A Study of Benralizumab in Patients With Eosinophilic Esophagitis (MESSINA)
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|ClinicalTrials.gov Identifier: NCT04543409|
Recruitment Status : Recruiting
First Posted : September 10, 2020
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis||Biological: Benralizumab Biological: Matching placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis|
|Actual Study Start Date :||September 22, 2020|
|Estimated Primary Completion Date :||March 8, 2022|
|Estimated Study Completion Date :||November 14, 2023|
Benralizumab active solution will be administered SC to patients by healthcare professionals in this clinical study using an accessorized prefilled syringe (APFS)
Solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
Placebo Comparator: Placebo
Placebo solution will be administered SC to patients by healthcare professionals in this clinical study using an accessorized prefilled syringe (APFS)
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
- Proportion of patients with a histologic response at Week 24, defined as a peak esophageal intraepithelial eosinophil count ≤ 6 eos/hpf. [ Time Frame: Week 24 ]
- Changes from baseline in Dysphagia Symptom Questionnaire (DSQ) [ Time Frame: Week 24 ]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.
- Changes from baseline in Endoscopic Reference Score (EREFS) [ Time Frame: Week 24 ]EREFS is a scoring system for assessing the presence and severity of the major endoscopic signs of EoE.The score ranges from 0 (normal) to 9 (severe disease).
- Esophageal histopathology findings [ Time Frame: Week 24 ]Histopathology findings analyzed by Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS). EoE-HSS assesses the severity (grade) and extent (stage) of abnormalities using a 4-point scale (0 normal; 3 maximum change)
- Dysphagia-free days [ Time Frame: Week 24 ]Dysphagia free days is a count ranging from 0-28. Higher counts indicate better outcomes.
- Frequency of dysphagia episodes as captured by the Eosinophilic Esophagitis Daily Dysphagia Diary (EoE-3D) [ Time Frame: Week 24 ]EoE-3D is a daily diary focused on the patient experience of EoE. The dysphagia-associated pain, discomfort, and overall severity scores range from 0 to 10, with higher scores meaning worse outcomes.
- Changes from baseline in dysphagia associated pain, discomfort, and overall severity as captured by the EoE-3D [ Time Frame: Week 24 ]
- Changes from baseline in abdominal pain and nausea as captured by the daily diary. [ Time Frame: Week 24 ]
- Changes from baseline in Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EOE-QoL-A) [ Time Frame: Week 24 ]The Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EoE-QoL-A) is a 30-item assessment developed specifically to measure health-related quality of life in patients with EoE. The overall score ranges from 0 to 96, with higher scores meaning better quality of life.
- Change from baseline in Short Form 36-item health survey (version 2, acute recall) (SF-36v2) [ Time Frame: Week 24 ]The Short Form 36-item Health Survey, version 2, acute recall (SF-36v2) is a 36-item, self-report survey of functional health and well-being, with a 1-week recall period. There are 8 domain scores: Physical Functioning (PF), Role Limitations due to Physical Health (RP), Bodily Pain (BP), General Health Perceptions (GH), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (RE), and Mental Health (MH). All scores range from 0-100, with higher scores meaning better outcomes.
- Healthcare resource utilization [ Time Frame: Week 24 ]Percent of patients with relevant concomitant procedures and healthcare resource utilization during the study through Week 24.
- Patient reported overall severity of disease as measured by Patient Global Impression of Severity (PGI-S) [ Time Frame: Week 24 ]Patient Global Impression of Severity (PGI-S) is an assessment of the patient's perceived disease severity. The answer options are "no symptoms," "very mild," "mild," "moderate," "severe," and "very severe."
- Patient reported change in health status since baseline as measured by Patient Global Impression of Change (PGI-C) [ Time Frame: Week 24 ]Patient Global Impression of Change (PGI-C) measures the patient's overall impression of response to treatment since the initial dose. The answer options are "much better," "moderately better," "a little better," "about the same/no change," "a little worse," "moderately worse," and "much worse."
- Benralizumab Pharmacokinetics [ Time Frame: Minimum of 52 weeks ]Serum concentrations of benralizumab.
- Immunogenicity of benralizumab [ Time Frame: Minimum of 52 weeks ]Immunogenicity of benralizumab assessed by ADA and nAb.
- Safety and tolerability [ Time Frame: Minimum of 52 weeks ]- Percentage of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543409
|Contact: AstraZeneca Clinical Study Information Centeremail@example.com|
|Principal Investigator:||Marc E. Rothenberg, MD, PhD||Children's Hospital Medical Center, Cincinnati|