Trial · NCT04543409
A Study of Benralizumab in Patients With Eosinophilic Esophagitis
NCT04543409, Phase 3, Terminated, AstraZeneca; results first posted 2023-11-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Benralizumab in Patients With Eosinophilic Esophagitis. Trials, record NCT04543409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04543409
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Benralizumab in Patients With Eosinophilic Esophagitis
- NCT number
- NCT04543409
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 211 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Eosinophilic Esophagitis
- Interventions
- Benralizumab, Matching placebo
- First posted
- 2020-09-10
- Last updated
- 2023-11-18
- Other registries' IDs
- eudract:2019-002871-32
- Results first posted
- 2023-11-18
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With a Histologic Response, Defined as a Peak Esophageal Intraepithelial Eosinophil Count ≤ 6 Eos/Hpf. | Week 24, Week 52 | Percentage of patients with a histologic response at Week 24 and Week 52. A histologic response is defined as a peak esophageal intraepithelial eosinophil count \<= 6 eos/hpf across all available esophageal levels. Subjects with no biopsy data at Week 24 or with intercurrent events prior to Week 24 such as changes to background medications or additional new therapies for EoE are considered non-responders. The number analyzed represents the number of participants in the treatment group that could have made it to the timepoint by the data cut off. |
| Primary | Changes From Baseline in Dysphagia Symptom Questionnaire (DSQ) | Week 24, Week 52 | 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. At least 8 days with evaluable daily score in 14-day period are required; otherwise the DSQ score for the period is set to missing. The number analyzed represents the number of participants with data at that visit (including patients with imputed values post intercurrent events). |
| Secondary | Percent Change From Baseline in Tissue Eosinophils | Week 24, Week 52 | Percent change from baseline in tissue eosinophils (eos) at Week 24 and Week 52. The number analyzed represents the number of participants with data at that visit (including imputed values). |
| Secondary | Change From Baseline in Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS) Total Grade Score at Week 24 | Week 24 | EoE-HSS Grade and Stage Scores evaluate eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Total grade score (TGS): mean of the grade score ratios per region. Grade score ratio per region is the sum of all available feature grade scores divided by the maximum possible score. The maximum possible total grade score is 1. The number analyzed represents the number of participants with data at that visit (including imputed values). |
| Secondary | Change From Baseline in Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS) Total Stage Score at Week 24 | Week 24 | EoE-HSS Grade and Stage Scores evaluate eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, and lamina propria fibrosis. Severity (grade) and extent (stage) of abnormalities will be scored using a 4-point scale (0 normal; 3 maximum change). Total stage score (TSS): mean of the stage score ratios per region. Stage score ratio per region is the sum of all available feature stage scores divided by the maximum possible score. The maximum possible total stage score is 1. The number analyzed represents the number of participants with data at that visit (including imputed values). |
| Secondary | Changes From Baseline in Centrally-read Endoscopic Reference Score (EREFS) | Week 24, Week 52 | 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). EREFS total score (TS): The worst score for each individual component from the proximal and distal scores were summed to form the EREFS total score (TS). The number analyzed represents the number of participants with data at that visit (including patients with imputed values post intercurrent events). |
| Secondary | Treatment Responder Rate at Week 24, Defined as a Composite of Histological Response (≤6eos/Hpf) and Clinically Meaningful Improvement From Baseline in Dysphagia Symptom Questionnaire (DSQ) (30% Improvement) at Week 24 | Week 24 | Percentage of participants with a treatment response at Week 24. A treatment response is defined as composite of histologic response and clinically meaningful improvement (30% reduction) from baseline in DSQ score. Participants with missing data at Week 24 or with intercurrent events prior to Week 24 are considered non-responders. |
| Secondary | Centrally-read Biopsies for Additional Histopathology Including Tissue Eosinophil Counts at Week 24 | Week 24 | Esophagogastroduodenoscopy biopsies were collected at week 24 and sent to the central lab for slide preparation and for central, blinded pathology review of tissue eosinophil counts and histopathology. Centralized slide assessments and scoring from an independent physician review was performed for all biopsies. |
| Secondary | Dysphagia-free Days as Captured by the Dysphagia Symptom Questionnaire (DSQ) | Week 24, Week 52 | Dysphagia free days is a count ranging from 0-28. Higher counts indicate better outcomes. The number analyzed represents the number of participants with data at that visit. |
| Secondary | Frequency of Dysphagia Episodes as Captured by the Eosinophilic Esophagitis Daily Dysphagia Diary (EoE-3D) | Week 24, Week 52 | EoE-3D is a daily diary focused on the patient experience of EoE. Dysphagia episode frequency is summarized as the total number of dysphagia episodes occurring over each 28-day period following randomization, scaled up to 28 days based on missing days. Requires at least 8 days of evaluable data in each 14-day period within each 28-day period; otherwise the period is set to missing. The number analyzed represents the number of participants with data at that visit. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With a Histologic Response, Defined as a Peak Esophageal Intraepithelial Eosinophil Count ≤ 6 Eos/Hpf. | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Percentage of Participants | NUMBER |
| PRIMARY | Changes From Baseline in Dysphagia Symptom Questionnaire (DSQ) | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Score | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Tissue Eosinophils | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS) Total Grade Score at Week 24 | Week 24 | Full analysis set (All randomized participants who received at least one dose of IP). | Grade Score Ratio Change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Eosinophilic Esophagitis-Histology Scoring System (EoE-HSS) Total Stage Score at Week 24 | Week 24 | Full analysis set (All randomized participants who received at least one dose of IP). | Grade Score Ratio Change | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Centrally-read Endoscopic Reference Score (EREFS) | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Score | LEAST_SQUARES_MEAN |
| SECONDARY | Treatment Responder Rate at Week 24, Defined as a Composite of Histological Response (≤6eos/Hpf) and Clinically Meaningful Improvement From Baseline in Dysphagia Symptom Questionnaire (DSQ) (30% Improvement) at Week 24 | Week 24 | Full analysis set (All randomized participants who received at least one dose of IP). | Percentage of Participants | NUMBER |
| SECONDARY | Centrally-read Biopsies for Additional Histopathology Including Tissue Eosinophil Counts at Week 24 | Week 24 | Full analysis set (All randomized participants who received at least one dose of IP). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dysphagia-free Days as Captured by the Dysphagia Symptom Questionnaire (DSQ) | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Days | MEAN |
| SECONDARY | Frequency of Dysphagia Episodes as Captured by the Eosinophilic Esophagitis Daily Dysphagia Diary (EoE-3D) | Week 24, Week 52 | Full analysis set (All randomized participants who received at least one dose of IP). | Ratio of Episodes per 28 Day period | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group228
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With a Histologic Response, Defined as a Peak Esophageal Intraepithelial Eosinophil Count ≤ 6 Eos/Hpf. | Benralizumab | Week 24 | 87.4 | 95% Confidence Interval 80.97 to 93.79 | Percentage of Participants |
| Percentage of Patients With a Histologic Response, Defined as a Peak Esophageal Intraepithelial Eosinophil Count ≤ 6 Eos/Hpf. | Placebo | Week 24 | 6.5 | 95% Confidence Interval 1.86 to 11.23 | Percentage of Participants |
| Percentage of Patients With a Histologic Response, Defined as a Peak Esophageal Intraepithelial Eosinophil Count ≤ 6 Eos/Hpf. | Benralizumab | Week 52 | 82.6 | 95% Confidence Interval 71.66 to 93.56 | Percentage of Participants |
| Percentage of Patients With a Histologic Response, Defined as a Peak Esophageal Intraepithelial Eosinophil Count ≤ 6 Eos/Hpf. | Placebo | Week 52 | 89.4 | 95% Confidence Interval 80.55 to 98.18 | Percentage of Participants |
| Changes From Baseline in Dysphagia Symptom Questionnaire (DSQ) | Benralizumab | Week 24 | -12.102 | 95% Confidence Interval -16.05 to -8.15 | Score |
| Changes From Baseline in Dysphagia Symptom Questionnaire (DSQ) | Placebo | Week 24 | -15.101 | 95% Confidence Interval -19.02 to -11.19 | Score |
| Changes From Baseline in Dysphagia Symptom Questionnaire (DSQ) | Benralizumab | Week 52 | -19.409 | 95% Confidence Interval -25.65 to -13.17 | Score |
| Changes From Baseline in Dysphagia Symptom Questionnaire (DSQ) | Placebo | Week 52 | -19.806 | 95% Confidence Interval -25.70 to -13.91 | Score |
| Percent Change From Baseline in Tissue Eosinophils | Benralizumab | Week 24 | -94.8 | 95% Confidence Interval -100.00 to -82.45 | Percentage of change |
| Percent Change From Baseline in Tissue Eosinophils | Placebo | Week 24 | 1.4 | 95% Confidence Interval -11.75 to 14.60 | Percentage of change |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment Period | STARTED | Benralizumab | 103 | |
| Double-Blind Treatment Period | STARTED | Placebo | 107 | |
| Double-Blind Treatment Period | COMPLETED | Benralizumab | 101 | |
| Double-Blind Treatment Period | COMPLETED | Placebo | 106 | |
| Double-Blind Treatment Period | NOT COMPLETED | Benralizumab | 2 | |
| Double-Blind Treatment Period | NOT COMPLETED | Placebo | 1 | |
| Open-Label Treatment Period | STARTED | Benralizumab | 100 | |
| Open-Label Treatment Period | STARTED | Placebo | 105 | |
| Open-Label Treatment Period | COMPLETED | Benralizumab | 79 | |
| Open-Label Treatment Period | COMPLETED | Placebo | 82 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events93
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 | Nasopharyngitis | Infections and infestations | Benra 30 mg | 12 | 103 | 20 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 6 | 107 | 6 |
| other | Nasopharyngitis | Infections and infestations | All Benra | 19 | 208 | 29 |
| other | Pharyngitis | Infections and infestations | Benra 30 mg | 5 | 103 | 5 |
| other | Pharyngitis | Infections and infestations | Placebo | 0 | 107 | 0 |
| other | Pharyngitis | Infections and infestations | All Benra | 5 | 208 | 5 |
| other | Upper respiratory tract infection | Infections and infestations | Benra 30 mg | 4 | 103 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 5 | 107 | 6 |
| other | Upper respiratory tract infection | Infections and infestations | All Benra | 8 | 208 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | Benra 30 mg | 2 | 103 | 2 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benra 30 mg | 0 | 103 |
| Total, all-cause mortality | Placebo | 0 | 107 |
| Total, all-cause mortality | All Benra | 0 | 208 |
| Total, other adverse events | Benra 30 mg | 60 | 103 |
| Total, other adverse events | Placebo | 42 | 107 |
| Total, other adverse events | All Benra | 95 | 208 |
| Total, serious adverse events | Benra 30 mg | 4 | 103 |
| Total, serious adverse events | Placebo | 1 | 107 |
| Total, serious adverse events | All Benra | 9 | 208 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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/NCT04543409
GET https://conductscience.org/api/trials/v1/NCT04543409/registered?page=2