 |
| Eosinophils; Week 12; n= 63, 65 | 0.027 ± 0.3515 | -0.364 ± 0.8407 |
| Eosinophils; Week 16; n= 64, 68 | 0.058 ± 0.4092 | -0.355 ± 0.8280 |
| Eosinophils; Week 20; n= 61, 66 | 0.162 ± 0.5900 | -0.347 ± 0.8266 |
| Eosinophils; Week 24; n= 61, 66 | 0.136 ± 0.4044 | -0.364 ± 0.8211 |
| Eosinophils; Week 28; n= 62, 65 | 0.172 ± 0.4365 | -0.360 ± 0.8258 |
| Eosinophils; Week 32; n= 61, 66 | 0.079 ± 0.3759 | -0.347 ± 0.8310 |
| Eosinophils; Week 36; n= 60, 66 | 0.086 ± 0.3758 | -0.347 ± 0.8388 |
| Eosinophils; Week 40; n= 61, 65 | 0.022 ± 0.4448 | -0.358 ± 0.8396 |
| Eosinophils; Week 44; n= 59, 61 | 0.051 ± 0.4472 | -0.365 ± 0.8604 |
| Eosinophils; Week 48; n= 59, 64 | 0.109 ± 0.3873 | -0.364 ± 0.8540 |
| Eosinophils; Week 52; n= 60, 64 | 0.055 ± 0.3764 | -0.341 ± 0.8456 |
| Eosinophils; Week 56; n= 59, 61 | 0.071 ± 0.4137 | -0.351 ± 0.8624 |
| Eosinophils; Week 60; n= 58, 64 | 0.111 ± 0.4666 | -0.302 ± 0.8352 |
| Absolute Leukocytes; Baseline; n= 68, 68 | 9.91 ± 2.714 | 9.54 ± 3.130 |
| Leukocytes; Week 4; 66, 66 | -0.11 ± 2.109 | -0.77 ± 2.356 |
| Leukocytes; Week 8; n= 65, 66 | -0.18 ± 2.562 | -0.83 ± 2.511 |
| Leukocytes; Week 12; n= 63, 65 | -0.53 ± 1.765 | -1.24 ± 2.716 |
| Leukocytes; ; Week 16; n= 64, 68 | 0.01 ± 2.567 | -1.16 ± 2.827 |
| Leukocytes; Week 20; n= 61, 66 | -0.13 ± 2.269 | -1.43 ± 2.649 |
| Leukocytes; Week 24; n= 61, 66 | -0.73 ± 2.110 | -1.47 ± 2.738 |
| Leukocytes; Week 28; n= 62, 65 | -0.01 ± 2.297 | -1.66 ± 2.804 |
| Leukocytes; week 32; n= 61, 66 | -0.33 ± 2.218 | -1.54 ± 2.725 |
| Leukocytes; Week 36; n= 60, 66 | -0.17 ± 2.501 | -1.37 ± 2.578 |
| Leukocytes; Week 40; n= 61, 65 | 0.17 ± 2.912 | -1.28 ± 3.284 |
| Leukocytes; Week 44; n= 59, 61 | 0.25 ± 3.166 | -1.57 ± 2.198 |
| Leukocytes; Week 48; n= 59, 64 | -0.10 ± 3.092 | -1.46 ± 2.546 |
| Leukocytes; Week 52; n= 60, 64 | -0.12 ± 3.114 | -1.50 ± 2.521 |
| Leukocytes; Week 56; n= 59, 61 | -0.05 ± 3.357 | -1.50 ± 2.840 |
| Leukocytes; Week 60; n= 58, 64 | 0.19 ± 3.533 | -1.20 ± 2.396 |
| Absolute Lymphocytes; Baseline; n= 68, 68 | 1.638 ± 0.9375 | 1.508 ± 0.8230 |
| Lymphocytes; Week 4; n= 66, 66 | 0.031 ± 0.8990 | 0.145 ± 0.7485 |
| Lymphocytes; Week 8; n= 65, 66 | 0.245 ± 0.8804 | -0.048 ± 0.6388 |
| Lymphocytes; Week 12; n= 63, 65 | 0.160 ± 0.9043 | -0.071 ± 0.7665 |
| Lymphocytes; Week 16; n= 64, 68 | 0.078 ± 1.0337 | 0.079 ± 0.7254 |
| Lymphocytes; Week 20; n= 61, 66 | 0.137 ± 0.7984 | 0.127 ± 0.7096 |
| Lymphocytes; Week 24; n= 61, 66 | 0.056 ± 0.8778 | 0.011 ± 0.8077 |
| Lymphocytes; Week 28; n= 62, 65 | 0.261 ± 1.0966 | 0.004 ± 0.7328 |
| Lymphocytes; Week 32; n= 61, 66 | 0.244 ± 0.9633 | 0.031 ± 0.7986 |
| Lymphocytes; Week 36; n= 60, 66 | 0.156 ± 1.0399 | 0.031 ± 0.5939 |
| Lymphocytes; Week 40; n= 61, 65 | 0.064 ± 1.0537 | 0.037 ± 0.6391 |
| Lymphocytes; Week 44; n= 59, 61 | 0.130 ± 0.8773 | 0.059 ± 0.6471 |
| Lymphocytes; Week 48; n=59, 64 | 0.106 ± 0.8396 | 0.035 ± 0.7368 |
| Lymphocytes; Week 52; n= 60, 64 | 0.144 ± 0.9262 | 0.031 ± 0.6244 |
| Lymphocytes; Week 56; n= 59, 61 | 0.200 ± 0.8356 | 0.128 ± 0.7824 |
| Lymphocytes; Week 60; n= 58, 64 | 0.076 ± 0.8821 | -0.101 ± 0.6848 |
| Absolute Monocytes; Baseline; n= 68, 68 | 0.377 ± 0.2126 | 0.405 ± 0.2376 |
| Monocytes; week 4; n= 66, 66 | 0.038 ± 0.2444 | 0.014 ± 0.2127 |
| Monocytes; Week 8; n= 65, 66 | 0.052 ± 0.2271 | 0.039 ± 0.1988 |
| Monocytes; Week 12; n= 63, 65 | 0.077 ± 0.2468 | -0.004 ± 0.1985 |
| Monocytes; Week 16; n= 64, 68 | 0.086 ± 0.2790 | 0.031 ± 0.2157 |
| Monocytes; Week 20; n= 61, 66 | 0.132 ± 0.2684 | 0.030 ± 0.1967 |
| Monocytes; Week 24; n= 61, 66 | 0.061 ± 0.2290 | 0.013 ± 0.2412 |
| Monocytes; Week 28; n= 62, 65 | 0.107 ± 0.2363 | 0.035 ± 0.2350 |
| Monocytes; Week 32; n= 61, 66 | 0.108 ± 0.2839 | 0.057 ± 0.2069 |
| Monocytes; Week 36; n= 60, 66 | 0.089 ± 0.2992 | 0.072 ± 0.2416 |
| Monocytes; Week 40; n= 61, 65 | 0.084 ± 0.2495 | 0.050 ± 0.2096 |
| Monocytes; Week 44; n= 59, 61 | 0.090 ± 0.2494 | 0.077 ± 0.2176 |
| Monocytes; Week 48; n= 59, 64 | 0.078 ± 0.2261 | 0.025 ± 0.2235 |
| Monocytes; Week 52; n= 60, 64 | 0.075 ± 0.2407 | 0.024 ± 0.2098 |
| Monocytes; Week 56; n= 59, 61 | 0.051 ± 0.2104 | 0.037 ± 0.2303 |
| Monocytes; Week 60; n= 58, 64 | 0.052 ± 0.2600 | 0.001 ± 0.2165 |
| Absolute Neutrophils; Baseline; n= 68, 68 | 7.500 ± 2.7424 | 7.198 ± 2.9732 |
| Neutrophils; Week 4; n= 66, 66 | -0.124 ± 2.6170 | -0.583 ± 2.2703 |
| Neutrophils; Week 8; n= 65, 66 | -0.572 ± 2.6791 | -0.443 ± 2.56476 |
| Neutrophils; Week 12; n= 63, 65 | -0.797 ± 2.2948 | -0.799 ± 2.6278 |
| Neutrophils; Week 16; n= 64, 68 | -0.222 ± 2.7666 | -0.914 ± 2.6034 |
| Neutrophils; Week 20; n= 61, 66 | -0.560 ± 2.3679 | -1.243 ± 2.6857 |
| Neutrophils; Week 24; n= 61, 66 | -0.980 ± 2.3151 | -1.120 ± 2.8349 |
| Neutrophils; Week 28; n= 62, 65 | -0.555 ± 2.3719 | -1.335 ± 2.9428 |
| Neutrophils; Week 32; n= 61, 66 | -0.762 ± 2.4952 | -1.286 ± 2.6995 |
| Neutrophils; Week 36; n= 60, 66 | -0.509 ± 2.8231 | -1.131 ± 2.4261 |
| Neutrophils; Week 40; n= 61, 65 | -0.009 ± 3.0467 | -1.010 ± 3.3999 |
| Neutrophils; Week 44; n= 59, 61 | -0.020 ± 3.3497 | -1.344 ± 2.1031 |
| Neutrophils; Week 48; n= 59, 64 | -0.403 ± 3.2656 | -1.151 ± 2.5806 |
| Neutrophils; Week 52; n= 60, 64 | -0.391 ± 3.4463 | -1.211 ± 2.2815 |
| Neutrophils; Week 56; n= 59, 61 | -0.381 ± 3.4297 | -1.311 ± 3.0024 |
| Neutrophils; Week 60; n= 58, 64 | -0.048 ± 3.5724 | -0.795 ± 2.6501 |
| Absolute Platelets; Baseline; n= 68, 68 | 259.8 ± 61.16 | 270.3 ± 60.86 |
| Platelets; Week 4; n= 66, 67 | 4.5 ± 38.14 | -1.4 ± 33.79 |
| Platelets; Week 8; n= 66, 66 | 5.0 ± 43.97 | 4.1 ± 26.48 |
| Platelets; Week 12; n= 63, 65 | 3.1 ± 50.60 | -4.3 ± 37.89 |
| Platelets; Week 16; n= 64, 68 | 15.4 ± 71.20 | 1.8 ± 40.25 |
| Platelets; Week 20; n= 61, 68 | 12.3 ± 49.92 | 6.1 ± 52.76 |
| Platelets; Week 24; n= 62, 65 | 10.9 ± 50.38 | -4.2 ± 40.07 |
| Platelets; Week 28; n= 62, 66 | 13.3 ± 55.12 | 5.4 ± 41.57 |
| Platelets; Week 32; n= 61, 67 | 12.1 ± 45.36 | 0.7 ± 43.85 |
| Platelets; Week 36; n= 60, 66 | 9.3 ± 42.64 | 0.6 ± 37.87 |
| Platelets; Week 40; n= 61, 65 | 14.7 ± 45.63 | 2.0 ± 42.12 |
| Platelets; Week 44; n= 60, 63 | 19.3 ± 48.88 | 4.9 ± 40.27 |
| Platelets; Week 48; n= 59, 64 | 14.2 ± 53.93 | 5.4 ± 44.80 |
| Platelets; Week 52; n= 60, 64 | 14.7 ± 48.19 | -3.7 ± 46.34 |
| Platelets; Week 56; n= 59, 61 | 20.3 ± 47.35 | -1.0 ± 48.51 |
| Platelets; Week 60; n= 59, 64 | 13.0 ± 50.07 | -2.0 ± 41.32 |
Blood samples were collected to evaluate change from Baseline in MCHC and hemoglobin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
| g/L | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute MCHC; Baseline; n= 68, 68 | 324.9 ± 7.53 | 324.4 ± 7.37 |
| MCHC; Week 4; n= 66, 67 | -1.2 ± 6.02 | -1.1 ± 5.92 |
| MCHC; Week 8; n= 66, 66 | -1.5 ± 6.69 | -1.5 ± 6.86 |
| MCHC; Week 12; n= 63, 65 | -1.3 ± 7.73 | 0.3 ± 6.60 |
| MCHC; Week 16; n= 64, 68 | -2.3 ± 7.11 | -2.1 ± 7.88 |
| MCHC; Week 20; n= 61, 68 | -2.2 ± 6.65 | -1.2 ± 7.88 |
| MCHC; Week 24; n= 62, 66 | -3.2 ± 10.19 | -2.6 ± 7.39 |
| MCHC; Week 28; n= 62, 66 | -4.3 ± 7.07 | -2.6 ± 7.33 |
| MCHC; Week 32; n= 61, 67 | -6.6 ± 8.19 | -3.6 ± 7.56 |
| MCHC; Week 36; n= 60, 66 | -4.7 ± 8.05 | -3.3 ± 8.37 |
| MCHC; Week 40; n= 61, 65 | -4.5 ± 8.04 | -3.2 ± 8.96 |
| MCHC; Week 44; n= 60, 64 | -4.7 ± 8.51 | -4.5 ± 9.40 |
| MCHC; Week 48; n= 59, 64 | -6.0 ± 8.03 | -4.8 ± 10.56 |
| MCHC; Week 52; n= 60, 64 | -5.2 ± 7.79 | -5.3 ± 7.72 |
| MCHC; Week 56; n= 59, 61 | -6.9 ± 7.74 | -5.3 ± 7.47 |
| MCHC; Week 60; n= 59, 64 | -7.5 ± 7.41 | -4.7 ± 9.90 |
| Absolute Hemoglobin; Baseline; n= 68, 68 | 141.6 ± 12.67 | 140.6 ± 12.99 |
| Hemoglobin; Week 4; n= 66, 67 | -2.3 ± 6.86 | -1.8 ± 6.43 |
| Hemoglobin; Week 8; n= 66, 66 | -2.5 ± 7.56 | -1.1 ± 6.28 |
| Hemoglobin; Week 12; n= 63, 65 | -1.6 ± 8.28 | -2.2 ± 7.17 |
| Hemoglobin; Week 16; n= 64, 68 | -1.6 ± 8.24 | -1.9 ± 7.64 |
| Hemoglobin; Week 20; n= 61, 68 | -0.3 ± 6.85 | -1.4 ± 7.64 |
| Hemoglobin; Week 24; n= 62, 66 | -1.1 ± 8.06 | -1.6 ± 8.51 |
| Hemoglobin; Week 28; n= 62, 66 | -1.3 ± 7.48 | -1.3 ± 8.94 |
| Hemoglobin; Week 32; n= 61, 67 | -1.3 ± 8.03 | -1.6 ± 9.22 |
| Hemoglobin; Week 36; n= 60, 66 | -0.2 ± 8.50 | -0.4 ± 10.23 |
| Hemoglobin; Week 40; n= 61, 65 | 0.1 ± 8.35 | -0.9 ± 9.74 |
| Hemoglobin; Week 44; n= 60, 64 | 0.7 ± 9.59 | -1.9 ± 10.47 |
| Hemoglobin; Week 48; n= 59, 64 | 0.5 ± 8.20 | -1.9 ± 11.07 |
| Hemoglobin; Week 52; n= 60, 64 | 0.1 ± 8.57 | -1.9 ± 10.36 |
| Hemoglobin; Week 56; n= 59, 61 | -1.5 ± 9.92 | -1.9 ± 11.48 |
| Hemoglobin; Week 60; n= 59, 64 | -1.8 ± 9.86 | -2.4 ± 11.36 |
Blood samples were collected to evaluate change from Baseline in MCV values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
| femtoliter (fL) | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute, Baseline; n= 68, 68 | 94.8 ± 9.02 | 94.8 ± 6.14 |
| Week 4; n= 66, 67 | 0.4 ± 1.67 | 0.0 ± 2.33 |
| Week 8; n= 66, 66 | 0.3 ± 2.50 | 0.0 ± 2.58 |
| Week 12; n= 63, 65 | 0.2 ± 2.00 | -0.7 ± 2.30 |
| Week 16; n= 64, 68 | 0.0 ± 2.22 | -0.4 ± 2.94 |
| Week 20; n= 61, 68 | -0.3 ± 1.87 | -0.9 ± 2.66 |
| Week 24; n= 62, 66 | -0.5 ± 2.21 | -1.0 ± 2.92 |
| Week 28; n= 62, 66 | -0.4 ± 2.86 | -1.4 ± 3.48 |
| Week 32; n= 61, 67 | -0.2 ± 3.01 | -1.7 ± 3.56 |
| Week 36; n= 60, 66 | -0.5 ± 3.55 | -1.9 ± 3.74 |
| Week 40; n= 61, 65 | -0.9 ± 4.09 | -1.4 ± 3.73 |
| Week 44; n= 60, 64 | -1.2 ± 5.06 | -1.5 ± 3.91 |
| Week 48; n= 59, 64 | -1.1 ± 5.96 | -1.5 ± 4.04 |
| Week 52; n= 60, 64 | -0.8 ± 6.52 | -1.3 ± 4.29 |
| Week 56; n= 59, 61 | -0.5 ± 6.47 | -1.0 ± 4.15 |
| Week 60; n= 59, 64 | -0.6 ± 6.57 | -1.0 ± 4.49 |
Blood samples were collected to evaluate change from Baseline in MCH values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
| Picogram (pg) | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute, Baseline; n= 68, 68 | 30.77 ± 2.902 | 30.77 ± 2.255 |
| Week 4; n= 66, 67 | 0.04 ± 0.331 | -0.12 ± 0.785 |
| Week 8; n= 66, 66 | -0.02 ± 0.950 | -0.16 ± 0.653 |
| Week 12; n= 63, 65 | -0.04 ± 0.550 | -0.17 ± 0.769 |
| Week 16; n= 64, 68 | -0.21 ± 0.845 | -0.34 ± 0.769 |
| Week 20; n= 61, 68 | -0.28 ± 0.665 | -0.41 ± 0.851 |
| Week 24; n= 62, 66 | -0.45 ± 1.270 | -0.59 ± 0.959 |
| Week 28; n= 62, 66 | -0.51 ± 0.618 | -0.70 ± 1.184 |
| Week 32; n= 61, 67 | -0.66 ± 0.764 | -0.88 ± 1.368 |
| Week 36; n= 60, 66 | -0.60 ± 0.910 | -0.90 ± 1.395 |
| Week 40; n= 61, 65 | -0.67 ± 1.171 | -0.79 ± 1.390 |
| Week 44; n= 60, 64 | -0.78 ± 1.566 | -0.95 ± 1.484 |
| Week 48; n= 59, 64 | -0.87 ± 1.745 | -0.96 ± 1.654 |
| Week 52; n= 60, 64 | -0.69 ± 1.908 | -0.95 ± 1.585 |
| Week 56; n= 59, 61 | -0.79 ± 2.056 | -0.83 ± 1.713 |
| Week 60; n= 59, 64 | -0.86 ± 2.094 | -0.80 ± 1.818 |
Blood samples were collected to evaluate change from Baseline in erythrocytes values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
| 10^12 cells/L | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute, Baseline; n= 68, 68 | 4.64 ± 0.511 | 4.58 ± 0.456 |
| Week 4; n= 66, 67 | -0.07 ± 0.228 | -0.03 ± 0.226 |
| Week 8; n= 66, 66 | -0.07 ± 0.278 | -0.01 ± 0.211 |
| Week 12; n= 63, 65 | -0.04 ± 0.273 | -0.04 ± 0.252 |
| Week 16; n= 64, 68 | -0.02 ± 0.266 | -0.01 ± 0.243 |
| Week 20; n= 61, 68 | 0.03 ± 0.243 | 0.03 ± 0.252 |
| Week 24; n= 62, 66 | 0.02 ± 0.252 | 0.05 ± 0.265 |
| Week 28; n= 62, 66 | 0.03 ± 0.286 | 0.08 ± 0.264 |
| Week 32; n= 61, 67 | 0.06 ± 0.300 | 0.09 ± 0.273 |
| Week 36; n= 60, 66 | 0.08 ± 0.314 | 0.14 ± 0.299 |
| Week 40; n= 61, 65 | 0.09 ± 0.274 | 0.09 ± 0.270 |
| Week 44; n= 60, 64 | 0.13 ± 0.332 | 0.08 ± 0.260 |
| Week 48; n= 59, 64 | 0.14 ± 0.293 | 0.10 ± 0.271 |
| Week 52; n= 60, 64 | 0.10 ± 0.309 | 0.09 ± 0.251 |
| Week 56; n= 59, 61 | 0.06 ± 0.365 | 0.07 ± 0.284 |
| Week 60; n= 59, 64 | 0.07 ± 0.384 | 0.05 ± 0.318 |
Blood samples were collected for the determination of anti-Mepolizumab antibodies. Participants who showed presence of anti-Mepolizumab antibody were termed as 'positive' and those who did not have anti-Mepolizumab antibody in blood sample were termed as 'negative'. Participants who did not have a positive ADA assay prior to the first dose of investigational product were included in the analysis.
| Participants | Placebo | Mepolizumab 300mg |
|---|---|---|
| Negative | 66 | 65 |
| Positive | 1 | 1 |
SBP and DBP were measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
| millimeter of mercury (mm of Hg) | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute SBP; Baseline; n= 68, 68 | 127.46 ± 17.794 | 122.46 ± 14.134 |
| SBP; Week 4; n= 68, 68 | 0.47 ± 15.865 | 0.93 ± 12.370 |
| SBP; Week 8; n= 67, 68 | 0.07 ± 14.192 | 1.29 ± 11.066 |
| SBP; Week 12; n= 66, 68 | -1.12 ± 14.380 | -1.41 ± 12.071 |
| SBP; Week 16; n= 64, 68 | -0.97 ± 16.630 | -0.41 ± 11.579 |
| SBP; Week 20; n= 63, 68 | -0.97 ± 15.028 | -0.85 ± 12.019 |
| SBP; Week 24; n= 63, 67 | -1.54 ± 15.449 | -1.57 ± 12.824 |
| SBP; Week 28; n= 63, 67 | -0.06 ± 14.337 | -0.15 ± 13.240 |
| SBP; Week 32; n= 62, 67 | -2.35 ± 14.027 | 0.04 ± 11.181 |
| SBP; Week 36; n= 62, 67 | 1.02 ± 14.663 | 0.48 ± 14.397 |
| SBP; Week 40; n= 62, 66 | 0.90 ± 14.202 | 1.27 ± 12.075 |
| SBP; Week 44; n= 61, 66 | 1.41 ± 16.143 | -0.36 ± 13.694 |
| SBP; Week 48; n= 61, 65 | -0.41 ± 17.140 | -0.22 ± 12.351 |
| SBP: Week 52; n= 61, 65 | -1.03 ± 13.200 | -0.32 ± 13.091 |
| SBP; Week 56; n= 62, 63 | 0.06 ± 15.216 | 1.02 ± 13.559 |
| SBP; Week 60; n= 61, 65 | 0.61 ± 15.627 | -0.63 ± 11.656 |
| Absolute DBP; Baseline; n= 68, 68 | 80.21 ± 10.127 | 76.22 ± 9.646 |
| DBP; Week 4; n= 68, 68 | -2.26 ± 10.046 | 1.01 ± 10.130 |
| DBP; Week 8; n= 67, 68 | -2.04 ± 8.461 | -0.34 ± 10.078 |
| DBP; Week 12; n= 66, 68 | -1.92 ± 10.115 | -0.37 ± 9.167 |
| DBP; Week 16; n= 64, 68 | -1.36 ± 10.237 | 0.46 ± 9.824 |
| DBP; Week 20; n= 63, 68 | -1.25 ± 8.092 | -1.19 ± 9.214 |
| DBP; Week 24; n= 63, 67 | -2.24 ± 8.751 | -1.16 ± 9.629 |
| DBP; Week 28; n= 63, 67 | -2.02 ± 9.939 | 0.36 ± 10.071 |
| DBP; Week 32; n= 62, 67 | -4.27 ± 9.313 | -0.49 ± 10.652 |
| DBP; Week 36; n= 62, 67 | -1.97 ± 10.995 | 0.16 ± 10.988 |
| DBP; Week 40; n= 62, 66 | -0.48 ± 9.625 | -0.03 ± 8.868 |
| DBP; Week 44; n= 61, 66 | -0.79 ± 9.930 | -1.03 ± 9.595 |
| DBP; Week 48; n= 61, 65 | -3.26 ± 10.466 | -1.71 ± 9.239 |
| DBP; Week 52; n= 61, 65 | -3.66 ± 10.628 | -0.06 ± 9.236 |
| DBP; Week 56; n= 62, 63 | -3.48 ± 10.570 | 0.11 ± 8.899 |
| DBP; Week 60; n= 61, 65 | -2.54 ± 11.278 | -0.45 ± 9.836 |
Pulse rate was measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
| beats per minute (bpm) | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute Baseline; n= 68, 68 | 77.38 ± 13.763 | 75.75 ± 10.404 |
| Week 4; n= 68, 68 | 2.01 ± 12.294 | 1.87 ± 10.543 |
| Week 8; n= 67, 68 | 0.97 ± 10.718 | -1.01 ± 10.304 |
| Week 12; n= 66, 68 | 1.52 ± 12.393 | -0.12 ± 10.855 |
| Week 16; n= 64, 68 | 0.59 ± 11.287 | 0.44 ± 11.411 |
| Week 20; n= 63, 68 | 1.03 ± 11.521 | -0.56 ± 9.687 |
| Week 24; n= 63, 67 | 0.79 ± 12.134 | 0.37 ± 10.057 |
| Week 28; n= 62, 67 | 1.29 ± 10.439 | 0.16 ± 10.093 |
| Week 32; n= 62, 67 | 1.60 ± 11.703 | -0.31 ± 10.530 |
| Week 36; n= 62, 67 | 3.47 ± 12.538 | -0.57 ± 11.422 |
| Week 40; n= 62, 66 | 2.65 ± 12.297 | 0.74 ± 11.669 |
| Week 44; n= 61, 66 | 3.10 ± 12.195 | 0.15 ± 12.763 |
| Week 48; n= 61, 65 | 3.85 ± 12.383 | -1.12 ± 10.315 |
| Week 52; n= 61, 65 | 1.85 ± 11.987 | -2.17 ± 9.596 |
| Week 56; n= 62, 63 | 2.60 ± 14.041 | -0.35 ± 9.986 |
| Week 60; n= 61, 65 | 1.51 ± 12.793 | 0.09 ± 10.280 |
Body temperature was measured from Baseline throughout follow-up (till Week 60). The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. The analysis was performed on Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.
| Degree celsius | Placebo | Mepolizumab 300mg |
|---|---|---|
| Absolute Baseline; n= 68, 68 | 36.52 ± 0.385 | 36.51 ± 0.462 |
| Week 4; n= 68, 68 | 0.05 ± 0.439 | -0.04 ± 0.411 |
| Week 8; n= 67,68 | -0.01 ± 0.379 | -0.02 ± 0.425 |
| Week 12; n= 66, 68 | 0.05 ± 0.410 | -0.03 ± 0.447 |
| Week 16; n= 64, 68 | -0.01 ± 0.421 | -0.03 ± 0.432 |
| Week 20; n= 63, 68 | -0.08 ± 0.351 | -0.13 ± 0.376 |
| Week 24; n= 62, 67 | -0.06 ± 0.449 | -0.06 ± 0.389 |
| Week 28; n= 63, 67 | -0.06 ± 0.499 | -0.14 ± 0.411 |
| Week 32; n= 62, 67 | -0.09 ± 0.392 | -0.07 ± 0.355 |
| Week 36; n= 62, 67 | -0.05 ± 0.431 | 0.03 ± 0.468 |
| Week 40; n= 62, 66 | -0.03 ± 0.530 | -0.13 ± 0.406 |
| Week 44; n= 61, 65 | -0.03 ± 0.550 | -0.08 ± 0.396 |
| Week 48; n= 61, 64 | -0.04 ± 0.452 | -0.09 ± 0.414 |
| Week 52; n= 60, 65 | -0.04 ± 0.423 | -0.12 ± 0.541 |
| Week 56; n= 61, 63 | -0.08 ± 0.530 | -0.00 ± 0.402 |
| Week 60; n= 61, 64 | 0.03 ± 0.467 | -0.02 ± 0.479 |
Single measurements of 12-lead electrocardiogram (ECGs) were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Mean change from Baseline in QTcF and QTcB values were measured. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| milliseconds (msec) | Placebo | Mepolizumab 300mg |
|---|---|---|
| QTcF; Week 8; n= 66, 66 | 0.1 ± 17.90 | 1.0 ± 15.03 |
| QTcF; Week 16; n= 64, 66 | 0.8 ± 15.26 | 0.2 ± 14.05 |
| QTcF; Week 24; n= 60, 66 | 2.8 ± 14.43 | 1.9 ± 16.66 |
| QTcF; Week 32; n= 61, 66 | 6.2 ± 25.19 | 1.5 ± 17.16 |
| QTcF; Week 40; n= 61, 65 | -0.5 ± 15.25 | -0.3 ± 17.53 |
| QTcF; Week 52; n= 58, 64 | 2.0 ± 15.96 | 3.0 ± 16.04 |
| QTcF; Week 60; n= 58, 63 | 3.0 ± 14.30 | 2.9 ± 14.97 |
| QTcF; Any time post Baseline; n= 68, 68 | 16.9 ± 23.74 | 15.4 ± 13.79 |
| QTcB; Week 8; n= 66, 66 | -0.8 ± 19.05 | 0.9 ± 17.31 |
| QTcB; Week 16; n= 64, 66 | -0.1 ± 18.33 | -0.9 ± 14.76 |
| QTcB; Week 24; n= 60, 66 | 1.4 ± 17.89 | 1.0 ± 18.10 |
| QTcB; Week 32; n= 61, 66 | 5.2 ± 29.63 | 0.0 ± 19.63 |
| QTcB; Week 40; n= 61, 65 | -0.6 ± 17.83 | -1.4 ± 18.88 |
| QTcB; Week 52; n= 58, 64 | 1.8 ± 17.64 | 0.7 ± 18.27 |
| QTcB; Week 60; n= 58, 63 | 1.2 ± 16.56 | 2.7 ± 17.27 |
| QTcB; Any time post Baseline; n= 68, 68 | 18.8 ± 26.46 | 18.1 ± 15.28 |
Single measurements of 12-lead ECGs were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Maximum change from Baseline in QTcF and QTcB values were measured.
| msec | Placebo | Mepolizumab 300mg |
|---|---|---|
| QTcB interval | 18.8 ± 26.46 | 18.1 ± 15.28 |
| QTcF interval | 16.9 ± 23.74 | 15.4 ± 13.79 |
Collected over On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/68 (0%) | 18/68 (26.5%) | 61/68 (89.7%) |
| Mepolizumab 300mg | 1/68 (1.5%) | 12/68 (17.6%) | 65/68 (95.6%) |
| Event | Placebo | Mepolizumab 300mg |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 4/68 | 2/68 |
| InfluenzaInfections and infestations | 2/68 | 0/68 |
| PneumoniaInfections and infestations | 2/68 | 0/68 |
| Lower respiratory infectionInfections and infestations | 2/68 | 0/68 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 2/68 | 0/68 |
| AppendicitisInfections and infestations | 1/68 | 0/68 |
| BronchitisInfections and infestations | 1/68 | 0/68 |
| CellulitisInfections and infestations | 1/68 | 0/68 |
| Corona virus infectionInfections and infestations | 1/68 | 0/68 |
| Enterococcal infectionInfections and infestations | 0/68 | 1/68 |
| Event | Placebo | Mepolizumab 300mg |
|---|---|---|
| HeadacheNervous system disorders | 12/68 | 22/68 |
| NasopharyngitisInfections and infestations | 16/68 | 12/68 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 12/68 | 15/68 |
| SinusitisInfections and infestations | 11/68 | 14/68 |
| Upper respiratory tract infectionInfections and infestations | 11/68 | 14/68 |
| NauseaGastrointestinal disorders | 13/68 | 11/68 |
| DiarrhoeaGastrointestinal disorders | 8/68 | 12/68 |
| VomitingGastrointestinal disorders | 4/68 | 11/68 |
| FatigueGeneral disorders | 10/68 | 10/68 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 7/68 | 10/68 |
| Age, Continuous(Years) | Placebo | Mepolizumab 300mg | Total |
|---|---|---|---|
| Mean | 48.2 ± 14.32 | 48.7 ± 12.39 | 48.5 ± 13.34 |
| Sex: Female, Male(Participants) | Placebo | Mepolizumab 300mg | Total |
|---|---|---|---|
| Female | 38 | 42 | 80 |
| Male | 30 | 26 | 56 |
| Race/Ethnicity, Customized(Participants) | Placebo | Mepolizumab 300mg | Total |
|---|---|---|---|
| Race customized — American Indian or Alaskan Native | 0 | 1 | 1 |
| Race customized — Asian - Japanese Heritage | 3 | 3 | 6 |
| Race customized — Asian - South East Asian Heritage | 2 | 0 | 2 |
| Race customized — White - Arabic/North African Heritage | 0 | 2 | 2 |
| Race customized — White - White/Caucasian/European Heritage | 61 | 62 | 123 |
| Race customized — Mixed Race | 2 | 0 | 2 |
Ran from Feb 2014 to primary completion in Sep 2016, 31 months.
Results were first posted in Jan 2018, 1 year 4 months after primary completion.
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Studies of the drug tested here: Mepolizumab