Phase 2 N=59 Randomized Double-blind Treatment

Intravenous Mepolizumab In Children With Eosinophilic Esophagitis

Oesophagitis, Eosinophilic

Bottom Line

View on ClinicalTrials.gov: NCT00358449 ↗

Enrolled (actual)

Serious AEs

5.1%

Results posted

Mar 2016

Primary outcome: Primary: 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) — 18; 15; 18; 15 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: mepolizumab (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Nov 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY 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)	18; 15; 18; 15; 9; 10	—
PRIMARY Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period.	3; 0; 3; 1; 0; 1	—
PRIMARY Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period.	1; 2; 0; 0; 0; 0	—
PRIMARY Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline	1; 0; 0; 18; 20; 20	—
PRIMARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points	1.2; 3.4; 7.4; -3.2; 0.8; 4.8	—
PRIMARY Change From Baseline in Heart Rate at the Indicated Time Points	0.7; 4.0; 2.3; -3.6; 1.7; 0.1	—
PRIMARY Change From Baseline in Temperature at the Indicated Time Points	-0.18; 0.01; -0.07; -0.44; -0.30; -0.14	—
PRIMARY Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit.	15; 15; 16; 4; 5; 4	—
PRIMARY Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12	3; 2; 0	0.865
PRIMARY Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab	2.00; 2.29; 2.14; 1.36; 1.55; 1.46	—
PRIMARY Plasma Clearance (CL) of Mepolizumab	0.14; 0.15; 0.14	—
SECONDARY Change From Baseline in Pain in Stomach Severity Scores	-0.277; -0.149; -0.157; -0.479; -0.144; -0.268	0.551
SECONDARY Change From Baseline in Pain in Chest/Throat Severity Scores	-0.419; -0.063; -0.049; -0.524; -0.091; -0.181	0.139
SECONDARY Change From Baseline in Percentage of Days With Pain in Stomach	-14.02; -12.44; -10.11; -22.80; -10.97; -7.70	0.832
SECONDARY Change From Baseline in Percentage of Days With Pain in Chest/Throat	-24.37; -5.09; -10.16; -27.12; -9.43; -6.01	0.046 sig
SECONDARY Change From Baseline in Regurgitation Bothersome Scores	-0.307; 0.017; -0.047; -0.387; -0.034; -0.563	0.241
SECONDARY Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores	-10.26; 3.80; -4.64; -13.77; 2.28; -19.19	0.123
SECONDARY Change From Baseline in Frequency of Vomiting	-0.048; 0.040; -0.060; -0.009; -0.004; 0.096	0.572
SECONDARY Change From Baseline in Percentage of Days With Vomiting	-2.40; -3.54; -4.56; 1.62; -2.98; 1.11	0.666
SECONDARY Change From Baseline in Daily Degree of Difficulty With Drinking	0.008; 0.046; -0.152; -0.137; -0.049; -0.070	0.762
SECONDARY Change From Baseline in Pain With Drinking Severity Scores	-0.005; 0.085; -0.166; -0.193; -0.006; -0.118	0.691
SECONDARY Change From Baseline in Percentage of Days on Which the Participant Drank	-0.24; -1.08; 0.66; -0.04; -1.09; -1.05	0.515
SECONDARY Change From Baseline in Difficulty With Eating Solid Foods	-0.474; -0.174; -0.119; -0.427; -0.245; -0.305	0.142
SECONDARY Change in Baseline in Pain With Eating Solid Foods Severity Scores	-0.493; -0.123; -0.137; -0.399; -0.109; -0.271	0.077
SECONDARY Change From Baseline in the Percentage of Days Participants Ate Solid Foods	3.64; 1.85; 3.05; 2.26; 0.65; 1.81	0.609
SECONDARY Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only)	-0.751; -0.238; -0.510; -0.785; -0.075; -0.535	0.062
SECONDARY Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years)	-21.56; -12.11; -17.44; -21.33; -10.76; -15.84	0.270
SECONDARY Number of Participants With Maintenance of Response	12; 18; 18; 1; 0; 2	0.400
SECONDARY Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24	-76.8; -95.2; -78.9; -26.3; -41.6; -60.1	0.421
SECONDARY Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24	-27.34; -29.97; -34.04; -8.23; -17.48; -26.03	0.747
SECONDARY Absolute Blood Eosinophils Count at the Indicated Time Points	0.441; 0.524; 0.493; 0.419; 0.476; 0.559	—
SECONDARY Plasma Concentration of Mepolizumab	11.3; 39.56; 177.94; 11.34; 42.38; 192.99	—

Summary

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

Eligibility Criteria

Inclusion Criteria

A subject will be eligible for inclusion in this study only if all of the following criteria apply. Inclusion criteria pertain to all subjects in both cohorts (treatment and observational) unless otherwise stated.
The subject signs and dates a written assent form (age appropriate) and the parent/guardian signs and dates a written informed consent form prior to the initiation of any study-related activities, including discontinuation of any prohibited medications.
Male or female subjects aged 2 to 17 years (from 2nd birthday up to and not including 18th birthday), who weigh 1.5 times upper limit of normal range (ULN). Note that this exclusion criterion does not apply for subjects who are considered for enrollment in the observational cohort.
Exhibits evidence of hepatic disease, impairment or abnormal liver function test i.e. AST, ALT >1.5 times ULN, bilirubin >1.5 times ULN. Note that this exclusion criterion does not apply for subjects who are considered for enrollment in the observational cohort.
Known evidence of the following infections/infestations: HIV, Hepatitis B or C, Bacterial infection, Parasitic infestation.
History or suspicion of current drug abuse and alcohol abuse within the last 6 months.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00358449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.