Trial · NCT05251909

Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)

NCT05251909, Phase 3, Terminated, AstraZeneca; results first posted 2025-07-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study). Trials, record NCT05251909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05251909

On this page

Trial

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

Title: Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
NCT number: NCT05251909
Status: Terminated
Phases: Phase 3
Enrollment: 12 participants, actual
Lead sponsor: AstraZeneca
Conditions: Eosinophilic Gastritis, Eosinophilic Gastroenteritis
Interventions: Benralizumab, Placebo
First posted: 2022-02-23
Last updated: 2025-07-14
Other registries' IDs: eudract:2021-000085-14
Results first posted: 2025-07-14
Limitations and caveats: Due to early termination of study limited numbers of patients was randomized and thus data not analysed on group level.

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Proportion of Patients With a Histologic Response at Week 24	at week 24	the proportion of patients achieving a histological response at Week 24, is defined as below: * 6 eosinophils/hpf in the stomach for the patients with only gastric disease at baseline. * 6 eosinophils/hpf in the stomach and ≤15 eosinophils/hpf in the duodenum for the patients with gastric + duodenal disease at baseline. * 15 eosinophils/hpf in the duodenum for the patients with only duodenal disease at baseline.
Primary	Change From Baseline in SAGED Score at Week 24	at week 24	The Symptom Assessment for Gastrointestinal Eosinophilic Diseases (SAGED) instrument was developed to measure gastrointestinal symptoms in participants diagnosed with EG/EGE. It is a daily diary completed by participants each evening from screening until week 76 to record symptoms during the past 24 hours. Severity for each concept is assessed using an 11-point numerical rating scale (0 = 'none' and 10 = 'worst imaginable'). The total SAGED score (range 0-50) is calculated as a 14-day mean of the sum of individual severity items of abdominal pain, nausea, bloating, early satiety and loss of appetite daily. Higher scores indicate greater symptom severity. Three additional items are collected that aren't part of the total SAGED score and are considered separately: severity of vomiting, severity of diarrhoea and frequency of vomiting. Change in SAGED score at week 24 is the week 24 score (study days 155 to 168) minus the baseline score (study days -14 to -1).

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Patients With a Histologic Response at Week 24	at week 24		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change From Baseline in SAGED Score at Week 24	at week 24		score	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Proportion of Patients With a Histologic Response at Week 24	Benralizumab	5		Participants
Proportion of Patients With a Histologic Response at Week 24	Placebo	0		Participants
Change From Baseline in SAGED Score at Week 24	Benralizumab	-9.59	Standard Error 7.26	score
Change From Baseline in SAGED Score at Week 24	Placebo	-13.69	Standard Error 4.37	score

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Double Blind Period	STARTED	Benralizumab	6
Double Blind Period	STARTED	Placebo	6
Double Blind Period	COMPLETED	Benralizumab	6
Double Blind Period	COMPLETED	Placebo	3
Double Blind Period	NOT COMPLETED	Benralizumab	0
Double Blind Period	NOT COMPLETED	Placebo	3
Open Label Extension	STARTED	Benralizumab	6
Open Label Extension	STARTED	Placebo	3
Open Label Extension	COMPLETED	Benralizumab	5
Open Label Extension	COMPLETED	Placebo	2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events120

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	Nausea	Gastrointestinal disorders	Benralizumab	2	6	2
other	Nausea	Gastrointestinal disorders	Placebo	1	6	1
other	Nausea	Gastrointestinal disorders	Open Label Benralizumab	0	9	0
other	Toothache	Gastrointestinal disorders	Benralizumab	1	6	1
other	Toothache	Gastrointestinal disorders	Placebo	0	6	0
other	Toothache	Gastrointestinal disorders	Open Label Benralizumab	0	9	0
other	Vomiting	Gastrointestinal disorders	Benralizumab	0	6	0
other	Vomiting	Gastrointestinal disorders	Placebo	0	6	0
other	Vomiting	Gastrointestinal disorders	Open Label Benralizumab	1	9	1
other	Injection site reaction	General disorders	Benralizumab	1	6	1

1 to 10 of 120Source ClinicalTrials.gov

See all 120 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Benralizumab	0	6
Total, all-cause mortality	Placebo	0	6
Total, all-cause mortality	Open Label Benralizumab	0	9
Total, other adverse events	Benralizumab	6	6
Total, other adverse events	Placebo	3	6
Total, other adverse events	Open Label Benralizumab	6	9
Total, serious adverse events	Benralizumab	0	6
Total, serious adverse events	Placebo	0	6
Total, serious adverse events	Open Label Benralizumab	0	9

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons1

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

Comparison
Benralizumab vs Placebo: Proportion of Patients With a Histologic Response at Week 24

Source Trial comparisons

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/NCT05251909

GET https://conductscience.org/api/trials/v1/NCT05251909/events?page=2

API reference For AI assistants