Mepo for EoE Study

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT03656380
• Date of registration: 30/08/2018
• Prospective Registration: Yes
• Primary sponsor: University of North Carolina, Chapel Hill
• Public title: Mepo for EoE Study
• Scientific title: A Multi-center, Randomized, Double Blind, Parallel-arm, Placebo Controlled Trial of Mepolizumab for Treatment of Adults and Adolescents With Active Eosinophilic Esophagitis and Dysphagia-predominant Symptoms
• Date of first enrolment: March 20, 2019
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03656380
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Evan S Dellon, MD, MPH
• Affiliation: UNC Chapel Hill

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age 16-75

- Diagnosis of EoE as per consensus guidelines (including PPI non-response)*

- Active eosinophilia on esophageal biopsy, with a peak count of least 15 EOS/hpf from
at least one esophageal level.

- Biopsies from the stomach and duodenum that have ruled out alternative etiologies in
all children and in adults with abnormal endoscopic findings or when other gastric or
small intestinal conditions are clinical possibilities. If these samples have been
obtained during a previous endoscopic evaluation and in the judgement of the
site-Investigator the patient has not had a clinically significant change that would
merit repeat gastric/duodenal biopsies, then prior normal gastric and duodenal
biopsies are acceptable to exclude alternate etiologies.

- Active symptoms of dysphagia with more than 3 episodes of dysphagia over a period of 2
weeks during the screening period, and an Eosinophilic Esophagitis Symptom Activity
Index (EEsAI; see below for details) score of = 27 at baseline.

- Able to read, comprehend, and sign consent form.

- Have maintained a stable diet for 6 weeks prior to enrollment.

- Able to maintain a stable diet throughout the duration of the study period.

- Female subjects of childbearing potential who have had their first menses agree to use
a highly effective method of birth control during the study and for 30 days after the
last dose of study drug. Female subjects with reproductive potential who are using
systemic contraceptives (e.g., oral contraceptives, injectable contraceptives,
implantable/insertable hormonal contraceptive products, or transdermal patches) to
prevent pregnancy must have stable use for =28 days prior to screening.

- PPI non-response is defined as >15 eos/hpf after at least 6 weeks of high dose
administration (40mg total per day or higher) of any approved PPI medication or
documented evidence of intolerance or allergy to PPIs. The length of the PPI
trial period or documented intolerance/allergy will be determined according to
the local clinical standard of care.

Exclusion Criteria:

- Esophageal dilation within 8 weeks of the screening endoscopy.

- Inability to pass a standard upper endoscope (8-10mm) due to esophageal narrowing or
stricturing.

- Swallowed/topical steroids for EoE within 4 weeks of the screening endoscopy, or a
course of systemic corticosteroids within 8 weeks of the screening endoscopy.

- Not having maintained a stable diet for at least 6 weeks preceding the screening
endoscopy.

- Initiation, discontinuation, or change of dose regimen of PPIs; leukotriene
inhibitors; or nasal, inhaled, and/or orally administered topical corticosteroids for
any condition (such as gastroesophageal reflux disease, asthma, or allergic rhinitis)
within the 8 weeks prior to the qualifying esophagogastroduodenoscopy (EGD).

- Presence of concomitant eosinophilic gastritis (EG), eosinophilic gastroenteritis
(EGE), eosinophilic colitis (EC), Crohn's disease, ulcerative colitis, or celiac
disease.

- History of malignancy within 5 years prior to screening, except completely treated in
situ carcinoma of the cervix and completely treated non-metastatic squamous or basal
cell carcinoma of the skin.

- History of achalasia.

- Prior esophageal surgery.

- History of bleeding disorder or esophageal varices.

- Active parasitic infection or suspicion of an active parasitic infection, which, in
the opinion of the site-Investigator, has not been previously evaluated or treated.
Subjects presenting with signs of active parasitic infection or suspicion of active
parasitic infection as assessed by current diarrhea and/or blood or mucus in stool
will be referred to their clinical physician for further testing to rule out parasitic
infection.

- Any other active infections judged at the discretion of the site-Investigator.

- Any other medical or psychological condition that, in the opinion of the
site-investigator, may present an unreasonable risk to the study patient as a result
of his/her participation in this clinical trial, may make patient's participation
unreliable, or may interfere with study assessments. The specific justification for
patients excluded under this criterion will be noted in study documents.

- Patient or his/her immediate family is a member of the investigational team.

- Pregnancy or breastfeeding.

- Women of children bearing potential who are not on highly-effective contraception.



Age minimum: 16 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

EoE

Intervention(s)

Other: Placebo

Drug: Mepolizumab 100 mg

Drug: Mepolizumab 300 mg

Primary Outcome(s)

Mean Change in Dysphagia from Baseline to 3 months Post-treatment [Time Frame: Baseline, Month 3 Post-Treatment]

Secondary Outcome(s)

Proportion of Participants with a Clinical Remission (EEsAI Score of = 20 points) after 3 months of treatment [Time Frame: After 3 months of treatment]

Proportion of Participants with a Clinical Response (EEsAI Score Decrease of = 20 points) after 3 months of treatment [Time Frame: After 3 months of treatment]

Mean change in the Straumann Dysphagia Instrument (SDI) Score from Baseline to 3 months Post-treatment [Time Frame: Baseline, 3 months post-treatment]

Absolute Peak Eosinophil count (measured in eos/hpf) after 3 months of treatment [Time Frame: After 3 months of treatment]

Histologic Response Levels after 3 Treatment Months [Time Frame: After 3 months of treatment]

Mean Change in EoE Endoscopic Reference Score (EREFS) from Baseline to 3 months Post-treatment [Time Frame: Baseline, 3 months post-treatment]

Secondary ID(s)

18-0431

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Northwestern University

University of Utah

MNGI Digestive Health, P.A.

GlaxoSmithKline