A Phase 3 interventional study of Benralizumab and Placebo in Eosinophilic Gastritis and Eosinophilic Gastroenteritis, sponsored by AstraZeneca. Terminated at 20 sites in 9 countries. Open to participants aged 12 Years to 130 Years. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
This is a 3-part study. Part A is randomized, double-blinded, placebo-controlled and includes patients with eosinophilic gastritis and/or duodenal-only disease. After completing Part A, participants can continue to Part C - open-label benralizumab treatment period. Following the decision to close enrollment, patients in both Part A and Part C will be given the option to proceed to 6-months of open-label benralizumab treatment in Part D.
28 studies on the registry are indexed under Eosinophilic enteropathy; 5 are open to participants now.
This study's enrollment of 12 is below the median of 36 across 16 interventional studies indexed under Eosinophilic enteropathy.
Browse Eosinophilic enteropathy studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm is a subcutaneous dose of Benralizumab
Biological: Benralizumab
This arm is a subcutaneous dose of Placebo
Biological: Placebo
Benralizumab is a humanized, afucosylated, monoclonal antibody that binds specifically to the IL-5Rα on the target cell and thus directly depletes eosinophils through antibody-dependent cell-mediated cytotoxicity. Benralizumab has been widely approved for treatment of asthma.
Also known as: Fasenra
Placebo will be injected as a comparator to injection with Benralizumab to examine effect on both the signs and symptoms of EG/EGE and the underlying eosinophilic inflammation, with dual primary outcome variables
Proportion of Patients With a Histologic Response 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.
Time frame: at week 24
Change From Baseline in SAGED Score 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).
Time frame: at week 24
A total of 34 participants were screened. Of those, 12 participants were randomised to either the treatment (6 participants) or placebo (participants) arms of the double-blinded treatment period.
| Milestone | Benralizumab | Placebo |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 3 |
| Not completed | 0 | 3 |
| Milestone | Benralizumab | Placebo |
|---|---|---|
| Started | 6 | 3 |
| Completed | 5 | 2 |
| Not completed | 1 | 1 |
| Withdrew: Subjects who discontinued treatment with study drug in ole but completed study follow-up | 1 | 1 |
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.
| Participants | Benralizumab | Placebo |
|---|---|---|
| Proportion of Patients With a Histologic Response at Week 24 | 5 | 0 |
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).
| score | Benralizumab | Placebo |
|---|---|---|
| Change From Baseline in SAGED Score at Week 24 | -9.59 ± 7.26 | -13.69 ± 4.37 |
Collected over AEs in the on-study period are defined as those with onset between day of first dose of study treatment and the day of the scheduled follow-up visit, inclusive, approximately up to Week 88.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Benralizumab | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Placebo | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Open Label Benralizumab | 0/9 (0%) | 0/9 (0%) | 6/9 (66.7%) |
| Event | Benralizumab | Placebo | Open Label Benralizumab |
|---|---|---|---|
| NauseaGastrointestinal disorders | 2/6 | 1/6 | 0/9 |
| PyrexiaGeneral disorders | 2/6 | 0/6 | 0/9 |
| COVID-19Infections and infestations | 0/6 | 1/6 | 2/9 |
| Abdominal pain upperGastrointestinal disorders | 1/6 | 0/6 | 2/9 |
| ToothacheGastrointestinal disorders | 1/6 | 0/6 | 0/9 |
| Injection site reactionGeneral disorders | 1/6 | 0/6 | 0/9 |
| BronchitisInfections and infestations | 1/6 | 0/6 | 0/9 |
| Genitourinary tract infectionInfections and infestations | 1/6 | 0/6 | 0/9 |
| AnaemiaBlood and lymphatic system disorders | 1/6 | 0/6 | 0/9 |
| Herpes zosterInfections and infestations | 1/6 | 0/6 | 0/9 |
| Age, Categorical(Participants) | Benralizumab | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 5 | 4 | 9 |
| >=65 years | 1 | 1 | 2 |
| Sex: Female, Male(Participants) | Benralizumab | Placebo | Total |
|---|---|---|---|
| Female | 5 | 1 | 6 |
| Male | 1 | 5 | 6 |
| Race (NIH/OMB)(Participants) | Benralizumab | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 5 | 4 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers can request access to anonymised individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access criteria: When a request has been approved AstraZeneca will provide access to the de- identified individual patient-level data in an approved sponsor tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Data sharing details ↗ · astrazenecagroup-dt.pharmacm.com
This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Benralizumab