NCT00358449

Intravenous Mepolizumab In Children With Eosinophilic Esophagitis

Completed Phase 2 Results posted Last updated 24 July 2018

What this trial tests

Phase 2 trial testing mepolizumab in Oesophagitis, Eosinophilic in 84 participants. Completed in 25 November 2008.

Timeline

11 September 2006

Primary endpoint
25 November 2008

25 November 2008

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	84
Start date	11 September 2006
Primary completion	25 November 2008
Estimated completion	25 November 2008
Sites	29 locations across United Kingdom, Canada, United States, Australia

Drugs / interventions tested

• mepolizumab (MEPOLIZUMAB) — full drug profile →

Conditions studied

• Oesophagitis, Eosinophilic — all drugs for Oesophagitis, Eosinophilic →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 2 to 17, any sex, with Oesophagitis, Eosinophilic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) Primary · From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is defined as any untoward medical occurrence that, at any dose that Results in death, life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; a congenital anomaly/birth defect. Drug-related AE's were considered to have a reasonable possibility of being related to treatment by the investigator. AE, SAE and drug-related

Any AE, TP

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	18
Mepolizumab 2.5 mg/kg	15
Mepolizumab 10 mg/kg	18

Any AE, FP

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	15
Mepolizumab 2.5 mg/kg	9
Mepolizumab 10 mg/kg	10

Drug-Related AE, TP

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	6
Mepolizumab 2.5 mg/kg	4
Mepolizumab 10 mg/kg	3

Drug-Related AE, FP

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	3
Mepolizumab 2.5 mg/kg	0
Mepolizumab 10 mg/kg	0

Any SAE, TP

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0
Mepolizumab 2.5 mg/kg	1
Mepolizumab 10 mg/kg	2

Any SAE, FP

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0
Mepolizumab 2.5 mg/kg	0
Mepolizumab 10 mg/kg	1

Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. Primary · From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)

Blood samples were collected at Day 1, Weeks 4, 8, 12, 16, 20 and 24 to estimate the following biochemistry parameters: alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (Ab), total protein (ToP), creatinine (Cr), total bilirubin (TB), calcium (Ca), bicarbonate (Bi), chloride (Cl), glucose (Glu), potassium (Pot), and sodium (Sod). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value

ALT - RR High, n=19 ,20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	3
Mepolizumab 2.5 mg/kg	0
Mepolizumab 10 mg/kg	3

ALT - RR Low, n=19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	1
Mepolizumab 2.5 mg/kg	0
Mepolizumab 10 mg/kg	1

AST - RR High, n=19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	5
Mepolizumab 2.5 mg/kg	4
Mepolizumab 10 mg/kg	7

AST - RR Low, n=19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0
Mepolizumab 2.5 mg/kg	2
Mepolizumab 10 mg/kg	0

Ab - RR High, n=19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	5
Mepolizumab 2.5 mg/kg	1
Mepolizumab 10 mg/kg	2

Ab - RR Low, n=19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	4
Mepolizumab 2.5 mg/kg	3
Mepolizumab 10 mg/kg	5

ToP - RR High, n=19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0
Mepolizumab 2.5 mg/kg	2
Mepolizumab 10 mg/kg	1

ToP - RR Low, n=19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	6
Mepolizumab 2.5 mg/kg	4
Mepolizumab 10 mg/kg	6

Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. Primary · From first dose of study treatment (Day 1) up to Long-term Follow-up Phase (Week 34)

Blood samples were collected pre-infusion at Day 1, Week 4 and Week 8; and 24h and 72h post-infusion at Day 1, Week 4 and Week 8 time points and at Weeks 2, 6, 10, 12, 16, 20, 24, and 34 to estimate the following hematology parameters: basophils (Bas), percentage of basophils (% Bas), lymphocytes (Lym), percentage of Lym (% Lym), monocytes (Mon), percentage of Mon (% Mon), platelet count (PC), total neutrophils (TN), percentage of TN (% TN), white blood cell count (WBC), hematocrit (He), hemoglobin (Hg), and red blood cell count (RBC). Laboratory abnormalities outside the reference range (high

Bas - RR High

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	1
Mepolizumab 2.5 mg/kg	2
Mepolizumab 10 mg/kg	0

Bas - RR Low

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0
Mepolizumab 2.5 mg/kg	0
Mepolizumab 10 mg/kg	0

% Bas - RR High

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0
Mepolizumab 2.5 mg/kg	3
Mepolizumab 10 mg/kg	3

% Bas - RR Low

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0
Mepolizumab 2.5 mg/kg	0
Mepolizumab 10 mg/kg	0

Lym - RR High

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0
Mepolizumab 2.5 mg/kg	1
Mepolizumab 10 mg/kg	0

Lym - RR Low

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	1
Mepolizumab 2.5 mg/kg	0
Mepolizumab 10 mg/kg	0

% Lym -RR High

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	12
Mepolizumab 2.5 mg/kg	10
Mepolizumab 10 mg/kg	12

% Lym -RR Low

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	2
Mepolizumab 2.5 mg/kg	1
Mepolizumab 10 mg/kg	4

Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline Primary · Screening, Weeks 4, 8 and 12

12-lead ECG assessments were obtained at the following time points: screening, and Weeks 4, 8 and 12.. Overall ECG findings were summarized using the worst case findings without regard to visits ie. "any time post Baseline". Change from Baseline in ECG findings were categorized as clinically significant change from Baseline; no clinically significant change from Baseline and not applicable.

Clinically significant change from

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	1
Mepolizumab 2.5 mg/kg	0
Mepolizumab 10 mg/kg	0

No clinically significant change from

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	18
Mepolizumab 2.5 mg/kg	20
Mepolizumab 10 mg/kg	20

Not applicable

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0
Mepolizumab 2.5 mg/kg	0
Mepolizumab 10 mg/kg	0

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points Primary · Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24

SBP and DBP measurements were obtained at the following time points: screening, pre-infusion, 10 minutes (m), 30m, 1 hour (h), 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

SBP, Day 1 pre-infusion, n= 19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	1.2	± 10.65
Mepolizumab 2.5 mg/kg	3.4	± 16.10
Mepolizumab 10 mg/kg	7.4	± 14.09

SBP, Day 1, 10m, n= 19, 20, 19

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-3.2	± 10.82
Mepolizumab 2.5 mg/kg	0.8	± 12.16
Mepolizumab 10 mg/kg	4.8	± 15.27

SBP, Day 1, 30m, n= 19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-1.7	± 11.94
Mepolizumab 2.5 mg/kg	1.6	± 12.75
Mepolizumab 10 mg/kg	5.4	± 15.53

SBP, Day 1, 1h, n= 19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	1.1	± 13.68
Mepolizumab 2.5 mg/kg	2.0	± 13.45
Mepolizumab 10 mg/kg	3.6	± 14.55

SBP, Day 1, 2h, n= 19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-0.6	± 10.32
Mepolizumab 2.5 mg/kg	2.8	± 10.08
Mepolizumab 10 mg/kg	2.7	± 15.92

SBP, Week 4 pre-infusion, n= 19, 20, 19

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	4.2	± 8.74
Mepolizumab 2.5 mg/kg	0.2	± 11.04
Mepolizumab 10 mg/kg	5.7	± 12.67

SBP, Week 4, 10m, n= 19, 20, 19

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-1.7	± 11.32
Mepolizumab 2.5 mg/kg	-0.8	± 15.93
Mepolizumab 10 mg/kg	3.2	± 13.62

SBP, Week 4, 30m, n= 19, 19, 19

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	1.2	± 10.71
Mepolizumab 2.5 mg/kg	-4.1	± 15.26
Mepolizumab 10 mg/kg	2.5	± 16.33

Change From Baseline in Heart Rate at the Indicated Time Points Primary · Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24

Heart rate measurements were obtained at the following time points: Screening, pre-infusion, 10m, 30m, 1h, 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Day 1 pre-infusion, n= 19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0.7	± 10.29
Mepolizumab 2.5 mg/kg	4.0	± 12.21
Mepolizumab 10 mg/kg	2.3	± 10.76

Day 1, 10m, n= 19, 20, 19

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-3.6	± 9.39
Mepolizumab 2.5 mg/kg	1.7	± 15.36
Mepolizumab 10 mg/kg	0.1	± 12.34

Day 1, 30m, n= 19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-2.5	± 13.02
Mepolizumab 2.5 mg/kg	3.5	± 14.36
Mepolizumab 10 mg/kg	1.9	± 11.56

Day 1, 1h, n= 19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-4.2	± 11.51
Mepolizumab 2.5 mg/kg	3.0	± 13.56
Mepolizumab 10 mg/kg	0.9	± 15.40

Day 1, 2h, n= 19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	1.6	± 11.31
Mepolizumab 2.5 mg/kg	4.7	± 15.08
Mepolizumab 10 mg/kg	-0.5	± 12.53

Week 4 pre-infusion, n= 19, 20, 19

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0.4	± 19.19
Mepolizumab 2.5 mg/kg	2.0	± 13.13
Mepolizumab 10 mg/kg	1.4	± 14.56

Week 4, 10m, n= 19, 20, 19

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-0.9	± 13.56
Mepolizumab 2.5 mg/kg	-1.6	± 11.93
Mepolizumab 10 mg/kg	-4.8	± 14.83

Week 4, 30m, n= 19, 19, 19

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-1.4	± 15.36
Mepolizumab 2.5 mg/kg	-4.3	± 13.67
Mepolizumab 10 mg/kg	-4.0	± 9.71

Change From Baseline in Temperature at the Indicated Time Points Primary · Screening, Day 1, Weeks 4, 8, 12, 16, 20 and 24

Temperature measurements were obtained at the following time points: Screening, Day 1, and Weeks 4, 8, 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Day 1, n=19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-0.18	± 0.472
Mepolizumab 2.5 mg/kg	0.01	± 0.824
Mepolizumab 10 mg/kg	-0.07	± 0.758

Week 4, n=19, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-0.44	± 1.023
Mepolizumab 2.5 mg/kg	-0.30	± 0.614
Mepolizumab 10 mg/kg	-0.14	± 0.909

Week 8, n=19, 20, 19

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-0.44	± 0.490
Mepolizumab 2.5 mg/kg	-0.13	± 0.696
Mepolizumab 10 mg/kg	-0.06	± 0.819

Week 12, n=18, 20, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0.03	± 0.661
Mepolizumab 2.5 mg/kg	-0.09	± 0.671
Mepolizumab 10 mg/kg	-0.08	± 0.914

Week 16, n=15, 17, 20

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-0.01	± 0.518
Mepolizumab 2.5 mg/kg	0.05	± 0.491
Mepolizumab 10 mg/kg	0.02	± 0.753

Week 20, n=15, 18, 18

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	0.00	± 0.626
Mepolizumab 2.5 mg/kg	-0.12	± 0.696
Mepolizumab 10 mg/kg	-0.12	± 0.644

Week 24, n=17, 20, 19

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-0.11	± 0.506
Mepolizumab 2.5 mg/kg	-0.31	± 0.668
Mepolizumab 10 mg/kg	-0.12	± 0.826

Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. Primary · Day 1, Weeks 4, 8, 12, 24, and 34

Blood samples for testing anti-mepolizumab antibodies were collected on Day 1, Week 4 and 8 Infusion Visit (before the IV infusion) and at Week 12, 24 and 34 Week follow-up visits. The presence of anti-human mepolizumab antibodies was assessed using an immunoelectrochemiluminescent (ECL) assay. To address transient positive results, an assessment of repeated results were made. For any visit category: results were considered as positive if it was positive at any visit during the study, and results were considered as negative if it were negative at all visits during the study. For repeat visit c

Any Visit- ECL Screening Positive

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	15
Mepolizumab 2.5 mg/kg	15
Mepolizumab 10 mg/kg	16

Any Visit- ECL Screening Negative

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	4
Mepolizumab 2.5 mg/kg	5
Mepolizumab 10 mg/kg	4

Repeat Visit-ECL Screening Positive

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	13
Mepolizumab 2.5 mg/kg	5
Mepolizumab 10 mg/kg	7

Repeat Visit-ECL Screening Negative

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	6
Mepolizumab 2.5 mg/kg	15
Mepolizumab 10 mg/kg	13

Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12 Primary · Week 12

A responder was defined as a participant achieving a reduction in esophageal eosinophils to \<5 cells per HPF as the highest count of eosinophils per HPF in all the esophageal sites biopsied at Week 12, confirmed by biopsy at Week 12 or at an early withdrawal visit prior to Week 12. A worst case (WC) approach was considered, if a particiapant withdrew prematurely : If a particiapnt dropped out of the study without having a biopsy taken, due to lack of efficacy or an adverse event, their response was imputed as not achieved. Participants who withdrew, without a biopsy, for other reasons (e.g. l

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	3
Mepolizumab 2.5 mg/kg	2
Mepolizumab 10 mg/kg	0

Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab Primary · Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34

Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug. Central volume of distribution is a hypothetical volume into which a drug initially distributes upon administration. Peripheral volume of distribution is the sum of all tissue spaces outside the central compartment. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Week

Central volume of distribution (V1)

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	2.00	1.62 – 2.48
Mepolizumab 2.5 mg/kg	2.29	1.76 – 2.98
Mepolizumab 10 mg/kg	2.14	1.60 – 2.88

Peripheral Volume of distribution (V2)

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	1.36	1.10 – 1.69
Mepolizumab 2.5 mg/kg	1.55	1.19 – 2.03
Mepolizumab 10 mg/kg	1.46	1.09 – 1.96

Steady-State Volume of distribution (Vss)

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	3.37	2.72 – 4.17
Mepolizumab 2.5 mg/kg	3.84	2.95 – 5.00
Mepolizumab 10 mg/kg	3.60	2.68 – 4.84

Plasma Clearance (CL) of Mepolizumab Primary · Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34

Clearance is defined as the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate plasma clearance of mepolizumab.

Group	Value	95% CI
Mepolizumab 0.55/ 2.5/ 10 mg/kg	0.14	0.11 – 0.18
Mepolizumab 2.5 mg/kg	0.15	0.12 – 0.19
Mepolizumab 10 mg/kg	0.14	0.12 – 0.18

Change From Baseline in Pain in Stomach Severity Scores Secondary · Screening, Weeks 9-12 and Weeks 21-24

Par.and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in stomach was not experienced. If pain in stomach was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) div

Weeks 9-12, n= 15,18,13

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-0.277	-0.617 – 0.062
Mepolizumab 2.5 mg/kg	-0.149	-0.412 – 0.115
Mepolizumab 10 mg/kg	-0.157	-0.458 – 0.144

Weeks 21-24, n=13,16,11

Group	Value	95% CI
Mepolizumab 0.55 mg/kg	-0.479	-0.942 – 0.016
Mepolizumab 2.5 mg/kg	-0.144	-0.467 – 0.178
Mepolizumab 10 mg/kg	-0.268	-0.677 – 0.142

Adverse events — posted to ClinicalTrials.gov

Time frame: On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the date of the first dose of study medication up to the Week 12.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Mepolizumab 0.55 mg/kg

Serious: 0/19 (0%)

Deaths: —

Mepolizumab 2.5 mg/kg

Serious: 1/20 (5%)

Deaths: —

Mepolizumab 10 mg/kg

Serious: 2/20 (10%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Mepolizumab 0.55 mg/kg	Mepolizumab 2.5 mg/kg	Mepolizumab 10 mg/kg
Foreign body trauma	Injury, poisoning and procedural complications	—	—	—
Oesophageal injury	Injury, poisoning and procedural complications	—	—	—
Chest discomfort	General disorders	—	—	—

Other adverse events (121 terms — click to expand)

Reaction	System	Mepolizumab 0.55 mg/kg	Mepolizumab 2.5 mg/kg	Mepolizumab 10 mg/kg
Any event	Gastrointestinal disorders	—	—	—
Any event	Infections and infestations	—	—	—
Any event	Respiratory, thoracic and mediastinal disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Any event	Nervous system disorders	—	—	—
Any event	Skin and subcutaneous tissue disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Any event	General disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Pyrexia	General disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Any event	Injury, poisoning and procedural complications	—	—	—
Any event	Immune system disorders	—	—	—
Influenza	Infections and infestations	—	—	—
Sinusitis	Infections and infestations	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—
Otitis media	Infections and infestations	—	—	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Chest pain	General disorders	—	—	—
Seasonal allergy	Immune system disorders	—	—	—
Any event	Renal and urinary disorders	—	—	—
Any event	Eye disorders	—	—	—
Any event	Musculoskeletal and connective tissue disorders	—	—	—
Any event	Blood and lymphatic system disorders	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—
Any event	Reproductive system and breast disorders	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—
Eosinophilic oesophagitis	Gastrointestinal disorders	—	—	—
Faeces discoloured	Gastrointestinal disorders	—	—	—

Most-reported serious reactions: Foreign body trauma, Oesophageal injury, Chest discomfort.

Data from ClinicalTrials.gov NCT00358449 adverse events section.

Sponsor's own description

This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the Interleukin-5 Pathway for Treatment of Eosinophilic Conditions Other than Asthma.
   Roufosse F. · · 2018 · cited 130× · PMID 29682504 · DOI 10.3389/fmed.2018.00049
2. Anti-IL-5 therapy reduces mast cell and IL-9 cell numbers in pediatric patients with eosinophilic esophagitis.
   Otani IM, Anilkumar AA, Newbury RO, Bhagat M, et al · · 2013 · cited 127× · PMID 23623266 · DOI 10.1016/j.jaci.2013.02.042
3. The link between allergies and eosinophilic esophagitis: implications for management strategies.
   Brown-Whitehorn TF, Spergel JM. · · 2010 · cited 31× · PMID 20161677 · DOI 10.1586/eci.09.74
4. Medical treatment of eosinophilic esophagitis.
   Franciosi JP, Gordon M, Sinopoulou V, Dellon ES, et al · · 2023 · cited 25× · PMID 37470293 · DOI 10.1002/14651858.cd004065.pub4
5. Mepolizumab: 240563, anti-IL-5 monoclonal antibody - GlaxoSmithKline, anti-interleukin-5 monoclonal antibody - GlaxoSmithKline, SB 240563.
   · 2008 · cited 18× · PMID 18298130 · DOI 10.2165/00126839-200809020-00006
6. From Pathogenesis to Treatment: Targeting Type-2 Inflammation in Eosinophilic Esophagitis.
   Barchi A, Mandarino FV, Yacoub MR, Albarello L, et al · · 2024 · cited 8× · PMID 39334846 · DOI 10.3390/biom14091080
7. Predictors of histologic response to mepolizumab in pediatric eosinophilic esophagitis.
   Wong ECL, Gleave AL, Marshall JK, Narula N. · · 2023 · cited 3× · PMID 37577798 · DOI 10.1097/meg.0000000000002623
8. Biologic Therapies Targeting Eosinophilic Gastrointestinal Diseases.
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