Benralizumab for Eosinophilic Gastritis (BEGS) (BEGS)
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|ClinicalTrials.gov Identifier: NCT03473977|
Recruitment Status : Active, not recruiting
First Posted : March 22, 2018
Results First Posted : August 17, 2021
Last Update Posted : October 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Gastritis or Gastroenteritis||Biological: Benralizumab Biological: Placebo||Phase 2 Phase 3|
To assess the efficacy of repeat subcutaneous (SC) doses of benralizumab, compared with placebo, to reduce eosinophilic inflammation in the gastrointestinal tract of patients with Eosinophilic Gastritis
To assess changes in endoscopic score, histological features, blood and biopsy eosinophil counts, clinical symptoms, and gastric tissue transcriptome before and after treatment with benralizumab.
26 subjects are planned to be enrolled into the study at Cincinnati Children's Hospital Medical Center. Qualifying Subjects will receive subcutaneous injections every 4 weeks (3 total) of benralizumab/Placebo, followed by optional Open Label Extension periods.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will receive doses of drug or placebo. Optional open label extensions available following the double blind period.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Participant/care providers, investigators, and outcome assessor (pathology) were blinded to assignment. Randomization performed by external investigational pharmacy staff (dispenses the drug/placebo).|
|Official Title:||A Randomized, Double-Blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Benralizumab (Anti-IL5RA) in Subjects With Eosinophilic Gastritis|
|Actual Study Start Date :||April 23, 2018|
|Actual Primary Completion Date :||June 22, 2020|
|Estimated Study Completion Date :||March 30, 2022|
Subcutaneous dose of 30 mg of Benralizumab every 4 weeks
Benralizumab (anti-IL5Ra) will be injected every 4 weeks in doses of 30 mg (total of 3 injections) in subjects with active Eosinophilic Gastritis.
Other Name: Fasenra
Placebo Comparator: Placebo
Subcutaneous dose of Placebo every 4 weeks
Placebo will be injected every 4 weeks (total of 3 injections) as a comparator to Benralizumab in subjects with active Eosinophilic Gastritis.
- Percent of Patients in Histological Remission (<30 Eos/Hpf) [ Time Frame: 12 weeks after start of treatment ]Percent of patients in histologic remission in drug versus placebo groups. Remission is defined as gastric peak eosinophil count < 30 eosinophils per high powered field (eos/hpf).
- Change in Gastric Endoscopic Score (Lanza) [ Time Frame: 12 weeks after start of treatment ]The gastric endoscopic score (Lanza) utilizes standardized criteria for the presence and degree of 5 major endoscopic features (granularity, nodularity, erosion/ulceration, friability, erythema). Total score is the maximum score of the five feature scores from the body, antrum, or fundus. Total scores range from 0 - 14. Change in total endoscopic reference score is defined as post-treatment score minus pre-treatment score. Changes in scores are compared between drug and Placebo. A reduction (negative change) in score indicates improvement.
- Change in Gastric Histology Score [ Time Frame: 12 weeks after start of treatment ]The gastric histology score quantifies inflammatory and structural histologic abnormalities in the stomach. Total score is the sum of features scores divided by the maximum possible score for the biopsy. Features include lamina propria eosinophil sheets, periglandular circumferential collars, eosinophils in surface epithelium, eosinophil glandulitis, eosinophil gland abscesses, eosinophils in muscularis mucosa, lamina propria fibroplasia, lamina propria smooth muscle hyperplasia, reactive epithelial changes, acute inflammatory cells, and surface erosion. Total scores range from 0 - 1. Change in gastric total histology scoring is defined as post-treatment total score minus pretreatment total score. Changes in scores are compared between drug and placebo. A reduction (negative change) in score indicates improvement.
- Change in Blood Eosinophil Count [ Time Frame: 12 weeks after start of treatment ]Change in absolute eosinophil counts (cells per microliter) is defined as post treatment counts minus pre-treatment counts. Changes in counts are compared between drug and Placebo. A decrease in count is expected due to the effects of the drug.
- Change in Eosinophilic Gastritis Diagnostic Panel [ Time Frame: 12 weeks after start of treatment ]The transcriptomic signature of gastric biopsy samples was obtained using real-time polymerase chain reaction amplification on the EG diagnostic panel (EGDP) comprising a set of 48 gastric transcripts. The EGDP value was calculated by summing delta CT (threshold cycle) values of the most highly dysregulated genes. Change is defined as post treatment value minus pre-treatment value. An increase (positive change) indicates improvement (normalization of gene expression).
- Change in Gastric Peak Eosinophil Count [ Time Frame: 12 weeks after starting treatment ]Change in gastric peak eosinophil count is defined as post-treatment peak count minus pre-treatment peak count. Changes in peak count are compared between Drug and Placebo. A reduction (negative change) in peak count indicates improvement.
- Change in Clinical Symptoms [ Time Frame: 12 weeks after start of treatment ]The symptom of dyspepsia (SODA) questionnaire captures symptoms associated with gastric dyspepsia including symptoms associated with "pain" and "non-pain" as well as general "satisfaction" with present symptoms. The scores range from 0 to 47 for pain; 0 to 35 for non-pain, and 0 to 23 for satisfaction. Higher scores indicate more frequent and/or severe symptoms for pain and non-pain. Higher scores indicate greater Satisfaction. Change in score is defined as post-treatment total score minus pre-treatment total score. A reduction (negative change) indicates improvement in pain and non-pain. An increase (positive change) indicates improvement in satisfaction.
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): NCT03473977
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Marc E Rothenberg, MD, PhD||Children's Hospital Medical Center, Cincinnati|