A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis

JRCT ID: jRCT2061200026

Registered date:04/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Eosinophilic Esophagitis
• Date of first enrollment: 16/12/2020
• Target sample size: 170
• Countries of recruitment: Canada,Japan,France,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Russia,Japan,Spain,Japan,UK,Japan,US,Japan
• Study type: Interventional

Intervention(s)

Biological: Benralizumab
Solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume.
Biological: Matching placebo
Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC), 1 mL fill volume

Outcome(s)

• Primary Outcome: Proportion of patients with a histologic response at Week 24, defined as a peak esophageal intraepithelial eosinophil count less or equal to 6 eos/hpf. The Dysphagia Symptom Questionnaire (DSQ) captures the presence and severity of dysphagia symptoms in the past day in a 4-item questionnaire. The DSQ score is calculated over 14-day periods and ranges from 0 to 84, with a lower score indicating less severe dysphagia.

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

- Patients 12 to 65 years of age, inclusive, at the time of signing the informed consent or assent (if applicable) form.

- Documented previous diagnosis of EoE by endoscopy.

- Must be symptomatic at Visit 1 (screening) and Visit 2 (randomization)

1. A patient reported average of at least 2 days per week with an episode of dysphagia over the 4 weeks prior to the Visit 1 AND

2. An average of at least 2 days per week with an episode of dysphagia (Daily DSQ 2 or more) between Visit 1 and Visit 2, and at least 2 days per week with an episode of dysphagia (Daily DSQ 2 or more) in each of the 2 weeks immediately prior to randomization

- May be on background medications for EoE and related treatments during the study as long as the background medications have been stable for at least 4 weeks (8 weeks for PPI) prior to the screening. and there is agreement not to change type of background medication or dosage during the run-in period and for the first 52 weeks of the study unless a change is medically indicated.

- Negative serum pregnancy test for female patients of childbearing potential at Visit1.

- Women of childbearing potential must agree to use a highly effective form of birth control (confirmed by the Investigator) from randomization throughout the study duration and within 12 weeks after last dose if IP

Exclude criteria

- Other GI disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, or celiac disease.

- Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation during the run-in period.

- Esophageal dilation performed within 8 weeks prior to screening.

- Use of a feeding tube, or not eating solid food daily during the run-in period.

- Hypereosinophilic syndrome, defined by multiple organ involvement and persistent blood eosinophil count greater than1500 eos/ micro little.

- EGPA vasculitis.

- Eosinophilic gastritis, gastroenteritis, enteritis, or colitis documented by biopsy.

- Current malignancy, or history of malignancy with some specific exceptions.

- History of anaphylaxis to any biologic therapy or vaccine.

- Current active liver disease:

_Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen [HBsAg] or hepatitis C antibody), or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria.

_Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level equal or greater than 3 times the upper limit of normal (ULN), confirmed by repeated testing during the run-in period.

- Helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent or assent (if applicable) is obtained that has not been treated with or has failed to respond to standard of care therapy.

- History of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
- Concomitant use of immunosuppressive medication.

- Initiation or change of a food-elimination diet regimen or reintroduction of a previously eliminated food group in the 6 weeks prior to start of the run-in period.

- Currently pregnant, breastfeeding, or lactating women.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT04543409