Trial · NCT03656380

Mepo for Eosinophilic Esophagitis (EoE) Study

NCT03656380, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2023-06-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Mepo for Eosinophilic Esophagitis (EoE) Study. Trials, record NCT03656380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03656380

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Mepo for Eosinophilic Esophagitis (EoE) Study
NCT number: NCT03656380
Status: Completed
Phases: Phase 2
Enrollment: 66 participants, actual
Lead sponsor: University of North Carolina, Chapel Hill
Conditions: EoE, Eosinophilic Esophagitis
Interventions: Mepolizumab 300 mg, Mepolizumab 100 mg, Placebo
First posted: 2018-09-04
Last updated: 2023-08-23
Results first posted: 2023-06-23

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change in Dysphagia Score	Baseline, Month 3 Post-Treatment	Dysphagia will be assessed by the Eosinophilic Esophagitis Symptom Activity Index (EEsAI) which measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
Secondary	Percent of Participants With a Clinical Remission (EEsAI Score of ≤ 20 Points)	After 3 months of treatment	The EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
Secondary	Percent of Participants With a Clinical Response (EEsAI Score Decrease of ≥ 20 Points)	After 3 months of treatment	The EEsAI measures dysphagia frequency, dysphagia severity, and food avoidance/modification behaviors. EEsAI scores range from 0 to 100, with higher scores indicating more severe symptoms. A decrease of ≥ 20 points is felt to be a meaningful clinical response and scores ≤ 20 representing clinical remission.
Secondary	Absolute Peak Eosinophil Count	After 3 months of treatment	Absolute peak eosinophil (EOS) count (measured in EOS/hpf) after 3 months of treatment.
Secondary	Number of Participants With Histologic Response as Assessed by Eosinophils Per High Powered Field	After 3 months of treatment	Number of participants with a histologic response as assessed by having \<15, ≤ 6, and ≤ 1 Eosinophils per high powered field (EOS/hpf).
Secondary	Mean Change in Eosinophilic Esophagitis Endoscopic Reference Score (EREFS)	Baseline, 3 months post-treatment	Mean change in severity of endoscopic findings as measured by the EoE (Eosinophilic Esophagitis) Endoscopic Reference Score (EREFS). The EREFS, measures features of EoE including esophageal edema, rings, exudate, furrows, and strictures. The instrument grades edema as absent (0) or present (1); furrows as absent (0), mild (1), or severe (2); rings as absent (0), mild (1, subtle circumferential ridges), moderate (2, distinct rings) and severe (3, rings that impair passage of a standard adult diagnostic endoscope); exudates as absent (0), mild (1, less than 10% of the esophageal surface area) or severe (2, greater or equal to 10% of the esophageal surface area); and strictures as absent (0) or present (1) with an estimation of the minimal luminal diameter. Higher scores indicate more severe disease (range 0 - 9).
Secondary	Mean Change in the Straumann Dysphagia Instrument (SDI) Score	Baseline, 3 months post-treatment	The Straumann Dysphagia Instrument (SDI) is a direct measure of dysphagia frequency and severity which is completed by participants and reported over the previous week. The score ranges from 0-9, with higher scores indicating more severe dysphagia.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Mean Change in Dysphagia Score	Baseline, Month 3 Post-Treatment	score on a scale	MEAN
SECONDARY	Percent of Participants With a Clinical Remission (EEsAI Score of ≤ 20 Points)	After 3 months of treatment	percent of participants	NUMBER
SECONDARY	Percent of Participants With a Clinical Response (EEsAI Score Decrease of ≥ 20 Points)	After 3 months of treatment	percent of participants	NUMBER
SECONDARY	Absolute Peak Eosinophil Count	After 3 months of treatment	eosinophils per high power field	MEAN
SECONDARY	Number of Participants With Histologic Response as Assessed by Eosinophils Per High Powered Field	After 3 months of treatment	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Change in Eosinophilic Esophagitis Endoscopic Reference Score (EREFS)	Baseline, 3 months post-treatment	score on a scale	MEAN
SECONDARY	Mean Change in the Straumann Dysphagia Instrument (SDI) Score	Baseline, 3 months post-treatment	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Change in Dysphagia Score	Mepolizumab 300 mg		15.4	Standard Deviation 18.1	score on a scale
Mean Change in Dysphagia Score	Placebo, Followed by Mepolizumab 100 mg		8.3	Standard Deviation 18	score on a scale
Percent of Participants With a Clinical Remission (EEsAI Score of ≤ 20 Points)	Mepolizumab 300 mg		6.45		percent of participants
Percent of Participants With a Clinical Remission (EEsAI Score of ≤ 20 Points)	Placebo, Followed by Mepolizumab 100 mg		6.06		percent of participants
Percent of Participants With a Clinical Response (EEsAI Score Decrease of ≥ 20 Points)	Mepolizumab 300 mg		35.48		percent of participants
Percent of Participants With a Clinical Response (EEsAI Score Decrease of ≥ 20 Points)	Placebo, Followed by Mepolizumab 100 mg		21.21		percent of participants
Absolute Peak Eosinophil Count	Mepolizumab 300 mg		35.7	Standard Deviation 43	eosinophils per high power field
Absolute Peak Eosinophil Count	Placebo, Followed by Mepolizumab 100 mg		163	Standard Deviation 133.1	eosinophils per high power field
Number of Participants With Histologic Response as Assessed by Eosinophils Per High Powered Field	Mepolizumab 300 mg	<15 eos/hpf	13		Participants
Number of Participants With Histologic Response as Assessed by Eosinophils Per High Powered Field	Placebo, Followed by Mepolizumab 100 mg	<15 eos/hpf	1		Participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Mepolizumab 300 mg	32
Overall Study	STARTED	Placebo, Followed by Mepolizumab 100 mg	34
Overall Study	Received Intervention	Mepolizumab 300 mg	32
Overall Study	Received Intervention	Placebo, Followed by Mepolizumab 100 mg	33
Overall Study	Completed Month 3	Mepolizumab 300 mg	31
Overall Study	Completed Month 3	Placebo, Followed by Mepolizumab 100 mg	33
Overall Study	Subsequent 3 Months of Treatment (Part 2)	Mepolizumab 300 mg	28
Overall Study	Subsequent 3 Months of Treatment (Part 2)	Placebo, Followed by Mepolizumab 100 mg	28
Overall Study	Completed Month 6	Mepolizumab 300 mg	28
Overall Study	Completed Month 6	Placebo, Followed by Mepolizumab 100 mg	28

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events72

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Injection site reaction	General disorders	Mepolizumab 300 mg: Baseline to Month 3	9	32	14
other	Injection site reaction	General disorders	Placebo Only to Month 3	4	34	4
other	Injection site reaction	General disorders	Mepolizumab 300 mg Continuing to 6 Months	8	28	12
other	Injection site reaction	General disorders	Placebo Switch to Mepolizumab 100 mg: Month 3 to Month 6	5	28	5
other	Injection site bruise	General disorders	Mepolizumab 300 mg: Baseline to Month 3	1	32	2
other	Injection site bruise	General disorders	Placebo Only to Month 3	3	34	4
other	Injection site bruise	General disorders	Mepolizumab 300 mg Continuing to 6 Months	2	28	2
other	Injection site bruise	General disorders	Placebo Switch to Mepolizumab 100 mg: Month 3 to Month 6	4	28	4
other	Headache	Nervous system disorders	Mepolizumab 300 mg: Baseline to Month 3	2	32	2
other	Headache	Nervous system disorders	Placebo Only to Month 3	3	34	4

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mepolizumab 300 mg: Baseline to Month 3	0	32
Total, all-cause mortality	Placebo Only to Month 3	0	34
Total, all-cause mortality	Mepolizumab 300 mg Continuing to 6 Months	0	28
Total, all-cause mortality	Placebo Switch to Mepolizumab 100 mg: Month 3 to Month 6	0	28
Total, other adverse events	Mepolizumab 300 mg: Baseline to Month 3	13	32
Total, other adverse events	Placebo Only to Month 3	19	34
Total, other adverse events	Mepolizumab 300 mg Continuing to 6 Months	12	28
Total, other adverse events	Placebo Switch to Mepolizumab 100 mg: Month 3 to Month 6	18	28
Total, serious adverse events	Mepolizumab 300 mg: Baseline to Month 3	2	32
Total, serious adverse events	Placebo Only to Month 3	0	34

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37423717	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03656380

GET https://conductscience.org/api/trials/v1/NCT03656380/events?page=2

API reference For AI assistants